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

Adam S. Kibel, MD · with National Cancer Institute (NCI) · NCT06398639

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–69 · Men only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
1500
US sites recruiting
2
Study start
May 7, 2024
Record last updated
November 10, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Polygenic Risk Score (PRS)

Conditions: Prostate Cancer; Polygenic Risk Score

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Keyan Salari, MD, PhD · 857-238-3838 · ksalari@mgh.harvard.edu

  • Brigham and Women's Hospital

    Boston, MA 02155

    Site contact: Adam S Kibel, MD, MHCM · 617-525-7697 · akibel@bwh.harvard.edu

Study contacts (from the official record)

  • Adam S Kibel, MD, MHCM · (617) 525-7697 · akibel@bwh.harvard.edu
  • Daniella Furtado · (617) 525-8782 · dfurtado1@bwh.harvard.edu
All healthy volunteers studies in Massachusetts →
Polygenic Risk Stratification Combined With mpMRI to Identify… (NCT06398639) | Bored Studies