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RECRUITING
NCT06398639
NA

Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer

Sponsor: Adam S. Kibel, MD

View on ClinicalTrials.gov

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

Interventions

OTHER

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