Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer
- Conditions
- Recurrent Prostate CancerAdenocarcinoma of the ProstateHormone-resistant Prostate CancerStage IV Prostate Cancer
- Interventions
- Dietary Supplement: dietary interventionOther: pharmacological studyOther: questionnaire administrationOther: laboratory biomarker analysis
- Registration Number
- NCT01913015
- Lead Sponsor
- OHSU Knight Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 3
- Histologically confirmed adenocarcinoma of the prostate
- About to initiate or currently being treated with abiraterone acetate 1000 mg orally once daily
- Clinically able to receive abiraterone acetate in the opinion of the investigator in accordance with standard prescribing practices
- Ability to consume a low fat and high fat diet
- Expected duration of continuous abiraterone therapy > 8 weeks
- Signed and dated informed consent
- Patients taking medications that strongly inhibit or induce cytochrome P450 (CYP)3A4 within 28 days prior to the start of the study will be excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm I (abiraterone acetate, low then high fat breakfast) questionnaire administration Patients receive standard dose abiraterone acetate PO 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 I (abiraterone acetate, low then high fat breakfast) pharmacological study Patients receive standard dose abiraterone acetate PO 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 (abiraterone acetate, high then low fat breakfast) dietary intervention 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. Arm II (abiraterone acetate, high then low fat breakfast) questionnaire administration 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. Arm II (abiraterone acetate, high then low fat breakfast) pharmacological study 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. Arm I (abiraterone acetate, low then high fat breakfast) dietary intervention Patients receive standard dose abiraterone acetate PO 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 I (abiraterone acetate, low then high fat breakfast) laboratory biomarker analysis Patients receive standard dose abiraterone acetate PO 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 (abiraterone acetate, high then low fat breakfast) laboratory biomarker analysis 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. Arm I (abiraterone acetate, low then high fat breakfast) abiraterone acetate Patients receive standard dose abiraterone acetate PO 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 (abiraterone acetate, high then low fat breakfast) abiraterone acetate 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.
- Primary Outcome Measures
Name Time Method Area under the curve (AUC)0-24 measurement Up to 24 hours (day 1) 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.
- Secondary Outcome Measures
Name Time Method Accuracy of patient-collected DBS sampling technique Day 3 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.
Patient adherence to pre-defined sampling schedule Up to day 14 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.
Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method Day 14 Paired t-test will be conducted to compare the DBC (or transformed DBC) for the evaluation of carry-over effect.
Trial Locations
- Locations (1)
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States