Prostate Cancer Genetic Risk Evaluation and Screening Study
Recruiting · NCT05129605 · Observational (researchers observe without assigning treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Prior diagnosis or treatment of prostate cancer
- Inability to undergo prostate MRI
- Inability to receive MRI contrast agent
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States