Clinical validation of IsoPSA, a single parameter, structure-focused assay for improved detection of prostate cancer: A prospective, multicenter study.

IsoPSA is a blood-based test that assesses prostate cancer (CaP) risk by partitioning and detecting cancer-specific structural isoforms of prostate specific antigen (PSA) with an aqueous 2- phase system.

To validate the diagnostic performance of IsoPSA for High-Grade CaP and Any CaP risk on biopsy in men age ≥ 50 with total PSA ≥ 4 ng/ml.

Prospective, multicenter study of 888 men scheduled for prostate biopsy at 8 academic and community sites between August 2015 and August 2020.

IsoPSA test.

Receiver operating characteristic and likelihood ratio analysis used to validate diagnostic performance for previously established IsoPSA Index cutoffs for High-Grade CaP (Gleason Score ≥ 7) and Any CaP (Gleason Score ≥ 6), compare IsoPSA to total PSA and % free PSA, and evaluate subgroups (total PSA 4-10 ng/ml, total PSA > 10 ng/ml, biopsy naïve, prior negative biopsy).

The disease prevalence was 35.6% (High-Grade CaP) and 58.9% (Any CaP). The area under the receiver operating characteristic curve was 0.783 (High-Grade CaP) and 0.770 (Any CaP). IsoPSA outperformed total PSA and % free PSA on area under the receiver operating characteristic curve, specificity, positive and negative predictive value at similar sensitivity. Using selected IsoPSA Index cutoffs, an estimated 46% (High-Grade CaP) and 42% (Any CaP) of biopsies could be avoided in low-risk patients. IsoPSA displayed statistically informative likelihood ratio-based predictive characteristics. IsoPSA maintained accuracy in clinically relevant subgroups.

IsoPSA diagnostic performance and predictive value is validated for High-Grade CaP and Any CaP in men age ≥ 50 with total PSA ≥ 4 ng/ml undergoing diagnostic biopsy. IsoPSA outperforms total and % free PSA in discriminating the risk of prostate cancer on biopsy.

IsoPSA has the potential to reduce unnecessary biopsies and improve the risk-benefit ratio for CaP early detection.

Urologic oncology. 2022 Jul 12 [Epub ahead of print]

Eric A Klein, Alan Partin, Yair Lotan, Jack Baniel, Martin Dineen, Jason Hafron, Kannan Manickam, Marc Pliskin, Matthew Wagner, Aimee Kestranek, Mark Stovsky

Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland, OH; Stanford University Distinguished Careers Institute, Stanford, CA. Electronic address: ., Johns Hopkins James Buchanan Brady Urological Institute, Baltimore, MD., University of Texas Southwestern Medical Center Department of Urology, Dallas TX., Rabin Medical Center Department of Urology, Petah Tikvah, Israel., Advanced Urology Institute, Daytona Beach, FL., Michigan Institute of Urology, West Bloomfield, MI., Chesapeake Urology Associates, Baltimore, MD., The Urology Group, Cincinnati, OH., Kaiser Permanente Northwest, Clackamas, OR., Cleveland Diagnostics, Inc., Cleveland, OH.

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