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

Trial ID or NCT#

NCT00887198

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Metastatic castration-resistant prostate cancer (CRPC)* Previous anti-androgen therapy and progression after withdrawal* ECOG performance status of either 0 or 1* Medical or surgical castration with testosterone less than 50 ng/dL* Life expectancy of at least 6 months
Exclusion Criteria:
  1. * Prior cytotoxic chemotherapy or biologic therapy for CRPC* Prior ketoconazole for prostate cancer* Known brain metastasis or visceral organ metastasis* Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov