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

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov