Study on Niraparib Combined with Abiraterone Acetate and Prednisone for Treating Prostate Cancer with Specific Gene Mutations
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT04497844
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 castration-sensitive prostate cancer that has specific gene mutations.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if combining niraparib with Abiraterone Acetate and Prednisone is more effective than using Abiraterone Acetate and Prednisone alone in treating prostate cancer that has spread and has specific gene mutations. The main focus is on whether this combination can help patients live longer without the cancer getting worse, as seen on scans.
Description
Prostate cancer can vary greatly between patients, and recent research has identified specific genetic mutations that can affect how the cancer grows. The standard treatment for metastatic castration-sensitive prostate cancer (mCSPC) includes Abiraterone Acetate and Prednisone. Niraparib is a drug that has been approved for use in a different type of prostate cancer with BRCA mutations. This study is exploring whether adding niraparib to the standard treatment can improve outcomes for patients with mCSPC who have certain gene mutations.
The study is divided into four phases:
- Prescreening Phase: To check if patients have the necessary gene mutations to participate.
- Screening Phase: To ensure patients meet all the study requirements.
- Treatment Phase: Where patients receive the study medications.
- Follow-up Phase: To monitor patients' health and the effects of the treatment.
Patients will undergo various tests, including scans and blood tests, to evaluate the treatment's effectiveness and safety. The study will track tumor size, prostate-specific antigen (PSA) levels, and patient-reported outcomes. Safety will be monitored by checking for any side effects and changes in lab test results.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate adenocarcinoma.
- Have specific gene mutations related to homologous recombination repair (HRR).
- Cancer has spread to other parts of the body, confirmed by scans.
- Must have started hormone therapy at least 14 days before joining the study and be willing to continue it during the study.
- Allowed previous treatments include:
- Up to one course of radiation and one surgery for symptom control.
- Up to 6 months of hormone therapy before joining the study.
- Up to 45 days of Abiraterone Acetate and Prednisone before joining the study.
- Up to 2 weeks of ketoconazole for prostate cancer before joining the study.
Exclusion Criteria
- Previous treatment with a PARP inhibitor.
- History of adrenal gland problems.
- Long-term use of high-dose corticosteroids is not allowed, but short-term or local use is permitted if needed.
- History or current diagnosis of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
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 |
| Greater Los Angeles VA Healthcare System | 90073 | Los Angeles | California |
| University of California Irvine Medical Center Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| San Bernardino Urological Associates | 92404 | San Bernardino | California |
| University of San Francisco California | 94158 | San Francisco | California |
| Rocky Mountain Cancer Centers | 80907 | Colorado Springs | Colorado |
| AdventHealth Medical Group Urology of Denver | 80210 | Denver | Colorado |
| Colorado Clinical Research | 80228 | Lakewood | Colorado |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.