Background Low specificity of prostate-specific antigen results in a considerable number of unnecessary prostate biopsies in current practice. SelectMDx® predicts significant prostate cancer upon biopsy and is used to reduce the number of unnecessary initial prostate biopsies. Furthermore, potential overtreatment of insignificant prostate cancer can be reduced. Besides the diagnostic accuracy of the test, also the context in a specific country determines the potential health benefit and costeffectiveness. Therefore, the health benefit and cost-effectiveness of SelectMDx were assessed in France, Germany, Italy, and Spain. Subject and methods A decision model was used to compare the current standard of care in which men undergo initial prostate biopsy in case of an elevated prostate-specific antigen, to a strategy in which SelectMDx was used to select men for biopsy. Model inputs most relevant to each of the four countries were obtained. With use of the model long-term qualityadjusted life years (QALYs) and healthcare costs were calculated for both strategies. Results In all four countries, the SelectMDx resulted in QALY gain and cost savings compared with the current standard of care. In France, SelectMDx resulted in 0.022 QALYs gained and cost savings of €1217 per patient. For Germany, the model showed a QALY gain of 0.016 and a cost saving of €442. In Italy, the QALY gain and cost savings were 0.031 and €762. In Spain 0.020 QALYs were gained and €250 costs were saved. Conclusions The results of the model showed that with SelectMDx, QALYs could be gained while saving healthcare costs in the initial diagnosis of prostate cancer. The significant presence of overtreatment in the current standard of care in all four countries was the main factor that resulted in the beneficial outcomes with SelectMDx.

Background: Body mass index (BMI) and body composition have been associated with postoperative outcomes in oncological surgery. Evidence in renal cell cancer (RCC) is limited and inconsistent. Therefore, we examined BMI and body composition in relation to postoperative outcomes in patients with RCC.Methods: We conducted a multicenter population-based historical cohort study including 801 patients with RCC treated with radical (79%) or partial (21%) nephrectomy between 2008-2012. Computed Tomography images at third lumbar vertebrae were assessed for skeletal muscle (SM) index, SM density, visceral adipose tissue (VAT) index and subcutaneous adipose tissue index (SATI). Multivariable multilevel logistic regression analyses were used to examine associations between BMI, body composition and (major) postoperative complications and extended length of hospital stay (LOHS) (≥7 days). Discrimination of models for major complications was compared using receiver operating characteristics (ROC) curves.Results: In total, 19.6% of the patients had postoperative complications (6.2% Clavien grade ≥III) and 24.1% had extended LOHS. A 10-unit increase in SM density was inversely associated with extended LOHS [odds ratio (OR) 0.58; 95% confidence interval (95% CI): 0.44-0.78]. Associations of high BMI and lower SM density with risk of major complications and of higher VAT index with extended LOHS were also observed but statistical significance differed according to surgical procedure. Models predicting major complications with or without body composition parameters were not different.Conclusions: Lower SM density was associated with extended LOHS and non-significantly associated with higher risk of major postoperative complications. High BMI was associated with higher risk of major postoperative complications. Higher VAT was non-significantly associated with higher risk of extended LOHS. Results by surgical procedure were in the same direction but were only statistically significant for some subgroups. Validation of these results and investigation of the added value of body composition parameters to anatomic classification systems is needed.

ObjectiveTo evaluate the feasibility of confocal laser microscopy (CLM) for intraoperative margin assessment as faster alternative to neurovascular structure-adjacent frozen-section examination (NeuroSAFE) during robot-assisted radical prostatectomy (RARP). Patients and MethodsSurgical margins were assessed during 50 RARP procedures in patients scheduled for NeuroSAFE. Posterolateral sections were cut and imaged with CLM and further processed to conform with the NeuroSAFE protocol. Secondary resection (SR) was performed in case a positive surgical margin (PSM) was observed with NeuroSAFE. Afterwards, the CLM images were non-blinded assessed for the presence of PSMs. The accuracy of both NeuroSAFE and CLM was compared with conventional histopathology. Agreement for detection of PSMs between NeuroSAFE and CLM was evaluated with Cohen's kappa coefficient. Procedure times were compared with a Wilcoxon signed-ranks test. ResultsIn total, 96 posterolateral sections of RP specimens were evaluated for the presence of PSMs. CLM identified 15 (16%) PSMs and NeuroSAFE identified 14 (15%) PSMs. CLM had a calculated sensitivity, specificity, positive predictive value and negative predictive value of 86%, 96%, 80% and 98% respectively for the detection of PSMs compared to definite pathology. After SR, residual tumour was found in six of 13 cases (46%), which were all identified by both techniques. There was a substantial level of agreement between CLM and NeuroSAFE (j = 0.80). The median procedure time for CLM was significantly shorter compared to NeuroSAFE (8 vs 50 min, P < 0.001). The main limitation of this study was the nonblinded assessment of the CLM images. ConclusionsCompared to NeuroSAFE, CLM is a promising technique for intraoperative margin assessment and is able to reduce the time of intraoperative margin assessment.