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Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
Sponsor: Adam S. Kibel, MD
Summary
The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer. The main questions it aims to answer are: * If genetic data related to prostate cancer used with MRI can identify higher-grade, potentially fatal prostate cancer * What age a MRI is useful clinically for prostate cancer screening * If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers Participants will: * Get a prostate specific antigen (PSA) blood test * Get an mpMRI * Get the results of their genetic data to determine if they are considered high-, intermediate-, or low-risk for prostate cancer based on the trials genetic testing * Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI
Key Details
Gender
MALE
Age Range
40 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2024-05-07
Completion Date
2030-04-30
Last Updated
2025-11-10
Healthy Volunteers
Yes
Conditions
Interventions
Polygenic Risk Score (PRS)
Participants will be put into PRS cohorts based on their genetic data. All participants enrolled into the study will receive a PSA screening test and an mpMRI, regardless of their polygenic risk score.
Locations (5)
Howard University Hospital
Washington D.C., District of Columbia, United States
National Cancer Institute
Bethesda, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States