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Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix

NCT07543757 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-07-21

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Labcorp Corporation of America Holdings, Inc

    collaborator INDUSTRY

  • Sequenom, Inc.

    lead INDUSTRY

Principal Investigators

  • Neil Shore, MD · Carolina Urologic Research Center

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-03
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543757 on ClinicalTrials.gov