CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 375 enrolled
Drug / intervention
enzalutamide +1 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.

Search/NCT01288911
NCT01288911Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Astellas Pharma Inc·interventional·Posted Feb 3, 2011·Updated Dec 6, 2024

In Brief

A Phase 2 clinical trial evaluating enzalutamide and bicalutamide for Prostatic Neoplasms. Completed, enrolled 375 participants across 88 sites in 8 countries.

Detailed Summary

The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesBelgium, Canada, Denmark, France, Germany, Romania, United Kingdom, United States
CollaboratorsMedivation LLC, a wholly owned subsidiary of Pfizer Inc.

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2011
Enrollment StartMar 22, 2011
Primary CompletionOct 19, 2014
Study CompletionNov 8, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.4 years ago

Interventions

enzalutamidedrug

capsules

bicalutamidedrug

tablets