NCT06398639Recruiting
Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 28 Apr 2024
- Start date
- 7 May 2024
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Adam S. Kibel, MD
- Diseases
- Prostate cancer
- NCT number
- NCT06398639
What you commit to
- Study type: Interventional
- Planned participants: 1500
- From 7 May 2024 to the primary completion date, 30 Apr 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Unwillingness to sign the informed consent form.
- Unable to undergo an MRI.
Who the study is looking for
- 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.
Age in the registry: 40 years to 69 years · Sex: Male · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Walter Reed National Military Medical Center Coordinator of this site? Confirm its status | Bethesda | United States | Not yet recruiting |
| National Cancer Institute Coordinator of this site? Confirm its status | Bethesda | United States | Not yet recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Howard University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.