[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-detection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-detection":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"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":19,"type":20},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.",[24],"Prostate Cancer Detection",[26],"prostate cancer, screening","RECRUITING","2026-06-09",{"date":30,"type":31},"2026-06-11","ACTUAL",{"date":33,"type":31},"2026-04-03",{"date":35,"type":20},"2027-03-31",{"name":37,"class":38},"Sequenom, Inc.","INDUSTRY",""]