an efficacy and safety study of abiraterone acetate and prednisone in participants with prostate cancer who failed androgen deprivation and docetaxel-based chemotherapy

Conditions: Prostatic Neoplasms; Prostate Cancer

Summary: 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.

Eligibility criteria:
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 (\ = 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

Keywords: prostatic neoplasms prostate cancer abiraterone acetate cb7630 prednisone