Recruiting

Polygenic Risk Stratification

Sponsor:

Adam S. Kibel, MD

Code:

NCT06398639

Conditions

Prostate Cancer

Polygenic Risk Score

Eligibility Criteria

Sex: Male

Age: 40 - 69

Healthy Volunteers: Accepted

Interventions

Polygenic Risk Score (PRS)

Study Details

Brief 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

Conditions

Prostate Cancer

Polygenic Risk Score

Study ID

NCT06398639

Start date

May 7, 2024

Status verified date

Nov, 2025

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 69

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Low Risk Cohort

Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.

other: Intermediate Risk Cohort

Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.

other: High Risk Cohort

Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.

Interventions

Polygenic 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.

Primary outcome measure

  • Risk Ratio - Three Age Groups [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts and Locations

Central contacts

Adam S Kibel, MD, MHCM

(617) 525-7697akibel@bwh.harvard.edu

Daniella Furtado

(617) 525-8782dfurtado1@bwh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Keyan Salari, MD, PhD

857-238-3838ksalari@mgh.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02155

Contacts

Adam S Kibel, MD, MHCM

617-525-7697akibel@bwh.harvard.edu

More Information

Sponsor

Adam S. Kibel, MD

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Polygenic Risk Score
  • Prostate Cancer
  • Prostate Cancer Screening
  • Multiparametric MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Adam S. Kibel, MD on 2025-11-10.