Adenocarcinoma of the Prostate Clinical Trial
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)
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.
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.
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