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.
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 30 days of the Screening Visit;
Up to 100 subjects will have a SOC tPSA of 2-<4 ng/mL
None
1. Previous diagnosis of prostate cancer; 2. Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood draw; 3. Acute or chronic urinary tract infection within 3 months of the Screening Visit; 4. Men with an indwelling catheter or intermittent self-catheterization; 5. Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the Screening Visit blood draw; 6. Men who had an invasive urological procedure for benign prostate hyperplasia/obstruction (e.g. transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), aquablation, prostatic artery embolization, Rezum, laser vaporization, etc.) or biopsy of the prostate 6 months prior to the Screening Visit blood draw; 7. Subject is not able to read and comprehend English or Spanish; or 8. Previous enrollment in this protocol.
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.
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Sequenom, Inc.
Lead sponsor
Labcorp Corporation of America Holdings, Inc
Collaborator
