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

Clinicaltrials.gov identifier:
NCT04030559

Treatment
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]

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 niraparib works, when given before a radical prostatectomy, for people with high-risk 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, , CDK12, CHEK1/2 FANCA, FANCD2, FANCL, GEN1, , , RAD51, , and .

What the Study Entails

  • All study participants will receive 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 .
  • 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]

This Study is Open To:

People diagnosed with cancer who meet the following criteria:

  • must have localized 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 cancer.
  • cancer tumors must have at least one mutation in a gene involved in repair as determined by a Foundation One test:
    • , , , , , , 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:

  • received prior treatment for cancer.
  • previously received a .

  • significant abnormal heart rhythm.

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