At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 509 enrolled
Drug / intervention
Enzalutamide +3 moredrug
Likely dose
Enzalutamide 160 mgfrom 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 PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
In Brief
A Phase 4 clinical trial evaluating Enzalutamide, Abiraterone, and 2 other interventions for Prostate Cancer. Completed, enrolled 509 participants across 95 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Belgium, Denmark, Finland, France, Italy, Slovakia, Spain, Sweden, United Kingdom, United States
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedNov 2013
Primary CompletionNov 2016
Study CompletionAug 2022
TodayJul 2026
First PostedNov 26, 2013
Enrollment StartOct 22, 2013
Primary CompletionNov 15, 2016
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.6 years ago
Interventions
Enzalutamidedrug
160 mg by mouth once daily
Abirateronedrug
1000 mg by mouth once daily
Placebo for Enzalutamidedrug
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
Prednisonedrug
5 mg by mouth twice daily