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

This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy due to suspicion of prostate cancer. The study will compare ClarityDX Prostate test results with biopsy outcomes to determine the test's ability to identify the presence of clinically significant prostate cancer.

Sex

Male

Minimum age

40 Years

Maximum age

75 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

• RESULTPaproski RJ, Kinnaird A, Hyndman ME, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Predicting clinically significant prostate cancer with or without digital rectal exam and MRI data using ClarityDX Prostate models. NPJ Digit Med. 2026 Apr 17;9(1):467. doi: 10.1038/s41746-026-02642-1. PMID 41998222
• RESULTHyndman ME, Paproski RJ, Kinnaird A, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform. NPJ Digit Med. 2024 Jun 20;7(1):163. doi: 10.1038/s41746-024-01167-9. PMID 38902526