MedTrace Logo

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

NCT06398639 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2025-11-10

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Adam S. Kibel, MD

    lead OTHER

Principal Investigators

  • Adam S Kibel, MD, MHCM · Brigham and Women's Hospital

  • Peter Pinto, MD · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2028-04-30
Completion
2030-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398639 on ClinicalTrials.gov