This clinical trial evaluates whether genetic data can be used along with magnetic resonance imaging (MRI) to improve the ability to detect prostate cancer. A way to improve prostate-specific antigen screening is to identify a population of men at higher risk of prostate cancer so the whole population does not need to be screened. Common genetic variants offer the promise of risk stratification. A polygenic risk score (PRS) is a measure of patients' risk of developing a disease based off of their genes. PRS only indicates if patients are at increased or decreased risk of developing a medical condition. Multiparametric magnetic resonance imaging is a special type of MRI that shows a more detailed image of the prostate gland, to determine if patients have prostate cancer. Information gathered from this study will may help researchers learn how genetic data and MRIs may improve the ability to detect prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06398639.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Adam Stuart Kibel
Brigham and Women's HospitalStatus: Active
Contact: Adam Stuart Kibel
Phone: 617-732-6665
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Keyan Salari
PRIMARY OBJECTIVE:
I. To evaluate a screening algorithm to detect clinically relevant prostate cancer (Gleason score ≥ 7) using genetic data (PRS) to determine risk of cancer and multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer.
SECONDARY OBJECTIVES:
I. To determine optimal age to begin screening using PRS and mpMRI.
II. To determine if rare variants in DNA repair enzymes could help refine screening.
III. To determine if deep learning methods applied to mpMRI and informed by genetic risk can more accurately predict significant cancers.
OUTLINE:
Patients undergo retrieval of existing archived blood samples, or undergo blood sample collection, for prostate specific antigen (PSA) and genetic testing and undergo mpMRI. Patients receive the results of their PRS stratification. Patients with an elevated PSA and/or an abnormal mpMRI result may undergo standard of care (SOC) biopsy.
After completion of study intervention, patients are followed every 12 months up to 10 years.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAdam Stuart Kibel
