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

Inclusion Criteria:

1. Subject is male ≥40 and ≤75 years of age at the time of enrollment;
2. Subject provides a signed and dated informed consent;
3. Subject has a SOC tPSA of 2-10 ng/mL inclusive within 90 days of the study blood draw;
4. Subject is presenting to the clinic to discuss a potential prostate biopsy;
5. Subject agrees to provide all diagnostic test results throughout the study; and
6. Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.

7 Study blood sample will be collected prior to MRI (if conducted) and prior to the biopsy.

Exclusion Criteria

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 collection;
3. Acute or chronic urinary tract infection within 3 months of the study blood collection;
4. Men with an indwelling catheter or intermittent self-catheterization within 30 days of the study blood collection;
5. Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the study blood collection;
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 within 6 months prior to the study blood collection;
7. Subject is not able to read or comprehend the informed consent form;
8. Previous enrollment in this protocol with valid biopsy results; or
9. Men who had an MRI of the prostate within 90 days prior to the study blood collection.