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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Marc Dall'Era, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the impact of neoadjuvant niraparib tosylate monohydrate (niraparib) therapy prior to radical prostatectomy (RP) on pathologic tumor stage, frequency of lymph node metastases and positive margin rates for patients undergoing radical prostatectomy for high-risk, clinically localized prostate cancer with alterations in DNA repair pathways. SECONDARY OBJECTIVE: I. To assess 5-year biochemical recurrence in subjects with high-risk prostate cancer and DNA-damage response defects after prostatectomy. OUTLINE: Patients receive niraparib orally (PO) once daily (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. 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.

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

Type	Name	Description
DRUG	Niraparib	Given PO
DRUG	Niraparib Tosylate Monohydrate	Given PO
PROCEDURE	Radical Prostatectomy	Undergo standard of care surgery

Timeline

• Start date: 2020-02-25
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-07-24
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study