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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
800
Undergo biopsy
Undergo MPS2 urine test
Ancillary studies
Undergo MRI
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
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.
Time frame: Up to 120 days
Number of biopsies performed
Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Time frame: Up to 120 days
Detection of GG1 cancers
Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Time frame: Up to 120 days
Number of multiparametric magnetic resonance imaging performed
Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Time frame: Up to 120 days
Adherence to the management recommendations in the biomarker-based arm
Time frame: Up to 120 days
My Prostate Score 2 (MPS2) performance for detecting csPCa
The sensitivity and specificity of MPS2 will be calculated using the established threshold both for a population of all patients (assuming patients without a biopsy do not have csPCa) and separately for patients with Prostate Imaging Reporting and Data System 3-5 who undergo a biopsy.
Time frame: Up to 120 days
Cost
Will be compared between arms using Wilcoxon Rank Sum Tests due to expected skewed distributions. These analyses will be conducted as a 2-sided .05 alpha level.
Time frame: Up to 120 days
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