A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate

This is a nonrandomized (individuals will not be assigned by chance to study treatments),

open-label (individuals will know the identity of study treatments), long-term safety

follow-up study of abiraterone acetate in approximately 300 patients from other completed

abiraterone acetate clinical studies. Patients must have received at least 3 months of

treatment with abiraterone acetate and a low-dose corticosteroid and, based on

investigator assessment, may benefit from continued treatment. This study will consist of

a screening period followed by open-label treatment of continued abiraterone acetate

access. The patients will continue with the same abiraterone acetate and low-dose

corticosteroid dosing regimen they were receiving in the previous abiraterone acetate

clinical study until the investigator determines that the patient is no longer receiving

benefit or the sponsor terminates the study. Patients can be withdrawn from the study if

an alternative access (eg, patient-assistance program or commercial source of abiraterone

acetate) is available and feasible. Each cycle of treatment will be 28 days.

Investigators will monitor and assess the patients for response to treatment or

progression according to routine practice or as clinically indicated to determine whether

continued treatment with abiraterone acetate is warranted. No efficacy data are being

collected. Safety will be monitored throughout the study for a maximum duration of 9

years. End-of-study assessments will be performed at least 30 days after the last dose of

abiraterone or upon early withdrawal.