RecruitingNot ApplicableNCT06398639

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

Sponsor

Adam S. Kibel, MD

Enrollment

1,500 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Polygenic Risk Score

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

Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining a polygenic risk score (a genetic risk measure) with an MRI of the prostate can better identify men who have clinically significant prostate cancer and need a biopsy. **You may be eligible if...** - You are between 40 and 69 years old - You have no history of prostate cancer - You have not had a prostate biopsy or prostate MRI within the past 5 years - You have a life expectancy of more than 10 years - You are willing and able to give informed consent **You may NOT be eligible if...** - You have a known bleeding or clotting disorder that prevents a safe biopsy - You have uncontrolled serious illness that would make a biopsy or surgery unsafe - You are unable to undergo an MRI - You are unwilling to sign the informed consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPolygenic 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.