| Exclusion Criteria: | 1) Histologic variants other than adenocarcinoma in the primary tumor
2) More than 2 different prior chemotherapeutic regimens for metastatic prostate cancer.
3) 3. Abnormal liver functions consisting of any of the following: • Serum bilirubin >/= 1.5 x ULN • AST and ALT >/= 2.5 x ULN, (for patients with known liver metastasis, AST and ALT </= 5 x ULN is allowed)
4) Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), Ketoconazole, finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug.
5) Active infection or intercurrent illness that are not controlled
6) Unstable angina, myocardial infarction within the previous 6 months, or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, uncontrolled hypertension. NYHA Class III or IV Congestive Heart Failure
7) Prior radiation therapy completed < 4 weeks or single fraction of palliative radiotherapy within 14 days prior to first dose of study drug.
8) Any currently active second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months
9) Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
10) Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
11) Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV)
12) Acute or chronic hepatitis B or C
13) Chemotherapy and other investigational therapies (targeted or immunotherapy) will require a 4 week washout period before treatment initiation
14) Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug. Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy during the study.
15) Long QT syndrome or bundle branch block or hemiblock or other history of life-threatening arrythmia(unless the patient has been effectively treated for it and is considered stable). Participation in the study of patients with known non pathologic RBBB is at the discretion of the Principal Investigator.
16) Known Brain metastasis
17) History of pituitary or adrenal dysfunction
18) History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.
19) Prior therapy with abiraterone acetate
20) 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 neuropathy is allowed.
21) 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. |