Urine Prostate Screening Integrated With MRI for Early Detection of Prostate Cancer, UPRISE Trial

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT07526545
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Diagnostic Procedure — DEVICE
    Undergo MPS2 urine test
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2030
Completion
Mar 1, 2030

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Arm I (MPS2)
    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 SOC MRI and/or biopsy.
  • Active Comparator: Arm II (MPS2)
    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.

Primary Outcome Measure

Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5 [ Time Frame: Up to 120 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Uprise StudyTeam
734-615-6662
Udit Singhal, MD (PRINCIPAL_INVESTIGATOR)
Todd Morgan, MD (PRINCIPAL_INVESTIGATOR)

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