Actively Recruiting
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
Eligibility Criteria
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
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
AI-Screening
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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
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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