Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
Recruiting now · Not applicable
Conditions studied: Prostate Cancer, Polygenic Risk Score
In brief
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
Key facts
- Study ID
- NCT06398639
- Run by
- Adam S. Kibel, MD
- People needed
- 1500
- Starts
- 2024-05-07
- Expected to finish
- 2030-04-30
- Last updated by the study team
- 2025-11-10
Who can join
Age: 40 and older, up to 69. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Howard University Hospital — Washington D.C., District of Columbia, United States
- National Cancer Institute — Bethesda, Maryland, United States
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.