Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Janssen Research & Development, LLC

Stanford Investigator(s):

Intervention(s):

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

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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:

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting