BACKGROUND: To compare the clinical performance of a new PCa serum biomarker based on fPSA glycoprofiling to fPSA% and PHI. METHODS: Serum samples from men who underwent prostate biopsy due to increased PSA were used. A comparison between two equal groups (with histologically confirmed PCa or benign, non-cancer condition) was used for the clinical validation of a new glycan-based PCa oncomarker. SPSS and R software packages were used for the multiparametric analyses of the receiver operating curve (ROC) and for genetic algorithm metaheuristics. RESULTS: When comparing the non-cancer and PCa cohorts, the combination of four fPSA glycoforms with two clinical parameters (PGI, prostate glycan index (PGI)) showed an area under receiver operating curve (AUC) value of 0.821 (95% CI 0.754-0.890). AUC values were 0.517 for PSA, 0.683 for fPSA%, and 0.737 for PHI. A glycan analysis was also applied to discriminate low-grade tumors (GS = 6) from significant tumors (GS ≥ 7). CONCLUSIONS: Compared to PSA on its own, or fPSA% and the PHI, PGI showed improved discrimination between presence and absence of PCa and in predicting clinically significant PCa. In addition, the use of PGI would help practitioners avoid 63.5% of unnecessary biopsies, while the use of fPSA% and PHI would help avoid 17.5% and 33.3% of biopsies, respectively, while missing four significant tumors (9.5%).

Department of Clinical Research University of Southern Denmark J B Winsløws Vej 23 5000 Odense C Denmark Department of Urology Odense University Hospital J B Winsløws Vej 4 5000 Odense C Denmark

Department of Glycobiotechnology Institute of Chemistry Slovak Academy of Sciences Dubravska cesta 9 845 38 Bratislava Slovakia

Department of Glycobiotechnology Institute of Chemistry Slovak Academy of Sciences Dubravska cesta 9 845 38 Bratislava Slovakia Glycanostics Ltd Dubravska cesta 9 845 38 Bratislava Slovakia

Department of Immunochemistry Diagnostics University Hospital in Pilsen E Benese 1128 13 301 00 Pilsen Czech Republic

Department of Molecular Oncology Cancer Research Institute Biomedical Research Center of the Slovak Academy of Sciences Dubravska cesta 9 845 04 Bratislava Slovakia

Department of Urology Medical University Innsbruck Anichstrasse 35 A 6020 Innsbruck Austria

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