Proclarix Test Validates Prostate Cancer Risk Across Ethnic Populations
Summary
A prospective, multi-center validation study registered on ClinicalTrials.gov evaluates the Proclarix assay for prostate cancer risk identification in a multi-ethnic cohort across up to 10 US urological clinics. Whole blood samples (up to 20 mL) will be collected within 30 days before scheduled prostate biopsy and sent to Labcorp for evaluation using the Proclarix assay. The study defines clinically significant prostate cancer (csPCa) as ISUP Grade Group ≥2 on biopsy and will compare assay results to histopathological findings.
“A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy.”
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What changed
A new observational clinical trial registration (NCT07543757) has been added to ClinicalTrials.gov describing a prospective, multi-center validation study for the Proclarix assay as a prostate cancer risk identification tool across ethnic populations. The study will enroll subjects from up to 10 US urological clinics, collect blood samples within 30 days before scheduled prostate biopsy, and send blinded samples to Labcorp for assay evaluation. A csPCa is defined as ISUP Grade Group ≥2 on biopsy.
Affected parties include clinical investigators conducting prostate cancer detection research, urological clinics participating as study sites, and manufacturers of diagnostic assays targeting prostate cancer risk stratification. The study represents an addition to the body of clinical evidence for non-invasive prostate cancer screening tools and may inform future diagnostic test development targeting multi-ethnic patient populations.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
Observational NCT07543757 Kind: OBSERVATIONAL Apr 22, 2026
Abstract
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.
Conditions: Prostate Cancer Detection
Interventions: Proclarix
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