18 and older, male only, with Metastatic Castration-Resistant 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.
Radiographic Progression-free Survival (rPFS)Primary· From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.
Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical
Group
Value
95% CI
Enzalutamide
8.1
6.11 – 8.28
Overall Survival (OS)Secondary· From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years.
OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discon
Group
Value
95% CI
Enzalutamide
NA
18.14 – NA
Percentage of Participants With a Prostate-specific Antigen (PSA) ResponseSecondary· From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months.
PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution.
Group
Value
95% CI
Enzalutamide
22.0
16.61 – 28.11
Time to PSA ProgressionSecondary· From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.
The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progressi
Group
Value
95% CI
Enzalutamide
5.7
5.55 – 5.78
Number of Participants With Adverse Events (AEs)Secondary· From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).
Any TEAE
Group
Value
95% CI
Enzalutamide
199
NCI-CTCAE Grade ≥3
Group
Value
95% CI
Enzalutamide
95
Study Drug-Related
Group
Value
95% CI
Enzalutamide
127
Study Drug-Related NCI-CTCAE Grade ≥3
Group
Value
95% CI
Enzalutamide
18
TEAEs with Death as an Outcome
Group
Value
95% CI
Enzalutamide
22
Serious Adverse Event (SAE)
Group
Value
95% CI
Enzalutamide
82
Study Drug-related SAE
Group
Value
95% CI
Enzalutamide
8
TEAEs Leading to Study Drug Discontinuation
Group
Value
95% CI
Enzalutamide
76
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Enzalutamide Total
Serious: 82/214 (38%)
Deaths: 73/214
Serious adverse events (107 terms)
Reaction
System
Enzalutamide Total
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
General physical health deterioration
General disorders
—
Spinal cord compression
Nervous system disorders
—
Haematuria
Renal and urinary disorders
—
Anaemia
Blood and lymphatic system disorders
—
Renal failure acute
Renal and urinary disorders
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
Pneumonia
Infections and infestations
—
Bone pain
Musculoskeletal and connective tissue disorders
—
Cardiac failure
Cardiac disorders
—
Asthenia
General disorders
—
Back pain
Musculoskeletal and connective tissue disorders
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
Neutropenia
Blood and lymphatic system disorders
—
Diarrhoea
Gastrointestinal disorders
—
Pyrexia
General disorders
—
Lower respiratory tract infection
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.
Publications & conference data
7 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
Other recruiting trials for Metastatic Castration-Resistant Prostate Cancer
Currently open trials in the same condition.
NCT07287150 — A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
NCT06842498 — A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
· Phase 2
· recruiting
NCT07344311 — A Phase I Trial of A-CAR032 in Participants With mCRPC
· Phase 1
· recruiting
NCT07339267 — A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
· Phase 1
· recruiting
NCT07005154 — A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
· Phase 2
· recruiting
Other Astellas Pharma Europe B.V. trials
Trials by the same sponsor.
NCT03702777 — A Study of ASP8302 in Participants With Underactive Bladder
· Phase 2
· completed
NCT04742517 — A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects
· Phase 1
· completed
NCT03282318 — A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Sub
· Phase 2
· completed
NCT03108755 — A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Sub
· Phase 1
· completed
NCT02788123 — A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole An
· Phase 4
· terminated
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 Europe B.V.
Last refreshed: 6 December 2024
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/NCT02116582.