[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634751":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":53,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"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,"role":23,"phone":24,"phoneExt":10,"email":25},"Senior Clinical Trial Manager","CONTACT","858-202-2000","clinicalaffairsSD@labcorp.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Idaho Urologic Institute","RECRUITING","Meridian","Idaho","83642","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-116.39151,43.61211,{"lat":39,"lon":38},[42,46,50],{"name":43,"role":23,"phone":44,"phoneExt":10,"email":45},"Brian Mihm, LPN","208-639-4946","bmihm@idurology.com",{"name":47,"role":23,"phone":48,"phoneExt":10,"email":49},"Karrie Fox, BS","208-639-4884","karried@idurology.com",{"name":51,"role":52,"phone":10,"phoneExt":10,"email":10},"Joseph Williams, MD","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[56],{"name":57,"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":69,"type":70},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.",[74],"Prostate Cancer Detection",[76],"prostate cancer, screening","2026-06-09",{"date":79,"type":80},"2026-06-11","ACTUAL",{"date":82,"type":80},"2026-04-03",{"date":84,"type":70},"2027-03-31",{"name":5,"class":6},1]