OHSU

IRB #

IRB00009130

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)

Principal Investigator

Tomasz Beer

Study Purpose

Abiraterone acetate is a medication used to treat metastatic prostate cancer and is taken once a day on an empty stomach. While it has been shown to work well in metastatic castrate resistant prostate cancer, it is a very expensive drug. Studies have shown that taking abiraterone with food can increase the level of drug in your blood. We want to determine if taking a lower dose of abiraterone with breakfast can achieve the same level of drug in your blood and therefore save money on prescription costs.

Medical Condition(s)

prostate cancer that is no longer responding to hormones and has spread outside the prostate (ie- metastatic prostate cancer)

Eligibility Criteria

1) Patients must have metastatic prostate cancer.
2) Patients must be currently taking or about to begin taking abiraterone acetate for prostate cancer.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Approximately 6-8 weeks

Minors Included

No

Contact

To be determined

Sponsor

OHSU Knight Cancer Institute

Recruitment End

Compensation Provided

No


Go Back