Urine Screening + MRI for Prostate Cancer

(UPRISE Trial)

US
Overseen ByUprise StudyTeam
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new urine test, My Prostate Score 2 (MPS2), to determine its effectiveness in early detection of aggressive prostate cancer. The test identifies specific genetic markers in urine that suggest the presence of cancer requiring treatment. By combining this test with MRI scans, researchers aim to improve the identification of serious cancer cases and reduce unnecessary procedures. Men with PSA levels between 3 and 20 ng/ml in the last three months, who have not undergone a prostate biopsy in the past four years, may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance early detection methods for aggressive prostate cancer.

What prior data suggests that this urine screening test and MRI protocol is safe for prostate cancer detection?

Research has shown that the My Prostate Score 2 (MPS2) test is generally easy for patients to handle. This non-invasive test involves only a urine sample, avoiding surgery or needles. Studies have found that it accurately identifies 42% to 51% of patients who do not have significant prostate cancer. The test effectively determines when a biopsy isn't needed, with sensitivity rates of 91% to 94% and negative predictive values of 92% to 96%. This indicates that the test is both accurate and safe, with no reported side effects. Overall, MPS2 aims to reduce unnecessary procedures, making it a promising option for early prostate cancer detection.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more precise method for detecting prostate cancer. Unlike the standard approach, which often relies on MRIs and biopsies without additional insights, the My Prostate Score 2 (MPS2) test provides crucial information from a simple urine sample. This could help doctors decide more accurately when further tests like MRIs or biopsies are necessary, potentially reducing unnecessary procedures. The trial aims to find out if using MPS2 can streamline the diagnostic process, making it less invasive and more efficient for patients.

What evidence suggests that the My Prostate Score 2 (MPS2) test is effective for early detection of prostate cancer?

Research shows that the My Prostate Score 2 (MPS2) test effectively identifies aggressive prostate cancer. Studies indicate that MPS2 detects 94% of serious prostate cancers, specifically those graded GG2 or higher. The test excels at ruling out less serious prostate cancer (GG1), helping to avoid unnecessary treatments. In this trial, treating physicians will review MPS2 test results for participants in Arm I to decide if standard-of-care (SOC) MRI and/or biopsy is necessary. Participants in Arm II will have their MPS2 test results collected, but these results will not guide biopsy decisions after SOC MRI. Regarding safety, MPS2 identifies 42% to 51% of patients without significant prostate cancer, reducing unnecessary biopsies. Overall, MPS2 offers more accurate risk assessments compared to other tests.23678

Who Is on the Research Team?

US

Udit Singhal, MD

Principal Investigator

University of Michigan Rogel Cancer Center

TM

Todd Morgan, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

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
See 3 more

Exclusion Criteria

Contraindication to MRI (e.g. claustrophobia, pacemaker)
Contraindication to prostate biopsy
I have been diagnosed with prostate cancer before.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MPS2 Testing

Participants undergo urine sample collection for MPS2 testing. Results are used to determine if patients undergo SOC MRI and/or biopsy.

Up to 120 days

Follow-up

Participants are monitored for detection of clinically significant prostate cancer and other outcomes.

Up to 120 days

What Are the Treatments Tested in This Trial?

Interventions

  • My Prostate Score 2 (MPS2)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (MPS2)Experimental Treatment4 Interventions
Group II: Arm II (MPS2)Active Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

MyProstateScore 2.0 (MPS2) - Providers

Identifying Low-Risk Patients: MPS2 safely identifies 42% to 51% of patients who do not have clinically significant prostate cancer. Optimized for Accuracy: ...

Why You Want Your Medical Test to be Peer Reviewed & ...

Furthermore, the study shows how MPS2 outperforms other biomarker tests for prostate cancer and can identify up to half of the patients ...

Clinical Validation of MyProstateScore 2.0 Testing Using ...

In this study, we validated the MPS2 test in urine specimens obtained without DRE and evaluated its clinical performance for detection of GG ≥ 2 PCa.

Analytical Validation of MyProstateScore 2.0 - PMC - NIH

The test had a similarly strong biopsy rule-out performance with a sensitivity of 91–94% and negative predictive values of 92–96% [9].

MPS2 test validated for detection of high-grade prostate ...

Overall, the MPS2 test was able to detect 94% of GG2 or higher cancers. The test was also more accurate than other risk assessments, with an ...

MyProstateScore 2.0 | Prostate Cancer Risk Assessment

MPS2 is optimized for unrivaled accuracy for both previously negative biopsy and biopsy naïve patients, offering clear insights and certainty for peace of mind.

MYPROSTATESCORE (MPS) FREQUENTLY ASKED ... - MLabs

The MPS high grade cancer risk score provides a quantitative risk of having potentially aggressive prostate cancer detected on biopsy. Individual patients may ...

MPS2-AS outperforms mpMRI for prostate cancer ...

A noninvasive urine-based assay, MyProstateScore 2.0–Active Surveillance (MPS2-AS), demonstrated improved diagnostic performance compared ...