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Not yet recruiting NCT07526545

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

No phase Interventional Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy Procedure, Diagnostic Procedure, Electronic Health Record Review, Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: 50 years — 75 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Biopsy Procedure
    Undergo biopsy
  • Device Diagnostic Procedure
    Undergo MPS2 urine test
  • Other Electronic Health Record Review
    Ancillary studies
  • Procedure Magnetic Resonance Imaging
    Undergo MRI

Primary outcome measures

  • Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5 [Time frame: Up to 120 days]
Secondary outcome measures (6)
  • Number of biopsies performed [Time frame: Up to 120 days]
  • Detection of GG1 cancers [Time frame: Up to 120 days]
  • Number of multiparametric magnetic resonance imaging performed [Time frame: Up to 120 days]
  • Adherence to the management recommendations in the biomarker-based arm [Time frame: Up to 120 days]
  • My Prostate Score 2 (MPS2) performance for detecting csPCa [Time frame: Up to 120 days]
  • Cost [Time frame: Up to 120 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • University of Michigan Rogel Cancer Center — Ann Arbor

Identifiers

NCT: NCT07526545 · UMCC 2025.092 · NCI-2026-01859 · HUM00273579 · P50CA186786

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗