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

NCT06398639 | Recruiting DMC

• 2 other identifiers: 23-564U01CA268810
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 5

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

Conditions

Prostate Cancer; Polygenic Risk Score

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Risk Ratio - Three Age Groups

  The ratio between men with high PRS and intermediate PRS in each of the three age groups (40-54, 55-64, 65-69) regardless of their ethnicity.

  Through study completion, an average of 1 year.

Secondary Outcomes (2)

• Risk Ratio - Six Age Groups

  Through study completion, an average of 1 year.

• Rare Variants

  Through study completion, an average of 1 year.

Study Arms (3)

Low Risk Cohort

OTHER

Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.

Other: Polygenic Risk Score (PRS)

Intermediate Risk Cohort

OTHER

Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.

Other: Polygenic Risk Score (PRS)

High Risk Cohort

OTHER

Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.

Other: Polygenic Risk Score (PRS)

Interventions

Polygenic Risk Score (PRS) OTHER

Participants will be put into PRS cohorts based on their genetic data. All participants enrolled into the study will receive a PSA screening test and an mpMRI, regardless of their polygenic risk score.

High Risk Cohort; Intermediate Risk Cohort; Low Risk Cohort

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Adam S. Kibel, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

NOT YET RECRUITING

National Cancer Institute

Bethesda, Maryland, 20814, United States

NOT YET RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02155, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Genetic Risk Score

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam S Kibel, MD, MHCM

  Brigham and Women's Hospital

  STUDY CHAIR

• Peter Pinto, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Central Study Contacts

Adam S Kibel, MD, MHCM

CONTACT

(617) 525-7697; akibel@bwh.harvard.edu

Daniella Furtado

CONTACT

(617) 525-8782; dfurtado1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Department of Urology, Brigham Health & Dana-Farber Cancer Institute; DiNovi Family Distinguished Chair in Urology, Brigham and Women's Hospital; Elliott Carr Cutler Professor of Surgery, Harvard Medical School

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 3, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (5)