Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03075735
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2017-03-06
Brief Title:
Prospective Multicentre Cohort Study PROREPAIR-B mCRPC
Sponsor:
Centro Nacional de Investigaciones Oncologicas CARLOS III
Organization:
Centro Nacional de Investigaciones Oncologicas CARLOS III
Study Overview
Official Title:
Prospective Multicentre Cohort Study of the Prevalence and Clinical Impact of Germline Deleterious Mutations in DNA Repair Genes of Patients With Metastatic Castration Resistant Prostate Cancer mCRPC
Status:
COMPLETED
Status Verified Date:
2019-02
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:
None
Brief Summary:
PROREPAIR is a prospective multicenter observational cohort study of unselected patients with metastatic Castration Resistant Prostate Cancer mCRPC with unknown germline mutational status at study entry and who are candidates to start 1st line treatment with any approved survival-prolonging agent
The study aims to evaluate the impact of aberrations in DNA-repair genesBRCA1 BRCA2 ATM and PALB2 and other genes on cause-specific survival from the diagnosis of the metastatic castration resistant status and other outcomes
The study aims to evaluate the impact of aberrations in DNA-repair genesBRCA1 BRCA2 ATM and PALB2 and other genes on cause-specific survival from the diagnosis of the metastatic castration resistant status and other outcomes
Detailed Description:
This is a non-interventional study in which eligible patients are prospectively followed-up until death or the end-of-study whichever happens first
Patients are enrolled after mCRPC diagnosis and before or within the 6 first months of starting a first-line treatment with any approved survival-prolonging agent for mCRPC First and subsequent treatment lines will be chosen according to the patients and their treating physicians preferences and will not be dictated by this study
A whole blood sample for germline DNA extraction as well as any available archival prostate cancer tissue samples will be collected at baseline Optional plasma serum and whole blood samples will be collected at baseline and at different time points along the evolution of the disease A sample will be collected within the last 6 months of life
Survival and treatment outcomes including biochemical radiological and clinical progression with standard approved agents abiraterone enzalutamide docetaxel cabazitaxel and radium-223 will be prospectively collected
Primary aim is to evaluate the prevalence and impact of DNA repair germline mutations in the BRCA1 BRCA2 ATM and PALB2 genes on cause-specific survival from mCRPC Secondary aims will include the correlation of additional germline alterations in DNA-repair with survival and treatment outcomes the analyses of the survival and treatment outcomes impact of somatic alterations in these genes and the role of germline and somatic defects in the clonal evolution of prostate cancer
Patients are enrolled after mCRPC diagnosis and before or within the 6 first months of starting a first-line treatment with any approved survival-prolonging agent for mCRPC First and subsequent treatment lines will be chosen according to the patients and their treating physicians preferences and will not be dictated by this study
A whole blood sample for germline DNA extraction as well as any available archival prostate cancer tissue samples will be collected at baseline Optional plasma serum and whole blood samples will be collected at baseline and at different time points along the evolution of the disease A sample will be collected within the last 6 months of life
Survival and treatment outcomes including biochemical radiological and clinical progression with standard approved agents abiraterone enzalutamide docetaxel cabazitaxel and radium-223 will be prospectively collected
Primary aim is to evaluate the prevalence and impact of DNA repair germline mutations in the BRCA1 BRCA2 ATM and PALB2 genes on cause-specific survival from mCRPC Secondary aims will include the correlation of additional germline alterations in DNA-repair with survival and treatment outcomes the analyses of the survival and treatment outcomes impact of somatic alterations in these genes and the role of germline and somatic defects in the clonal evolution of prostate cancer
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