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

NCT01288911 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2024-12-06

Study results available
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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.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

enzalutamide

capsules

DRUG

bicalutamide

tablets

Sponsors & Collaborators

  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · Carolina Urologic Research Center

  • Associate Medical Science Director · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-22
Primary Completion
2014-10-19
Completion
2017-11-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288911 on ClinicalTrials.gov