Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387056
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-21
Brief Title:
Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer SEGNO
Sponsor:
The First Affiliated Hospital of Xiamen University
Organization:
The First Affiliated Hospital of Xiamen University
Study Overview
Official Title:
An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer SEGNO
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SEGNO
Brief Summary:
To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer
Detailed Description:
According to the results of the genomic profile patients will be assigned to 4 neoadjuvant therapy NT groups Queue 1 to 4 Queue 1 No targetable actionable aberration Queue 2 Homologous recombination repair HRR alterations BRCA12 Queue 3 Homologous recombination repair alterations except BRCA12 and CDK12 Queue 4 MSI-HdMMR TMB10mutMb or CDK12 alterations without other HRR alterations A following PSMA PETCT for evaluating the efficacy of NT and radical prostatectomy RP plus pelvic lymph node dissection PLND will be perform The histopathological and survival data after RP plus PLND will also be evaluated
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?:
None
Is an FDA AA801 Violation?:
None