Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects

About the Study

This study will look at how well the PARP Inhibitor niraparib works, when given before a radical prostatectomy, for people with high-risk prostate cancer that has not spread to other parts of the body, and who have a tumor mutation in any of the following genes:BRCA1/2, ATM, CDK12, CHEK1/2 FANCA, FANCD2, FANCL, GEN1, NBN, PALB2, RAD51, RAD51c, and BRIP1.

What the Study Entails

• All study participants will receive niraparib orally once daily.
• Treatment will continue for up to 3 cycles of 28 days (a total of up to 84 days) in the absence of disease progression or unacceptable toxicity.
• Following completion of treatment, patients will undergo a radical prostatectomy (surgery).
• After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, and then every 6 months for up to 3 years.

Study Site

California
Sacramento, CA
University of California Davis Comprehensive Cancer Center 
Contact: Dr. Marc Dall'Era by phone: 916-734-3771 or by email: [email protected]

People diagnosed with prostate cancer who meet the following criteria:

• must have localized prostate cancer that is classified as high risk per National Comprehensive Cancer Network (NCCN) guideline.
• life expectancy of greater than 10 years.
• planning radical prostatectomy as the primary treatment for their prostate cancer.
• prostate cancer tumors must have at least one mutation in a gene involved in DNA repair as determined by a Foundation One test:
  • BRCA1, BRCA2, ATM, CHEK2, PALB2, RAD51C, BRIP1 and others. Check clinicaltrials.gov or study contact for a full list of genes. 

People with the following may not participate:

• received prior treatment for prostate cancer.
• previously received a PARP inhibitor.

• significant abnormal heart rhythm.

Check clinicaltrials.gov or study contact for a full list of exclusion criteria.