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Clinical trial Recruiting at 2 sites Interventional Ages 40 to 69 Men only

Using genetic data and MRI to identify significant prostate cancer

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

Run by Brigham and Women's Hospital · NCT06398639 · Data updated 2026-11-12

This study is testing a new way to find significant prostate cancer in men by using genetic information and advanced MRI scans to see if it helps identify those at higher risk.

Quick facts

Study typeInterventional
Ages40 Years to 69 Years
SexMen only
Enrollment1500 (estimated)
SponsorBrigham and Women's Hospital
Academic / other
Locations5 sites (Washington D.C., District of Columbia and 4 other locations)
StatusRecruiting
StartedMay 7, 2024
Main results expectedApril 30, 2028
Study endsApril 30, 2030
Registry record updatedNovember 10, 2025
Trial IDNCT06398639 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men aged 40-69 with no history of prostate cancer and an estimated life expectancy of over 10 years.

Probably not a fit

Patients with a history of prostate cancer or those who have undergone a prostate biopsy or MRI in the past five years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a novel screening method that combines polygenic risk scores with multiparametric magnetic resonance imaging (mpMRI) to detect clinically relevant prostate cancer. The study aims to determine if genetic data can help identify men at higher risk for aggressive cancer and establish the optimal age for screening. Participants will undergo a prostate-specific antigen (PSA) test, an mpMRI, and genetic testing to assess their risk levels. Follow-up will be tailored based on individual risk assessments and findings from the screenings.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate identification of men at risk for aggressive prostate cancer, potentially improving early detection and treatment outcomes.

How similar studies have gone: Other studies have shown promise in using genetic risk scores for cancer screening, but this specific combination of polygenic risk assessment and mpMRI is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Massachusetts General Hospital
    Boston, Massachusetts, United States     Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States     Recruiting
  • Howard University Hospital
    Washington D.C., District of Columbia, United States     Not yet recruiting
  • National Cancer Institute
    Bethesda, Maryland, United States     Not yet recruiting
  • Walter Reed National Military Medical Center
    Bethesda, Maryland, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464Brigham and Women's Hospital 1507
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.