An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in
 participants with advanced prostate cancer (a disease in which cells in the prostate gland
 become abnormal and start to grow uncontrollably, forming tumors).
This is an open-label (all people know the identity of the intervention), single-arm,
 multicenter (when more than one hospital or medical school team work on a medical research
 study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in
 participants with prostate cancer who have failed androgen deprivation and docetaxel-based
 chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000
 milligram (mg) orally (by mouth) once daily after an overnight fast and
 prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants
 will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and
 continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days),
 Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated
 primarily for prostate specific antigen response according to Prostate Specific Antigen
 Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.
Inclusion Criteria:

 -  Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor
 with a glandular organization)of the prostate (a gland in the male reproductive system
 found below the bladder and in front of the rectum), but not with neuroendocrine
 (specialized neurons that produce hormones, such as neuropeptides or biogenic amines)
 differentiation or of small cell histology

 -  Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for
 prostate cancer with regimen(s) containing docetaxel

 -  Documented prostate specific antigen (PSA) progression according to Prostate Specific
 Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (>) 5 nanogram
 per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in
 Solid Tumors (RESIST) criteria

 -  Ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per
 deciliter (ng/dL)

 -  Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to
 (<=) 2 (Karnofsky Performance Status >= 50 percent)

 Exclusion Criteria:

 -  Active or uncontrolled autoimmune disease (disorder in which a person's immune system
 attacks parts of his or her own body) that may require corticosteroid therapy

 -  Serious or uncontrolled co-existent non-malignant disease, including active and
 uncontrolled infection

 -  Uncontrolled hypertension (high blood pressure)

 -  Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion
 support

 -  Abnormal liver (large organ that helps in many body functions, including digestion,
 metabolism, and storage of substances) function