Prostate Cancer Genetic Risk Evaluation and Screening Study — PROGRESS  

Prostate Cancer Clinical Trial

Official title: Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

Status Recruiting

Clinical Trial 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 or a positive family history 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.

Clinical Trial 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 and/or markers for early detection. ;

Related Conditions & MeSH terms

• ATM Gene Mutation
• BRCA1 Mutation
• BRCA2 Mutation
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Genetic Predisposition to Disease
• Lynch Syndrome
• Prostate Cancer
• Prostatic Neoplasm
• Prostatic Neoplasms

• NCT number: NCT05129605
• Study type: Observational [Patient Registry]
• Source: Massachusetts General Hospital
• Contact: Olympia Price
• Phone: 857-238-3838
• Email: oprice@partners.org
• Status: Recruiting
• Start date: February 12, 2020
• Completion date: December 2040