RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-05-07
Study Completion:2030-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06398639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 69 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * They must have the ability to understand and the willingness to sign a written information consent document.
  2. * Estimated life expectancy of greater than 10 years.
  3. * No history of prostate cancer.
  4. * 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.
  5. * No biopsy for prostate cancer within the past 5 years.
  6. * No prostate MRI within the past 5 years.
  1. * Unwillingness to sign the informed consent form.
  2. * Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder.
  3. * 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.
  4. * Unable to undergo an MRI.

Contacts and Locations

Study Contact

Adam S Kibel, MD, MHCM
CONTACT
(617) 525-7697
akibel@bwh.harvard.edu
Daniella Furtado
CONTACT
(617) 525-8782
dfurtado1@bwh.harvard.edu

Principal Investigator

Adam S Kibel, MD, MHCM
STUDY_CHAIR
Brigham and Women's Hospital
Peter Pinto, MD
STUDY_CHAIR
National Cancer Institute (NCI)

Study Locations (Sites)

Howard University Hospital
Washington, District of Columbia, 20060
United States
National Cancer Institute
Bethesda, Maryland, 20814
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02155
United States

Collaborators and Investigators

Sponsor: Adam S. Kibel, MD

  • Adam S Kibel, MD, MHCM, STUDY_CHAIR, Brigham and Women's Hospital
  • Peter Pinto, MD, STUDY_CHAIR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-07
Study Completion Date2030-04-30

Study Record Updates

Study Start Date2024-05-07
Study Completion Date2030-04-30

Terms related to this study

Keywords Provided by Researchers

  • Polygenic Risk Score
  • Prostate Cancer
  • Prostate Cancer Screening
  • Multiparametric MRI

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Polygenic Risk Score