Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer
This is an open-label (identity of assigned study drug will be known), observational study
to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with
advanced metastatic CRPC who have received prior chemotherapy containing a taxane.
Approximately 50 patients will be enrolled. Abiraterone acetate will be administered
according to the approved product insert with a low-dose glucocorticoid (prednisone or
prednisolone). Patient assessments will be based on the accepted clinical practice in the
Philippines. Patients will be monitored for 40 weeks.
Observational Model: Cohort, Time Perspective: Prospective
Number of participants affected by an adverse event
Up to 30 days after the last dose of study medication
is Janssen Pharmaceutica, Philippines Clinical Trial
Janssen Pharmaceutica, Philippines
Philippines: Bureau of Food and Drugs