The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, 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. If a prostate biopsy is performed, it 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 is required if a systematic biopsy is performed. 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.
Subject is male ≥40 and ≤75 years of age at the time of enrollment;
Subject provides a signed and dated informed consent;
Subject has a SOC tPSA of 2-10 ng/mL inclusive within 90 days of the study blood draw;
Subject is presenting to the clinic to discuss a potential prostate biopsy;
Previous diagnosis of prostate cancer;
Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood collection;
Acute or chronic urinary tract infection within 3 months of the study blood collection;
Men with an indwelling catheter or intermittent self-catheterization within 30 days of the study blood collection;
Approximately 500 subjects will be enrolled in this study, of which approximately 400 subjects will have a tPSA value of 4-10 ng/mL and 100 subjects will have a tPSA of 2-\<4 ng/mL.
Case-only
Prospective
Proclarix
Diagnostic testProclarix® 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.
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy.
Evaluate Proclarix's clinical ability to correlate with and add to the results of other diagnostic tests performed as standard of care (i.e., MRI, ultrasound, etc.)
Compare study test results to SOC screening and diagnostic tests.
Assess Proclarix®'s clinical performance compared with percent free PSA (%fPSA), the Prostate Health Index (phi), and a risk calculator as proposed by the American Urological Association (AUA) guidelines.
Compare other validated study endpoints to study test results.
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Sequenom, Inc.
Lead sponsor
Labcorp Corporation of America Holdings, Inc
Collaborator
