Using genetic data and MRI to identify significant prostate cancer
Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
This study is testing a new way to find significant prostate cancer in men by using genetic information and advanced MRI scans to see if it helps identify those at higher risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 5 sites (Washington D.C., District of Columbia and 4 other locations) |
| Trial ID | NCT06398639 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel screening method that combines polygenic risk scores with multiparametric magnetic resonance imaging (mpMRI) to detect clinically relevant prostate cancer. The study aims to determine if genetic data can help identify men at higher risk for aggressive cancer and establish the optimal age for screening. Participants will undergo a prostate-specific antigen (PSA) test, an mpMRI, and genetic testing to assess their risk levels. Follow-up will be tailored based on individual risk assessments and findings from the screenings.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 40-69 with no history of prostate cancer and an estimated life expectancy of over 10 years.
Not a fit: Patients with a history of prostate cancer or those who have undergone a prostate biopsy or MRI in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate identification of men at risk for aggressive prostate cancer, potentially improving early detection and treatment outcomes.
How similar studies have performed: Other studies have shown promise in using genetic risk scores for cancer screening, but this specific combination of polygenic risk assessment and mpMRI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Washington D.C., District of Columbia and 4 other locations
- Howard University Hospital — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- National Cancer Institute — Bethesda, Maryland, United States (Not_yet_recruiting)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Adam S Kibel, MD, MHCM
- Email: akibel@bwh.harvard.edu
- Phone: (617) 525-7697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.