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.
Males aged 50-75
PSA 3-20 ng/ml within the previous 3 months
Fit to undergo all procedures listed in protocol per treating physician's discretion
No prostate biopsy in the past 4 years
Prior diagnosis of prostate cancer
Contraindication to MRI (e.g. claustrophobia, pacemaker)
Contraindication to prostate biopsy
Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
Parallel
Biopsy Procedure
Procedure/SurgeryUndergo biopsy
Diagnostic Procedure
DeviceUndergo MPS2 urine test
Electronic Health Record Review
Other interventionAncillary studies
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5
Will compare the proportions of patients with detected csPCa in the intervention and control arms (p1 and p2, respectively) using the OBrien Fleming stopping boundaries which control the overall one-sided Type I error rate to be less than .10.
Number of biopsies performed
Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Detection of GG1 cancers
Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Number of multiparametric magnetic resonance imaging performed
Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Adherence to the management recommendations in the biomarker-based arm
Click on the lead sponsor to view all of their trials.
University of Michigan Rogel Cancer Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
