Study on the Effectiveness and Safety of Apalutamide with Abiraterone Acetate and Prednisone for Prostate Cancer
Sponsor: Aragon Pharmaceuticals, Inc.
ClinicalTrials ID:NCT02257736
This clinical trial is comparing two treatments for men with metastatic castration-resistant prostate cancer who have not received chemotherapy. The study aims to see if adding apalutamide to the standard treatment of abiraterone acetate and prednisone can improve outcomes.
Patient Parameters
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Program Overview
The study is designed to find out if adding apalutamide to the usual treatment of abiraterone acetate and prednisone can help men with metastatic castration-resistant prostate cancer live longer without their cancer getting worse. This type of prostate cancer continues to grow even when testosterone levels are reduced to very low levels. Participants in the study have not received chemotherapy for their cancer before.
Description
This clinical trial involves randomly assigning participants to receive either the combination of apalutamide, abiraterone acetate, and prednisone or just abiraterone acetate and prednisone. The study is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment. It takes place across multiple medical centers and includes three phases: Screening, Treatment, and Follow-up. At the end of the study, the results will be analyzed, and participants may have the option to continue treatment in an open-label phase, where they will know which treatment they are receiving. Throughout the study, participants' health and safety will be closely monitored.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with adenocarcinoma of the prostate.
- Cancer has spread to other parts of the body, confirmed by specific scans.
- Prostate cancer that continues to grow despite low testosterone levels, shown by rising PSA levels.
- If previously treated with certain anti-androgen medications, must have stopped them at least 6 weeks before joining the study and show continued cancer growth.
- Cancer progression confirmed by rising PSA levels or scans showing tumor growth.
- Participants switching from prednisone alone to the combination treatment must still be in the double-blind phase and have a performance status score of 0, 1, or 2.
Exclusion Criteria
- Have a different type of prostate cancer, such as small cell or neuroendocrine carcinoma.
- Have cancer that has spread to the brain.
- Have received chemotherapy for prostate cancer, except in specific early treatment settings.
- Have been treated with ketoconazole for prostate cancer for more than 7 days.
- Must stop certain medications and supplements at least 4 weeks before joining the study, including those that lower seizure thresholds or affect PSA levels.
- Require strong pain medications at the start of the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Phoenix | Arizona | ||
| La Mesa | California | ||
| Los Angeles | California | ||
| Modesto | California | ||
| San Diego | California | ||
| San Francisco | California | ||
| Santa Barbara | California | ||
| Aurora | Colorado | ||
| Denver | Colorado | ||
| Jensen Beach | Florida |
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