Study Comparing Niraparib with Abiraterone Acetate and Prednisone to Abiraterone Acetate and Prednisone Alone for Treating Metastatic Prostate Cancer
Sponsor: Janssen Research & Development, LLC
Sponsor score: 60
ClinicalTrials ID:NCT03748641
This clinical trial is testing whether adding the drug niraparib to the standard treatment of abiraterone acetate and prednisone can improve outcomes for patients with metastatic prostate cancer compared to the standard treatment alone.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to see if combining the drug niraparib with abiraterone acetate and prednisone is more effective than using abiraterone acetate and prednisone alone in treating men with metastatic prostate cancer. Researchers want to find out if this combination can better control the cancer.
Eligibility Criteria
Inclusion Criteria
- Have a specific gene change related to DNA repair (HRR gene alteration) or be eligible based on HRR status.
- Have prostate cancer that has spread to other parts of the body, confirmed by scans.
- Have low testosterone levels due to treatment or surgery.
- Be able to continue hormone therapy if not surgically castrated.
- Have a pain score of 3 or less on a pain questionnaire about the worst pain in the last 24 hours.
Exclusion Criteria
- Have previously been treated with a PARP inhibitor.
- Have received certain other cancer treatments, like specific hormone therapies or chemotherapy, for more than 4 months before joining the study.
- Have cancer that has spread to the brain and is causing symptoms.
- Have a history or current diagnosis of certain blood disorders like MDS or AML.
- Have had another type of cancer within the last 2 years, unless it was a non-serious type like certain skin cancers or bladder cancer that is in complete remission.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Urology Centers Of Alabama | 35209 | Homewood | Alabama |
| Mayo Clinic Arizona | 85054 | Phoenix | Arizona |
| Urological Associates of Southern Arizona, P.C. | 85741 | Tucson | Arizona |
| Arkansas Urology | 72211 | Little Rock | Arkansas |
| Kaiser Permanente | 92505 | Riverside | California |
| San Bernardino Urological Associates | 92404 | San Bernardino | California |
| University of California San Francisco | 94158 | San Francisco | California |
| Sansum Clinic Pharm | 93105 | Santa Barbara | California |
| The Urology Center of Colorado | 80211 | Denver | Colorado |
| Colorado Clinical Research | 80228 | Lakewood | Colorado |
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