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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Adam S. Kibel, MD
Study ID
NCT06398639
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 69 Years
Healthy Volunteers
Accepted

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.

Study Details

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

Key Dates

Start date
May 7, 2024
Status verified
Nov 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
1,500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.

Primary Outcome Measure

Risk Ratio - Three Age Groups [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Howard University HospitalWashington D.C.District of Columbia20060
Pamela Coleman, MD
Tamaro S Hudson, PhD, MPH (SUB_INVESTIGATOR)
National Cancer InstituteBethesdaMaryland20814
Peter A Pinto, MD
[email protected]
204-858-7200
Ismail B Turkbey, MD (SUB_INVESTIGATOR)
Peter L Choyke, MD, FACR (SUB_INVESTIGATOR)
Walter Reed National Military Medical CenterBethesdaMaryland20814
Gregory T Chesnut, MD
[email protected]
301-319-2900
Brigham and Women's HospitalBostonMassachusetts02155
Adam S Kibel, MD, MHCM
[email protected]
617-525-7697
Massachusetts General HospitalBostonMassachusetts02114
Keyan Salari, MD, PhD
[email protected]
857-238-3838

Find similar trials in Washington D.C., DC

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Howard University Hospital· Washington D.C., DCNational Cancer Institute· Bethesda, MDWalter Reed National Military Medical Center· Bethesda, MDBrigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

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