PRIMARY OBJECTIVES:
I. To assess the dietary effects of a low fat and high fat diet at a low abiraterone acetate dose (250 mg) on drug levels compared to standard dose administered in a fasting condition.
SECONDARY OBJECTIVES:
I. To potentially guide decisions in the future to use low dose abiraterone in a fed state and decrease overall cost.
II. To evaluate the potential relationship between esterase activity and abiraterone metabolism in an exploratory analysis.
III. To determine the feasibility of using patient-collected dried blood spot (DBS) samples for pharmacokinetic monitoring.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard dose abiraterone acetate orally (PO) once daily (QD) (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
ARM II: Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
