Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects
High-risk localized prostate cancer
Study Contact Information:
For additional information, contact:
Dr. Marc Dall'Era by phone: 916-734-3771
or by email: [email protected]
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.
University of California Davis Comprehensive Cancer Center
Contact: Dr. Marc Dall'Era by phone: 916-734-3771 or by email: [email protected]
This Study is Open To:
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.
This Study is Not Open To:
People with the following may not participate:
Check clinicaltrials.gov or study contact for a full list of exclusion criteria.
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.