Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05129605
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2021-11-02
Brief Title:
Prostate Cancer Genetic Risk Evaluation and Screening Study
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Prostate Cancer Genetic Risk Evaluation and Screening Study PROGRESS
Status:
RECRUITING
Status Verified Date:
2024-10
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:
PROGRESS
Brief Summary:
This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations family history or BlackAfrican ancestry and evaluate the utility of prostate MRI as a screening tool The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer characterization of the penetrance of specific mutations and potentially identify new genetic risk mutations
Detailed Description:
Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men Prostate cancer has substantial inherited predisposition and men harboring specific genetic variants or a positive family history have been associated with an increased risk of developing prostate cancer Men with specific genetic variants such as pathogenic BRCA2 mutations are at particularly greater risk of developing aggressive forms of prostate cancer and thus warrant undergoing careful screening for prostate cancer However the penetrance of many mutations in prostate cancer risk genes is unknown and some men have no identifiable mutations in known risk genes despite a strong family history of prostate cancer Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance the understanding of how specific mutations contribute to the development of prostate cancer and how these prostate cancers might be best detected The purpose of this study is to prospectively screen men at high risk genetic risk for prostate cancer by prostate exam PSA and prostate MRI to characterize the penetrance and cancer-related outcomes of specific mutations identify potentially novel genetic risk mutations andor markers for early detection
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