NCT01913015

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

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	abiraterone acetate	Given PO
DIETARY_SUPPLEMENT	dietary intervention	Receive low fat breakfast
DIETARY_SUPPLEMENT	dietary intervention	Receive high fat breakfast
OTHER	pharmacological study	Correlative studies
OTHER	questionnaire administration	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-06-01
• First posted: 2013-07-31
• Last updated: 2017-04-28

Locations

1 site across 1 country: United States