Clinical trial NCT01913015: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-31
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area under the curve (AUC)0-24 measurement
timeFrame: Up to 24 hours (day 1)
Secondary outcomes:
measure: Accuracy of patient-collected DBS sampling technique
timeFrame: Day 3
measure: Patient adherence to pre-defined sampling schedule
timeFrame: Up to day 14
measure: Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method
timeFrame: Day 14
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Tomasz Beer
role: PRINCIPAL_INVESTIGATOR
References: