Active Not Recruiting PHASE2 INTERVENTIONAL 1-arm NCT04030559

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

Phase II Trial of PARP Inhibitor Niraparib for Men With High Risk Prostate Cancer and DNA Damage Response Defects

Sponsor: Janssen, LP

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 Niraparib Niraparib Tosylate Monohydrate Radical Prostatectomy

Updated 14 times since 2019 Last updated: Aug 19, 2025 Started: Feb 25, 2020 Primary completion: Dec 31, 2025 Completion: Dec 31, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04030559, this PHASE2 trial focuses on ATM Gene Mutation and BRCA1 Gene Mutation and remains ongoing. Sponsored by Janssen, LP, it has been updated 14 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

14 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
Feb 2025 — Sep 2025 [monthly]

Recruiting PHASE2
Sep 2024 — Feb 2025 [monthly]

Recruiting PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE2
Feb 2024 — Jul 2024 [monthly]

Recruiting PHASE2

▶ Show 9 earlier versions

Nov 2022 — Feb 2024 [monthly]

Recruiting PHASE2
Feb 2022 — Nov 2022 [monthly]

Recruiting PHASE2
May 2021 — Feb 2022 [monthly]

Recruiting PHASE2
Jan 2021 — May 2021 [monthly]

Recruiting PHASE2
May 2020 — Jan 2021 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
Feb 2020 — May 2020 [monthly]

Not Yet Recruiting PHASE2
Dec 2019 — Feb 2020 [monthly]

Not Yet Recruiting PHASE2
Oct 2019 — Dec 2019 [monthly]

Not Yet Recruiting PHASE2
Aug 2019 — Oct 2019 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Janssen, LP
Marc Dall'Era, MD
National Cancer Institute (NCI)

Data source: University of California, Davis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Sacramento, United States