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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Abiraterone Acetate

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