OncRef

Clinical Trial: NCT00887198

Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Janssen Research & Development, LLC
Information Provided By:Janssen Research & Development, LLC
Last Update Posted:2025-02-04

Study Overview

Brief Summary

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

Official Title

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Conditions

Prostate Cancer

Intervention / Treatment

  • Drug: Abiraterone acetate
  • Drug: Placebo
  • Drug: Prednisone

Other Study ID Numbers

  • CR016927
  • COU-AA-302
  • 2008-008004-41
  • 2008

Start Date (Actual)

2009-04-28

Primary Completion Date (Actual)

2014-03-31

Study Completion Date (Actual)

2017-05-25

Enrollment (Actual)

1088

Study Type

Interventional

Phase

Phase 3