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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Given PO
Receive low fat breakfast
Receive high fat breakfast
Correlative studies
Ancillary studies
Correlative studies
OHSU Knight Cancer Institute
Portland, Oregon, United States
Area under the curve (AUC)0-24 measurement
The cross-over difference (log\[AUC0-24(low fat)\] - log\[AUC0-24(high fat)\]) of each patient will be computed and graphically illustrated. The cross-over difference will be estimated and reported with 95% confidence interval. Hills-Armitage approach will be used to adjust for the period effect for the estimation. In addition, a bioequivalence range will be computed for the log(AUC0-24\[1000 mg with fasting food\]), allowing for 20% differences in each side.
Time frame: Up to 24 hours (day 1)
Accuracy of patient-collected DBS sampling technique
The first three patients enrolled will have duplicate venous blood samples obtained in clinic 2 hours post-dose for in vivo confirmation of the DBS methodology.
Time frame: Day 3
Patient adherence to pre-defined sampling schedule
Patients will document the date/time of drug administration and the date/time of sample collection using a drug and DBS sample diary. Deviations greater than 10% of the shorter of the two time intervals surrounding the pre-defined time point will be considered non-adherent. Adherence rates will be compared for different time points.
Time frame: Up to day 14
Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method
Paired t-test will be conducted to compare the DBC (or transformed DBC) for the evaluation of carry-over effect.
Time frame: Day 14
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