At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 688 enrolled
Drug / intervention
Enzalutamide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone
In Brief
A Phase 3 clinical trial evaluating Enzalutamide, Docetaxel, and 2 other interventions for Metastatic Castration Resistant Prostate Cancer. Completed, enrolled 688 participants across 89 sites in 16 countries.
Detailed Summary
The purpose of the study was to understand if there was benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer had gotten worse when treated with enzalutamide alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartDec 2014
Primary CompletionApr 2020
Study CompletionMar 2024
TodayJul 2026
First PostedNov 11, 2014
Enrollment StartDec 1, 2014
Primary CompletionApr 30, 2020
Study CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 11.6 years ago
Interventions
Enzalutamidedrug
Oral
Docetaxeldrug
intravenous infusion
Prednisolonedrug
Oral
Placebodrug
Oral