Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostatic Neoplasms

In brief

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

Key facts

Study ID

NCT00638690

Run by

Cougar Biotechnology, Inc.

People needed

1195

Starts

2008-05-01

Expected to finish

2012-10-01

Last updated by the study team

2014-04-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies
• At least one chemotherapy must have contained docetaxel
• Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
• Medical or surgical castration with testosterone < 50 ng/dL
• Adequate bone marrow, hepatic and renal function
• Potassium >= 3.5 mmol/L
• Able to swallow the study drug whole as a tablet
• Informed Consent

You may not qualify if…

• More than two prior cytotoxic chemotherapy regimens
• Prior Ketoconazole for prostate cancer
• Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
• Uncontrolled hypertension
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Clinically significant heart disease
• Other malignancy
• Known brain metastasis
• GI disorder affecting absorption
• Not willing to use contraception

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Duarte, California, United States
• Study site — Los Angeles, California, United States
• Study site — Marina del Rey, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Bristol, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Stamford, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Galesburg, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Westwood, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Marrero, Louisiana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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