Recruiting

MPS2

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07526545

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Biopsy Procedure

Diagnostic Procedure

Electronic Health Record Review

Magnetic Resonance Imaging

Study Details

Brief summary:

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.

Conditions

Prostate Carcinoma

Study ID

NCT07526545

Start date

Dec 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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
  • No prostate MRI in the past 2 years
  • Able to provide written informed consent

Exclusion Criteria:

  • 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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Biopsy Procedure

Undergo biopsy

Diagnostic Procedure

Undergo MPS2 urine test

Electronic Health Record Review

Ancillary studies

Magnetic Resonance Imaging

Undergo 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 and Locations

Central contacts

Uprise StudyTeam

734-615-6662uprise-spore@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Uprise StudyTeam

734-615-6662uprise-spore@med.umich.edu

Principal Investigator:

Udit Singhal, MD

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.