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

NCT07526545 | Not Yet Recruiting DMC FDA Device

• 4 other identifiers: UMCC 2025.092NCI-2026-01859HUM00273579P50CA186786
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 120 days

Secondary Outcomes (6)

• Number of biopsies performed

  Up to 120 days

• Detection of GG1 cancers

  Up to 120 days

• Number of multiparametric magnetic resonance imaging performed

  Up to 120 days

• Adherence to the management recommendations in the biomarker-based arm

  Up to 120 days

• My Prostate Score 2 (MPS2) performance for detecting csPCa

  Up to 120 days

Study Arms (2)

Arm I (MPS2)

EXPERIMENTAL

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.

Procedure: Biopsy Procedure; Device: Diagnostic Procedure; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging

Arm II (MPS2)

ACTIVE COMPARATOR

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.

Procedure: Biopsy Procedure; Device: Diagnostic Procedure; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging

Interventions

Biopsy Procedure PROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Arm I (MPS2); Arm II (MPS2)

Diagnostic Procedure DEVICE

Undergo MPS2 urine test

Also known as: Diagnostic, Diagnostic Method, Diagnostic Technique, Diagnostic Test, Evaluation Basis of Disease Status

Arm I (MPS2); Arm II (MPS2)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (MPS2); Arm II (MPS2)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (MPS2); Arm II (MPS2)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Tests, Routine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Udit Singhal, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

• Todd Morgan, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uprise StudyTeam

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)