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A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (ARCHES)

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: NCT02677896
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Results First Posted : January 21, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Metastatic Hormone Sensitive Prostate Cancer
Interventions Drug: Enzalutamide
Drug: Placebo
Enrollment 1150
Recruitment Details Participants with metastatic hormone sensitive prostate cancer (mHSPC) were enrolled in 204 study sites worldwide.
Pre-assignment Details The randomization was stratified by volume of disease (low vs high) and prior docetaxel therapy for prostate cancer (no prior docetaxel, 1 to 5 cycles, 6 cycles).
Arm/Group Title Enzalutamide + Androgen Deprivation Therapy (ADT) Placebo + Androgen Deprivation Therapy (ADT)
Hide Arm/Group Description Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Period Title: Overall Study
Started 574 576
Treated 572 574
Completed [1] 437 332
Not Completed 137 244
Reason Not Completed
Adverse Event             28             21
Death             9             7
Lost to Follow-up             0             1
Progressive disease:             65             171
Protocol deviation             2             1
Withdrawal by patient:             25             30
Miscellaneous             6             11
Did not receive study drug             2             2
[1]
Participants still on treatment. Overall survival assessed when at least 342 deaths are observed.
Arm/Group Title Enzalutamide + ADT Placebo + ADT Total
Hide Arm/Group Description Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. Total of all reporting groups
Overall Number of Baseline Participants 574 576 1150
Hide Baseline Analysis Population Description
All Randomized Participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 574 participants 576 participants 1150 participants
69.5  (8.0) 69.5  (8.4) 69.5  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 574 participants 576 participants 1150 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
574
 100.0%
576
 100.0%
1150
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 574 participants 576 participants 1150 participants
Hispanic or Latino
46
   8.0%
37
   6.4%
83
   7.2%
Not Hispanic or Latino
504
  87.8%
514
  89.2%
1018
  88.5%
Unknown or Not Reported
24
   4.2%
25
   4.3%
49
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 574 participants 576 participants 1150 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
75
  13.1%
80
  13.9%
155
  13.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
   1.4%
8
   1.4%
16
   1.4%
White
466
  81.2%
460
  79.9%
926
  80.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
25
   4.4%
28
   4.9%
53
   4.6%
Volume of Disease   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 574 participants 576 participants 1150 participants
Low
220
  38.3%
203
  35.2%
423
  36.8%
High
354
  61.7%
373
  64.8%
727
  63.2%
[1]
Measure Description: High volume of disease was defined as metastases involving the viscera or, in the absence of visceral lesions, 4 or more bone lesions, at least 1 of which was in a bony structure beyond the vertebral column and pelvic bone. Low volume was anything that wasn't considered high volume by definition provided.
[2]
Measure Analysis Population Description: Intent-to-Treat (ITT)
Prior Docetaxel Therapy Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 574 participants 576 participants 1150 participants
None
471
  82.1%
474
  82.3%
945
  82.2%
1 to 5 cycles
14
   2.4%
11
   1.9%
25
   2.2%
6 cycles
89
  15.5%
91
  15.8%
180
  15.7%
[1]
Measure Analysis Population Description: ITT
1.Primary Outcome
Title Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria
Hide Description rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
Time Frame From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined as all participants who were randomized in this study.
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
19.4 [1] 
(16.59 to NA)
[1]
Not reached. Data was not reached due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments rPFS Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.30 to 0.50
Estimation Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
2.Primary Outcome
Title rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria
Hide Description rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
Time Frame From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
19.0
(16.59 to 22.24)
[1]
Not reached. Data was not reached due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments rPFS Treatment Comparision
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox proportional hazards model
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.30 to 0.50
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive.
Time Frame Up to 78 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Prostate Specific Antigen (PSA) Progression
Hide Description Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).
Time Frame From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(16.59 to NA)
[1]
Not reached. Data was not reached due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments Time to PSA Progression Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.13 to 0.26
Estimation Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
5.Secondary Outcome
Title Time to Start of New Antineoplastic Therapy
Hide Description In participants with a new antineoplastic therapy initiated for prostate cancer after randomization, time to start of a new antineoplastic therapy was defined as the time interval from randomization to the date of the first dose administration of the first antineoplastic therapy. In participants with no new antineoplastic therapy initiated for prostate cancer after randomization, time to start of new antineoplastic therapy was censored on the last visit date or the date of randomization, whichever occurred last.
Time Frame From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
30.2 [1] 
(NA to NA)
NA [1] 
(21.06 to NA)
[1]
Not reached. Data was not reached due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments Time to Start of New Therapy Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.20 to 0.40
Estimation Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
6.Secondary Outcome
Title PSA Undetectable Rate
Hide Description The PSA undetectable rate was defined as the percentage of participants with undetectable (< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.
Time Frame Up to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with detectable PSA at baseline
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 511 506
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.1
(63.9 to 72.1)
17.6
(14.4 to 21.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments PSA Undetectable Rate Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in rate
Estimated Value 50.5
Confidence Interval (2-Sided) 95%
45.3 to 55.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description The ORR was calculated as the percentage of participants who achieved a completed response (CR) or a partial response (PR) (unconfirmed responses) in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by ICR.
Time Frame Up to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT participants with measurable disease at baseline
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 177 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.1
(76.7 to 88.3)
63.7
(56.3 to 70.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments ORR Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in rate
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
10.4 to 28.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time to Deterioration in Urinary Symptoms
Hide Description In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.
Time Frame From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(19.35 to NA)
16.8 [1] 
(14.06 to NA)
[1]
Not reached. Data was not reached due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments Time to Deterioration of Urinary Symptoms Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2162
Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.72 to 1.08
Estimation Comments Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
9.Secondary Outcome
Title Time to First Symptomatic Skeletal Event (SSE)
Hide Description Time to first SSE was calculated as the time from randomization to the occurrence of the first SSE prior to the data analysis cut-off date. An SSE was defined as radiation to bone, surgery to bone, clinically apparent pathological bone fracture, or spinal cord compression. In participants with no SSE by the time of the data cut-off point, time to SSE was censored on the last visit date or the date of randomization, whichever occurred last.
Time Frame From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Not reached. Data was not reached due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments Time to SSE Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.33 to 0.80
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Time to Castration Resistance
Hide Description Time to castration resistance was calculated as the time from randomization to the first castration-resistant event. A castration resistance event was defined as any of the following in the presence of castrate levels of testosterone (< 50 ng/dL): radiographic disease progression, PSA progression or SSE, whichever occurred first. In participants with no documented castration resistance event, the time to castration resistance was censored on the latest date from: the date of last radiologic assessment, the last PSA sample taken prior to the start of any new prostate cancer therapy and prior to 2 or more consecutive missed PSA assessments (if applicable), and the last visit date performed.
Time Frame From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
13.9
(11.40 to 17.18)
[1]
Not reached. Data was not reached due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments Time to Castration Resistance Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.22 to 0.36
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Hide Description Time to deterioration of QoL was calculated as the time interval from the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score was recorded. The FACT-P consists of 27 core items that assess participant function in 4 domains and 12 prostate cancer-related items grouped into 5 subscales as follows: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and prostate cancer subscale. Each item is rated on a 0 to 4 Likert-type scale. The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0 to 156), where high score represent better quality of life. In participants without FACT-P progression, the time to deterioration of QoL was censored on the date of the last FACT-P total score was calculable.
Time Frame From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
11.3
(11.04 to 13.83)
11.1
(8.48 to 13.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments Time to Deterioration of QoL in FACT-P Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6548
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.81 to 1.14
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)
Hide Description Time to pain progression was defined as time from randomization to the first pain progression event. Pain progression was defined as an increase of ≥ 30% from baseline in the average BPI-SF pain severity score. BPI-SF contains 9 questions with rating scales from 0 (no pain/no interference) to 10 (worst pain/interferes completely). Total score was calculated as the average of each question. Higher scores represent a higher level of pain or interference. In participants with no pain progression event, time to pain progression was censored on the last visit date where BPI-SF was collected.
Time Frame From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description:
Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Overall Number of Participants Analyzed 574 576
Median (95% Confidence Interval)
Unit of Measure: months
8.3
(8.25 to 10.91)
8.3
(5.65 to 8.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enzalutamide + ADT, Placebo + ADT
Comments Time to Pain Progression Based on BPI-SF Treatment Comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2715
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox hazard ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.78 to 1.07
Estimation Comments [Not Specified]
Time Frame From first dose of study drug up to 30 days after last dose of study or prior to initiation of new therapy for prostate cancer, whichever occurred first. Maximum duration of treatment to the data cut-off date of 14 October 2018 was 26.6 months.
Adverse Event Reporting Description Safety Analysis Set (SAF) consisted of all randomized participants who received at least one dose of study drug.
 
Arm/Group Title Enzalutamide + ADT Placebo + ADT
Hide Arm/Group Description Participants received enzalutamide orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. Participants received matching placebo orally once daily. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
All-Cause Mortality
Enzalutamide + ADT Placebo + ADT
Affected / at Risk (%) Affected / at Risk (%)
Total   39/572 (6.82%)      45/574 (7.84%)    
Hide Serious Adverse Events
Enzalutamide + ADT Placebo + ADT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   104/572 (18.18%)      112/574 (19.51%)    
Blood and lymphatic system disorders     
Anaemia  1  4/572 (0.70%)  4 3/574 (0.52%)  5
Immune thrombocytopenic purpura  1  1/572 (0.17%)  6 0/574 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Angina pectoris  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Angina unstable  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Arteriosclerosis coronary artery  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Atrial fibrillation  1  2/572 (0.35%)  2 4/574 (0.70%)  4
Atrial flutter  1  1/572 (0.17%)  1 2/574 (0.35%)  2
Atrioventricular block  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Atrioventricular block complete  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Atrioventricular block second degree  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Cardiac arrest  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Cardiac failure  1  2/572 (0.35%)  2 1/574 (0.17%)  1
Cardiac failure chronic  1  1/572 (0.17%)  2 0/574 (0.00%)  0
Cardio-respiratory arrest  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Cardiopulmonary failure  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Myocardial infarction  1  2/572 (0.35%)  2 2/574 (0.35%)  2
Ventricular fibrillation  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Endocrine disorders     
Goitre  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Hyperparathyroidism  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Eye disorders     
Eye haemorrhage  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Retinal detachment  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Ulcerative keratitis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  2/572 (0.35%)  2 2/574 (0.35%)  2
Colitis ischaemic  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Diarrhoea  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Diverticulum intestinal haemorrhagic  1  1/572 (0.17%)  3 0/574 (0.00%)  0
Duodenal ulcer perforation  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Duodenitis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Dyspepsia  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Epiploic appendagitis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Gastritis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Gastritis erosive  1  1/572 (0.17%)  2 0/574 (0.00%)  0
Gastrointestinal haemorrhage  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Impaired gastric emptying  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Incarcerated inguinal hernia  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Inguinal hernia  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Large intestinal obstruction  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Large intestine perforation  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Nausea  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Pneumoperitoneum  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Proctalgia  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Retroperitoneal fibrosis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Small intestinal obstruction  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Subileus  1  1/572 (0.17%)  1 0/574 (0.00%)  0
General disorders     
Asthenia  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Death  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Euthanasia  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Fatigue  1  2/572 (0.35%)  3 0/574 (0.00%)  0
General physical health deterioration  1  1/572 (0.17%)  1 2/574 (0.35%)  3
Malaise  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Pyrexia  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Sudden cardiac death  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Sudden death  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Hepatobiliary disorders     
Cholecystitis acute  1  0/572 (0.00%)  0 1/574 (0.17%)  2
Hepatic function abnormal  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Jaundice cholestatic  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Infections and infestations     
Anorectal infection  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Appendicitis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Bronchitis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Bronchopulmonary aspergillosis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Cellulitis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Cholecystitis infective  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Device related infection  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Diverticulitis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Erysipelas  1  1/572 (0.17%)  1 2/574 (0.35%)  2
Escherichia pyelonephritis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Escherichia urinary tract infection  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Genital abscess  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Groin abscess  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Infected lymphocele  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Influenza  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Otitis media chronic  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Pneumonia  1  2/572 (0.35%)  2 2/574 (0.35%)  3
Pyelonephritis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Sepsis  1  3/572 (0.52%)  4 3/574 (0.52%)  3
Septic shock  1  1/572 (0.17%)  2 0/574 (0.00%)  0
Urinary tract infection  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Urinary tract infection bacterial  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Urosepsis  1  2/572 (0.35%)  2 1/574 (0.17%)  1
Injury, poisoning and procedural complications     
Accidental overdose  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Bone fissure  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Cervical vertebral fracture  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Clavicle fracture  1  1/572 (0.17%)  2 1/574 (0.17%)  1
Comminuted fracture  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Coronary artery restenosis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Fall  1  3/572 (0.52%)  3 2/574 (0.35%)  2
Femoral neck fracture  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Fracture displacement  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Limb injury  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Lumbar vertebral fracture  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Multiple fractures  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Peripheral artery restenosis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Radius fracture  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Road traffic accident  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Stenosis of vesicourethral anastomosis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Subarachnoid haemorrhage  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Subdural haematoma  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Thoracic vertebral fracture  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Ulna fracture  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Urinary retention postoperative  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Urinary tract stoma complication  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Wound  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Investigations     
Alanine aminotransferase increased  1  2/572 (0.35%)  3 0/574 (0.00%)  0
Antineutrophil cytoplasmic antibody increased  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Aspartate aminotransferase increased  1  2/572 (0.35%)  3 0/574 (0.00%)  0
Blood alkaline phosphatase increased  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Blood bilirubin increased  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Blood creatinine increased  1  1/572 (0.17%)  2 1/574 (0.17%)  1
Blood testosterone increased  1  0/572 (0.00%)  0 1/574 (0.17%)  2
General physical condition abnormal  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Intraocular pressure increased  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Liver function test abnormal  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Transaminases increased  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Dehydration  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Hypercalcaemia  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Hypoglycaemia  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  2/572 (0.35%)  2 2/574 (0.35%)  2
Bone pain  1  2/572 (0.35%)  2 0/574 (0.00%)  0
Muscular weakness  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Musculoskeletal chest pain  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Neck pain  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Osteoarthritis  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Pain in extremity  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Pathological fracture  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Spinal osteoarthritis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Basal cell carcinoma  1  4/572 (0.70%)  4 4/574 (0.70%)  4
Benign pancreatic neoplasm  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Bladder cancer  1  2/572 (0.35%)  2 0/574 (0.00%)  0
Bone cancer  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Bronchial carcinoma  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Cancer pain  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Colon cancer  1  2/572 (0.35%)  2 2/574 (0.35%)  4
Diffuse large B-cell lymphoma  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Gastric cancer  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Laryngeal squamous cell carcinoma  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Lung adenocarcinoma  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Lung adenocarcinoma stage 0  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Lung adenocarcinoma stage I  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Lung neoplasm malignant  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Malignant melanoma in situ  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Malignant neoplasm progression  1  6/572 (1.05%)  6 3/574 (0.52%)  4
Metastases to liver  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Monoclonal gammopathy  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Neuroendocrine carcinoma  1  2/572 (0.35%)  2 1/574 (0.17%)  1
Non-small cell lung cancer  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Paraproteinaemia  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Plasmacytoma  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Squamous cell carcinoma  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Squamous cell carcinoma of head and neck  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Squamous cell carcinoma of skin  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Transitional cell carcinoma  1  0/572 (0.00%)  0 1/574 (0.17%)  3
Tumour pain  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Nervous system disorders     
Carotid arteriosclerosis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Cerebellar infarction  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Cerebral haemorrhage  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Cerebral ischaemia  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Cerebrovascular accident  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Cervicobrachial syndrome  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Dementia  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Guillain-Barre syndrome  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Ischaemic stroke  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Lethargy  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Monoparesis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Paraparesis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Seizure  1  2/572 (0.35%)  2 2/574 (0.35%)  2
Spinal cord compression  1  3/572 (0.52%)  3 6/574 (1.05%)  6
Syncope  1  3/572 (0.52%)  3 0/574 (0.00%)  0
Toxic encephalopathy  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Transient global amnesia  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Transient ischaemic attack  1  1/572 (0.17%)  1 2/574 (0.35%)  3
Psychiatric disorders     
Completed suicide  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Confusional state  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Delirium  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Renal and urinary disorders     
Acute kidney injury  1  2/572 (0.35%)  2 2/574 (0.35%)  2
Bladder perforation  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Calculus bladder  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Dysuria  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Haematuria  1  4/572 (0.70%)  4 2/574 (0.35%)  2
Hydronephrosis  1  4/572 (0.70%)  4 3/574 (0.52%)  4
Renal colic  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Renal failure  1  2/572 (0.35%)  2 0/574 (0.00%)  0
Renal impairment  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Ureterolithiasis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Urethral obstruction  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Urethral stenosis  1  0/572 (0.00%)  0 1/574 (0.17%)  2
Urinary retention  1  3/572 (0.52%)  3 4/574 (0.70%)  4
Urinary tract obstruction  1  2/572 (0.35%)  2 0/574 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/572 (0.35%)  2 1/574 (0.17%)  1
Pelvic pain  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Dyspnoea  1  0/572 (0.00%)  0 2/574 (0.35%)  2
Interstitial lung disease  1  2/572 (0.35%)  2 0/574 (0.00%)  0
Pneumonia aspiration  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Pulmonary embolism  1  3/572 (0.52%)  3 3/574 (0.52%)  3
Vascular disorders     
Aortic aneurysm  1  1/572 (0.17%)  1 1/574 (0.17%)  1
Aortic dissection  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Aortic dissection rupture  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Deep vein thrombosis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Granulomatosis with polyangiitis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Hypertensive crisis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Peripheral ischaemia  1  0/572 (0.00%)  0 1/574 (0.17%)  1
Phlebitis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Thrombosis  1  1/572 (0.17%)  1 0/574 (0.00%)  0
Vena cava thrombosis  1  0/572 (0.00%)  0 1/574 (0.17%)  1
1
Term from vocabulary, MedDRA 21
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enzalutamide + ADT Placebo + ADT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   353/572 (61.71%)      348/574 (60.63%)    
Gastrointestinal disorders     
Constipation  1  28/572 (4.90%)  30 31/574 (5.40%)  31
Diarrhoea  1  34/572 (5.94%)  38 33/574 (5.75%)  34
Nausea  1  37/572 (6.47%)  43 29/574 (5.05%)  29
General disorders     
Asthenia  1  31/572 (5.42%)  42 26/574 (4.53%)  33
Fatigue  1  111/572 (19.41%)  127 88/574 (15.33%)  98
Oedema peripheral  1  29/572 (5.07%)  33 38/574 (6.62%)  46
Investigations     
Weight increased  1  35/572 (6.12%)  46 44/574 (7.67%)  50
Musculoskeletal and connective tissue disorders     
Arthralgia  1  70/572 (12.24%)  86 61/574 (10.63%)  73
Back pain  1  42/572 (7.34%)  50 60/574 (10.45%)  62
Musculoskeletal pain  1  36/572 (6.29%)  39 23/574 (4.01%)  27
Nervous system disorders     
Dizziness  1  29/572 (5.07%)  30 20/574 (3.48%)  22
Vascular disorders     
Hot flush  1  155/572 (27.10%)  173 128/574 (22.30%)  132
Hypertension  1  46/572 (8.04%)  54 32/574 (5.57%)  33
1
Term from vocabulary, MedDRA 21
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Results Point of Contact
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Name/Title: Clinical Trial Disclosure
Organization: Astellas Pharma Inc.
Phone: +81 3-3244-0512
EMail: astellas.resultsdisclosure@astellas.com
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Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT02677896    
Other Study ID Numbers: 9785-CL-0335
2015-003869-28 ( EudraCT Number )
First Submitted: February 5, 2016
First Posted: February 9, 2016
Results First Submitted: January 8, 2020
Results First Posted: January 21, 2020
Last Update Posted: July 7, 2020