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

RecruitingNAAges 40 Years - 69 YearsMaleAdam S. Kibel, MD
NCT06398639 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 g

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📋 Eligibility rules (as published)
Inclusion Criteria: * They must have the ability to understand and the willingness to sign a written information consent document. * Estimated life expectancy of greater than 10 years. * No history of prostate cancer. * Participants must be between 40-69 years of age. This is the age at which screening for prostate cancer is recommended. This is due to younger patients not being at risk for the disease and older patients not benefiting from diagnosis. * No biopsy for prostate cancer within the past 5 years. * No prostate MRI within the past 5 years. Exclusion Criteria: * Unwillingness to sign the informed consent form. * Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery. * Unable to undergo an MRI.
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What it tests

  • Polygenic Risk Score (PRS)
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Where

5 sites
Howard University Hospital
Washington D.C., United States
National Cancer Institute
Bethesda, United States
Walter Reed National Military Medical Center
Bethesda, United States
Massachusetts General Hospital
Boston, United States
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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