Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

Inclusion Criteria:

Males between 40-75 (inclusive) years of age;
With and without family history of prostate cancer;
No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
Total PSA results >/= 3ng/mL collected within 6m of enrollment;
Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta) to disclose health-related information to study;
Undergoing a diagnostic prostate biopsy; and
Provided informed consent to participate in the study.

Exclusion Criteria:

Unwilling to participate in the study;
Unavailable for biopsy procedure in recruitment areas;
Not undergoing a prostate biopsy;
Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
Under the age of 40 years of age or over the age of 75 years of age.