The current prostate cancer (PCa) screen test, prostate-specific antigen (PSA), has a high sensitivity for PCa but low specificity for high-risk, clinically significant PCa (csPCa), resulting in overdiagnosis and overtreatment of non-csPCa. Early identification of csPCa while avoiding unnecessary biopsies in men with non-csPCa is challenging. We built an optimized machine learning platform (ClarityDX) and showed its utility in generating models predicting csPCa. Integrating the ClarityDX platform with blood-based biomarkers for clinically significant PCa and clinical biomarker data from a 3448-patient cohort, we developed a test to stratify patients' risk of csPCa; called ClarityDX Prostate. When predicting high risk cancer in the validation cohort, ClarityDX Prostate showed 95% sensitivity, 35% specificity, 54% positive predictive value, and 91% negative predictive value, at a ≥ 25% threshold. Using ClarityDX Prostate at this threshold could avoid up to 35% of unnecessary prostate biopsies. ClarityDX Prostate showed higher accuracy for predicting the risk of csPCa than PSA alone and the tested model-based risk calculators. Using this test as a reflex test in men with elevated PSA levels may help patients and their healthcare providers decide if a prostate biopsy is necessary.
NPJ digital medicine. 2024 Jun 20*** epublish ***
M Eric Hyndman, Robert J Paproski, Adam Kinnaird, Adrian Fairey, Leonard Marks, Christian P Pavlovich, Sean A Fletcher, Roman Zachoval, Vanda Adamcova, Jiri Stejskal, Armen Aprikian, Christopher J D Wallis, Desmond Pink, Catalina Vasquez, Perrin H Beatty, John D Lewis
Department of Surgical Oncology, University of Calgary, Prostate Cancer Centre, Calgary, T2P 1P9, AB, Canada., Nanostics Inc., 4550 10230 Jasper Avenue, Edmonton, T5J 4P6, AB, Canada., Division of Urology, Department of Surgery, University of Alberta, Kipnes Urology Centre, Edmonton, T6G 1Z1, AB, Canada., UCLA Health, Westwood Urology 200 Medical Plaza, Suite 140, Los Angeles, CA, 90095, USA., James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, 21287, MD, USA., Department of Urology, 3rd Faculty of Medicine of Charles University and Thomayer University Hospital, Prague, Czech Republic., Division of Urology, Department of Surgery, University of Toronto, Toronto, M5T 1P5, ON, Canada., Nanostics Inc., 4550 10230 Jasper Avenue, Edmonton, T5J 4P6, AB, Canada. .