Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
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
Description
Background: * Prostate cancer is the most commonly diagnosed cancer among men in the United States * Prostate cancer screening using the marker prostate-specific antigen (PSA) is controversial * PSA based screening is less effective, at least in part, because it rests on screening the entire population * Polygenic risk scores stratify men based on their prostate cancer genetic predisposition and may improve population level screening programs by focusing on men with higher risk of disease and sparing low risk men * It is critical that studies aiming to translate the development of an early-de…
Eligibility
- Age range
- 40–69 years
- Sex
- Male
- Healthy volunteers
- Yes
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 si…
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.
Locations (5)
- Howard University HospitalWashington D.C., District of Columbia
- National Cancer InstituteBethesda, Maryland
- Walter Reed National Military Medical CenterBethesda, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts