Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 69
Healthy Volunteers: t
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• 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.

Locations
United States
Washington, D.c.
Howard University Hospital
NOT_YET_RECRUITING
Washington D.c.
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
National Cancer Institute
NOT_YET_RECRUITING
Bethesda
Walter Reed National Military Medical Center
NOT_YET_RECRUITING
Bethesda
Contact Information
Primary
Adam S Kibel, MD, MHCM
akibel@bwh.harvard.edu
(617) 525-7697
Backup
Daniella Furtado
dfurtado1@bwh.harvard.edu
(617) 525-8782
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 1500
Treatments
Other: Low Risk Cohort
Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.
Other: Intermediate Risk Cohort
Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.
Other: High Risk Cohort
Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.
Related Therapeutic Areas
Sponsors
Leads: Adam S. Kibel, MD
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov