Pre-Surgery Niraparib for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well niraparib, when given before surgery, works in treating patients with high risk prostate cancer that has not spread to other parts of the body (localized) and alterations in deoxyribonucleic acid (DNA) repair pathways. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take medications that prolong QTc or certain antiretroviral therapies that may interfere with the study drug. It's best to consult with the trial's principal investigator for specific guidance.
What data supports the idea that Pre-Surgery Niraparib for Prostate Cancer is an effective drug?
The available research shows that Niraparib, when used in combination with other treatments like abiraterone acetate and prednisone, has shown promising results for patients with metastatic castration-resistant prostate cancer. Specifically, the phase II QUEST study indicated that this combination was effective and had a manageable safety profile. Additionally, the GALAHAD trial demonstrated that patients with certain genetic alterations experienced improvements in their quality of life and pain levels when treated with Niraparib. These findings suggest that Niraparib can be an effective option for treating prostate cancer, especially in patients with specific genetic backgrounds.12345
What safety data is available for pre-surgery Niraparib treatment in prostate cancer?
The provided research does not contain specific safety data for pre-surgery Niraparib treatment in prostate cancer. The studies focus on other treatments such as parenteral oestrogen, estramustine phosphate, paclitaxel, and docetaxel, but do not mention Niraparib or its safety profile in the context of prostate cancer treatment.678910
Is the drug Niraparib a promising treatment for prostate cancer?
Yes, Niraparib shows promise as a treatment for prostate cancer. It has been effective in improving the quality of life and managing symptoms in patients with specific genetic profiles, particularly those with BRCA gene alterations. Studies have shown that it can be combined with other therapies to enhance its effectiveness, making it a hopeful option for treating advanced prostate cancer.12345
Research Team
Marc Dall'Era
Principal Investigator
University of California, Davis
Eligibility Criteria
Men with high-risk localized prostate cancer and specific DNA repair gene alterations (like BRCA1/2, ATM) can join. They must have chosen surgery as primary treatment and not received prior therapies like PARP inhibitors or hormone therapy. Participants need to be able to swallow capsules, avoid sperm donation, use condoms, and have a life expectancy of at least 10 years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib orally once daily on days 1-28, repeated every 28 days for up to 3 cycles
Surgery
Participants undergo standard of care radical prostatectomy following completion of niraparib treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment and surgery
Treatment Details
Interventions
- Niraparib
- Niraparib Tosylate Monohydrate
- Radical Prostatectomy
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
Marc Dall'Era, MD
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE Business School
Biljana Naumovic
Janssen, LP
Chief Medical Officer since 2023
MD from Belgrade University Medical School