NCT06392841

Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations

Hispanic/Latino and Non-Hispanic BlAck Patients Treated With niRaparib and Abiraterone Acetate Plus Prednisone for Metastatic hOrmone Sensitive Prostate Cancer With Deleterious Homologous recombinatioN Repair Alterations: a Phase II, Open Label studY

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Qian Qin · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s). These include pathologic alterations in BRCA 1/2, BRIP1, CHEK2, FANCA, PALB2, RAD51B, and/or RAD54L. A total of 64 people will be enrolled to the study.

Conditions

• Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
• Deleterious HRR Gene Mutation
• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• BRIP1 Gene Mutation
• CHEK2 Gene Mutation
• FANCA Gene Mutation
• PALB2 Gene Mutation
• RAD51B Gene Mutation
• RAD54L Gene Mutation

Interventions

Type	Name	Description
DRUG	Androgen Deprivation Therapy (ADT)	Medical castration per ADT with GnRH agonist or antagonist (or surgical castration per orchiectomy)
DRUG	Niraparib/Abiraterone Acetate DAT	Niraparib 200 mg/ Abiraterone acetate 1000 mg orally
DRUG	Abiraterone Acetate	1000 mg orally
DRUG	Prednisone	5 mg orally
DRUG	Docetaxel	75 mg/m2 IV

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-01-31
• Completion: 2029-01-31
• First posted: 2024-04-30
• Last updated: 2026-04-08

Regulatory

• FDA-regulated drug study