Spots Global Cancer Trial Database for Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer

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Trial Identification

Brief Title: Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer

Official Title: An Open-Label, Phase I, Randomized Pharmacokinetic Study of Dietary Effects on Abiraterone Acetate Drug Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (DEAL)

Study ID: NCT01913015

Conditions

Adenocarcinoma of the Prostate

Hormone-resistant Prostate Cancer

Recurrent Prostate Cancer

Stage IV Prostate Cancer

Interventions

abiraterone acetate

dietary intervention

pharmacological study

questionnaire administration

laboratory biomarker analysis

Study Description

Brief Summary: This randomized pilot phase I trial studies the side effects of dietary fat levels and abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone acetate.

Detailed Description: 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.