Study on Abiraterone Acetate for Patients with Advanced Prostate Cancer
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials ID:NCT01217697
This clinical trial is gathering more information on the safety of using abiraterone acetate with prednisone in patients with advanced prostate cancer that has spread and become resistant to standard hormone treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to collect safety information about the drug abiraterone acetate when used with prednisone in men with advanced prostate cancer that has spread and is no longer responding to hormone therapy. This type of cancer is known as metastatic castration-resistant prostate cancer (CRPC).
Description
This study focuses on understanding the side effects of abiraterone acetate in men with advanced prostate cancer that has spread and is resistant to hormone treatments. To join, patients must have already tried 1 or 2 chemotherapy treatments, including one with a drug like docetaxel, and live in an area where abiraterone acetate is not yet available through local healthcare. They also should not be eligible for other ongoing studies of abiraterone acetate.
Abiraterone acetate is a drug being developed to treat men with CRPC. Participants will take abiraterone and prednisone daily until their cancer progresses, as shown by symptoms or test results. Treatment may also stop if side effects occur, if other cancer treatments start, or if the patient cannot follow the treatment plan.
Patients will take four 250-mg tablets of abiraterone at least 1 hour before or 2 hours after a meal, any time up to 10 pm daily. They will also take 5 mg of prednisone twice a day. Each treatment cycle lasts 28 days, and patients will continue taking abiraterone daily until their disease progresses, at which point abiraterone will be stopped and prednisone may be reduced if needed. After stopping abiraterone, patients will be monitored for 30 days.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate cancer
- Cancer has progressed after previous chemotherapy
- Have had 1 or 2 chemotherapy treatments for metastatic CRPC, with at least one including a taxane like docetaxel
- Low testosterone levels (less than 50 ng/dL)
- Good overall health, able to perform daily activities, with an ECOG performance status of 0 to 2
Exclusion Criteria
- Have serious or uncontrolled non-cancerous diseases, including active infections
- Have active or symptomatic liver disease or abnormal liver function
- Have significant heart disease or uncontrolled high blood pressure
- Have digestive issues that affect drug absorption or problems with the pituitary or adrenal glands
- Have cancer that has spread to the brain
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.