Status:
COMPLETED
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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-re...
Detailed Description
This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2017
Estimated Enrollment :
1088 Patients enrolled
Trial Details
Trial ID
NCT00887198
Start Date
April 28 2009
End Date
May 25 2017
Last Update
February 4 2025
Active Locations (134)
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1
Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
Bellflower, California, United States
4
Los Angeles, California, United States