[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07526545":3,"trial-entities:NCT07526545":143,"trial-summary:NCT07526545":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":75,"secondary_outcomes":80,"sex":96,"minimum_age":97,"maximum_age":98,"healthy_volunteers":15,"eligibility_criteria":99,"std_ages":113,"locations":116,"central_contacts":136,"overall_officials":138,"references":141,"see_also_links":142},"NCT07526545","UMCC 2025.092","Urine Prostate Screening Integrated With MRI for Early Detection of Prostate Cancer, UPRISE Trial","UPRISE (Urine Prostate Screening Integrated With MRI for Prostate Cancer Early Detection)","NOT_YET_RECRUITING","2030-03-01","2026-06","2026-06-09","2026-09-01","University of Michigan Rogel Cancer Center","OTHER",true,"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.",null,[19],"Prostate Carcinoma",[],"INTERVENTIONAL","SCREENING",[24],"NA",{"count":26,"type":27},800,"ESTIMATED",[29,40,51,55],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"PROCEDURE","Biopsy Procedure","Undergo biopsy",[34,35],"Arm I (MPS2)","Arm II (MPS2)",[37,38,39],"Biopsy","BIOPSY_TYPE","Bx",{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DEVICE","Diagnostic Procedure","Undergo MPS2 urine test",[34,35],[46,47,48,49,50],"Diagnostic","Diagnostic Method","Diagnostic Technique","Diagnostic Test","Evaluation Basis of Disease Status",{"type":14,"name":52,"description":53,"armGroupLabels":54},"Electronic Health Record Review","Ancillary studies",[34,35],{"type":30,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Magnetic Resonance Imaging","Undergo MRI",[34,35],[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",[76],{"measure":77,"description":78,"timeFrame":79},"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",[81,84,86,88,90,93],{"measure":82,"description":83,"timeFrame":79},"Number of biopsies performed","Will be compared between arms using Farrington-Manning (score) tests for the difference in two independent proportions.",{"measure":85,"description":83,"timeFrame":79},"Detection of GG1 cancers",{"measure":87,"description":83,"timeFrame":79},"Number of multiparametric magnetic resonance imaging performed",{"measure":89,"timeFrame":79},"Adherence to the management recommendations in the biomarker-based arm",{"measure":91,"description":92,"timeFrame":79},"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.",{"measure":94,"description":95,"timeFrame":79},"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.","MALE","50 Years","75 Years",{"inclusion":100,"exclusion":107,"raw_text":112},[101,102,103,104,105,106],"Males aged 50-75","PSA 3-20 ng\u002Fml 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",[108,109,110,111],"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","Inclusion Criteria:\n\n* Males aged 50-75\n* PSA 3-20 ng\u002Fml within the previous 3 months\n* Fit to undergo all procedures listed in protocol per treating physician's discretion\n* No prostate biopsy in the past 4 years\n* No prostate MRI in the past 2 years\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Prior diagnosis of prostate cancer\n* Contraindication to MRI (e.g. claustrophobia, pacemaker)\n* Contraindication to prostate biopsy\n* Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work",[114,115],"ADULT","OLDER_ADULT",[117],{"facility":13,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":133},"Ann Arbor","Michigan","48109","United States",[123,128,131],{"name":124,"role":125,"phone":126,"email":127},"Uprise StudyTeam","CONTACT","734-615-6662","uprise-spore@med.umich.edu",{"name":129,"role":130},"Udit Singhal, MD","PRINCIPAL_INVESTIGATOR",{"name":132,"role":130},"Todd Morgan, MD",{"lat":134,"lon":135},42.27756,-83.74088,[137],{"name":124,"role":125,"phone":126,"email":127},[139,140],{"name":129,"affiliation":13,"role":130},{"name":132,"affiliation":13,"role":130},[],[],{"nct_id":4,"conditions":144,"biomarkers":145},[19],[],{"nct_id":4,"found":15,"summary":147,"prompt_version":157},{"design":148,"status":149,"heading":150,"summary":151,"follow_up":152,"word_count":153,"commitments":154,"compensation":155,"drugs_mentioned":156},"This is an interventional study planning to enroll 800 male participants. It is testing a urine test (MPS2) and MRI for prostate cancer detection.","completed","UPRISE Trial: Urine Test and MRI for Prostate Cancer Detection","This study, called the UPRISE Trial, is looking at how well a urine test called My Prostate Score 2 (MPS2) combined with an MRI (Magnetic Resonance Imaging) can find prostate cancer early. MPS2 is a new urine test that measures genetic information to help predict the chance of having aggressive prostate cancer. The goal is to find only the cancers that truly need treatment. You may be able to join if you are a man between 50 and 75 years old, have a PSA (prostate-specific antigen) level between 3-20 ng\u002Fml, and have not had a prostate biopsy in the last 4 years or an MRI in the last 2 years. The study will measure if these methods can accurately detect clinically significant prostate cancer.","The primary outcome, clinically significant prostate cancer, will be measured up to 120 days.",124,"Participants will undergo a biopsy procedure, an MPS2 urine test, and an MRI. There will also be a review of your electronic health records.","Not stated in the trial record.",[56],"v2"]