Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects
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|ClinicalTrials.gov Identifier: NCT04030559|
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : October 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Niraparib Drug: Niraparib Tosylate Monohydrate Procedure: Radical Prostatectomy||Phase 2|
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.
I. To assess 5-year biochemical recurrence in subjects with high-risk prostate cancer and DNA-damage response defects after prostatectomy.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of PARP Inhibitor Niraparib for Men With High Risk Prostate Cancer and DNA Damage Response Defects|
|Actual Study Start Date :||February 25, 2020|
|Estimated Primary Completion Date :||August 1, 2024|
|Estimated Study Completion Date :||February 1, 2025|
Experimental: Treatment (niraparib)
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.
Drug: Niraparib Tosylate Monohydrate
Other Name: Zejula
Procedure: Radical Prostatectomy
Undergo standard of care surgery
Other Name: Prostatovesiculectomy
- Pathologic response rate (pRR) [ Time Frame: At the time of radical prostatectomy procedure ]
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.
- Biochemical prostate specific antigen (PSA) progression free survival [ Time Frame: Up to 5 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030559
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Marc Dall'Era 916-734-3771 firstname.lastname@example.org|
|Principal Investigator: Marc Dall'Era|
|Principal Investigator:||Marc Dall'Era||University of California, Davis|