Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392841
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-25
Brief Title:
Niraparib Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
Sponsor:
Qian Qin
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
HispanicLatino and Non-Hispanic BlAck Patients Treated With niRaparib and Abiraterone Acetate Plus Prednisone for Metastatic hOrmone Sensitive Prostate Cancer With Deleterious Homologous recombinatioN Repair Alterations a Phase II Open Label studY
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HARMONY
Brief Summary:
This is an open label phase II trial in subjects with treatment naïve metastatic hormone sensitive prostate cancer mHSPC with deleterious homologous recombination repair HRR alterations These include pathologic alterations in BRCA 12 BRIP1 CHEK2 FANCA PALB2 RAD51B andor RAD54L A total of 64 people will be enrolled to the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None