A Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate, but not with neuroendocrine differentiation or of small cell histology
• Prior chemotherapy for prostate cancer with regimen(s) containing paclitaxel or docetaxel
• Documented prostate-specific antigen (PSA) progression according to PSA Working Group eligibility criteria with a PSA >5 ng/mL
• On-going androgen deprivation with serum testosterone <50 ng/dL (< 2.0nM)
• Serum potassium >=3.5 mmol/L
• Eastern Cooperative Oncology Group (ECOG) Performance Status of <=2 (Karnofsky Performance Status >=50%)
• No history of adrenal insufficiency or hyperaldosteronism
• Any acute toxicities of prior chemotherapy, radiotherapy have resolved to a NCI CTCAE (version 3) grade of <=1 (chemotherapy induced alopecia and grade-2 neuropathy are excluded from this consideration)
• No radiotherapy, chemotherapy, or immunotherapy within 30 days of administration of the Cycle 1 Day 1 (supportive care with glucocorticoid is not considered as an immunotherapy; however, PSA progression must be documented under current dose/regimen)
• No surgery or local prostatic intervention within 28 days of the first dose and any clinically relevant sequelae from the surgery must have resolved prior to Cycle 1 Day 1)
• Agrees to protocol-defined use of effective contraception
• Life expectancy >12 weeks

Exclusion Criteria:

• Active or uncontrolled autoimmune disease that may require corticosteroid therapy
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• Uncontrolled hypertension
• Laboratory values not within protocol-defined parameters
• Clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
• Other malignancy within the previous 5 years other than basal cell or squamous cell carcinomas of skin with a >30% probability of recurrence within 12 months
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1
• Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study