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

Phase 2

Not yet recruiting

• Conditions: Prostate Cancer; Homologous Recombination Deficiency; Castrate Resistant Prostate Cancer
• Interventions: Drug: Niraparib/Abirate rone acetate fixed-dose combination; Drug: Prednisone

• Registration Number: NCT06527690
• Lead Sponsor: Latin American Cooperative Oncology Group

Brief 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.

Detailed Description

This study will enroll up to 70 participants, divided into two cohorts of 35 each. Cohort A will include participants self-identified as of black origin, as defined by the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, including those with more than one race, such as pardos. Cohort B will include (1) participants self-identified from Native Indigenous American origins and (2) participants self-identified from White origin who ethnically identify as Latinos, both as per the FDA guidance. The study will consist of five phases: Prescreening for biomarker evaluation, Screening, Treatment, Extension, and Follow-Up. Participants will be assessed during prescreening using the sponsor's required assays or previous results from CLIA-certified labs showing a pathogenic germline or somatic HRR alteration.

The combination of niraparib/AA plus prednisone is FDA-approved for treating homologous repair deficient metastatic castration-resistant prostate cancer (HRD mCRPC). Given the benefits of this combination and the lack of representation in previous studies, a placebo-controlled study is deemed unethical. Thus, the study design includes two independent cohorts, both receiving the standard of care treatment. This study aims to provide additional information on the benefits of this therapy in underrepresented populations. Conducted with input from experts in racial inequities, the study results may be shared with participants through a plain language summary. Participants will be fully informed about the study's risks and requirements and will receive new information affecting their participation decision. Consent to participate is voluntary and can be withdrawn at any time without penalty. Written consent will be obtained following regulations and participant preferences.

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14
• Study Start: 2025-04-30
• Primary Completion: 2027-09-30
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Racially self-identified as Native Indigenous American or self-identified Latino and racially White	Niraparib/Abirate rone acetate fixed-dose combination	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.
self-identified as from Black racial origin irrespective of ethnicity	Niraparib/Abirate rone acetate fixed-dose combination	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.
self-identified as from Black racial origin irrespective of ethnicity	Prednisone	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.
Racially self-identified as Native Indigenous American or self-identified Latino and racially White	Prednisone	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 Measures

Name	Time	Method
12-month radiographic Progression-Free Survival (rPFS)	12 months	Assessed by modified RECIST v1.1 and PCWG3 criteria, and defined as time from enrollment until progression of soft tissue lesions measured by CT or MRI as defined in RECIST 1.1, progression of bone lesions observed by bone scan and based on PCWG3, or death from any cause.