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NCT Number: NCT07526545

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

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location contact

Todd Morgan, MD

PRINCIPAL_INVESTIGATOR

Udit Singhal, MD

PRINCIPAL_INVESTIGATOR

Uprise StudyTeam

CONTACT

[email protected]

734-615-6662

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy Procedure

Procedure

Undergo biopsy

Other names: Biopsy, BIOPSY_TYPE, Bx

Diagnostic Procedure

Device

Undergo MPS2 urine test

Other names: Diagnostic, Diagnostic Method, Diagnostic Technique, Diagnostic Test, Evaluation Basis of Disease Status

Electronic Health Record Review

Other

Ancillary studies

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: 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

Primary outcomes

  1. Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5

    Time frame: Up to 120 days

    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.

Secondary outcomes

  1. Number of biopsies performed

    Time frame: Up to 120 days

    Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.

  2. Detection of GG1 cancers

    Time frame: Up to 120 days

    Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.

  3. Number of multiparametric magnetic resonance imaging performed

    Time frame: Up to 120 days

    Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.

  4. Adherence to the management recommendations in the biomarker-based arm

    Time frame: Up to 120 days

  5. My Prostate Score 2 (MPS2) performance for detecting csPCa

    Time frame: Up to 120 days

    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.

  6. Cost

    Time frame: Up to 120 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Uprise StudyTeam

CONTACT

[email protected]

734-615-6662

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: UPRISE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 13, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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