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

OHSU Knight Cancer Institute

Status and phase

Terminated

Phase 1

Conditions

Hormone-resistant Prostate Cancer

Stage IV Prostate Cancer

Adenocarcinoma of the Prostate

Recurrent Prostate Cancer

Treatments

Drug: abiraterone acetate

Other: questionnaire administration

Other: pharmacological study

Dietary Supplement: dietary intervention

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01913015

9130

NCI-2013-01223 (Registry Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

3 participants in 2 patient groups

Arm I (abiraterone acetate, low then high fat breakfast)

Experimental group

Description:

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.

Treatment:

Other: questionnaire administration

Dietary Supplement: dietary intervention

Other: pharmacological study

Other: laboratory biomarker analysis

Dietary Supplement: dietary intervention

Drug: abiraterone acetate

Arm II (abiraterone acetate, high then low fat breakfast)

Experimental group

Description:

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.

Treatment: