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Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00974311
Recruitment Status : Active, not recruiting
First Posted : September 10, 2009
Results First Posted : October 30, 2012
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Castration-Resistant Prostate Cancer
Interventions: Drug: Enzalutamide
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multicenter, global clinical trial

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized 2:1 to receive either Enzalutamide or placebo

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Participant Flow:   Overall Study
    Enzalutamide   Placebo
STARTED   800   399 
COMPLETED   254 [1]   163 [1] 
NOT COMPLETED   546   236 
Lost to Follow-up                1                1 
Death                305                211 
Withdrawal of consent                9                5 
Continuing Treatment                231                19 
[1] Indicates participants continuing long-term follow-up as of 25 September 2011.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population (ITT) included all participants who were randomized into the study.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Total Total of all reporting groups

Baseline Measures
   Enzalutamide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 800   399   1199 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      232  29.0%      130  32.6%      362  30.2% 
>=65 years      568  71.0%      269  67.4%      837  69.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.8  (7.96)   68.6  (8.39)   68.7  (8.11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      800 100.0%      399 100.0%      1199 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   181   107   288 
Spain   23   13   36 
Austria   15   10   25 
Chile   6   5   11 
United Kingdom   82   50   132 
Italy   20   10   30 
France   193   80   273 
Canada   82   25   107 
Argentina   7   3   10 
Belgium   27   18   45 
Poland   7   4   11 
Australia   60   33   93 
South Africa   3   3   6 
Germany   62   24   86 
Netherlands   32   14   46 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: During study period (up to 3 years) ]

Measure Type Primary
Measure Title Overall Survival
Measure Description Survival is defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cutoff date (this included participants who were known to have died after the data analysis cutoff date).
Time Frame During study period (up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT included all participants who were randomized into the study.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 800   399 
Overall Survival 
[Units: Months]
Median (95% Confidence Interval)
 18.4 [1] 
 (17.3 to N/A) 
 13.6 
 (11.3 to 15.8) 
[1] The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment


Statistical Analysis 1 for Overall Survival
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] <0.0001
Hazard Ratio (HR) [5] 0.63
95% Confidence Interval 0.53 to 0.75
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory – Short Form score (Question #3)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Hazard Ratio and 95% confidence interval are from Cox regression model.



2.  Secondary:   Radiographic Progression-free Survival   [ Time Frame: During study period (up to 3 years) ]

Measure Type Secondary
Measure Title Radiographic Progression-free Survival
Measure Description Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Participants who did not reach the endpoint were right censored at their last assessment.
Time Frame During study period (up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT included all participants who were randomized into the study.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 800   399 
Radiographic Progression-free Survival 
[Units: Months]
Median (95% Confidence Interval)
 8.3 
 (8.2 to 9.4) 
 2.9 
 (2.8 to 3.4) 


Statistical Analysis 1 for Radiographic Progression-free Survival
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] <0.0001
Hazard Ratio (HR) [5] 0.40
95% Confidence Interval 0.35 to 0.47
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline ECOG performance status and mean Brief Pain Inventory – Short Form score (Question #3)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Hazard Ratio and 95% confidence interval are from Cox regression model.



3.  Secondary:   Time to First Skeletal-related Event   [ Time Frame: During study period (up to 3 years) ]

Measure Type Secondary
Measure Title Time to First Skeletal-related Event
Measure Description The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.
Time Frame During study period (up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT included all participants who were randomized into the study.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 800   399 
Time to First Skeletal-related Event 
[Units: Months]
Median (95% Confidence Interval)
 16.7 
 (14.6 to 19.1) 
 13.3 [1] 
 (9.9 to N/A) 
[1] The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment


Statistical Analysis 1 for Time to First Skeletal-related Event
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.0001
Hazard Ratio (HR) [5] 0.69
95% Confidence Interval 0.566 to 0.835
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline ECOG performance status and mean Brief Pain Inventory – Short Form score (Question #3)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Hazard Ratio and 95% confidence interval are from Cox regression model.



4.  Secondary:   Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)   [ Time Frame: Baseline up to 3 years ]

Measure Type Secondary
Measure Title Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Measure Description The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.
Time Frame Baseline up to 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable intent to treat (ITT) - all participants who were part of the ITT population and had a global FACT-P score at baseline and at least 1 post-baseline assessment.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 651   257 
Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P) 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 43.2 
 (39.3 to 47.1) 
 18.3 
 (13.8 to 23.6) 


Statistical Analysis 1 for Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Cochran-Mantel-Haenszel
P Value [4] <0.0001
Difference in Percentage of Participants [5] 24.9
95% Confidence Interval 18.8 to 30.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline ECOG performance status and mean Brief Pain Inventory – Short Form score (Question #3)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Confidence Interval based on standard normal approximation



5.  Secondary:   Time to Prostate-specific Antigen (PSA) Progression   [ Time Frame: Baseline and at every study visit from week 13 while on study drug (up to 3 years) ]

Measure Type Secondary
Measure Title Time to Prostate-specific Antigen (PSA) Progression
Measure Description Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).
Time Frame Baseline and at every study visit from week 13 while on study drug (up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT included all participants who were randomized into the study.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 800   399 
Time to Prostate-specific Antigen (PSA) Progression 
[Units: Months]
Median (95% Confidence Interval)
 8.3 
 (5.8 to 8.3) 
 3.0 
 (2.9 to 3.7) 


Statistical Analysis 1 for Time to Prostate-specific Antigen (PSA) Progression
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] <0.0001
Hazard Ratio (HR) [5] 0.248
95% Confidence Interval 0.204 to 0.303
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Stratified
[5] Other relevant estimation information:
  Hazard Ratio and 95% confidence interval are from Cox regression model.



6.  Secondary:   Percentage of Participants With Pain Palliation   [ Time Frame: Baseline up to 3 years ]

Measure Type Secondary
Measure Title Percentage of Participants With Pain Palliation
Measure Description The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as >=30% reduction in average pain score at Week 13 compared to baseline without a >=30% increase in analgesic use.
Time Frame Baseline up to 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable ITT Population. Participants with metastatic bone disease at baseline; provided answers to Question #3 of the Brief Pain Inventory – Short Form for a minimum of 4 out of 7 days in the baseline run-in period; stable baseline pain; stable analgesic use; and had an average pain score during the baseline run-in period of ≥ 4.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 49   15 
Percentage of Participants With Pain Palliation 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 44.9 
 (30.7 to 59.8) 
 6.7 
 (0.2 to 31.9) 


Statistical Analysis 1 for Percentage of Participants With Pain Palliation
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.0079
Difference in Rate of Pain Palliation [5] 38.2
95% Confidence Interval 19.4 to 57.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline Eastern Cooperative Oncology Group performance status (0–1 vs. 2)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Confidence Interval based on standard normal approximation



7.  Secondary:   Percentage of Participants With Prostate Specific Antigen (PSA) Response   [ Time Frame: During study period (up to 3 years) ]

Measure Type Secondary
Measure Title Percentage of Participants With Prostate Specific Antigen (PSA) Response
Measure Description Participants were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.
Time Frame During study period (up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Intent to Treat. Participants who were part of the ITT Population and had a PSA level measured at baseline and at least 1 post-baseline assessment.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 731   330 
Percentage of Participants With Prostate Specific Antigen (PSA) Response 
[Units: Percentage of participants]
   
Decline >=50% from baseline   54   2 
Decline >=90% from baseline   25   1 

No statistical analysis provided for Percentage of Participants With Prostate Specific Antigen (PSA) Response



8.  Secondary:   Percentage of Participants With Soft-tissue Objective Response   [ Time Frame: During study period (up to 3 years) ]

Measure Type Secondary
Measure Title Percentage of Participants With Soft-tissue Objective Response
Measure Description The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the investigators’ response assessments and also the derived response assessments by treatment group. Only participants with measurable soft tissue disease at screening were included in this analysis. Participants with measurable disease at screening are participants who had at least 1 target lesion identified per RECIST v1.1 at screening. Percentage of participants summarizes the number of participants with complete or partial objective response (%). Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.
Time Frame During study period (up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT) with Measurable Disease. Participants who were part of the ITT Population and had measurable soft tissue disease at screening, defined by at least 1 target lesion according to RECIST v1.1.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 446   208 
Percentage of Participants With Soft-tissue Objective Response 
[Units: Percentage of participants]
 29   4 

No statistical analysis provided for Percentage of Participants With Soft-tissue Objective Response



9.  Secondary:   European Quality of Life Five-Domain (EQ-5D) Scale   [ Time Frame: Week 13 ]

Measure Type Secondary
Measure Title European Quality of Life Five-Domain (EQ-5D) Scale
Measure Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scale (1= no problems, 2= some/moderate problems and 3= severe problem). Score were transformed and resulted in a total EQ-5D score range of 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health and quality of life.
Time Frame Week 13  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Intent to Treat. Participants who were part of the ITT Population and who were evaluable for EQ-5D.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 126   55 
European Quality of Life Five-Domain (EQ-5D) Scale 
[Units: Units on a scale]
Mean (Standard Deviation)
 67.2  (19.29)   60.0  (19.26) 

No statistical analysis provided for European Quality of Life Five-Domain (EQ-5D) Scale



10.  Secondary:   Percentage of Participants With Circulating Tumor Cell (CTC) Conversion   [ Time Frame: Baseline up to 3 years ]

Measure Type Secondary
Measure Title Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
Measure Description CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.
Time Frame Baseline up to 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
CTC Evaluable Population.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.

Measured Values
   Enzalutamide   Placebo 
Participants Analyzed 
[Units: Participants]
 127   62 
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 48 
 (39.09 to 57.07) 
 9.7 
 (3.63 to 19.88) 

No statistical analysis provided for Percentage of Participants With Circulating Tumor Cell (CTC) Conversion




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information