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

UPRISE (Urine Prostate Screening Integrated With MRI for Prostate Cancer Early Detection)

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 Overview

• Status: Not yet recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Other: Electronic Health Record Review; Procedure: Biopsy Procedure; Device: Diagnostic Procedure

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uprise StudyTeam; Phone Number: 734-615-6662; Email: uprise-spore@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
      • Principal Investigator: Todd Morgan, MD
      • Contact: Uprise StudyTeam; Phone Number: 734-615-6662; Email: uprise-spore@med.umich.edu
      • Principal Investigator: Udit Singhal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Other: Electronic Health Record Review; Ancillary studies; Procedure: Biopsy Procedure; Undergo biopsy; Other Names: Bx; BIOPSY_TYPE; Biopsy; Device: Diagnostic Procedure; Undergo MPS2 urine test; Other Names: Diagnostic Method; Diagnostic Technique; Diagnostic Test; Diagnostic; Evaluation Basis of Disease Status
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.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Other: Electronic Health Record Review; Ancillary studies; Procedure: Biopsy Procedure; Undergo biopsy; Other Names: Bx; BIOPSY_TYPE; Biopsy; Device: Diagnostic Procedure; Undergo MPS2 urine test; Other Names: Diagnostic Method; Diagnostic Technique; Diagnostic Test; Diagnostic; Evaluation Basis of Disease Status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of biopsies performed	Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.	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.	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.	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	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.	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.	Up to 120 days

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Udit Singhal, MD, University of Michigan Rogel Cancer Center; Principal Investigator: Todd Morgan, MD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Chemistry Techniques, Analytical; Spectrum Analysis; Biopsy; Magnetic Resonance Spectroscopy; Diagnosis; Diagnostic Techniques and Procedures; Diagnostic Tests, Routine
• Other Study ID Numbers: UMCC 2025.092; NCI-2026-01859 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00273579 (Other Identifier: University of Michigan Rogel Cancer Center); P50CA186786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No