[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100345992":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":55,"collaborators":58,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":10,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Michigan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Initial prostate biopsy",null,"Men who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy.",[13],"Diagnostic Test: MRI prostate",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","MRI prostate","MRI and laboratory biomarkers",[9],[21],"urine and blood biomarkers",[23],{"name":24,"affiliation":5,"role":25},"John T Wei, MD, MS","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Jackie Dahlgren","CONTACT","206-667-3438","jdahlgre@fredhutch.org",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-83.74088,42.27756,{"lat":44,"lon":43},[47,51],{"name":48,"role":29,"phone":49,"phoneExt":10,"email":50},"John T Wei, MD","7346153040","jtw@med.umich.edu",{"name":52,"role":29,"phone":53,"phoneExt":10,"email":54},"Rabia Martin","7347637508","rabia@med.umich.edu",{"type":25,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"John Wei","David A Bloom Professor of Urology, Medical Director of Brighton Center for Specialty Care and Professor of Urology, Medical School",[59,61,63,65,67,69,71,73,75,77,79,81],{"name":60,"class":6},"The University of Texas Health Science Center at San Antonio",{"name":62,"class":6},"University of Alabama at Birmingham",{"name":64,"class":6},"University of Chicago",{"name":66,"class":6},"Cornell University",{"name":68,"class":6},"H. Lee Moffitt Cancer Center and Research Institute",{"name":70,"class":6},"Vanderbilt University",{"name":72,"class":6},"Emory University",{"name":74,"class":6},"University of Miami",{"name":76,"class":6},"University of Texas",{"name":78,"class":6},"Beth Israel Deaconess Medical Center",{"name":80,"class":6},"Brigham and Women's Hospital",{"name":82,"class":6},"Fred Hutchinson Cancer Center","100345992","edrn-prostate-mri-biomarker-study-100345992",false,"NCT03784924","EDRN Prostate MRI Biomarker Study","EDRN Prostate MRI Biomarker Study and Reference Set","P-MRI","Inclusion Criteria:\n\n* Men with suspected but undiagnosed prostate cancer\n* To be scheduled\u002Fscheduled for biopsy as routine clinical care\n\nExclusion Criteria:\n\n* Inability to obtain blood and urine per SOP or conduct an attentive DRE\n* Unable to undergo\u002Ftolerate a prostate MRI or failure to conduct the MRI\n* Prior diagnosis of prostate cancer\n* Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)\n* Participating in clinical trial for prostate disease\n* Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift\n* Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose","MALE","18 Years",{"count":94,"type":95},950,"ESTIMATED","OBSERVATIONAL","The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.",[99,100],"PSA","Prostate Cancer",[102,103,104,105],"Prostate cancer","psa","early detection","MRI","2026-01-06",{"date":108,"type":109},"2026-01-08","ACTUAL",{"date":111,"type":109},"2019-02-04",{"date":113,"type":95},"2028-12-31",{"name":5,"class":6},1]