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- Observational
- Diagnostic Test
- Massachusetts General Hospital
- 35 - 74 Years
Study Purpose
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 Black/African 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.
Intervention
Diagnostic Test : Prostate cancer screening
Eligibility Requirements
Men 35-74 years old
No known diagnosis of prostate cancer
Life expectancy \>10 years
Meet cohort A, B, or C criteria
Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
Minimum age: 35
Prior diagnosis or treatment of prostate cancer
Inability to undergo prostate MRI
Inability to receive MRI contrast agent
Recruiting status
Recruiting
Estimated enrollment
400
Study start date
Feb 12, 2020
Study end date
Dec 31, 2040
Last updated
Mar 23, 2025
Primary purpose
N/A
Design
Observational
Intervention
Diagnostic Test
Study phase
N/A
Allocation
N/A
Sponsor:
Massachusetts General Hospital
Collaborator:
N/A
Investigator:
Keyan Salari, MD, PhD
N/A
Publications
Websites
N/A
NCT05129605
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