NCT06398639 Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
| NCT ID | NCT06398639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Adam S. Kibel, MD |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2024-05-07 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Contact & Investigator
Adam S Kibel, MD, MHCM
STUDY CHAIR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06398639 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 69 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06398639 currently recruiting?
Yes, NCT06398639 is actively recruiting participants. Contact the research team at akibel@bwh.harvard.edu for enrollment information.
Where is the NCT06398639 trial being conducted?
This trial is being conducted at Washington D.C., United States, Bethesda, United States, Bethesda, United States, Boston, United States and 1 additional location.
Who is sponsoring the NCT06398639 clinical trial?
NCT06398639 is sponsored by Adam S. Kibel, MD. The principal investigator is Adam S Kibel, MD, MHCM at Brigham and Women's Hospital. The trial plans to enroll 1,500 participants.
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