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Polygenic Risk Stratification and mpMRI for Prostate Cancer Detection

This study is looking for men aged 40-69 who have not had prostate cancer to test a new way to screen for this disease. It combines your genetic information, specifically your Polygenic Risk Score (PRS), with an mpMRI (multiparametric magnetic resonance imaging) scan. The goal is to see if using both of these tools can better identify aggressive prostate cancer that might be life-threatening. All participants will receive a PSA (prostate-specific antigen) blood test and an mpMRI. The study aims to enroll 1500 participants and will measure how well this combined approach identifies prostate cancer over about one year.

Study design
This interventional study plans to enroll 1500 male participants between 40 and 69 years old. Participants will be grouped based on their Polygenic Risk Score (PRS) from genetic data.
What's involved
You will have a PSA blood test and an mpMRI scan. Your genetic data will be used to determine your Polygenic Risk Score.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06398639

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

Recruiting
NAAges 40–69InterventionalScreening
Adam S. Kibel, MD
~1,500 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Polygenic Risk Score (PRS)

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Risk Ratio - Three Age Groups
Measured over Through study completion, an average of 1 year.

Conditions

Prostate Cancer
Polygenic Risk Score

Explore related trials

Prostate Carcinoma

Where it's being run

5 sites across 3 states
Maryland2
Massachusetts2
District of Columbia1

Study leadership

  • Adam S Kibel, MD, MHCM · STUDY_CHAIR · Brigham and Women's Hospital
  • Peter Pinto, MD · STUDY_CHAIR · National Cancer Institute (NCI)

Who to contact

Adam S Kibel, MD, MHCM
[email protected]
(617) 525-7697
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Risk Ratio - Three Age GroupsThrough study completion, an average of 1 year.

    The ratio between men with high PRS and intermediate PRS in each of the three age groups (40-54, 55-64, 65-69) regardless of their ethnicity.