| Exclusion Criteria: | 1) Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
2) Abnormal liver functions consisting of any of the following: a)Serum bilirubin >/= 1.5 x ULN (except for patients with documented Gilbert's disease) b)AST or ALT >/= 2.5 x ULN, (for patients with known liver metastasis, AST or ALT </= 5 x ULN is allowed)
3) Uncontrolled hypertension (systolic BP >/= 140 mmHg or diastolic BP >/= 90 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy.
4) Active or symptomatic viral hepatitis or chronic liver disease
5) History of pituitary or adrenal dysfunction
6) Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
7) Other malignancy, except non-melanoma skin cancer, with a >/= 30% probability of recurrence within 12 months
8) Known brain metastasis
9) History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
10) Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer.
11) Prior therapy with ketoconazole for prostate cancer
12) Surgery or local prostatic intervention within 30 days of the first dose. In addition, any clinically relevant sequelae from the surgery must have resolved prior to Cycle 1 Day 1
13) Radiotherapy, chemotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1
14) Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 3) grade of </= 1. Chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed
15) Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1
16) 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
17) Not willing to comply with the procedural requirements of this protocol
18) Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration. |