Conditions: Prostatic Neoplasms Prostate Cancer
Keywords: Prostatic Neoplasms Prostate cancer Abiraterone acetate CB7630 Prednisone
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 58
Healthy volunteers: no

Brief 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).

Detailed description:
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.

Arms:
arm 1: Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.

Interventions: intervention 1: Abiraterone acetate intervention 2: Prednisone
Intervention descriptions: intervention 1: Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity. intervention 2: Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Protocol document: