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

NCT06392841 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-04-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • UT Southwestern Comprehensive Cancer Center

    collaborator UNKNOWN

  • Janssen, LP

    collaborator INDUSTRY

  • Qian Qin

    lead OTHER

Principal Investigators

  • Qian Qin, MD · UT Southwestern Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2028-01-31
Completion
2029-01-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06392841 on ClinicalTrials.gov