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Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

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ClinicalTrials.gov Identifier: NCT02003924
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Results First Posted : July 12, 2018
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nonmetastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Cancer of the Prostate
Interventions Drug: Enzalutamide
Drug: Placebo
Enrollment 1401
Recruitment Details  
Pre-assignment Details The study was conducted at 254 sites in 32 countries. Data reported based on primary analysis date (28 June 2017).
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression. Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Period Title: Overall Study
Started 933 468
Treated 930 465
Completed 0 0
Not Completed 933 468
Reason Not Completed
Ongoing in study             634             176
Disease progression             138             207
Protocol Violation             1             2
Lost to Follow-up             2             1
Other than specified             18             19
Withdrawal by Subject             49             34
Adverse Event             91             29
Arm/Group Title Enzalutamide 160 mg Placebo Total
Hide Arm/Group Description Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression. Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression. Total of all reporting groups
Overall Number of Baseline Participants 933 468 1401
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 933 participants 468 participants 1401 participants
73.8  (7.83) 72.9  (7.63) 73.5  (7.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 933 participants 468 participants 1401 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
933
 100.0%
468
 100.0%
1401
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 933 participants 468 participants 1401 participants
Asian
142
  15.2%
88
  18.8%
230
  16.4%
Black or African American
21
   2.3%
10
   2.1%
31
   2.2%
Native Hawaiian or Other Pacific Islander
3
   0.3%
2
   0.4%
5
   0.4%
White
671
  71.9%
320
  68.4%
991
  70.7%
Multiple
4
   0.4%
4
   0.9%
8
   0.6%
Other
15
   1.6%
5
   1.1%
20
   1.4%
Missing
77
   8.3%
39
   8.3%
116
   8.3%
1.Primary Outcome
Title Metastasis Free Survival (MFS)
Hide Description MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
36.6 [1] 
(33.1 to NA)
14.7
(14.2 to 15.0)
[1]
The upper limit of the 95% CI was not estimable due to the small number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.292
Confidence Interval (2-Sided) 95%
0.241 to 0.352
Estimation Comments HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
2.Secondary Outcome
Title Time to Prostate-Specific Antigen (PSA) Progression
Hide Description Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
37.2 [1] 
(33.1 to NA)
3.9
(3.8 to 4.0)
[1]
The upper limit of the 95% CI was not estimable due to the small number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.066
Confidence Interval (2-Sided) 95%
0.054 to 0.081
Estimation Comments HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
3.Secondary Outcome
Title Time to First Use of New Antineoplastic Therapy
Hide Description Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
39.6 [1] 
(37.7 to NA)
17.7
(16.2 to 19.7)
[1]
The upper limit of the 95% CI was not estimable due to the small number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.208
Confidence Interval (2-Sided) 95%
0.168 to 0.258
Estimation Comments HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization until death or discontinuation from the study whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
OS was not estimable due to the small number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments To maintain family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. OS tested at 0.05 only if both time to PSA progression and time to first use of new antineoplastic therapy were significant. If either of them failed to show significance,OS was tested at 0.03.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1519
Comments P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.795
Confidence Interval (2-Sided) 95%
0.580 to 1.089
Estimation Comments HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
5.Secondary Outcome
Title Time to Pain Progression
Hide Description Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: “Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours.” Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
18.5
(17.0 to 22.1)
18.4
(14.8 to 22.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6534
Comments P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.959
Confidence Interval (2-Sided) 95%
0.801 to 1.149
Estimation Comments HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
6.Secondary Outcome
Title Time to First Use of Cytotoxic Chemotherapy
Hide Description Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(38.1 to NA)
39.7
(38.9 to 41.3)
[1]
The median and upper limit of the 95% CI was not estimable due to the small number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.378
Confidence Interval (2-Sided) 95%
0.282 to 0.507
Estimation Comments HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
7.Secondary Outcome
Title Chemotherapy-Free Disease Specific Survival
Hide Description Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
39.6 [1] 
(37.7 to NA)
38.9
(30.9 to 41.3)
[1]
The upper limit of the 95% CI was not estimable due to the small number of events.
8.Secondary Outcome
Title Chemotherapy-Free Survival
Hide Description Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time Frame From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Median (95% Confidence Interval)
Unit of Measure: months
38.1 [1] 
(37.7 to NA)
34.0
(30.3 to 39.7)
[1]
The upper limit of the 95% CI was not estimable due to the small number of events.
9.Secondary Outcome
Title Percentage of Participants With Prostate Specific Antigen (PSA) Response
Hide Description PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.
Time Frame From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Overall number of participants analyzed’ = participants with baseline and at least one post-baseline PSA assessment.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Decrease from Baseline >= 50%
76.3
(73.5 to 79.0)
2.4
(1.2 to 4.2)
Decrease from Baseline >= 90%
55.9
(52.7 to 59.2)
0.4
(0.1 to 1.5)
Decrease to Undetectable Level
9.6
(7.8 to 11.7)
0
(0 to 0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments Decrease from Baseline >= 50%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rate
Estimated Value 73.96
Confidence Interval (2-Sided) 95%
70.91 to 77.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments Decrease from Baseline >= 90%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rate
Estimated Value 55.52
Confidence Interval (2-Sided) 95%
52.28 to 58.76
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
Comments Decrease to Undetectable Level
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rate
Estimated Value 9.65
Confidence Interval (2-Sided) 95%
7.75 to 11.54
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Hide Description The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 887 participants 439 participants
119.5  (17.75) 120.8  (16.73)
Change at Week 17 Number Analyzed 815 participants 403 participants
-4.0  (14.03) -3.0  (13.87)
Change at Week 33 Number Analyzed 718 participants 329 participants
-4.6  (14.82) -3.5  (13.74)
Change at Week 49 Number Analyzed 621 participants 239 participants
-3.9  (14.70) -5.0  (15.71)
Change at Week 65 Number Analyzed 522 participants 183 participants
-4.0  (15.84) -5.7  (15.04)
Change at Week 81 Number Analyzed 427 participants 139 participants
-4.1  (15.01) -7.5  (16.42)
Change at Week 97 Number Analyzed 354 participants 90 participants
-4.9  (15.31) -5.9  (15.80)
Change at Week 113 Number Analyzed 264 participants 68 participants
-5.5  (16.07) -5.8  (13.16)
Change at Week 129 Number Analyzed 186 participants 37 participants
-6.3  (17.33) -8.1  (13.99)
Change at Week 145 Number Analyzed 109 participants 17 participants
-5.5  (18.75) -9.8  (15.47)
Change at Week 161 Number Analyzed 38 participants 6 participants
-8.9  (19.88) -7.0  (10.95)
Change at Week 177 Number Analyzed 5 participants 1 participants
-4.8  (13.19) -5.0
11.Secondary Outcome
Title Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score
Hide Description EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline-No problem in walking Number Analyzed 884 participants 439 participants
578 298
Baseline-slight problem in walking Number Analyzed 884 participants 439 participants
183 100
Baseline-moderate problem in walking Number Analyzed 884 participants 439 participants
100 33
Baseline-severe problem in walking Number Analyzed 884 participants 439 participants
21 7
Baseline-unable to walk Number Analyzed 884 participants 439 participants
2 1
Week 17-no problem in walking Number Analyzed 840 participants 419 participants
526 274
Week 17-slight problem in walking Number Analyzed 840 participants 419 participants
190 88
Week 17-moderate problem in walking Number Analyzed 840 participants 419 participants
87 50
Week 17-severe problem in walking Number Analyzed 840 participants 419 participants
32 6
Week 17-unable to walk Number Analyzed 840 participants 419 participants
5 1
Week 33-no problem in walking Number Analyzed 738 participants 342 participants
431 223
Week 33-slight problem in walking Number Analyzed 738 participants 342 participants
162 85
Week 33-moderate problem in walking Number Analyzed 738 participants 342 participants
103 24
Week 33-severe problem in walking Number Analyzed 738 participants 342 participants
36 10
Week 33-unable to walk Number Analyzed 738 participants 342 participants
6 0
Week 49-no problem in walking Number Analyzed 635 participants 250 participants
362 156
Week 49-slight problem in walking Number Analyzed 635 participants 250 participants
158 57
Week 49-moderate problem in walking Number Analyzed 635 participants 250 participants
86 27
Week 49-severe problem in walking Number Analyzed 635 participants 250 participants
25 8
Week 49-unable to walk Number Analyzed 635 participants 250 participants
4 2
Week 65-no problem in walking Number Analyzed 536 participants 193 participants
319 121
Week 65-slight problem in walking Number Analyzed 536 participants 193 participants
109 44
Week 65-moderate problem in walking Number Analyzed 536 participants 193 participants
75 22
Week 65-severe problem in walking Number Analyzed 536 participants 193 participants
29 6
Week 65-unable to walk Number Analyzed 536 participants 193 participants
4 0
Week 81-no problem in walking Number Analyzed 435 participants 148 participants
236 88
Week 81-slight problem in walking Number Analyzed 435 participants 148 participants
111 39
Week 81-moderate problem in walking Number Analyzed 435 participants 148 participants
61 15
Week 81-severe problem in walking Number Analyzed 435 participants 148 participants
26 4
Week 81-unable to walk Number Analyzed 435 participants 148 participants
1 2
Week 97-no problem in walking Number Analyzed 365 participants 95 participants
189 59
Week 97-slight problem in walking Number Analyzed 365 participants 95 participants
94 24
Week 97-moderate problem in walking Number Analyzed 365 participants 95 participants
54 8
Week 97-severe problem in walking Number Analyzed 365 participants 95 participants
22 4
Week 97-unable to walk Number Analyzed 365 participants 95 participants
6 0
Week 113-no problem in walking Number Analyzed 275 participants 73 participants
140 45
Week 113-slight problem in walking Number Analyzed 275 participants 73 participants
76 14
Week 113-moderate problem in walking Number Analyzed 275 participants 73 participants
41 11
Week 113-severe problem in walking Number Analyzed 275 participants 73 participants
14 2
Week 113-unable to walk Number Analyzed 275 participants 73 participants
4 1
Week 129-no problem in walking Number Analyzed 193 participants 41 participants
94 26
Week 129-slight problem in walking Number Analyzed 193 participants 41 participants
48 9
Week 129-moderate problem in walking Number Analyzed 193 participants 41 participants
36 5
Week 129-severe problem in walking Number Analyzed 193 participants 41 participants
15 1
Week 129-unable to walk Number Analyzed 193 participants 41 participants
0 0
Week 145-no problem in walking Number Analyzed 116 participants 21 participants
56 13
Week 145-slight problem in walking Number Analyzed 116 participants 21 participants
35 5
Week 145-moderate problem in walking Number Analyzed 116 participants 21 participants
18 2
Week 145-severe problem in walking Number Analyzed 116 participants 21 participants
7 1
Week 145-unable to walk Number Analyzed 116 participants 21 participants
0 0
Week 161-no problem in walking Number Analyzed 40 participants 8 participants
22 2
Week 161-slight problem in walking Number Analyzed 40 participants 8 participants
7 5
Week 161-moderate problem in walking Number Analyzed 40 participants 8 participants
6 1
Week 161-severe problem in walking Number Analyzed 40 participants 8 participants
5 0
Week 161-unable to walk Number Analyzed 40 participants 8 participants
0 0
Week 177-no problem in walking Number Analyzed 6 participants 1 participants
3 0
Week 177-slight problem in walking Number Analyzed 6 participants 1 participants
2 1
Week 177-moderate problem in walking Number Analyzed 6 participants 1 participants
1 0
Week 177-severe problem in walking Number Analyzed 6 participants 1 participants
0 0
Week 177-unable to walk Number Analyzed 6 participants 1 participants
0 0
12.Secondary Outcome
Title Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score
Hide Description EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline:no problems washing or dressing Number Analyzed 884 participants 439 participants
805 415
Baseline:slight problems washing or dressing Number Analyzed 884 participants 439 participants
51 23
Baseline:moderate problems washing or dressing Number Analyzed 884 participants 439 participants
22 1
Baseline:severe problems washing or dressing Number Analyzed 884 participants 439 participants
2 0
Baseline:unable to wash or dress Number Analyzed 884 participants 439 participants
4 0
Week 17:no problems washing or dressing Number Analyzed 840 participants 419 participants
752 388
Week 17:slight problems washing or dressing Number Analyzed 840 participants 419 participants
60 26
Week 17:moderate problems washing or dressing Number Analyzed 840 participants 419 participants
21 5
Week 17:severe problems washing or dressing Number Analyzed 840 participants 419 participants
6 0
Week 17:unable to wash or dress Number Analyzed 840 participants 419 participants
1 0
Week 33:no problems washing or dressing Number Analyzed 738 participants 342 participants
642 310
Week 33:slight problems washing or dressing Number Analyzed 738 participants 342 participants
64 20
Week 33:moderate problems washing or dressing Number Analyzed 738 participants 342 participants
21 10
Week 33:severe problems washing or dressing Number Analyzed 738 participants 342 participants
4 1
Week 33:unable to wash or dress Number Analyzed 738 participants 342 participants
7 1
Week 49:no problems washing or dressing Number Analyzed 635 participants 250 participants
546 230
Week 49:slight problems washing or dressing Number Analyzed 635 participants 250 participants
59 9
Week 49:moderate problems washing or dressing Number Analyzed 635 participants 250 participants
23 7
Week 49:severe problems washing or dressing Number Analyzed 635 participants 250 participants
3 3
Week 49:unable to wash or dress Number Analyzed 635 participants 250 participants
4 1
Week 65:no problems washing or dressing Number Analyzed 536 participants 193 participants
453 179
Week 65:slight problems washing or dressing Number Analyzed 536 participants 193 participants
57 11
Week 65:moderate problems washing or dressing Number Analyzed 536 participants 193 participants
14 3
Week 65:severe problems washing or dressing Number Analyzed 536 participants 193 participants
9 0
Week 65:unable to wash or dress Number Analyzed 536 participants 193 participants
3 0
Week 81:no problems washing or dressing Number Analyzed 435 participants 148 participants
356 132
Week 81:slight problems washing or dressing Number Analyzed 435 participants 148 participants
57 11
Week 81:moderate problems washing or dressing Number Analyzed 435 participants 148 participants
17 3
Week 81:severe problems washing or dressing Number Analyzed 435 participants 148 participants
3 1
Week 81:unable to wash or dress Number Analyzed 435 participants 148 participants
2 1
Week 97:no problems washing or dressing Number Analyzed 365 participants 95 participants
292 85
Week 97:slight problems washing or dressing Number Analyzed 365 participants 95 participants
51 8
Week 97:moderate problems washing or dressing Number Analyzed 365 participants 95 participants
16 2
Week 97:severe problems washing or dressing Number Analyzed 365 participants 95 participants
1 0
Week 97:unable to wash or dress Number Analyzed 365 participants 95 participants
5 0
Week 113:no problems washing or dressing Number Analyzed 275 participants 73 participants
214 60
Week 113:slight problems washing or dressing Number Analyzed 275 participants 73 participants
46 7
Week 113:moderate problems washing or dressing Number Analyzed 275 participants 73 participants
11 5
Week 113:severe problems washing or dressing Number Analyzed 275 participants 73 participants
0 0
Week 113:unable to wash or dress Number Analyzed 275 participants 73 participants
4 1
Week 129:no problems washing or dressing Number Analyzed 193 participants 41 participants
147 35
Week 129:slight problems washing or dressing Number Analyzed 193 participants 41 participants
28 5
Week 129:moderate problems washing or dressing Number Analyzed 193 participants 41 participants
16 1
Week 129:severe problems washing or dressing Number Analyzed 193 participants 41 participants
2 0
Week 129:unable to wash or dress Number Analyzed 193 participants 41 participants
0 0
Week 145:no problems washing or dressing Number Analyzed 116 participants 21 participants
92 15
Week 145:slight problems washing or dressing Number Analyzed 116 participants 21 participants
16 5
Week 145:moderate problems washing or dressing Number Analyzed 116 participants 21 participants
6 0
Week 145:severe problems washing or dressing Number Analyzed 116 participants 21 participants
2 0
Week 145:unable to wash or dress Number Analyzed 116 participants 21 participants
0 1
Week 161:no problems washing or dressing Number Analyzed 40 participants 8 participants
33 7
Week 161:slight problems washing or dressing Number Analyzed 40 participants 8 participants
3 0
Week 161:moderate problems washing or dressing Number Analyzed 40 participants 8 participants
2 1
Week 161:severe problems washing or dressing Number Analyzed 40 participants 8 participants
1 0
Week 161:unable to wash or dress Number Analyzed 40 participants 8 participants
1 0
Week 177:no problems washing or dressing Number Analyzed 6 participants 1 participants
3 1
Week 177:slight problems washing or dressing Number Analyzed 6 participants 1 participants
3 0
Week 177:moderate problems washing or dressing Number Analyzed 6 participants 1 participants
0 0
Week 177:severe problems washing or dressing Number Analyzed 6 participants 1 participants
0 0
Week 171:unable to wash or dress Number Analyzed 6 participants 1 participants
0 0
13.Secondary Outcome
Title Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score
Hide Description EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline:no problems doing usual activities Number Analyzed 884 participants 439 participants
646 356
Baseline:slight problems doing usual activities Number Analyzed 884 participants 439 participants
167 64
Baseline:moderate problems Number Analyzed 884 participants 439 participants
56 14
Baseline:severe problems Number Analyzed 884 participants 439 participants
10 5
Baseline:unable to do usual activities Number Analyzed 884 participants 439 participants
5 0
Week 17:no problems doing usual activities Number Analyzed 840 participants 419 participants
571 305
Week 17:slight problems doing usual activities Number Analyzed 840 participants 419 participants
181 89
Week 17:moderate problems Number Analyzed 840 participants 419 participants
60 24
Week 17:severe problems Number Analyzed 840 participants 419 participants
21 0
Week 17:unable to do usual activities Number Analyzed 840 participants 419 participants
7 1
Week 33:no problems doing usual activities Number Analyzed 738 participants 342 participants
474 249
Week 33:slight problems doing usual activities Number Analyzed 738 participants 342 participants
170 68
Week 33:moderate problems Number Analyzed 738 participants 342 participants
68 18
Week 33:severe problems Number Analyzed 738 participants 342 participants
21 7
Week 33:unable to do usual activities Number Analyzed 738 participants 342 participants
5 0
Week 49:no problems doing usual activities Number Analyzed 635 participants 250 participants
418 185
Week 49:slight problems doing usual activities Number Analyzed 635 participants 250 participants
137 43
Week 49:moderate problems Number Analyzed 635 participants 250 participants
55 14
Week 49:severe problems Number Analyzed 635 participants 250 participants
20 6
Week 49:unable to do usual activities Number Analyzed 635 participants 250 participants
5 2
Week 65:no problems doing usual activities Number Analyzed 536 participants 193 participants
338 136
Week 65:slight problems doing usual activities Number Analyzed 536 participants 193 participants
123 42
Week 65:moderate problems Number Analyzed 536 participants 193 participants
60 11
Week 65:severe problems Number Analyzed 536 participants 193 participants
5 4
Week 65:unable to do usual activities Number Analyzed 536 participants 193 participants
10 0
Week 81:no problems doing usual activities Number Analyzed 435 participants 148 participants
267 106
Week 81:slight problems doing usual activities Number Analyzed 435 participants 148 participants
105 29
Week 81:moderate problems Number Analyzed 435 participants 148 participants
49 7
Week 81:severe problems Number Analyzed 435 participants 148 participants
10 3
Week 81:unable to do usual activities Number Analyzed 435 participants 148 participants
4 3
Week 97:no problems doing usual activities Number Analyzed 365 participants 95 participants
224 69
Week 97:slight problems doing usual activities Number Analyzed 365 participants 95 participants
90 16
Week 97:moderate problems Number Analyzed 365 participants 95 participants
39 8
Week 97:severe problems Number Analyzed 365 participants 95 participants
9 0
Week 97:unable to do usual activities Number Analyzed 365 participants 95 participants
3 2
Week 113:no problems doing usual activities Number Analyzed 275 participants 73 participants
165 47
Week 113:slight problems doing usual activities Number Analyzed 275 participants 73 participants
69 16
Week 113:moderate problems Number Analyzed 275 participants 73 participants
33 6
Week 113:severe problems Number Analyzed 275 participants 73 participants
5 3
Week 113:unable to do usual activities Number Analyzed 275 participants 73 participants
3 1
Week 129: Week :no problems doing usual activities Number Analyzed 193 participants 41 participants
108 30
Week 129 :slight problems doing usual activities Number Analyzed 193 participants 41 participants
56 8
Week 129:moderate problems Number Analyzed 193 participants 41 participants
26 3
Week 129:severe problems Number Analyzed 193 participants 41 participants
3 0
Week 129:unable to do usual activities Number Analyzed 193 participants 41 participants
0 0
Week 145:no problems doing usual activities Number Analyzed 116 participants 21 participants
67 14
Week 145:slight problems doing usual activities Number Analyzed 116 participants 21 participants
35 4
Week 145:moderate problems Number Analyzed 116 participants 21 participants
11 2
Week 145:severe problems Number Analyzed 116 participants 21 participants
3 1
Week 145:unable to do usual activities Number Analyzed 116 participants 21 participants
0 0
Week 161:no problems doing usual activities Number Analyzed 40 participants 8 participants
23 5
Week 161:slight problems doing usual activities Number Analyzed 40 participants 8 participants
9 2
Week 161:moderate problems Number Analyzed 40 participants 8 participants
5 1
Week 161:severe problems Number Analyzed 40 participants 8 participants
2 0
Week 161:unable to do usual activities Number Analyzed 40 participants 8 participants
1 0
Week 177:no problems doing usual activities Number Analyzed 6 participants 1 participants
3 0
Week 177:slight problems doing usual activities Number Analyzed 6 participants 1 participants
2 1
Week 177:moderate problems Number Analyzed 6 participants 1 participants
1 0
Week 177:severe problems Number Analyzed 6 participants 1 participants
0 0
Week 177:unable to do usual activities Number Analyzed 6 participants 1 participants
0 0
14.Secondary Outcome
Title Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score
Hide Description EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline:no pain or discomfort Number Analyzed 884 participants 439 participants
546 292
Baseline:slight pain or discomfort Number Analyzed 884 participants 439 participants
240 117
Baseline:moderate pain or discomfort Number Analyzed 884 participants 439 participants
86 25
Baseline:severe pain or discomfort Number Analyzed 884 participants 439 participants
10 4
Baseline:extreme pain or discomfort Number Analyzed 884 participants 439 participants
2 1
Week 17:no pain or discomfort Number Analyzed 840 participants 419 participants
464 248
Week 17:slight pain or discomfort Number Analyzed 840 participants 419 participants
269 128
Week 17: moderate pain or discomfort Number Analyzed 840 participants 419 participants
92 41
Week 17:severe pain or discomfort Number Analyzed 840 participants 419 participants
13 2
Week 17:extreme pain or discomfort Number Analyzed 840 participants 419 participants
2 0
Week 33:no pain or discomfort Number Analyzed 738 participants 342 participants
405 204
Week 33:slight pain or discomfort Number Analyzed 738 participants 342 participants
237 110
Week 33:moderate pain or discomfort Number Analyzed 738 participants 342 participants
79 21
Week 33:severe pain or discomfort Number Analyzed 738 participants 342 participants
16 7
Week 33:extreme pain or discomfort Number Analyzed 738 participants 342 participants
1 0
Week 49:no pain or discomfort Number Analyzed 635 participants 250 participants
340 134
Week 49:slight pain or discomfort Number Analyzed 635 participants 250 participants
209 82
Week 49:moderate pain or discomfort Number Analyzed 635 participants 250 participants
75 32
Week 49:severe pain or discomfort Number Analyzed 635 participants 250 participants
10 1
Week 49:extreme pain or discomfort Number Analyzed 635 participants 250 participants
1 1
Week 65:no pain or discomfort Number Analyzed 536 participants 193 participants
298 102
Week 65:slight pain or discomfort Number Analyzed 536 participants 193 participants
162 72
Week 65:moderate pain or discomfort Number Analyzed 536 participants 193 participants
61 15
Week 65:severe pain or discomfort Number Analyzed 536 participants 193 participants
11 3
Week 65:extreme pain or discomfort Number Analyzed 536 participants 193 participants
4 1
Week 81:no pain or discomfort Number Analyzed 435 participants 148 participants
231 86
Week 81:slight pain or discomfort Number Analyzed 435 participants 148 participants
133 45
Week 81:moderate pain or discomfort Number Analyzed 435 participants 148 participants
61 13
Week 81 :severe pain or discomfort Number Analyzed 435 participants 148 participants
10 2
Week 81:extreme pain or discomfort Number Analyzed 435 participants 148 participants
0 2
Week 97:no pain or discomfort Number Analyzed 365 participants 95 participants
202 58
Week 97:slight pain or discomfort Number Analyzed 365 participants 95 participants
115 28
Week 97:moderate pain or discomfort Number Analyzed 365 participants 95 participants
43 7
Week 97:severe pain or discomfort Number Analyzed 365 participants 95 participants
5 2
Week 97:extreme pain or discomfort Number Analyzed 365 participants 95 participants
0 0
Week 113:no pain or discomfort Number Analyzed 275 participants 73 participants
152 47
Week 113:slight pain or discomfort Number Analyzed 275 participants 73 participants
80 19
Week 113:moderate pain or discomfort Number Analyzed 275 participants 73 participants
37 5
Week 113:severe pain or discomfort Number Analyzed 275 participants 73 participants
6 2
Week 113:extreme pain or discomfort Number Analyzed 275 participants 73 participants
0 0
Week 129:no pain or discomfort Number Analyzed 193 participants 41 participants
108 27
Week 129:slight pain or discomfort Number Analyzed 193 participants 41 participants
55 11
Week 129:moderate pain or discomfort Number Analyzed 193 participants 41 participants
28 3
Week 129:severe pain or discomfort Number Analyzed 193 participants 41 participants
2 0
Week 129:extreme pain or discomfort Number Analyzed 193 participants 41 participants
0 0
Week 145:no pain or discomfort Number Analyzed 116 participants 21 participants
62 12
Week 145:slight pain or discomfort Number Analyzed 116 participants 21 participants
38 8
Week 145:moderate pain or discomfort Number Analyzed 116 participants 21 participants
15 1
Week 145:severe pain or discomfort Number Analyzed 116 participants 21 participants
1 0
Week 145:extreme pain or discomfort Number Analyzed 116 participants 21 participants
0 0
Week 161:no pain or discomfort Number Analyzed 40 participants 8 participants
24 2
Week 161:slight pain or discomfort Number Analyzed 40 participants 8 participants
8 5
Week 161:moderate pain or discomfort Number Analyzed 40 participants 8 participants
5 1
Week 161:severe pain or discomfort Number Analyzed 40 participants 8 participants
3 0
Week 161:extreme pain or discomfort Number Analyzed 40 participants 8 participants
0 0
Week 177:no pain or discomfort Number Analyzed 6 participants 1 participants
3 0
Week 177:slight pain or discomfort Number Analyzed 6 participants 1 participants
1 1
Week 177:moderate pain or discomfort Number Analyzed 6 participants 1 participants
2 0
Week 177:severe pain or discomfort Number Analyzed 6 participants 1 participants
0 0
Week 177:extreme pain or discomfort Number Analyzed 6 participants 1 participants
0 0
15.Secondary Outcome
Title Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score
Hide Description EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline:not anxious or depressed Number Analyzed 884 participants 439 participants
595 310
Baseline:slightly anxious or depressed Number Analyzed 884 participants 439 participants
231 100
Baseline:moderately anxious or depressed Number Analyzed 884 participants 439 participants
51 24
Baseline:severely anxious or depressed Number Analyzed 884 participants 439 participants
6 5
Baseline:extremely anxious or depressed Number Analyzed 884 participants 439 participants
1 0
Week 17:not anxious or depressed Number Analyzed 840 participants 419 participants
517 265
Week 17:slightly anxious or depressed Number Analyzed 840 participants 419 participants
251 119
Week 17:moderately anxious or depressed Number Analyzed 840 participants 419 participants
62 31
Week 17:severely anxious or depressed Number Analyzed 840 participants 419 participants
7 4
Week 17:extremely anxious or depressed Number Analyzed 840 participants 419 participants
3 0
Week 33:not anxious or depressed Number Analyzed 738 participants 342 participants
458 223
Week 33:slightly anxious or depressed Number Analyzed 738 participants 342 participants
208 89
Week 33:moderately anxious or depressed Number Analyzed 738 participants 342 participants
61 23
Week 33:severely anxious or depressed Number Analyzed 738 participants 342 participants
9 5
Week 33:extremely anxious or depressed Number Analyzed 738 participants 342 participants
2 2
Week 49:not anxious or depressed Number Analyzed 635 participants 250 participants
410 155
Week 49:slightly anxious or depressed Number Analyzed 635 participants 250 participants
172 72
Week 49:moderately anxious or depressed Number Analyzed 635 participants 250 participants
41 20
Week 49:severely anxious or depressed Number Analyzed 635 participants 250 participants
8 2
Week 49:extremely anxious or depressed Number Analyzed 635 participants 250 participants
4 1
Week 65:not anxious or depressed Number Analyzed 536 participants 193 participants
336 128
Week 65:slightly anxious or depressed Number Analyzed 536 participants 193 participants
149 56
Week 65:moderately anxious or depressed Number Analyzed 536 participants 193 participants
43 8
Week 65:severely anxious or depressed Number Analyzed 536 participants 193 participants
8 1
Week 65:extremely anxious or depressed Number Analyzed 536 participants 193 participants
0 0
Week 81:not anxious or depressed Number Analyzed 435 participants 148 participants
288 86
Week 81:slightly anxious or depressed Number Analyzed 435 participants 148 participants
106 48
Week 81:moderately anxious or depressed Number Analyzed 435 participants 148 participants
34 9
Week 81:severely anxious or depressed Number Analyzed 435 participants 148 participants
7 3
Week 81:extremely anxious or depressed Number Analyzed 435 participants 148 participants
0 2
Week 97:not anxious or depressed Number Analyzed 365 participants 95 participants
220 61
Week 97:slightly anxious or depressed Number Analyzed 365 participants 95 participants
114 27
Week 97:moderately anxious or depressed Number Analyzed 365 participants 95 participants
26 6
Week 97:severely anxious or depressed Number Analyzed 365 participants 95 participants
4 0
Week 97:extremely anxious or depressed Number Analyzed 365 participants 95 participants
1 1
Week 113:not anxious or depressed Number Analyzed 275 participants 73 participants
167 43
Week 113:slightly anxious or depressed Number Analyzed 275 participants 73 participants
87 27
Week 113:moderately anxious or depressed Number Analyzed 275 participants 73 participants
18 3
Week 113:severely anxious or depressed Number Analyzed 275 participants 73 participants
3 0
Week 113:extremely anxious or depressed Number Analyzed 275 participants 73 participants
0 0
Week 129:not anxious or depressed Number Analyzed 193 participants 41 participants
121 28
Week 129:slightly anxious or depressed Number Analyzed 193 participants 41 participants
51 10
Week 129:moderately anxious or depressed Number Analyzed 193 participants 41 participants
18 2
Week 129:severely anxious or depressed Number Analyzed 193 participants 41 participants
2 1
Week 129:extremely anxious or depressed Number Analyzed 193 participants 41 participants
1 0
Week 145:not anxious or depressed Number Analyzed 116 participants 21 participants
73 12
Week 145:slightly anxious or depressed Number Analyzed 116 participants 21 participants
30 8
Week 145:moderately anxious or depressed Number Analyzed 116 participants 21 participants
10 1
Week 145:severely anxious or depressed Number Analyzed 116 participants 21 participants
2 0
Week 145:extremely anxious or depressed Number Analyzed 116 participants 21 participants
1 0
Week 161:not anxious or depressed Number Analyzed 40 participants 8 participants
23 3
Week 161:slightly anxious or depressed Number Analyzed 40 participants 8 participants
16 4
Week 161:moderately anxious or depressed Number Analyzed 40 participants 8 participants
0 1
Week 161:severely anxious or depressed Number Analyzed 40 participants 8 participants
0 0
Week 161:extremely anxious or depressed Number Analyzed 40 participants 8 participants
1 0
Week 177:not anxious or depressed Number Analyzed 933 participants 1 participants
2 1
Week 177:slightly anxious or depressed Number Analyzed 6 participants 1 participants
2 0
Week 177:moderately anxious or depressed Number Analyzed 6 participants 1 participants
2 0
Week 177:severely anxious or depressed Number Analyzed 6 participants 1 participants
0 0
Week 177:extremely anxious or depressed Number Analyzed 6 participants 1 participants
0 0
16.Secondary Outcome
Title European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
Hide Description EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant’s self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 884 participants 439 participants
76.2  (16.92) 77.5  (15.97)
Week 17 Number Analyzed 840 participants 419 participants
74.7  (17.19) 74.9  (16.79)
Week 33 Number Analyzed 738 participants 342 participants
74.6  (16.69) 74.0  (17.51)
Week 49 Number Analyzed 635 participants 250 participants
74.7  (18.02) 73.7  (18.28)
Week 65 Number Analyzed 536 participants 193 participants
74.5  (17.79) 73.0  (17.11)
Week 81 Number Analyzed 435 participants 148 participants
75.5  (17.06) 73.3  (16.82)
Week 97 Number Analyzed 365 participants 95 participants
74.4  (17.39) 75.2  (17.88)
Week 113 Number Analyzed 275 participants 73 participants
73.6  (18.05) 74.7  (15.06)
Week 129 Number Analyzed 193 participants 41 participants
72.8  (18.25) 77.1  (12.83)
Week 145 Number Analyzed 116 participants 21 participants
75.3  (17.02) 74.2  (18.13)
Week 161 Number Analyzed 40 participants 8 participants
74.6  (21.28) 73.8  (17.60)
Week 177 Number Analyzed 6 participants 1 participants
74.5  (19.31) 69.0
17.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: “Have you had to urinate frequently during the day?”
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 884 participants 439 participants
285 162
Baseline: a little Number Analyzed 884 participants 439 participants
348 160
Baseline: quite a bit Number Analyzed 884 participants 439 participants
207 92
Baseline: very much Number Analyzed 884 participants 439 participants
44 25
Baseline: not answered Number Analyzed 884 participants 439 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
275 134
Week 17: a little Number Analyzed 839 participants 419 participants
324 168
Week 17: quite a bit Number Analyzed 839 participants 419 participants
194 90
Week 17: very much Number Analyzed 839 participants 419 participants
46 27
Week 17: not answered Number Analyzed 839 participants 419 participants
0 0
Week 33: not at all Number Analyzed 737 participants 341 participants
236 105
Week 33: a little Number Analyzed 737 participants 341 participants
285 145
Week 33: quite a bit Number Analyzed 737 participants 341 participants
176 70
Week 33: very much Number Analyzed 737 participants 341 participants
40 21
Week 33: not answered Number Analyzed 737 participants 341 participants
0 0
Week 49: not at all Number Analyzed 635 participants 250 participants
200 82
Week 49: a little Number Analyzed 635 participants 250 participants
260 92
Week 49: quite a bit Number Analyzed 635 participants 250 participants
148 67
Week 49: very much Number Analyzed 635 participants 250 participants
27 9
Week 49: not answered Number Analyzed 635 participants 250 participants
0 0
Week 65: not at all Number Analyzed 536 participants 193 participants
172 54
Week 65: a little Number Analyzed 536 participants 193 participants
209 79
Week 65: quite a bit Number Analyzed 536 participants 193 participants
125 48
Week 65: very much Number Analyzed 536 participants 193 participants
30 12
Week 65: not answered Number Analyzed 536 participants 193 participants
0 0
Week 81: not at all Number Analyzed 434 participants 148 participants
141 46
Week 81: a little Number Analyzed 434 participants 148 participants
181 60
Week 81: quite a bit Number Analyzed 434 participants 148 participants
92 31
Week 81: very much Number Analyzed 434 participants 148 participants
20 11
Week 81: not answered Number Analyzed 434 participants 148 participants
0 0
Week 97: not at all Number Analyzed 365 participants 95 participants
118 33
Week 97: a little Number Analyzed 365 participants 95 participants
146 40
Week 97: quite a bit Number Analyzed 365 participants 95 participants
80 19
Week 97: very much Number Analyzed 365 participants 95 participants
21 3
Week 97: not answered Number Analyzed 365 participants 95 participants
0 0
Week 113: not at all Number Analyzed 275 participants 73 participants
101 17
Week 113: a little Number Analyzed 275 participants 73 participants
112 40
Week 113: quite a bit Number Analyzed 275 participants 73 participants
46 14
Week 113: very much Number Analyzed 275 participants 73 participants
16 2
Week 113: not answered Number Analyzed 275 participants 73 participants
0 0
Week 129: not at all Number Analyzed 192 participants 41 participants
70 11
Week 129: a little Number Analyzed 192 participants 41 participants
79 16
Week 129: quite a bit Number Analyzed 192 participants 41 participants
39 10
Week 129: very much Number Analyzed 192 participants 41 participants
4 4
Week 129: not answered Number Analyzed 192 participants 41 participants
0 0
Week 145: not at all Number Analyzed 116 participants 21 participants
42 2
Week 145: a little Number Analyzed 116 participants 21 participants
51 14
Week 145: quite a bit Number Analyzed 116 participants 21 participants
20 4
Week 145: very much Number Analyzed 116 participants 21 participants
3 1
Week 145: not answered Number Analyzed 116 participants 21 participants
0 0
Week 161: not at all Number Analyzed 40 participants 8 participants
9 2
Week 161: a little Number Analyzed 40 participants 8 participants
20 4
Week 161: quite a bit Number Analyzed 40 participants 8 participants
7 1
Week 161: very much Number Analyzed 40 participants 8 participants
4 1
Week 161: not answered Number Analyzed 40 participants 8 participants
0 0
Week 177: not at all Number Analyzed 6 participants 1 participants
0 0
Week 177: a little Number Analyzed 6 participants 1 participants
4 1
Week 177: quite a bit Number Analyzed 6 participants 1 participants
2 0
Week 177: very much Number Analyzed 6 participants 1 participants
0 0
Week 177: not answered Number Analyzed 6 participants 1 participants
0 0
18.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: “Have you had to urinate frequently at night?”
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 884 participants 439 participants
193 108
Baseline: a little Number Analyzed 884 participants 439 participants
423 195
Baseline: quite a bit Number Analyzed 884 participants 439 participants
200 103
Baseline: very much Number Analyzed 884 participants 439 participants
68 33
Baseline: not answered Number Analyzed 884 participants 439 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
194 88
Week 17: a little Number Analyzed 839 participants 419 participants
407 199
Week 17: quite a bit Number Analyzed 839 participants 419 participants
184 98
Week 17: very much Number Analyzed 839 participants 419 participants
54 34
Week 17: not answered Number Analyzed 839 participants 419 participants
0 0
Week 33: not at all Number Analyzed 737 participants 341 participants
173 83
Week 33: a little Number Analyzed 737 participants 341 participants
351 161
Week 33: quite a bit Number Analyzed 737 participants 341 participants
169 69
Week 33: very much Number Analyzed 737 participants 341 participants
44 28
Week 33: not answered Number Analyzed 737 participants 341 participants
0 0
Week 49: not at all Number Analyzed 635 participants 250 participants
148 59
Week 49: a little Number Analyzed 635 participants 250 participants
313 116
Week 49: quite a bit Number Analyzed 635 participants 250 participants
141 59
Week 49: very much Number Analyzed 635 participants 250 participants
33 16
Week 49: not answered Number Analyzed 635 participants 250 participants
0 0
Week 65: not at all Number Analyzed 536 participants 193 participants
118 41
Week 65: a little Number Analyzed 536 participants 193 participants
266 89
Week 65: quite a bit Number Analyzed 536 participants 193 participants
111 48
Week 65: very much Number Analyzed 536 participants 193 participants
41 15
Week 65: not answered Number Analyzed 536 participants 193 participants
0 0
Week 81: not at all Number Analyzed 434 participants 148 participants
91 38
Week 81: a little Number Analyzed 434 participants 148 participants
231 60
Week 81: quite a bit Number Analyzed 434 participants 148 participants
89 38
Week 81: very much Number Analyzed 434 participants 148 participants
23 12
Week 81: not answered Number Analyzed 434 participants 148 participants
0 0
Week 97: not at all Number Analyzed 365 participants 95 participants
88 19
Week 97: a little Number Analyzed 365 participants 95 participants
169 53
Week 97: quite a bit Number Analyzed 365 participants 95 participants
82 19
Week 97: very much Number Analyzed 365 participants 95 participants
26 4
Week 97: not answered Number Analyzed 365 participants 95 participants
0 0
Week 113: not at all Number Analyzed 275 participants 73 participants
67 16
Week 113: a little Number Analyzed 275 participants 73 participants
137 32
Week 113: quite a bit Number Analyzed 275 participants 73 participants
54 23
Week 113: very much Number Analyzed 275 participants 73 participants
17 2
Week 113: not answered Number Analyzed 275 participants 73 participants
0 0
Week 129: not at all Number Analyzed 192 participants 41 participants
50 9
Week 129: a little Number Analyzed 192 participants 41 participants
97 18
Week 129: quite a bit Number Analyzed 192 participants 41 participants
37 10
Week 129: very much Number Analyzed 192 participants 41 participants
8 4
Week 129: not answered Number Analyzed 192 participants 41 participants
0 0
Week 145: not at all Number Analyzed 116 participants 21 participants
31 2
Week 145: a little Number Analyzed 116 participants 21 participants
59 14
Week 145: quite a bit Number Analyzed 116 participants 21 participants
24 5
Week 145: very much Number Analyzed 116 participants 21 participants
2 0
Week 145: not answered Number Analyzed 116 participants 21 participants
0 0
Week 161: not at all Number Analyzed 40 participants 8 participants
9 0
Week 161: a little Number Analyzed 40 participants 8 participants
23 7
Week 161: quite a bit Number Analyzed 40 participants 8 participants
5 0
Week 161: very much Number Analyzed 40 participants 8 participants
3 1
Week 161: not answered Number Analyzed 40 participants 8 participants
0 0
Week 177: not at all Number Analyzed 6 participants 1 participants
2 0
Week 177: a little Number Analyzed 6 participants 1 participants
2 1
Week 177: quite a bit Number Analyzed 6 participants 1 participants
2 0
Week 177: very much Number Analyzed 6 participants 1 participants
0 0
Week 177: not answered Number Analyzed 6 participants 1 participants
0 0
19.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: “When you felt the urge to pass urine, did you have to hurry to get to the toilet?”
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 884 participants 439 participants
406 197
Baseline: a little Number Analyzed 884 participants 439 participants
266 147
Baseline: quite a bit Number Analyzed 884 participants 439 participants
150 70
Baseline: very much Number Analyzed 884 participants 439 participants
62 25
Baseline: not answered Number Analyzed 884 participants 439 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
350 191
Week 17: a little Number Analyzed 839 participants 419 participants
297 150
Week 17: quite a bit Number Analyzed 839 participants 419 participants
127 55
Week 17: very much Number Analyzed 839 participants 419 participants
65 23
Week 17: not answered Number Analyzed 839 participants 419 participants
0 0
Week 33: not at all Number Analyzed 737 participants 341 participants
279 147
Week 33: a little Number Analyzed 737 participants 341 participants
278 126
Week 33: quite a bit Number Analyzed 737 participants 341 participants
126 48
Week 33: very much Number Analyzed 737 participants 341 participants
54 20
Week 33: not answered Number Analyzed 737 participants 341 participants
0 0
Week 49: not at all Number Analyzed 635 participants 250 participants
272 100
Week 49: a little Number Analyzed 635 participants 250 participants
222 95
Week 49: quite a bit Number Analyzed 635 participants 250 participants
96 38
Week 49: very much Number Analyzed 635 participants 250 participants
45 17
Week 49: not answered Number Analyzed 635 participants 250 participants
0 0
Week 65: not at all Number Analyzed 536 participants 193 participants
213 76
Week 65: a little Number Analyzed 536 participants 193 participants
213 72
Week 65: quite a bit Number Analyzed 536 participants 193 participants
71 31
Week 65: very much Number Analyzed 536 participants 193 participants
39 14
Week 65: not answered Number Analyzed 536 participants 193 participants
0 0
Week 81: not at all Number Analyzed 434 participants 148 participants
181 63
Week 81: a little Number Analyzed 434 participants 148 participants
157 52
Week 81: quite a bit Number Analyzed 434 participants 148 participants
69 27
Week 81: very much Number Analyzed 434 participants 148 participants
27 6
Week 81: not answered Number Analyzed 434 participants 148 participants
0 0
Week 97: not at all Number Analyzed 365 participants 95 participants
146 40
Week 97: a little Number Analyzed 365 participants 95 participants
131 40
Week 97: quite a bit Number Analyzed 365 participants 95 participants
59 12
Week 97: very much Number Analyzed 365 participants 95 participants
29 3
Week 97: not answered Number Analyzed 365 participants 95 participants
0 0
Week 113: not at all Number Analyzed 275 participants 73 participants
114 29
Week 113: a little Number Analyzed 275 participants 73 participants
106 34
Week 113: quite a bit Number Analyzed 275 participants 73 participants
40 9
Week 113: very much Number Analyzed 275 participants 73 participants
15 1
Week 113: not answered Number Analyzed 275 participants 73 participants
0 0
Week 129: not at all Number Analyzed 192 participants 41 participants
86 10
Week 129: a little Number Analyzed 192 participants 41 participants
72 21
Week 129: quite a bit Number Analyzed 192 participants 41 participants
26 6
Week 129: very much Number Analyzed 192 participants 41 participants
8 4
Week 129: not answered Number Analyzed 192 participants 41 participants
0 0
Week 145: not at all Number Analyzed 116 participants 21 participants
51 5
Week 145: a little Number Analyzed 116 participants 21 participants
39 12
Week 145: quite a bit Number Analyzed 116 participants 21 participants
21 4
Week 145: very much Number Analyzed 116 participants 21 participants
5 0
Week 145: not answered Number Analyzed 116 participants 21 participants
0 0
Week 161: not at all Number Analyzed 40 participants 8 participants
17 0
Week 161: a little Number Analyzed 40 participants 8 participants
19 5
Week 161: quite a bit Number Analyzed 40 participants 8 participants
3 3
Week 161: very much Number Analyzed 40 participants 8 participants
1 0
Week 161: not answered Number Analyzed 40 participants 8 participants
0 0
Week 177: not at all Number Analyzed 6 participants 1 participants
2 0
Week 177: a little Number Analyzed 6 participants 1 participants
1 1
Week 177: quite a bit Number Analyzed 6 participants 1 participants
3 0
Week 177: very much Number Analyzed 6 participants 1 participants
0 0
Week 177: not answered Number Analyzed 6 participants 1 participants
0 0
20.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: “Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?”
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 884 participants 439 participants
479 235
Baseline: a little Number Analyzed 884 participants 439 participants
273 146
Baseline: quite a bit Number Analyzed 884 participants 439 participants
93 40
Baseline: very much Number Analyzed 884 participants 439 participants
39 18
Baseline: not answered Number Analyzed 884 participants 439 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
437 214
Week 17: a little Number Analyzed 839 participants 419 participants
295 144
Week 17: quite a bit Number Analyzed 839 participants 419 participants
75 45
Week 17: very much Number Analyzed 839 participants 419 participants
32 16
Week 17: not answered Number Analyzed 839 participants 419 participants
0 0
Week 33: not at all Number Analyzed 737 participants 341 participants
392 180
Week 33: a little Number Analyzed 737 participants 341 participants
246 112
Week 33: quite a bit Number Analyzed 737 participants 341 participants
75 33
Week 33: very much Number Analyzed 737 participants 341 participants
24 16
Week 33: not answered Number Analyzed 737 participants 341 participants
0 0
Week 49: not at all Number Analyzed 635 participants 250 participants
340 119
Week 49: a little Number Analyzed 635 participants 250 participants
211 94
Week 49: quite a bit Number Analyzed 635 participants 250 participants
65 28
Week 49: very much Number Analyzed 635 participants 250 participants
19 9
Week 49: not answered Number Analyzed 635 participants 250 participants
0 0
Week 65: not at all Number Analyzed 536 participants 193 participants
286 92
Week 65: a little Number Analyzed 536 participants 193 participants
183 67
Week 65: quite a bit Number Analyzed 536 participants 193 participants
47 29
Week 65: very much Number Analyzed 536 participants 193 participants
20 5
Week 65: not answered Number Analyzed 536 participants 193 participants
0 0
Week 81: not at all Number Analyzed 434 participants 148 participants
221 70
Week 81: a little Number Analyzed 434 participants 148 participants
165 55
Week 81: quite a bit Number Analyzed 434 participants 148 participants
37 18
Week 81: very much Number Analyzed 434 participants 148 participants
11 5
Week 81: not answered Number Analyzed 434 participants 148 participants
0 0
Week 97: not at all Number Analyzed 365 participants 95 participants
185 47
Week 97: a little Number Analyzed 365 participants 95 participants
122 33
Week 97: quite a bit Number Analyzed 365 participants 95 participants
43 14
Week 97: very much Number Analyzed 365 participants 95 participants
15 1
Week 97: not answered Number Analyzed 365 participants 95 participants
0 0
Week 113: not at all Number Analyzed 275 participants 73 participants
135 31
Week 113: a little Number Analyzed 275 participants 73 participants
102 33
Week 113: quite a bit Number Analyzed 275 participants 73 participants
29 7
Week 113: very much Number Analyzed 275 participants 73 participants
9 2
Week 113: not answered Number Analyzed 275 participants 73 participants
0 0
Week 129: not at all Number Analyzed 192 participants 41 participants
103 13
Week 129: a little Number Analyzed 192 participants 41 participants
67 23
Week 129: quite a bit Number Analyzed 192 participants 41 participants
19 4
Week 129: very much Number Analyzed 192 participants 41 participants
3 1
Week 129: not answered Number Analyzed 192 participants 41 participants
0 0
Week 145: not at all Number Analyzed 116 participants 21 participants
59 9
Week 145: a little Number Analyzed 116 participants 21 participants
44 10
Week 145: quite a bit Number Analyzed 116 participants 21 participants
11 1
Week 145: very much Number Analyzed 116 participants 21 participants
2 1
Week 145: not answered Number Analyzed 116 participants 21 participants
0 0
Week 161: not at all Number Analyzed 40 participants 8 participants
21 2
Week 161: a little Number Analyzed 40 participants 8 participants
16 5
Week 161: quite a bit Number Analyzed 40 participants 8 participants
3 0
Week 161: very much Number Analyzed 40 participants 8 participants
0 1
Week 161: not answered Number Analyzed 40 participants 8 participants
0 0
Week 177: not at all Number Analyzed 6 participants 1 participants
3 0
Week 177: a little Number Analyzed 6 participants 1 participants
1 1
Week 177: quite a bit Number Analyzed 6 participants 1 participants
2 0
Week 177: very much Number Analyzed 6 participants 1 participants
0 0
Week 177: not answered Number Analyzed 6 participants 1 participants
0 0
21.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: “Have you had difficulty going out of the house because you needed to be close to a toilet?”
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 884 participants 439 participants
646 330
Baseline: a little Number Analyzed 884 participants 439 participants
177 84
Baseline: quite a bit Number Analyzed 884 participants 439 participants
45 18
Baseline: very much Number Analyzed 884 participants 439 participants
16 7
Baseline: not answered Number Analyzed 884 participants 439 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
604 295
Week 17: a little Number Analyzed 839 participants 419 participants
174 100
Week 17: quite a bit Number Analyzed 839 participants 419 participants
46 15
Week 17: very much Number Analyzed 839 participants 419 participants
15 9
Week 17: not answered Number Analyzed 839 participants 419 participants
0 0
Week 33: not at all Number Analyzed 737 participants 341 participants
501 242
Week 33: a little Number Analyzed 737 participants 341 participants
171 74
Week 33: quite a bit Number Analyzed 737 participants 341 participants
50 20
Week 33: very much Number Analyzed 737 participants 341 participants
15 5
Week 33: not answered Number Analyzed 737 participants 341 participants
0 0
Week 49: not at all Number Analyzed 635 participants 250 participants
436 174
Week 49: a little Number Analyzed 635 participants 250 participants
153 53
Week 49: quite a bit Number Analyzed 635 participants 250 participants
38 20
Week 49: very much Number Analyzed 635 participants 250 participants
8 3
Week 49: not answered Number Analyzed 635 participants 250 participants
0 0
Week 65: not at all Number Analyzed 536 participants 193 participants
369 132
Week 65: a little Number Analyzed 536 participants 193 participants
125 50
Week 65: quite a bit Number Analyzed 536 participants 193 participants
28 9
Week 65: very much Number Analyzed 536 participants 193 participants
14 2
Week 65: not answered Number Analyzed 536 participants 193 participants
0 0
Week 81: not at all Number Analyzed 434 participants 148 participants
308 105
Week 81: a little Number Analyzed 434 participants 148 participants
94 35
Week 81: quite a bit Number Analyzed 434 participants 148 participants
23 8
Week 81: very much Number Analyzed 434 participants 148 participants
9 0
Week 81: not answered Number Analyzed 434 participants 148 participants
0 0
Week 97: not at all Number Analyzed 365 participants 95 participants
241 67
Week 97: a little Number Analyzed 365 participants 95 participants
91 21
Week 97: quite a bit Number Analyzed 365 participants 95 participants
26 6
Week 97: very much Number Analyzed 365 participants 95 participants
7 1
Week 97: not answered Number Analyzed 365 participants 95 participants
0 0
Week 113: not at all Number Analyzed 275 participants 73 participants
180 47
Week 113: a little Number Analyzed 275 participants 73 participants
70 21
Week 113: quite a bit Number Analyzed 275 participants 73 participants
18 5
Week 113: very much Number Analyzed 275 participants 73 participants
7 0
Week 113: not answered Number Analyzed 275 participants 73 participants
0 0
Week 129: not at all Number Analyzed 192 participants 41 participants
131 26
Week 129: a little Number Analyzed 192 participants 41 participants
48 13
Week 129: quite a bit Number Analyzed 192 participants 41 participants
8 1
Week 129: very much Number Analyzed 192 participants 41 participants
5 1
Week 129: not answered Number Analyzed 192 participants 41 participants
0 0
Week 145: not at all Number Analyzed 116 participants 21 participants
74 13
Week 145: a little Number Analyzed 116 participants 21 participants
36 6
Week 145: quite a bit Number Analyzed 116 participants 21 participants
6 0
Week 145: very much Number Analyzed 116 participants 21 participants
0 2
Week 145: not answered Number Analyzed 116 participants 21 participants
0 0
Week 161: not at all Number Analyzed 40 participants 8 participants
24 4
Week 161: a little Number Analyzed 40 participants 8 participants
13 4
Week 161: quite a bit Number Analyzed 40 participants 8 participants
3 0
Week 161: very much Number Analyzed 40 participants 8 participants
0 0
Week 161: not answered Number Analyzed 40 participants 8 participants
0 0
Week 177: not at all Number Analyzed 6 participants 1 participants
3 0
Week 177: a little Number Analyzed 6 participants 1 participants
3 1
Week 177: quite a bit Number Analyzed 6 participants 1 participants
0 0
Week 177: very much Number Analyzed 6 participants 1 participants
0 0
Week 177: not answered Number Analyzed 6 participants 1 participants
0 0
22.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: “Have you had any unintentional release (leakage) of urine?”
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 884 participants 439 participants
550 283
Baseline: a little Number Analyzed 884 participants 439 participants
273 124
Baseline: quite a bit Number Analyzed 884 participants 439 participants
36 20
Baseline: very much Number Analyzed 884 participants 439 participants
25 12
Baseline: not answered Number Analyzed 884 participants 439 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
511 255
Week 17: a little Number Analyzed 839 participants 419 participants
264 126
Week 17: quite a bit Number Analyzed 839 participants 419 participants
39 27
Week 17: very much Number Analyzed 839 participants 419 participants
25 11
Week 17: not answered Number Analyzed 839 participants 419 participants
0 0
Week 33: not at all Number Analyzed 737 participants 341 participants
428 208
Week 33: a little Number Analyzed 737 participants 341 participants
246 104
Week 33: quite a bit Number Analyzed 737 participants 341 participants
34 19
Week 33: very much Number Analyzed 737 participants 341 participants
29 10
Week 33: not answered Number Analyzed 737 participants 341 participants
0 0
Week 49: not at all Number Analyzed 635 participants 250 participants
369 146
Week 49: a little Number Analyzed 635 participants 250 participants
209 78
Week 49: quite a bit Number Analyzed 635 participants 250 participants
41 22
Week 49: very much Number Analyzed 635 participants 250 participants
16 4
Week 49: not answered Number Analyzed 635 participants 250 participants
0 0
Week 65: not at all Number Analyzed 536 participants 193 participants
307 115
Week 65: a little Number Analyzed 536 participants 193 participants
170 66
Week 65: quite a bit Number Analyzed 536 participants 193 participants
47 8
Week 65: very much Number Analyzed 536 participants 193 participants
12 4
Week 65: not answered Number Analyzed 536 participants 193 participants
0 0
Week 81: not at all Number Analyzed 434 participants 148 participants
248 93
Week 81: a little Number Analyzed 434 participants 148 participants
158 41
Week 81: quite a bit Number Analyzed 434 participants 148 participants
23 11
Week 81: very much Number Analyzed 434 participants 148 participants
5 3
Week 81: not answered Number Analyzed 434 participants 148 participants
0 0
Week 97: not at all Number Analyzed 365 participants 95 participants
195 55
Week 97: a little Number Analyzed 365 participants 95 participants
134 33
Week 97: quite a bit Number Analyzed 365 participants 95 participants
25 7
Week 97: very much Number Analyzed 365 participants 95 participants
11 0
Week 97: not answered Number Analyzed 365 participants 95 participants
0 0
Week 113: not at all Number Analyzed 275 participants 73 participants
160 42
Week 113: a little Number Analyzed 275 participants 73 participants
91 28
Week 113: quite a bit Number Analyzed 275 participants 73 participants
17 3
Week 113: very much Number Analyzed 275 participants 73 participants
7 0
Week 113: not answered Number Analyzed 275 participants 73 participants
0 0
Week 129: not at all Number Analyzed 192 participants 41 participants
109 22
Week 129: a little Number Analyzed 192 participants 41 participants
68 13
Week 129: quite a bit Number Analyzed 192 participants 41 participants
13 5
Week 129: very much Number Analyzed 192 participants 41 participants
2 1
Week 129: not answered Number Analyzed 192 participants 41 participants
0 0
Week 145: not at all Number Analyzed 116 participants 21 participants
58 9
Week 145: a little Number Analyzed 116 participants 21 participants
45 11
Week 145: quite a bit Number Analyzed 116 participants 21 participants
10 0
Week 145: very much Number Analyzed 116 participants 21 participants
3 1
Week 145: not answered Number Analyzed 116 participants 21 participants
0 0
Week 161: not at all Number Analyzed 40 participants 8 participants
18 3
Week 161: a little Number Analyzed 40 participants 8 participants
21 4
Week 161: quite a bit Number Analyzed 40 participants 8 participants
0 1
Week 161: very much Number Analyzed 40 participants 8 participants
1 0
Week 161: not answered Number Analyzed 40 participants 8 participants
0 0
Week 177: not at all Number Analyzed 6 participants 1 participants
1 0
Week 177: a little Number Analyzed 6 participants 1 participants
3 1
Week 177: quite a bit Number Analyzed 6 participants 1 participants
1 0
Week 177: very much Number Analyzed 6 participants 1 participants
1 0
Week 177: not answered Number Analyzed 6 participants 1 participants
0 0
23.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: “Did you have pain when you urinated?”
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 884 participants 439 participants
775 380
Baseline: a little Number Analyzed 884 participants 439 participants
92 47
Baseline: quite a bit Number Analyzed 884 participants 439 participants
10 8
Baseline: very much Number Analyzed 884 participants 439 participants
7 4
Baseline: not answered Number Analyzed 884 participants 439 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
762 351
Week 17: a little Number Analyzed 839 participants 419 participants
65 58
Week 17: quite a bit Number Analyzed 839 participants 419 participants
12 8
Week 17: very much Number Analyzed 839 participants 419 participants
0 2
Week 17: not answered Number Analyzed 839 participants 419 participants
0 0
Week 33: not at all Number Analyzed 737 participants 341 participants
662 291
Week 33: a little Number Analyzed 737 participants 341 participants
63 39
Week 33: quite a bit Number Analyzed 737 participants 341 participants
11 8
Week 33: very much Number Analyzed 737 participants 341 participants
1 3
Week 33: not answered Number Analyzed 737 participants 341 participants
0 0
Week 49: not at all Number Analyzed 635 participants 250 participants
577 209
Week 49: a little Number Analyzed 635 participants 250 participants
49 34
Week 49: quite a bit Number Analyzed 635 participants 250 participants
6 3
Week 49: very much Number Analyzed 635 participants 250 participants
3 4
Week 49: not answered Number Analyzed 635 participants 250 participants
0 0
Week 65: not at all Number Analyzed 536 participants 193 participants
492 161
Week 65: a little Number Analyzed 536 participants 193 participants
32 29
Week 65: quite a bit Number Analyzed 536 participants 193 participants
9 2
Week 65: very much Number Analyzed 536 participants 193 participants
3 1
Week 65: not answered Number Analyzed 536 participants 193 participants
0 0
Week 81: not at all Number Analyzed 434 participants 148 participants
389 119
Week 81: a little Number Analyzed 434 participants 148 participants
40 27
Week 81: quite a bit Number Analyzed 434 participants 148 participants
4 2
Week 81: very much Number Analyzed 434 participants 148 participants
1 0
Week 81: not answered Number Analyzed 434 participants 148 participants
0 0
Week 97: not at all Number Analyzed 365 participants 95 participants
332 84
Week 97: a little Number Analyzed 365 participants 95 participants
28 11
Week 97: quite a bit Number Analyzed 365 participants 95 participants
4 0
Week 97: very much Number Analyzed 365 participants 95 participants
1 0
Week 97: not answered Number Analyzed 365 participants 95 participants
0 0
Week 113: not at all Number Analyzed 275 participants 73 participants
247 57
Week 113: a little Number Analyzed 275 participants 73 participants
26 13
Week 113: quite a bit Number Analyzed 275 participants 73 participants
1 3
Week 113: very much Number Analyzed 275 participants 73 participants
1 0
Week 113: not answered Number Analyzed 275 participants 73 participants
0 0
Week 129: not at all Number Analyzed 192 participants 41 participants
173 34
Week 129: a little Number Analyzed 192 participants 41 participants
16 7
Week 129: quite a bit Number Analyzed 192 participants 41 participants
1 0
Week 129: very much Number Analyzed 192 participants 41 participants
2 0
Week 129: not answered Number Analyzed 192 participants 41 participants
0 0
Week 145: not at all Number Analyzed 116 participants 21 participants
102 15
Week 145: a little Number Analyzed 116 participants 21 participants
14 6
Week 145: quite a bit Number Analyzed 116 participants 21 participants
0 0
Week 145: very much Number Analyzed 116 participants 21 participants
0 0
Week 145: not answered Number Analyzed 116 participants 21 participants
0 0
Week 161: not at all Number Analyzed 40 participants 8 participants
36 6
Week 161: a little Number Analyzed 40 participants 8 participants
3 1
Week 161: quite a bit Number Analyzed 40 participants 8 participants
1 1
Week 161: very much Number Analyzed 40 participants 8 participants
0 0
Week 161: not answered Number Analyzed 40 participants 8 participants
0 0
Week 177: not at all Number Analyzed 6 participants 1 participants
6 0
Week 177: a little Number Analyzed 6 participants 1 participants
0 1
Week 177: quite a bit Number Analyzed 6 participants 1 participants
0 0
Week 177: very much Number Analyzed 6 participants 1 participants
0 0
Week 177: not answered Number Analyzed 6 participants 1 participants
0 0
24.Secondary Outcome
Title Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38
Hide Description The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: “Has wearing an incontinence aid been a problem for you?”. This question was answered by only those participants who wore incontinence aid.
Time Frame Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.
Arm/Group Title Enzalutamide 160 mg Placebo
Hide Arm/Group Description:
Participants received 4 capsules of Enzalutamide 40 milligrams (mg) each (total dose 160 mg per day) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily from Week 1 till Week 17 and thereafter after every 16 weeks (up to a maximum of 42.8 months) until radiographic progression.
Overall Number of Participants Analyzed 933 468
Measure Type: Number
Unit of Measure: participants
Baseline: not at all Number Analyzed 144 participants 67 participants
83 37
Baseline: a little Number Analyzed 144 participants 67 participants
40 19
Baseline: quite a bit Number Analyzed 144 participants 67 participants
15 3
Baseline: very much Number Analyzed 144 participants 67 participants
6 8
Baseline: not answered Number Analyzed 144 participants 67 participants
0 0
Week 17: not at all Number Analyzed 839 participants 419 participants
77 34
Week 17: a little Number Analyzed 839 participants 419 participants
48 21
Week 17: quite a bit Number Analyzed 839 participants 419 participants
15 7
Week 17: very much Number Analyzed 839 participants 419 participants
6 6
Week 17: not answered Number Analyzed 839 participants 419 participants
693 351
Week 33: not at all Number Analyzed 737 participants 341 participants
76 30
Week 33: a little Number Analyzed 737 participants 341 participants
47 28
Week 33: quite a bit Number Analyzed