This clinical trial tests how well a urine prostate cancer screening test, My Prostate Score 2 (MPS2), integrated with magnetic resonance imaging (MRI) works for early detection of prostate cancer. MPS2 is an investigational urine-based test designed to help identify the likelihood of having aggressive prostate cancer. MPS2 testing works by measuring specific early detection biomarkers that include genetic information. This next-generation test aims to address a major challenge in prostate cancer care—detecting only the cancers that truly need treatment. Results may lead to paradigm shifts in early detection algorithms and reduce reliance on MRI and biopsy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07526545.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Rogel Cancer CenterStatus: Approved
Contact: Udit Singhal
Phone: 734-615-6662
PRIMARY OBJECTIVE:
I. To evaluate whether an MPS2 urine biomarker-driven approach is non-inferior to an MRI-guided approach for detection of clinically significant prostate cancer in men with elevated prostate-specific antigen (PSA).
SECONDARY OBJECTIVES:
I. To determine the impact of MPS2 testing on use of multiparametric MRI (mpMRI) and number of prostate biopsies performed.
II. To assess the performance of an MPS2-based approach on limiting detection of grade group 1 cancers.
III. To evaluate adherence to management recommendations based on MPS2 and mpMRI results.
IV. To determine the impact of an MPS2-based early detection algorithm on costs to the healthcare system.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians review and utilize the results of the MPS2 test to determine if patients undergo standard of care (SOC) MRI and/or biopsy.
ARM II: Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians do NOT review or utilize results of the MPS2 test to determine if patients undergo a biopsy after SOC MRI.
After completion of study intervention, patients are followed up for 120 days.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorUdit Singhal
