Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

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.

Niraparib Tosylate Monohydrate

Radical Prostatectomy

Marc Dall'Era

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.

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.

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

The study will assess the impact of neoadjuvant 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 deoxyribonucleic acid (DNA) repair pathways. Pathologic complete response (PCR) defined as no tumor identified on hematoxylin and eosin (H\&E) stained sections will be assessed; minimal residual disease (MRD) will be defined as tumor clusters limited to \< 5 mm and confined to prostate gland.

Exact 95% confidence intervals for pRR and other binary outcomes, adjusted for the two-stage design, will be calculated as described by Koyama and Chen. Response rates will be compared between patients with biallelic and monoallelic loss using Fisher's Exact Test.

Median biochemical progression free survival (bPFS) and quartiles (when reached) will be calculated from Kaplan-Meier estimates, and 95% confidence intervals will be calculated using Greenwood's formula.

National Cancer Institute (NCI)

Janssen, LP

Marc Dall'Era, MD

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects	NCT04030559	ATM Gene Mutati... BRCA1 Gene Muta... BRCA2 Gene Muta... BRIP1 Gene Muta... CDK12 Gene Muta... CHEK1 Gene Muta... CHEK2 Gene Muta... DNA Damage Resp... DNA Repair Gene... FANCA Gene Muta... FANCD2 Gene Mut... FANCL Gene Muta... GEN1 Gene Mutat... NBN Gene Mutati... Prostate Carcin... RAD51 Gene Muta... RAD51C Gene Mut...	Niraparib Niraparib Tosyl... Radical Prostat...	18 Years -	University of California, Davis
Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects	NCT04030559	ATM Gene Mutati... BRCA1 Gene Muta... BRCA2 Gene Muta... BRIP1 Gene Muta... CDK12 Gene Muta... CHEK1 Gene Muta... CHEK2 Gene Muta... DNA Damage Resp... DNA Repair Gene... FANCA Gene Muta... FANCD2 Gene Mut... FANCL Gene Muta... GEN1 Gene Mutat... NBN Gene Mutati... Prostate Carcin... RAD51 Gene Muta... RAD51C Gene Mut...	Niraparib Niraparib Tosyl... Radical Prostat...	18 Years -	University of California, Davis

Spots Global Cancer Trial Database for dna repair gene mutation