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

Conditions

• Prostate Cancer Detection

Eligibility Criteria

Sex

MALE

Age

40 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Proclarix — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

Start date

Apr 3, 2026

Status verified

Jun 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: Prostate cancer suspected
  Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy

Primary Outcome Measure

Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results. [ Time Frame: From enrollment to the collection of prostate biopsy results at 90 days ]

Central Contacts

• Senior Clinical Trial Manager
  858-202-2000
  [email protected]

Locations (1)

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