[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634751":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":146,"collaborators":148,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":153,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":10,"studyType":164,"phases":10,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Sequenom, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prostate cancer suspected",null,"Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy",[13],"Diagnostic Test: Proclarix",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Proclarix","Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age.",[9],[21],{"name":22,"affiliation":23,"role":24},"Neil Shore, MD","Carolina Urologic Research Center","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Senior Clinical Trial Manager","CONTACT","858-202-2000","clinicalaffairsSD@labcorp.com",[32,57,77,94,109,128],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Idaho Urologic Institute","RECRUITING","Meridian","Idaho","83642","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-116.39151,43.61211,{"lat":44,"lon":43},[47,51,55],{"name":48,"role":28,"phone":49,"phoneExt":10,"email":50},"Brian Mihm, LPN","208-639-4946","bmihm@idurology.com",{"name":52,"role":28,"phone":53,"phoneExt":10,"email":54},"Karrie Fox, BS","208-639-4884","karried@idurology.com",{"name":56,"role":24,"phone":10,"phoneExt":10,"email":10},"Joseph Williams, MD",{"facility":58,"status":34,"city":59,"state":60,"zip":61,"country":38,"countryCode":39,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Graves Gilbert Clinic","Bowling Green","Kentucky","42101",{"type":41,"coordinates":63},[64,65],-86.4436,36.99032,{"lat":65,"lon":64},[68,72,75],{"name":69,"role":28,"phone":70,"phoneExt":10,"email":71},"Christian Jones","716-249-6700","cjones@circuitclinical.com",{"name":73,"role":28,"phone":70,"phoneExt":10,"email":74},"Tanya Atkins","tatkins@circuitclinical.com",{"name":76,"role":24,"phone":10,"phoneExt":10,"email":10},"Diego Mastronardi, MD",{"facility":78,"status":34,"city":79,"state":80,"zip":81,"country":38,"countryCode":39,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Chesapeake Urology Associates","Hanover","Maryland","21076",{"type":41,"coordinates":83},[84,85],-76.72414,39.19289,{"lat":85,"lon":84},[88,92],{"name":89,"role":28,"phone":90,"phoneExt":10,"email":91},"Barbara Kyei","410-760-9400","bkyei@chesuro.com",{"name":93,"role":24,"phone":10,"phoneExt":10,"email":10},"Kaiser Robertson, MD",{"facility":78,"status":34,"city":95,"state":80,"zip":96,"country":38,"countryCode":39,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Towson","21204",{"type":41,"coordinates":98},[99,100],-76.60191,39.4015,{"lat":100,"lon":99},[103,107],{"name":104,"role":28,"phone":105,"phoneExt":10,"email":106},"Tawni Doliveira","410-825-5454","tawni.doliveira@chesuro.com",{"name":108,"role":24,"phone":10,"phoneExt":10,"email":10},"Brian Neuman, MD",{"facility":110,"status":34,"city":111,"state":112,"zip":113,"country":38,"countryCode":39,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Crystal Run Healthcare","Middletown","New York","10941",{"type":41,"coordinates":115},[116,117],-74.42293,41.44593,{"lat":117,"lon":116},[120,123,126],{"name":121,"role":28,"phone":70,"phoneExt":10,"email":122},"Dalea Frank","dfrank@circuitclinical.com",{"name":124,"role":28,"phone":70,"phoneExt":10,"email":125},"Lisa Crespi","lcrespi@circuitclinical.com",{"name":127,"role":24,"phone":10,"phoneExt":10,"email":10},"Steve Rowe, MD",{"facility":23,"status":34,"city":129,"state":130,"zip":131,"country":38,"countryCode":39,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Myrtle Beach","South Carolina","29572",{"type":41,"coordinates":133},[134,135],-78.88669,33.68906,{"lat":135,"lon":134},[138,142,145],{"name":139,"role":28,"phone":140,"phoneExt":10,"email":141},"Matt Parton","843-839-1679","matthew.parton@startresearch.com",{"name":143,"role":28,"phone":140,"phoneExt":10,"email":144},"Jennifer Smith","jennifer.smith@startresearch.com",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":147,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[149],{"name":150,"class":6},"Labcorp Corporation of America Holdings, Inc","100634751","prostate-cancer-risk-identification-in-a-multi-ethnic-cohort-a-prospective-us-based-multi-center-validation-study-of-proclarix-100634751",false,"NCT07543757","Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix","PRIME","Inclusion Criteria:\n\n1. Subject is male ≥40 and ≤75 years of age at the time of enrollment;\n2. Subject provides a signed and dated informed consent;\n3. Subject has a SOC tPSA of 2-10 ng\u002FmL inclusive within 30 days of the Screening Visit;\n\n   1. Up to 100 subjects will have a SOC tPSA of 2-\\\u003C4 ng\u002FmL\n   2. A minimum of 400 subjects will have a SOC tPSA of 4-10 ng\u002FmL\n4. Subject is scheduled to undergo a prostate biopsy within 30 days of the Screening Visit blood collection;\n5. Subject agrees to provide all diagnostic test results throughout the study; and\n6. Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.\n\nExclusion Criteria:\n\n\\-","MALE","40 Years","75 Years",{"count":162,"type":163},500,"ESTIMATED","OBSERVATIONAL","The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent and prior to the scheduled prostate biopsy (≤30 days), up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. Prostate biopsy will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores are required. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy. The assay results will be compared to the biopsy results.",[167],"Prostate Cancer Detection",[169],"prostate cancer, screening","2026-07-17",{"date":172,"type":173},"2026-07-21","ACTUAL",{"date":175,"type":173},"2026-04-03",{"date":177,"type":163},"2027-03-31",{"name":5,"class":6},6]