UPRISE (Urine Prostate Screening Integrated With MRI for Prostate Cancer Early Detection)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Arm I (MPS2)
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.
Intervention: Biopsy Procedure (Procedure)
Arm I (MPS2)
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.
Intervention: Diagnostic Procedure (Device)
Arm II (MPS2)
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.
Intervention: Biopsy Procedure (Procedure)
Arm II (MPS2)
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.
Intervention: Diagnostic Procedure (Device)
Arm II (MPS2)
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.
Intervention: Magnetic Resonance Imaging (Procedure)
Arm I (MPS2)
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.
Intervention: Electronic Health Record Review (Other)
Arm I (MPS2)
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.
Intervention: Magnetic Resonance Imaging (Procedure)
Arm II (MPS2)
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.
Intervention: Electronic Health Record Review (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of biopsies performed(Up to 120 days)
- Detection of GG1 cancers(Up to 120 days)
- Number of multiparametric magnetic resonance imaging performed(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(Up to 120 days)
- Cost(Up to 120 days)