How to cite: Stovsky, M. “Large-Scale, Prospective, Clinical Validation Study of the Diagnostic Performance of IsoPSA Without and in Combination with Multi-Parametric MRI for the Detection of High Grade Prostate Cancer.” September 15, 2025. Accessed Apr 2026. https://grandroundsinurology.com/large-scale-multicenter-prospective-clinical-validation-study-of-the-diagnostic-performance-of-isopsa-without-and-in-combination-with-multi-parametric-mri-for-the-detection-of-high-grade-prostate-c/
Mark Stovsky, MD, MBA, FACS, a board-certified urologist and Chief Medical Officer, Cleveland Diagnostics, Inc., Cleveland, Ohio”, presented results from a prospective clinical validation study of IsoPSA. IsoPSA differs from conventional prostate-specific antigen (PSA) testing in that it evaluates structural variants of PSA isoforms rather than PSA concentration. This approach aims to better distinguish elevated PSA due to high-grade prostate cancer versus benign conditions.
The study included 566 men aged 50 years or older with PSA 4–10 ng/mL, all undergoing biopsy and IsoPSA testing. The trial analyzed IsoPSA performance in two subgroups: (1) men without pre-biopsy magnetic resonance imaging (MRI), and (2) men with pre-biopsy MRI showing prostate imaging reporting and data system (PI-RADS) 1–3 scores. IsoPSA was assessed using likelihood ratio analysis, with lower and upper cutoffs of 6.0 and 10.0, respectively.
The study concluded that IsoPSA demonstrated a false negative rate of 4.4 percent in men without MRI, compared with baseline risk assessment alone. In men with PI-RADS 1–3 on MRI, IsoPSA’s false negative rate was 5.1 percent. Across both cohorts, IsoPSA provided statistically informative positive and negative predictive characteristics, with post-test risks significantly improving upon pretest risk estimates.
Dr. Stovsky asserts that incorporating IsoPSA into clinical pathways may enhance shared decision-making and reduce false negatives, leading to more appropriate biopsy selection.
The Global Summit on Precision Diagnosis and Treatment of Prostate Cancer is a unique multi-disciplinary forum organized to inform the key health care stakeholders about the emerging advances in clinical cases and research and create a consensus-based vision for the future of precision care and educational and research strategy for its realization. The mission of the Summit is to fill the currently existing gap between the key experts of in vivo imaging, the world authorities in the in vitro fluid- and tissue-based molecular diagnostics, including genomics, and thought leaders in the development of novel observation strategies (e.g., active surveillance, or AS) and therapeutic interventions.
ABOUT THE AUTHOR
Mark Stovsky, MD, MBA, FACS, is the Chief Medical Officer and Co-Founder of Cleveland Diagnostics in Cleveland, Ohio. Dr. Stovsky’s clinical expertise and research interests include the management of prostate cancer and benign prostate disease, diagnostic biomarkers for cancer and other diseases, and medical economics.
