Trial Outcomes & Findings for A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone (NCT NCT02288247)

Last Updated: 2025-04-08

Results Overview

PFS: time from randomization (Period 2 Week 1) to earliest progression event. Progression is defined as radiographic progression, unequivocal clinical progression, or death on study. Radiographic progression is defined for bone disease by appearance of ≥ 2 new lesions on whole-body radionuclide bone scan per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (i.e., unconfirmed progressive disease) that needs to be confirmed in the next assessment (i.e., progressive disease in the next assessment) or for soft tissue disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Unequivocal clinical progression is defined as new onset cancer pain requiring chronic administration of opiate analgesia or deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to ≥ 3, or initiation of subsequent lines of cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications of tumor progression.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

688 participants

Primary outcome timeframe

From date of randomization to the earliest of either documented disease progression (median duration: 35 weeks)

Results posted on

2025-04-08

Participant Flow

Male participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who had progressed while on luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy and had not yet received chemotherapy were enrolled in the study.

Following Screening, participants received open-label (OL) treatment with enzalutamide in period 1 followed by period 2 randomized double-blind (DB) treatment with continued enzalutamide or placebo, adding with docetaxel and prednisolone. Participants were stratified by disease progression in Period 1 (evidence of radiographic progression or not).

Participant milestones

Participant milestones
Measure	Enzalutamide Participants received OL enzalutamide 160 milligrams (mg) capsules orally once daily (QD) from Day 1 in Period (P) 1 until they were either randomized to P2 treatment, deemed ineligible, experienced intolerable toxicity, withdrew, or died, whichever came first. Participants with confirmed disease progression on enzalutamide in Period 1 who continued to meet eligibility criteria, were randomized to receive either placebo or enzalutamide 160 mg capsules orally QD with docetaxel 75 milligrams per meter square (mg/m\^2) in 1-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily in DB P2. Docetaxel and prednisolone were administered for up to 10 cycles (1 cycle = 3 weeks) or additional cycles as determined by investigator, while placebo/enzalutamide was continued until disease progression, intolerable toxicity, withdrawal, or death whichever occurred first. An Extension (EXT) phase was available for participants still in P1 and participants in P2 not meeting the primary endpoint, when the data cut-off for analysis was reached. Treatment with enzalutamide continued until the disease progression, intolerable toxicity, participant withdrawal or death. Participants who did not enter EXT phase had discontinued study and received local standard of care treatment. Those who were still benefiting from enzalutamide treatment in EXT phase at study closure continued enzalutamide therapy in another Astellas-sponsored study 9785-CL-0123 or via commercially available enzalutamide.	Placebo Participants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in P1 until randomization to P2 treatment, confirmation of ineligibility for P2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first. Participants with confirmed disease progression on enzalutamide in P1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB in P2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle = 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants discontinued the study and received local standard of care.
Period 1: OL Treatment (Max: 462 Weeks) STARTED	688	0
Period 1: OL Treatment (Max: 462 Weeks) Treated	687	0
Period 1: OL Treatment (Max: 462 Weeks) COMPLETED	0	0
Period 1: OL Treatment (Max: 462 Weeks) NOT COMPLETED	688	0
Period 2: DB Treatment (Max: 180 Weeks) STARTED	137	136
Period 2: DB Treatment (Max: 180 Weeks) Treated	136	135
Period 2: DB Treatment (Max: 180 Weeks) COMPLETED	0	1
Period 2: DB Treatment (Max: 180 Weeks) NOT COMPLETED	137	135

Reasons for withdrawal

Reasons for withdrawal
Measure	Enzalutamide Participants received OL enzalutamide 160 milligrams (mg) capsules orally once daily (QD) from Day 1 in Period (P) 1 until they were either randomized to P2 treatment, deemed ineligible, experienced intolerable toxicity, withdrew, or died, whichever came first. Participants with confirmed disease progression on enzalutamide in Period 1 who continued to meet eligibility criteria, were randomized to receive either placebo or enzalutamide 160 mg capsules orally QD with docetaxel 75 milligrams per meter square (mg/m\^2) in 1-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily in DB P2. Docetaxel and prednisolone were administered for up to 10 cycles (1 cycle = 3 weeks) or additional cycles as determined by investigator, while placebo/enzalutamide was continued until disease progression, intolerable toxicity, withdrawal, or death whichever occurred first. An Extension (EXT) phase was available for participants still in P1 and participants in P2 not meeting the primary endpoint, when the data cut-off for analysis was reached. Treatment with enzalutamide continued until the disease progression, intolerable toxicity, participant withdrawal or death. Participants who did not enter EXT phase had discontinued study and received local standard of care treatment. Those who were still benefiting from enzalutamide treatment in EXT phase at study closure continued enzalutamide therapy in another Astellas-sponsored study 9785-CL-0123 or via commercially available enzalutamide.	Placebo Participants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in P1 until randomization to P2 treatment, confirmation of ineligibility for P2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first. Participants with confirmed disease progression on enzalutamide in P1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB in P2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle = 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants discontinued the study and received local standard of care.
Period 1: OL Treatment (Max: 462 Weeks) Adverse Event	52	0
Period 1: OL Treatment (Max: 462 Weeks) Death	35	0
Period 1: OL Treatment (Max: 462 Weeks) Lost to Follow-up	1	0
Period 1: OL Treatment (Max: 462 Weeks) Progressive Disease	393	0
Period 1: OL Treatment (Max: 462 Weeks) Protocol Violation	9	0
Period 1: OL Treatment (Max: 462 Weeks) Withdrawal by Subject	54	0
Period 1: OL Treatment (Max: 462 Weeks) Other	142	0
Period 1: OL Treatment (Max: 462 Weeks) Study Terminated By Sponsor	2	0
Period 2: DB Treatment (Max: 180 Weeks) Adverse Event	10	8
Period 2: DB Treatment (Max: 180 Weeks) Death	8	4
Period 2: DB Treatment (Max: 180 Weeks) Lost to Follow-up	1	0
Period 2: DB Treatment (Max: 180 Weeks) Progressive Disease	87	94
Period 2: DB Treatment (Max: 180 Weeks) Protocol Violation	2	1
Period 2: DB Treatment (Max: 180 Weeks) Withdrawal by Subject	7	7
Period 2: DB Treatment (Max: 180 Weeks) Other	21	21
Period 2: DB Treatment (Max: 180 Weeks) Randomized but not treated	1	0

Baseline Characteristics

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enzalutamide n=687 Participants Participants received OL enzalutamide 160 mg capsules orally QD from Day 1 in Period 1 until they were either randomized to Period 2 treatment, deemed ineligible, experienced intolerable toxicity, withdrew, or died, whichever came first. Participants with confirmed disease progression on enzalutamide in Period 1, who continued to meet eligibility criteria, were randomized to receive either placebo or enzalutamide 160 mg capsules orally QD with docetaxel 75 mg/m\^2 in 1-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily in DB Period 2. Docetaxel and prednisolone were administered for up to 10 cycles (1 cycle = 3 weeks) or additional cycles as determined by investigator, while placebo/enzalutamide was continued until disease progression, intolerable toxicity, withdrawal, or death whichever occurred first. An EXT was available for patients still in P1 and patients in P2 not meeting the primary endpoint, when the data cut-off for analysis was reached. Treatment with enzalutamide continued until the disease progression, intolerable toxicity, participant withdrawal or death. Participants who did not enter extension phase had discontinued study and received local standard of care treatment. Those who were still benefiting from enzalutamide treatment in EXT phase at study closure continued enzalutamide therapy in another Astellas-sponsored study 9785-CL-0123 or via commercially available enzalutamide.
Age, Continuous	71.0 years STANDARD_DEVIATION 7.8 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	687 Participants n=93 Participants
Race/Ethnicity, Customized Race : White	681 participants n=93 Participants
Race/Ethnicity, Customized Race : Black Or African American	5 participants n=93 Participants
Race/Ethnicity, Customized Race : Other	1 participants n=93 Participants

PRIMARY outcome

Timeframe: From date of randomization to the earliest of either documented disease progression (median duration: 35 weeks)

Population: The Full Analysis Set (FAS) consisted of all participants who were randomized and received at least one dose of IMP.

Outcome measures

Outcome measures
Measure	Enzalutamide n=136 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.	Placebo n=135 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
Progression Free Survival (PFS)	9.53 months Interval 8.25 to 10.87	8.28 months Interval 6.28 to 8.71

SECONDARY outcome

Timeframe: From date of randomization to the first PSA value (median duration: 35 weeks)

Population: FAS

Time to PSA progression, defined as the time from randomization (Period 2 Week 1) to the date of the first PSA value in Period 2 demonstrating progression (Period 2). The PSA progression date is defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir recorded in Period 2 is documented, which must be confirmed by a second consecutive value obtained at least 3 weeks later.

Outcome measures

Outcome measures
Measure	Enzalutamide n=136 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.	Placebo n=135 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
Time to Prostate-specific Antigen (PSA) Progression	8.44 months Interval 8.18 to 9.0	6.24 months Interval 5.42 to 8.31

SECONDARY outcome

Timeframe: Randomization, Week 13, any time after randomization in Period 2 (median of 35 weeks)

Population: FAS

PSA response, defined as a decrease in percentage change from randomization (Period 2 Week 1) of 50% or more. PSA response was derived at Week 13 and at any time after randomization in Period 2. PSA response at any time is defined as a decrease in percentage change from randomization (Period 2 Week 1) at any time after randomization of 50% or more. Percentage of participants with PSA response was reported.

Outcome measures

Outcome measures
Measure	Enzalutamide n=136 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.	Placebo n=135 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
Prostate-specific Antigen (PSA) Response Week 13	44.9 percentage of participants	25.2 percentage of participants
Prostate-specific Antigen (PSA) Response Any time after randomization (median of 35 weeks)	55.9 percentage of participants	37.0 percentage of participants

SECONDARY outcome

Timeframe: From date of randomization up to median duration of 35 weeks

Population: FAS

ORR, defined as the best overall radiographic response after randomization (Period 2 Week 1) as per Investigator assessments of response for soft tissue disease per RECIST 1.1, in participants who had a measurable tumor. ORR was reported as the percentage of participants with complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Enzalutamide n=136 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.	Placebo n=135 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
Objective Response Rate (ORR)	31.6 percentage of participants Interval 0.6 to 0.76	25.9 percentage of participants Interval 0.66 to 0.81

SECONDARY outcome

Timeframe: From date of randomization up to median duration of 35 weeks

Population: Data was not estimable as none of the participants met the criteria for pain progression

The time to an increase of \>=30% from randomization (Period 2 Week 1) in average BPI-SF item scores (items 3, 4, 5, 6) at two consecutive evaluations \>=3 weeks apart without decrease in analgesic score according to the World health Organization (WHO). Only participants with an average pain intensity item score \>=4 were considered. The BPI-SF was an instrument to document pain-related functional impairment and contains 7 questions which included pain intensity \[(items 3, 4, 5 and 6): worst pain, least pain, average pain and current pain, with scales from 0 (no pain) to 10 (pain as bad as you can imagine)\] and pain interference \](items 9A to 9G): general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life, with scales from 0 (does not interfere) to 10 (completely interferes)\]. The BPI-SF total score for pain intensity was calculated as the mean of the 4 scores for the 4 items of pain intensity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization up to median duration of 35 weeks

Population: Data was not estimable as none of the participants had cancer-related pain.

Time to opiate use for cancer-related pain, defined as the time from randomization (Period 2 Week 1) to initiation of chronic administration of opiate analgesia \[parenteral opiate use for ≥7 days or use of WHO Analgesic Ladder Level 3 oral opiates for ≥3 weeks\].

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization up to median duration of 35 weeks

Population: FAS

Time to first SRE, defined as the time from randomization (Period 2 Week 1) to radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain.

Outcome measures

Outcome measures
Measure	Enzalutamide n=136 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.	Placebo n=135 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
Time to First Skeletal-related Event (SRE)	21.98 months Interval 15.18 to Upper limit of 95% confidence interval was not estimable due to insufficient number of events.	17.35 months Interval 17.35 to Upper limit of 95% confidence interval was not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Population: Participants in the FAS population with available data were analyzed.

FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), social/family well-being (SWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), emotional well-being (EWB) (6 items; 0 \[worst\] to 4 \[better\], score range 0-24), and functional well-being (FWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale \[PCS\] 12 items rated on Likert-type scale 0 \[worst\] to 4 \[better\], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life.

Outcome measures

Outcome measures
Measure	Enzalutamide n=124 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.	Placebo n=133 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Baseline	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 1	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 13	1.15 score on a scale Standard Deviation 4.15	1.36 score on a scale Standard Deviation 3.63
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 25	0.69 score on a scale Standard Deviation 3.85	1.03 score on a scale Standard Deviation 3.58
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 37	1.91 score on a scale Standard Deviation 3.85	1.43 score on a scale Standard Deviation 3.73
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 49	1.22 score on a scale Standard Deviation 3.62	0.73 score on a scale Standard Deviation 4.24
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 61	0.59 score on a scale Standard Deviation 4.52	2.00 score on a scale Standard Deviation 3.58
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 73	1.69 score on a scale Standard Deviation 3.13	-1.00 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 85	1.00 score on a scale Standard Deviation 4.06	-5.00 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 97	3.90 score on a scale Standard Deviation 4.75	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 109	2.93 score on a scale Standard Deviation 3.49	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 121	4.00 score on a scale Standard Deviation 2.83	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 133	2.00 score on a scale Standard Deviation 0.00	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 145	2.00 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 157	2.00 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 169	1.00 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) EWB: Change at Week 181	2.00 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Baseline	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 1	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 13	-1.8144 score on a scale Standard Deviation 5.0586	-0.3121 score on a scale Standard Deviation 4.7437
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 25	-2.4472 score on a scale Standard Deviation 5.2508	-0.8229 score on a scale Standard Deviation 5.2563
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 37	-1.5697 score on a scale Standard Deviation 6.3251	-0.1459 score on a scale Standard Deviation 3.2857
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 49	-1.1579 score on a scale Standard Deviation 6.7284	-1.3818 score on a scale Standard Deviation 4.5238
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 61	0.0000 score on a scale Standard Deviation 4.7651	-2.3333 score on a scale Standard Deviation 2.8048
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 73	-1.8182 score on a scale Standard Deviation 3.5726	-2.0000 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 85	1.2000 score on a scale Standard Deviation 4.8166	0.0000 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 97	-0.5000 score on a scale Standard Deviation 1.7321	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 109	-1.3333 score on a scale Standard Deviation 3.2146	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 121	-1.5000 score on a scale Standard Deviation 0.7071	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 133	-0.5000 score on a scale Standard Deviation 2.1213	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 145	-2.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 157	0.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 169	-1.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) FWB: Change at Week 181	0.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Baseline	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 1	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 13	-0.7836 score on a scale Standard Deviation 17.7356	1.7986 score on a scale Standard Deviation 16.3294
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 25	-5.9204 score on a scale Standard Deviation 18.2107	1.0762 score on a scale Standard Deviation 17.0168
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 37	-1.5351 score on a scale Standard Deviation 20.3721	0.1649 score on a scale Standard Deviation 15.8335
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 49	-4.4880 score on a scale Standard Deviation 24.6865	-4.6202 score on a scale Standard Deviation 17.9530
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 61	-0.2957 score on a scale Standard Deviation 17.6915	6.0939 score on a scale Standard Deviation 8.8208
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 73	-0.3917 score on a scale Standard Deviation 18.3346	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 85	1.7636 score on a scale Standard Deviation 11.7476	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 97	6.2864 score on a scale Standard Deviation 9.8128	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 109	-2.7333 score on a scale Standard Deviation 17.6299	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 121	4.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 133	-7.0000 score on a scale Standard Deviation 4.2426	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 145	-11.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 157	-1.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 169	-10.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Global Score: Change at Week 181	-4.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Baseline	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 1	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 13	-1.3322 score on a scale Standard Deviation 6.0823	-0.6347 score on a scale Standard Deviation 4.4643
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 25	-3.1317 score on a scale Standard Deviation 6.5208	-0.4590 score on a scale Standard Deviation 4.2887
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 37	-2.1786 score on a scale Standard Deviation 5.5611	-0.9556 score on a scale Standard Deviation 4.3691
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 49	-2.5316 score on a scale Standard Deviation 8.0882	-1.3913 score on a scale Standard Deviation 6.1625
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 61	-1.3889 score on a scale Standard Deviation 6.9886	1.3333 score on a scale Standard Deviation 3.8297
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 73	-0.3636 score on a scale Standard Deviation 8.0408	3.0000 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 85	1.0000 score on a scale Standard Deviation 10.3682	3.0000 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 97	1.7500 score on a scale Standard Deviation 10.4363	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 109	-0.6667 score on a scale Standard Deviation 13.6504	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 121	-4.0000 score on a scale Standard Deviation 1.4142	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 133	-4.5000 score on a scale Standard Deviation 0.7071	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 145	-4.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 157	0.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 169	-4.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PWB: Change at Week 181	-2.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Baseline	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 1	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 13	1.1842 score on a scale Standard Deviation 6.1843	1.6011 score on a scale Standard Deviation 6.0731
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 25	-0.4775 score on a scale Standard Deviation 6.2665	1.8632 score on a scale Standard Deviation 6.3433
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 37	-1.1433 score on a scale Standard Deviation 7.3006	0.6988 score on a scale Standard Deviation 7.1353
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 49	-1.8465 score on a scale Standard Deviation 8.6083	-0.7223 score on a scale Standard Deviation 7.8442
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 61	0.3690 score on a scale Standard Deviation 6.0031	4.2606 score on a scale Standard Deviation 3.1148
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 73	0.9174 score on a scale Standard Deviation 7.8001	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 85	2.1636 score on a scale Standard Deviation 5.6123	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 97	3.8864 score on a scale Standard Deviation 3.3380	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 109	-1.6667 score on a scale Standard Deviation 5.8595	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 121	2.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 133	-3.0000 score on a scale Standard Deviation 4.2426	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 145	-5.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 157	0.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 169	-3.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) PCS: Change at Week 181	-2.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Baseline	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 1	0.0000 score on a scale Standard Deviation 0.0000	0.0000 score on a scale Standard Deviation 0.0000
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 13	-0.1581 score on a scale Standard Deviation 4.1893	-0.2953 score on a scale Standard Deviation 5.0738
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 25	-0.3634 score on a scale Standard Deviation 5.6959	-0.0462 score on a scale Standard Deviation 3.7933
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 37	0.8798 score on a scale Standard Deviation 4.6897	-0.3963 score on a scale Standard Deviation 3.3279
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 49	-0.0719 score on a scale Standard Deviation 6.2561	-0.7536 score on a scale Standard Deviation 4.3164
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 61	-0.8167 score on a scale Standard Deviation 3.3323	0.8333 score on a scale Standard Deviation 5.7067
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 73	-0.8182 score on a scale Standard Deviation 2.7863	-24.0000 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 85	-3.6000 score on a scale Standard Deviation 3.7815	-24.0000 score on a scale
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 97	-2.7500 score on a scale Standard Deviation 5.8523	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 109	-2.0000 score on a scale Standard Deviation 4.3589	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 121	0.5000 score on a scale Standard Deviation 0.7071	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 133	-1.0000 score on a scale Standard Deviation 1.4142	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 145	-2.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 157	-3.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 169	-3.0000 score on a scale	—
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) SWB: Change at Week 181	-2.0000 score on a scale	—

SECONDARY outcome

Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Population: Participants in the FAS population with available data were analyzed.

The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable).

Outcome measures

Outcome measures
Measure	Enzalutamide n=121 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.	Placebo n=130 Participants Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Baseline	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 1	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 13	2.3 score on a scale Standard Deviation 19.7	-0.8 score on a scale Standard Deviation 17.8
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 25	-3.0 score on a scale Standard Deviation 18.6	-0.2 score on a scale Standard Deviation 17.7
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 37	-1.3 score on a scale Standard Deviation 21.7	0.4 score on a scale Standard Deviation 15.8
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 49	-2.5 score on a scale Standard Deviation 25.7	-8.3 score on a scale Standard Deviation 23.3
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 61	1.3 score on a scale Standard Deviation 22.6	2.5 score on a scale Standard Deviation 25.2
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 73	-3.5 score on a scale Standard Deviation 30.8	-20.0 score on a scale
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 85	7.2 score on a scale Standard Deviation 20.7	-10.0 score on a scale
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 97	17.8 score on a scale Standard Deviation 27.0	—
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 121	-7.0 score on a scale Standard Deviation 4.2	—
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 133	0.5 score on a scale Standard Deviation 13.4	—
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 109	17.7 score on a scale Standard Deviation 23.6	—
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 145	1.0 score on a scale	—
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 157	-4.0 score on a scale	—
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 169	2.0 score on a scale	—
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) Change at Week 181	-4.0 score on a scale	—

Adverse Events

Period 1: Enzalutamide

Serious events: 238 serious events

Other events: 523 other events

Deaths: 51 deaths

Period 2: Enzalutamide

Serious events: 67 serious events

Other events: 125 other events

Deaths: 18 deaths

Period 2: Placebo

Serious events: 52 serious events

Other events: 123 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Disclosure

Astellas Pharma Europe Ltd. (APEL)

Phone: +44 (0) 20 3379 8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER