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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04030559
Phase
PHASE2
Status
Terminated

Conditions

  • ATM Gene Mutation
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • BRIP1 Gene Mutation
  • CDK12 Gene Mutation
  • CHEK1 Gene Mutation
  • CHEK2 Gene Mutation
  • DNA Damage Response Gene Mutation
  • DNA Repair Gene Mutation
  • FANCA Gene Mutation
  • FANCD2 Gene Mutation
  • FANCL Gene Mutation
  • GEN1 Gene Mutation
  • NBN Gene Mutation
  • Prostate Carcinoma
  • RAD51 Gene Mutation
  • RAD51C Gene Mutation

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 25, 2020
Status verified
May 2026
Primary completion
Jan 10, 2024
Completion
Nov 7, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (niraparib)
    Patients receive niraparib PO QD on days 1-28. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Following completion of treatment, patients then undergo standard of care surgery.

Primary Outcome Measure

Pathologic Response Rate (pRR) [ Time Frame: Up to the time of radical prostatectomy procedure, about 5 months from start of treatment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-

Find similar trials in Sacramento, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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