Prostate CarcinomaUPRISENCT07526545
Urine Prostate Screening Integrated With MRI for Early Detection of Prostate Cancer, UPRISE Trial
A study testing Biopsy Procedure, Diagnostic Procedure and Electronic Health Record Review in people with Prostate Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Biopsy Procedure, Diagnostic Procedure and Electronic Health Record Review
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Uprise StudyTeam, 734-615-6662, uprise-spore@med.umich.edu
Udit Singhal, MD
About this study
Official title: 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Biopsy Procedure, Diagnostic Procedure, Electronic Health Record Review, Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Diagnostic ProcedureDevice
Also called Diagnostic, Diagnostic Method, Diagnostic Technique, Diagnostic Test
Undergo MPS2 urine test
Electronic Health Record ReviewOther
Ancillary studies
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Biopsy Procedure; Device: Diagnostic Procedure; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 120 days
Secondary outcomes (6)
Number of biopsies performed
Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.
Measured: 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.
Measured: 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.
Measured: Up to 120 days
Adherence to the management recommendations in the biomarker-based arm
Measured: 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.
Measured: 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.
Measured: Up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Udit Singhal, MD, Principal investigator, University of Michigan Rogel Cancer CenterTodd Morgan, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526545
- Sponsor's protocol ID
- UMCC 2025.092
- Other IDs
- NCI-2026-01859, HUM00273579, P50CA186786
- Acronym
- UPRISE
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPRISE (Urine Prostate Screening Integrated With MRI for Prostate Cancer Early Detection)
- ClinicalTrials.gov ID
- NCT07526545
- Acronym / sponsor ID
- UPRISE / UMCC 2025.092
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (MPS2) | Experimental | Procedure: Biopsy Procedure, Device: Diagnostic Procedure, Other: Electronic Health Record Review, Procedure: Magnetic Resonance ImagingPatients 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. |
| Arm II (MPS2) | Active comparator | Procedure: Biopsy Procedure, Device: Diagnostic Procedure, Other: Electronic Health Record Review, Procedure: Magnetic Resonance ImagingPatients 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Arm I (MPS2), Arm II (MPS2) |
| Diagnostic ProcedureAlso: Diagnostic, Diagnostic Method, Diagnostic Technique, Diagnostic TestUndergo MPS2 urine test | Device | Arm I (MPS2), Arm II (MPS2) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (MPS2), Arm II (MPS2) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Arm I (MPS2), Arm II (MPS2) |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Udit Singhal, MD principal investigator
University of Michigan Rogel Cancer Center
Todd Morgan, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy Procedure, Diagnostic Procedure and Electronic Health Record Review in people with Prostate Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uprise StudyTeam (734-615-6662, uprise-spore@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5 (time frame: Up to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.