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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07526545

Acronym

UPRISE

Enrollment

800

Registered

2026-04-13

Start date

2026-05-01

Completion date

2029-11-01

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Carcinoma

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.

Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

DEVICEDiagnostic Procedure

Undergo MPS2 urine test

OTHERElectronic Health Record Review

Ancillary studies

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5	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

Measure	Time frame	Description
Number of biopsies performed	Up to 120 days	Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Detection of GG1 cancers	Up to 120 days	Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Number of multiparametric magnetic resonance imaging performed	Up to 120 days	Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
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	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.
Cost	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.

Countries

United States

Contacts

CONTACTUprise StudyTeam

uprise-spore@med.umich.edu734-615-6662

PRINCIPAL_INVESTIGATORUdit Singhal, MD

University of Michigan Rogel Cancer Center

PRINCIPAL_INVESTIGATORTodd Morgan, MD