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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cougar Biotechnology, Inc.
• Treatments: Abiraterone Acetate; Docetaxel; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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