NCT01288911

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An open-label period was added to the main protocol. Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over bicalutamide as assessed by the primary endpoint, all ongoing enzalutamide treated participants and ongoing or previous bicalutamide treated participants that met entry criteria were offered open-label enzalutamide at the discretion of the participant and study investigators.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	enzalutamide	capsules
DRUG	bicalutamide	tablets

Timeline

• Start date: 2011-03-22
• Primary completion: 2014-10-19
• Completion: 2017-11-08
• First posted: 2011-02-03
• Last updated: 2024-12-06
• Results posted: 2015-12-03

Locations

88 sites across 8 countries: United States, Belgium, Canada, Denmark, France, Germany, Romania, United Kingdom

Regulatory

• FDA-regulated drug study