A Randomized Phase II Study Evaluating the Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate in Men With Castrate Resistant Prostate Cancer
I. To compare the pharmacodynamic effect of reduced dose (250mg daily) abiraterone acetate
in the prandial state (250mg-Fed) to the full, standard 1000mg daily dose in the fasting
state (1000mg-Fasting) as assessed by change in serum prostate-specific antigen (PSA).
I. To evaluate the effect of prandial states on plasma levels and the intra-patient
pharmacokinetic variability of abiraterone acetate.
II. To evaluate the safety profile of reduced dose abiraterone acetate taken in the prandial
III. To evaluate the pharmacodynamic effect of reduced dose abiraterone acetate in the
prandial state as assessed by reduction in the extra-gonadal androgen dihydroepiadrosterone
sulfate (DHEA-S) and dihydroepiandrostenedione (DHEA).
IV. To evaluate the effect of prandial state on time to disease progression (Working group
OUTLINE: Patients are randomized to one of two treatment arms.
ARM I: Patients receive abiraterone acetate orally (PO) daily first thing in morning after
an overnight fast of at least 8 hours.
ARM II: Patients receive abiraterone acetate PO daily within 30 minutes of a conventional
In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Both arms will also be treated with prednisone 5mg twice daily.
After completion of study treatment, patients are followed up within 30 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in PSA level
Analyzed on a log scale.
From baseline to 12 weeks
University of Chicago
United States: Institutional Review Board
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|University of Chicago||Chicago, Illinois 60637|
|Illinois Cancer Care||Peoria, Illinois 61615|