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
Sequenom, Inc.
Lead sponsor
Labcorp Corporation of America Holdings, Inc
Collaborator