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

NCT06527690 | Withdrawn Phase 2

• 2 other identifiers: LACOG 122367652000PCR2006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer; Castrate Resistant Prostate Cancer; Homologous Recombination Deficiency

Outcome Measures

Primary Outcomes (1)

• 12-month radiographic Progression-Free Survival (rPFS)

  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.

  12 months

Study Arms (2)

self-identified as from Black racial origin irrespective of ethnicity

EXPERIMENTAL

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.

Drug: Niraparib/Abirate rone acetate fixed-dose combination; Drug: Prednisone

Racially self-identified as Native Indigenous American or self-identified Latino and racially White

EXPERIMENTAL

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.

Drug: Niraparib/Abirate rone acetate fixed-dose combination; Drug: Prednisone

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.

Racially self-identified as Native Indigenous American or self-identified Latino and racially White; self-identified as from Black racial origin irrespective of ethnicity

Prednisone DRUG

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

Racially self-identified as Native Indigenous American or self-identified Latino and racially White; self-identified as from Black racial origin irrespective of ethnicity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligibility criteria - Prescreening Inclusion Age: ≥18 years of age (or the local legal age of consent) Participant Origin: Participants of the following origins: \- COHORT A: Participants self-identified as with 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. \- COHORT B: Participants self-identified 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. OR \- Participants self-identified from White origin as per the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, and ethnically self-identified as Latinos. Participant and Disease Characteristics * ECOG Performance Status 0-1 * Histologically or cytologically confirmed metastatic prostate adenocarcinoma * Metastatic disease documented by conventional imaging with CT or MRI (for soft tissue lesions) or 99mTc bone scan (for bone lesions) 1. Participants with a single bone lesion on 99mTc bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. 2. Participants with lymph node-only disease are not eligible. * Willing to provide tumor tissue (archival) for determination of deleterious germline or somatic HRR gene alterations, if no local (testing done at investigator center or commercial testing) or prior sponsor-approved test result is available. 1.Testing must demonstrate pathogenic gene alterations in ≥1 of the following genes to proceed to screening: ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, or PALB2. * Castration-resistant disease, defined by the PCWG3 as any of the following criteria while on castrate levels of testosterone (less than or equal to 50 ng/dL): 1. Visceral Progression OR 2. Bone progression (2 or more new prostate-cancer related new lesions compared to baseline) OR 3. PSA Progression, as defined by an increase in two consecutive measurements that fulfills all the following criteria: 1. The evaluations were performed with a minimum interval of 1 week. 2. Progressive worsening with an increase of at least 50% compared to baseline. 3. The minimum value of PSA is ≥ 1 ng/ml.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Janssen, LP: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

niraparib; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Fernando Cotait Maluf

  Latin American Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09