Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527690
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPRESENTATION
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 sponsors required assays or previous results from CLIA-certified labs showing a pathogenic germline or somatic HRR alteration
The combination of niraparibAA 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 studys 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
The combination of niraparibAA 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 studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None