Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-01859 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00273579 | Other Identifier | University of Michigan Rogel Cancer Center | |
| P50CA186786 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy Procedure | Procedure | Undergo biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of biopsies performed | Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uprise StudyTeam | Contact | 734-615-6662 | uprise-spore@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Udit Singhal, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Todd Morgan, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Diagnostic Procedure | Device | Undergo MPS2 urine test |
|
|
| Electronic Health Record Review | Other | Ancillary studies |
|
| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
|
| 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. | Up to 120 days |
| Adherence to the management recommendations in the biomarker-based arm | 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. | 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. | Up to 120 days |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003955 | Diagnostic Tests, Routine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
Not provided
Not provided