Clinical trial · Interventional

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

NCT06527690CI-TRIAL-00095889REPRESENTATIONwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): The study aimed to include multiple countries in Latin America, but only Brazil was feasible, making the intended ethnic and racial design unviable. Activities were closed and no sites were opened for recruitment.

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Castrate Resistant Prostate Cancer	—	UNRESOLVED	—
Homologous Recombination Deficiency	—	UNRESOLVED	—
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Niraparib/Abirate rone acetate fixed-dose combination	Drug	—	UNRESOLVED
Prednisone	Drug	Prednisone	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
self-identified as from Black racial origin irrespective of ethnicity
description
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.
interventionNames
1. Drug: Niraparib/Abirate rone acetate fixed-dose combination
2. Drug: Prednisone
type
EXPERIMENTAL
label
Racially self-identified as Native Indigenous American or self-identified Latino and racially White
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

\- 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.

References

Publications (0)

Data not yet available

No reference posted for this study.