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Treatment

High-risk localized prostate cancer

Clinicaltrials.gov identifier:
NCT04030559

Study Contact Information:

For additional information, contact:
Dr. Marc Dall'Era by phone: 916-734-3771
or by email: mdallera@ucdavis.edu

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

Treatment

High-risk localized prostate cancer

Clinicaltrials.gov identifier:
NCT04030559

Study Contact Information:

For additional information, contact:
Dr. Marc Dall'Era by phone: 916-734-3771
or by email: mdallera@ucdavis.edu

PRINTER FRIENDLY PAGE
Overview
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Details
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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 .

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. 

What the Study Involves

  • 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 Contact Information:

For additional information, contact:
Dr. Marc Dall'Era by phone: 916-734-3771
or by email: mdallera@ucdavis.edu

Locations:

California

City: Sacramento RECRUITING
Facility: University of California Davis Comprehensive Cancer Center
Contact Info:
mdallera@ucdavis.edu 916-734-3771
Marc Dall'Era