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

Prostate Carcinoma Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• 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
• Prostatic Neoplasms
• RAD51 Gene Mutation
• RAD51C Gene Mutation

• NCT number: NCT04030559
• Study type: Interventional
• Source: University of California, Davis
• Status: Recruiting
• Phase: Phase 2
• Start date: February 25, 2020
• Completion date: February 1, 2025