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

Inclusion Criteria6

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 Criteria4

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.

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.