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

Sponsor
Latin American Cooperative Oncology Group
Study ID
NCT06527690
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib/Abirate rone acetate fixed-dose combination — DRUG
    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.
  • Prednisone — DRUG
    Participants will receive prednisone 5mg 2 tablets once daily on days 1-28 of each 28-day cycle.

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: self-identified as from Black racial origin irrespective of ethnicity
    Cohort A will include participants self-identified as from Black origin as defined as having origins in any of the Black racial groups of Africa, as per the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, and irrespective of ethnicity. This includes participants with more than one race, including pardos.
  • Experimental: Racially self-identified as Native Indigenous American or self-identified Latino and racially White
    Cohort B will include participants of the following racial and ethnic backgrounds: 1. self-identified as from Native Indigenous American origins as per the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, irrespective of ethnicity (this includes participants with more than one race, including mestizos) 2. self-identified as from White origin as per the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, and ethnically self-identified as Latinos. This includes participants with mixed (or mestizo) races.

Primary Outcome Measure

12-month radiographic Progression-Free Survival (rPFS) [ Time Frame: 12 months ]

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