18 and older, male only, with Progressive Metastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Prostate-specific Antigen (PSA) ProgressionPrimary· From the date of randomization to PSA progression median follow-up time is 6.47 months for enzalutamide and 2.99 months for placebo
The time to Prostate Specific Antigen (PSA) progression was defined as the time from randomization to the PSA progression. The PSA progression was defined according to the consensus guidelines of Prostate Cancer Clinical Trials Working Group 2 (PCWG2).For participants with PSA decline at Week 13, the PSA progression date was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which would be confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at Week 13, the PSA progression date was defined as the date when
Group
Value
95% CI
Enzalutamide
8.31
5.72 – 10.25
Placebo
2.86
2.83 – 4.63
Duration of Overall SurvivalSecondary· From the date of randomization to deaths from any cause median follow-up time is 42.32 months for enzalutamide and 26.81 months for placebo
Duration of overall survival was defined as the time from the randomization to deaths from any cause. For participants who were alive at the time of the data analysis, overall survival time was censored to the last know date the participants were known to be alive.
Group
Value
95% CI
Enzalutamide
39.06
29.24 – 57.63
Placebo
27.10
21.88 – 37.82
Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility AssessmentSecondary· From the date of randomization to the rPFS event (deaths from any cause and radiographic disease progression) median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo
Duration of Radiographic Progression-free Survival (rPFS) was defined as the time from randomization to the rPFS event (deaths from any cause and radiographic disease progression). Radiographic disease progression is defined by RECIST 1.1 for soft tissue disease, or PCWG2 for bone lesions. If a participant met the criteria for more than 1 censoring rule, they were censored with the earliest censoring date. The radiographic progression date was the first date when progression definition was met, not confirmed.
Group
Value
95% CI
Enzalutamide
NA
10.97 – NA
Placebo
5.29
3.61 – 11.33
Time to First Skeletal-Related EventSecondary· From the date of randomization to the first skeletal-related event median follow-up time is 7.39 months for enzalutamide and 5.29 months for placebo
Time to first skeletal-related event (SRE) was defined as the time from randomization to the first skeletal-related event, defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Participants who have not had a SRE at the time of the analysis were censored at their last assessment indicating no evidence of SRE.
Group
Value
95% CI
Enzalutamide
NA
NA – NA
Placebo
NA
NA – NA
Time to Initiation of Cytotoxic ChemotherapySecondary· From the date of randomization to initiation of cytotoxic chemotherapy median follow-up time is 7.39 months for enzalutamide and 5.19 months for placebo
Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy. It included only therapies for prostate cancer. When multiple cytotoxic chemotherapies were initiated, the first chemotherapy was used to determine the time to event. Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of their last assessment indicating no evidence of cytotoxic chemotherapy usage.
Group
Value
95% CI
Enzalutamide
NA
NA – NA
Placebo
13.93
NA – NA
Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)Secondary· From baseline to the lowest post-baseline PSA result median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo
Best PSA response was defined as as ≥50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. Only participants who had both baseline and post-baseline assessments were included in the analysis.
Group
Value
95% CI
Enzalutamide
120
Placebo
15
Best Overall Soft Tissue ResponseSecondary· From the date of randomization median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo
Participants with measurable soft tissue disease at screening visit (i.e., at least one target lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) who have an objective response (complete response (CR) or partial response (PR)) during the study were included in the best overall soft tissue response assessment. The best overall soft tissue response was based on the investigator assessment using RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the c
Group
Value
95% CI
Enzalutamide
18
Placebo
1
Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2Secondary· From the date of randomization, Single Dosing Day 1 and Multiple Dosing Day 85
Day 1
Group
Value
95% CI
Enzalutamide
0.975
0.500 – 6.05
M1- Carboxylic Acid Metabolite
24.0
0.550 – 24.9
M2- N-Desmethyl Enzalutamide
24.0
0.550 – 24.9
Enzalutamide Plus M2
0.975
0.500 – 24.0
Day 85
Group
Value
95% CI
Enzalutamide
1.00
0 – 2.00
M1- Carboxylic Acid Metabolite
1.02
0.217 – 24.1
M2- N-Desmethyl Enzalutamide
0
0 – 23.8
Enzalutamide Plus M2
0.250
0 – 23.8
Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2Secondary· From the date of randomization, Single Dosing Day 1 and Multiple Dosing Day 85
Day 1
Group
Value
95% CI
Enzalutamide
3.92
± 1.37
M1- Carboxylic Acid Metabolite
0.112
± 0.0794
M2- N-Desmethyl Enzalutamide
0.175
± 0.0921
Enzalutamide Plus M2
3.94
± 1.34
Day 85
Group
Value
95% CI
Enzalutamide
20.0
± 3.22
M1- Carboxylic Acid Metabolite
14.0
± 23.5
M2- N-Desmethyl Enzalutamide
15.2
± 3.44
Enzalutamide Plus M2
34.2
± 4.98
AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2Secondary· From the date of randomization, Single Dosing Day 1 and Multiple Dosing Day 85
Group
Value
95% CI
Enzalutamide
43.1
± 9.64
M1- Carboxylic Acid Metabolite
1.81
± 0.972
M2- N-Desmethyl Enzalutamide
2.17
± 1.30
Enzalutamide Plus M2
45.3
± 10.1
Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2Secondary· From the date of randomization, Single Dosing Day 1 and Multiple Dosing Day 85
N is the number of participants with available data at this time point.
Day 1
Group
Value
95% CI
Enzalutamide
1.65
± 0.343
M1- Carboxylic Acid Metabolite
0.111
± 0.0801
M2- N-Desmethyl Enzalutamide
0.164
± 0.0942
Enzalutamide Plus M2
1.82
± 0.363
Day 85
Group
Value
95% CI
Enzalutamide
17.6
± 3.09
M1- Carboxylic Acid Metabolite
6.09
± 3.07
M2- N-Desmethyl Enzalutamide
13.7
± 2.91
Enzalutamide Plus M2
31.2
± 4.00
Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2Secondary· From the date of randomization up to Days 2, 3, 8, 22, 29, 43, 57, 85, 86, 113, 141 and 169
N is the number of participants with available data at this time point.
Day 2 predose
Group
Value
95% CI
Enzalutamide
1.65
± 0.343
M1- Carboxylic Acid Metabolite
0.111
± 0.0801
M2- N-Desmethyl Enzalutamide
0.164
± 0.0942
Enzalutamide Plus M2
1.82
± 0.363
Day 3 predose
Group
Value
95% CI
Enzalutamide
3.29
± 1.16
M1- Carboxylic Acid Metabolite
0.302
± 0.256
M2- N-Desmethyl Enzalutamide
0.367
± 0.188
Enzalutamide Plus M2
3.66
± 1.24
Day 8 predose
Group
Value
95% CI
Enzalutamide
9.39
± 2.07
M1- Carboxylic Acid Metabolite
1.21
± 0.923
M2- N-Desmethyl Enzalutamide
1.94
± 0.983
Enzalutamide Plus M2
11.3
± 2.62
Day 22 predose
Group
Value
95% CI
Enzalutamide
17.6
± 2.37
M1- Carboxylic Acid Metabolite
6.09
± 8.26
M2- N-Desmethyl Enzalutamide
8.34
± 2.74
Enzalutamide Plus M2
25.9
± 3.25
Day 29 predose
Group
Value
95% CI
Enzalutamide
19.6
± 4.00
M1- Carboxylic Acid Metabolite
8.16
± 12.5
M2- N-Desmethyl Enzalutamide
10.9
± 3.72
Enzalutamide Plus M2
30.5
± 5.47
Day 43 predose
Group
Value
95% CI
Enzalutamide
17.0
± 4.13
M1- Carboxylic Acid Metabolite
12.5
± 22.1
M2- N-Desmethyl Enzalutamide
14.0
± 3.99
Enzalutamide Plus M2
31.0
± 5.82
Day 57 predose
Group
Value
95% CI
Enzalutamide
17.8
± 3.09
M1- Carboxylic Acid Metabolite
18.4
± 28.2
M2- N-Desmethyl Enzalutamide
14.7
± 3.88
Enzalutamide Plus M2
32.5
± 4.57
Day 85 predose
Group
Value
95% CI
Enzalutamide
17.9
± 3.19
M1- Carboxylic Acid Metabolite
6.33
± 2.95
M2- N-Desmethyl Enzalutamide
14.9
± 3.67
Enzalutamide Plus M2
32.8
± 5.10
Adverse events — posted to ClinicalTrials.gov
Time frame: All cause mortality: From the date of randomization up to 123 months and 24 days AE: From first dose on Day 1 until 28 days after the last dose of study drug, or one day before the date of initiation of cytotoxic chemotherapy or an investigational agent for treatment of prostate cancer, whichever comes first, up to 123 months and 24 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Enzalutamide
Serious: 87/202 (43%)
Deaths: 85/202
Placebo
Serious: 57/193 (30%)
Deaths: 57/193
Placebo Patients Crossover to Enzalutamide 160 mg
Serious: 24/51 (47%)
Deaths: 21/51
Serious adverse events (175 terms)
Reaction
System
Enzalutamide
Placebo
Placebo Patients Crossover…
Pneumonia
Infections and infestations
—
—
—
Haematuria
Renal and urinary disorders
—
—
—
Urinary retention
Renal and urinary disorders
—
—
—
Cardiac failure
Cardiac disorders
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
Bone pain
Musculoskeletal and connective tissue disorders
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
Chemotherapy
Surgical and medical procedures
—
—
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
Asthenia
General disorders
—
—
—
Death
General disorders
—
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07287150 — A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
NCT07226986 — A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI i
· Phase 1, PHASE2
· recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum
· Phase 1
· recruiting
NCT07028853 — This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide W
· Phase 3
· recruiting
NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC)
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 24 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02294461.