NCT01543776

Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer

A Prospective Randomized Pilot Study Evaluating the Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate in Men With Castrate Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.

Detailed description

PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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 state. 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 criteria). 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 low-fat breakfast. 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.

Conditions

• Castration-resistant Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	abiraterone acetate	Given PO

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2012-03-05
• Last updated: 2019-07-05
• Results posted: 2019-07-05

Locations

6 sites across 2 countries: United States, Singapore

Regulatory

• FDA-regulated drug study