Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04425200
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2020-05-21
Brief Title:
Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer mCRPC Patients in Real World Setting
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer mCRPC Patients in Real World Setting
Status:
COMPLETED
Status Verified Date:
2021-11
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:
ZENSHIN
Brief Summary:
The purpose of this study is to investigate the prevalence of tissue homologous recombination repair HRR-related gene mutations positivenegativeVariant of uncertain significance VUS clinical outcome such as prostate-specific antigen-progression free survival PSA-PFS overall survivals OS and treatment pattern in mCRPC patients
Methods Study design multi-center prospective cohort study
Data Sources
In this study 155 patients expected recruitment patients maximum 205 patients will be enrolled from approximately 2030 sites in Japan Study Population mCRPC patients who diagnosed between 2014 and 2018 Exposures NA Outcomes Prevalence of tissue HRR-related gene mutations clinical outcomes such as Over survival and PSA-PFS Treatment pattern
Sample Size Estimations
The target population is 155 patients based on the prevalence of HRR-related genes BRCA1 BRCA2 and ATM which is reported in previous global study PROfound study
Statistical Analysis
This study is not intended to verify specific hypotheses and the results are evaluated descriptively There is no plan of interim analyses before the final analysis
Methods Study design multi-center prospective cohort study
Data Sources
In this study 155 patients expected recruitment patients maximum 205 patients will be enrolled from approximately 2030 sites in Japan Study Population mCRPC patients who diagnosed between 2014 and 2018 Exposures NA Outcomes Prevalence of tissue HRR-related gene mutations clinical outcomes such as Over survival and PSA-PFS Treatment pattern
Sample Size Estimations
The target population is 155 patients based on the prevalence of HRR-related genes BRCA1 BRCA2 and ATM which is reported in previous global study PROfound study
Statistical Analysis
This study is not intended to verify specific hypotheses and the results are evaluated descriptively There is no plan of interim analyses before the final analysis
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?:
None
Is an FDA AA801 Violation?:
None