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Nicolas von Landenberg, Julian Hanske, Joachim Noldus, Florian Bernhard Gerhard Roghmann, Karl Heinrich Tully, Jan Wald, Sebastian Berg, Marko Brock

• \(\bf Introduction:\) The risk of occult prostate carcinoma (PCa) after negative multiparametric MRI (mpMRI)-transrectal fusion biopsy (F-Bx) is unknown. To determine the false-negative predictive value, we examined PCa detection after prior negative F-Bx. \(\bf Methods:\) Between December 2012 and November 2016, 491 patients with suspected PCa and suspicious mpMRI findings underwent transrectal F-Bx. Patients with benign pathology (\(\it n\) = 191) were eligible for our follow-up (FU) survey. Patient characteristics and clinical parameters were correlated to subsequent findings of newly detected PCa. \(\bf Results:\) Complete FU with a median of 31 (interquartile range: 17–39) months was available for 176/191 (92.2%) patients. Of those, 54 men had either surgical interventions on the prostate or re-Bxs. Newly detected PCa was evident in 14/176 (7.95%) patients stratified to ISUP \(\leq\) 2 in 10 and \(\geq\) 3 in 4 cases. The comparison of patients with newly detected PCa to those without cancerous findings in FU showed significant differences in prostate-specific antigen (PSA) density (0.16 vs. 0.13 ng/mL\(^{2}\)) and prostate volume (45 vs. 67 mL, both \(\it p\) < 0.05). Both factors are significant predictors for newly detected cancer after initial negative F-Bx. \(\bf Conclusion:\) Only PSA density (>0.13 ng/mL\(^{2}\)) and small prostate volume are significant predictors for newly detected PCa after initial negative F-Bx. Despite negative mpMRI/TRUS F-Bx results, patients should be further monitored due to a risk of developing PCa over time. Notwithstanding the limitation of our study that not all patients underwent another Bx, we assume that the false-negative rate is low but existing. Our data represent a real-world scenario.