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Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer

NCT06527690 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-09-29

No results posted yet for this study

Summary

This is an open-label, multicenter, interventional study in racially self-identified black or ethnically self-identified hispanic and racially self-identified white or native American participants with metastatic castration-resistant prostate cancer whose tumors demonstrate molecular alterations compatible with homologous repair deficiency.

Conditions

  • Prostate Cancer
  • Castrate Resistant Prostate Cancer
  • Homologous Recombination Deficiency

Interventions

DRUG

Niraparib/Abirate rone acetate fixed-dose combination

Participants will receive niraparib/abiraterone acetate fixed-dose combination 100/500 mg 2 tablets once daily on days 1-28 of each 28-day cycle.

DRUG

Prednisone

Participants will receive prednisone 5mg 2 tablets once daily on days 1-28 of each 28-day cycle.

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Latin American Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Fernando Cotait Maluf · Latin American Cooperative Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-09-30
Completion
2028-02-28

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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 NCT06527690 on ClinicalTrials.gov