Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 35
Maximum Age: 74
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Olympia Price
oprice@partners.org
857-238-3838
Time Frame
Start Date: 2020-02-12
Estimated Completion Date: 2040-12
Participants
Target number of participants: 400
Treatments
Cohort A
Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene
Cohort B
Family history suggestive of high genetic risk for prostate cancer with clinical genetic testing negative for known pathogenic or likely pathogenic mutations in prostate cancer-related risk genes
Cohort C
Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov