Actively Recruiting

Phase Not Applicable
Age: 40Years - 69Years
MALE
Healthy Volunteers
NCT06398639

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

Led by Adam S. Kibel, MD · Updated on 2025-11-10

1500

Participants Needed

5

Research Sites

312 weeks

Total Duration

On this page

Sponsors

A

Adam S. Kibel, MD

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 69Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willingness to sign a written informed consent document
  • Estimated life expectancy greater than 10 years
  • No history of prostate cancer
  • Age between 40 and 69 years
  • No prostate biopsy within the past 5 years
  • No prostate MRI within the past 5 years
Not Eligible

You will not qualify if you...

  • Unwillingness to sign the informed consent form
  • Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder
  • Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting biopsy or surgery safety
  • Unable to undergo an MRI

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Trial Site Locations

Total: 5 locations

1

Howard University Hospital

Washington D.C., District of Columbia, United States, 20060

Not Yet Recruiting

2

National Cancer Institute

Bethesda, Maryland, United States, 20814

Not Yet Recruiting

3

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20814

Not Yet Recruiting

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

5

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02155

Actively Recruiting

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Research Team

A

Adam S Kibel, MD, MHCM

CONTACT

D

Daniella Furtado

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

3

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