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

NCT04030559 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-05-14

Study results available
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Summary

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.

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

Interventions

DRUG

Niraparib

Given PO

DRUG

Niraparib Tosylate Monohydrate

Given PO

PROCEDURE

Radical Prostatectomy

Undergo standard of care surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Janssen, LP

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Marc Dall'Era · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2024-01-10
Completion
2025-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030559 on ClinicalTrials.gov