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

Stopped early · Phase 1

Conditions studied: Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01913015

Run by

OHSU Knight Cancer Institute

People needed

3

Starts

2013-07-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• OHSU Knight Cancer Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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