Comparison of ciprofloxacin versus fosfomycin versus fosfomycin plus trimethoprim/sulfamethoxazole for preventing infections after transrectal prostate biopsy.

BACKGROUND: To evaluate antibiotic prophylaxis in transrectal prostate biopsies due to the recommendation of the European Medicines Agency (EMA): We describe our single center experience switching from ciprofloxacin to fosfomycin trometamol (FMT) alone and to an augmented prophylaxis combining fosfomycin and trimethoprim/sulfamethoxazole (TMP/SMX). METHODS: Between 01/2019 and 12/2020 we compared three different regimes. The primary endpoint was the clinical diagnosis of an infection within 4 weeks after biopsy. We enrolled 822 men, 398 (48%) of whom received ciprofloxacin (group-C), 136 (16.5%) received FMT (group-F) and 288 (35%) received the combination of TMP/SMX and FMT (group-BF). RESULTS: Baseline characteristics were similar between groups. In total 37/398 (5%) postinterventional infections were detected, of which 13/398 (3%) vs 18/136 (13.2%) vs 6/288 (2.1%) were detected in group-C, group-F and group-BF respectively. The relative risk of infectious complication was 1.3 (CI 0.7-2.6) for group-C vs. group-BF and 2.8 (CI 1.4-5.7) for group-F vs. group-BF respectively. CONCLUSION: The replacement of ciprofloxacin by fosfomycin alone resulted in a significant increase of postinterventional infections, while the combination of FMT and TMP/SMX had a comparable infection rate to FQ without apparent adverse events. Therefore, this combined regimen of FMT and TMP/SMX is recommended.

The learning curve for robotic-assisted transperineal MRI/US fusion-guided prostate biopsy.

Transperineal fusion prostate biopsy has a considerable learning curve (LC). Robotic-assisted transperineal MRI/Ultrasound fusion-guided biopsy (RA-TP-FBx) may have an easier LC due to automatization. We aimed to assess the LC of RA-TP-FBx and analyze its most difficult steps. We prospectively analyzed cases randomized to a biopsy-naïve urology resident, the chief resident, and an expert urologist in RA-TP-FBx (controls). We also analyzed consecutive cases in the LC of the expert. The LC was defined by procedure time, PCa detection rate (including stratification by PI-RADS), entrustable professional activities (EPA) assessment scores, and the NASA task load index. We collectively performed 246 RA-TP-FBx with the Mona Lisa device. Procedure time for residents decreased steeply from maximum 53 min to minimum 10 min, while the mean procedure time for the expert was 9 min (range 17-5 min). PCa detection for PI-RADS-4 lesions was 57% for the naïve resident, 61% for the chief resident and 62% for the expert. There was also no difference in Pca detection for PI-RADS-4 lesions when comparing the first and second half of the experts' biopsies (p = 0.8). Maximum EPA score was registered after 22 cases. Workload steeply declined. Proficient RA-TP-FBx performance appears feasible after 22 cases regardless of previous experience.

Opportunistic Prostate Cancer Screening with Biparametric Magnetic Resonance Imaging (VISIONING).

BACKGROUND: This study investigates the use of biparametric magnetic resonance imaging (bpMRI) as primary opportunistic screening for prostate cancer (PCa) without using a prostate-specific antigen (PSA) cut-off. OBJECTIVE: The primary endpoint was to assess the efforts and effectiveness of identifying 20 participants with clinically significant prostate cancer (csPCa) using bpMRI. DESIGN, SETTING, AND PARTICIPANTS: Biopsy-naïve men aged over 45 yr were included. All participants underwent 3 Tesla bpMRI, PSA, and digital rectal examination (DRE). Targeted-only biopsy was performed in participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3. Men with negative bpMRI but suspicious DRE or elevated PSA/PSA density had template biopsies. Preintended protocol adjustments were made after an interim analysis for PI-RADS 3 lesions: no biopsy and follow-up MRI after 6 mo and biopsy only if lesions persisted or upgraded. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Biopsy results underwent a comparison using Fisher's exact test and univariable logistic regression to identify prognostic factors for positive biopsy. RESULTS AND LIMITATIONS: A total of 229 men were enrolled in this study, of whom 79 underwent biopsy. Among these men, 77 displayed suspicious PI-RADS lesions. PCa was detected in 29 participants (12.7%), of whom 21 had csPCa (9.2%). Biparametric MRI detected 21 csPCa cases, while PSA and DRE would have missed 38.1%. Protocol adjustment led to a 54.6% biopsy reduction in PI-RADS 3 lesions. Overall, in this cohort of men with a median PSA value of 1.26 ng/ml, 10.9 bpMRI scans were needed to identify one participant with csPCa. A major limitation of the study is the lack of a control cohort undergoing systematic biopsies. CONCLUSIONS: Opportunistic screening utilising bpMRI as a primary tool has higher sensitivity in detecting csPCa than classical screening methods. PATIENT SUMMARY: Screening with biparametric magnetic resonance imaging (bpMRI) and targeted biopsy identified clinically significant prostate cancer in every 11th man, regardless of the prostate-specific antigen (PSA) levels. Preselecting patients based on PSA >1 ng/ml and a positive family history of prostate cancer, as well as other potential blood tests may further improve the effectiveness of bpMRI in this setting.

Prospective Multicenter Validation of the Stockholm3 Test in a Central European Cohort.

BACKGROUND: It has been shown that the Stockholm3 test decreases overdetection of prostate cancer (PCa) while retaining the ability to detect clinically significant PCa (csPCa) in a Swedish population. However, the test includes potentially population-specific testing of single-nucleotide polymorphisms and has yet not been validated outside Scandinavia. OBJECTIVE: To assess the performance of the Stockholm3 test in discriminating csPCa in a Central European cohort undergoing prostate biopsy (PBx). DESIGN, SETTING, AND PARTICIPANTS: This prospective multicenter validation study was conducted from August 2020 to September 2022 at two centers in Switzerland and one center in Germany. The study involved 342 men undiagnosed with PCa who were scheduled for PBx after prostate-specific antigen (PSA) testing and subsequent magnetic resonance imaging (MRI) of the prostate. Before PBx, participants had a blood sample taken for Stockholm3 testing. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the accuracy of the Stockholm3 test in detecting csPCa (International Society of Urological Pathology grade group [GG] ≥2) according to the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity, and the clinical consequences of using the model. RESULTS AND LIMITATIONS: The Stockholm3 test with a cutoff of 11% for csPCa detection had sensitivity of 92.3% (95% confidence interval [CI] 86.9-95.9%), specificity of 32.6% (95% CI 26.0-39.8%), a positive predictive value of 53.2% (95% CI 47.0-59.2%), and a negative predictive value of 83.6% (95% CI 73-91.2%). It showed superior discrimination for csPCa (AUC 0.77, 95% CI 0.72-0.82) in comparison to PSA (AUC 0.66, 95% CI 0.61-0.72; p < 0.001). Using a Stockholm3 cutoff of 11%, PBx could have been omitted for 73 men (21.0%), and 12/154 (8%) csPCa and 2/72 (2.8%) GG >2 cases would have been missed. Limitations include population selection bias. CONCLUSIONS: Our results show favorable clinical outcomes for the blood-based Stockholm3 biomarker test in a Central European patient cohort. PATIENT SUMMARY: The Stockholm3 blood test shows better accuracy in predicting prostate cancer than the more common PSA (prostate-specific antigen) test.

Water vapor thermal therapy of lower urinary tract symptoms due to benign prostatic obstruction: efficacy and safety analysis of a real-world cohort of 211 patients.

PURPOSE: This study assessed the efficacy, safety and durability outcomes of water vapor thermal therapy with Rezum in a real-world cohort of patients with lower urinary tract symptoms due to benign prostate obstruction. METHODS: Consecutive, unselected patients undergoing Rezum treatment between January 2014 and August 2022 were candidates for this pragmatic, observational, longitudinal, single-center cohort study. Pre- and perioperative data were descriptively summarized. The primary outcome was surgical efficacy, determined by International Prostate Symptom Score (IPSS), Quality of Life (QoL) Score, maximum urinary flow rate (Qmax), post-void residual (PVR) volume and prostate volume (PV) at baseline, 2 months, 6 months, 1 year, 2 years, and > 2 years. RESULTS: A total of 211 patients were enrolled for analysis. Overall, catheter removal was successful in 92.4% of patients after a median of 5 days. A preoperative catheter and the presence of a median lobe increased the risk of unsuccessful catheter removal. In total, 5.7% of patients were reoperated after a median of 407 days. Comparing baseline to the longest median follow-up, the postoperative IPSS decreased significantly by 65.7%, the QoL Score declined by 66.7% (both until a maximum median of 4.5 years) and Qmax improved by 66.7% (until 3.9 years). Post-void residual volume and PV were reduced by 85.7% (3.7 years) and 47% (4.0 years), respectively. Clavien-Dindo complication ≤ II occurred in 11.8%. CONCLUSION: Rezum is a safe minimally invasive treatment option in a real-world patient cohort with a beneficial improvement of micturition symptoms and voiding function during follow-up.

Medication-Related Osteonecrosis of the Jaw: A Cross-Sectional Survey among Urologists in Switzerland, Germany, and Austria.

Medication-related osteonecrosis of the jaw (MRONJ) is a potentially preventable adverse side effect of mainly antiresorptive drugs. MRONJ is expected to become a growing clinical problem due to the aging population and the increasing number of patients requiring antiresorptive agents. Knowledge and awareness about MRONJ and elimination of the oral and dental risk factors before starting antiresorptive therapy (AR) are fundamental to reducing the incidence of MRONJ. In urology, ARs are used primarily in patients suffering from bone metastases due to prostate cancer and to prevent cancer-treatment-induced bone loss (CTIBL) in prostate cancer patients receiving endocrine therapy. This postal survey aimed to evaluate disease-related knowledge and awareness about implementing oral examinations for patients starting AR among Swiss, German, and Austrian urologists. A total of 176 urologists returned the completed questionnaire, yielding a response rate of 11.7%. Of the respondents, 44.9% (n = 79) and 24.4% (n = 43) stated that they give more than five first-time prescriptions of denosumab and of intravenous or oral bisphosphonates per year, respectively. Only 14.8% (n = 26) of the participating urologists had never encountered MRONJ cases related to BPs. Of the participants, 89.8% (n = 158) had implemented referrals to dentists for oral examination before initiating AR. The mean percentage of correct answers regarding the knowledge about MRONJ was 70.9% ± 11.2%. In contrast to previous surveys on MRONJ among physicians, this study showed that the participating urologists were sufficiently informed about MRONJ, as reflected by the high number of participants implementing preventive dental screenings.

The impact of robotic-assisted transperineal biopsy of the prostate on erectile function.

BACKGROUND: Prostate biopsy represents one of the most frequently performed urologic procedures worldwide and therefore presupposes knowledge on potential effects like on the erectile function, especially in extensive or repeated biopsies. The robotic-assisted biopsy system (Mona Lisa) offers a minimal invasive approach via only two incision points ensuring maximal accuracy combined with protection of the neurovascular bundle of the prostate. OBJECTIVE: Our purpose was to analyse the impact of robotic-assisted transperineal biopsy of the prostate on the erectile function. METHODS: Our prospective study analyses the outcomes of 210 patients, who had undergone minimal-invasive, transperineal robotic-assisted biopsy of the prostate at the University Hospital Basel from January 2020 to March 2022 and provided sufficient data. Of these, 157 (74.8%) were included in final analysis. RESULTS: Mean (range) age, prostate volume, PSA and IIEF-5 score at baseline were 63.8 years (46.1-83.6), 46.4 ml (9-310), 13.2 ng/ml (0.2-561), and 18.8 points (6-25), respectively. EF before and 1 month after intervention was assessed with the IIEF-5 questionnaire for the whole cohort. No significant change of IIEF-5 was observed for the whole cohort with a mean (± SD) decrease of 0.4 (± 3.1) points. Except for patients > 69 years, subgroup analysis revealed no change of IIEF-5 in statistically significant manner for all subgroups. Number of biopsy cores (< 20 and ≥ 20), previous biopsies and active surveillance showed no significant influence. CONCLUSION: Our results suggest that the minimally invasive and highly precise robotic technique can spare the erectile function without limiting the extent of biopsy and without compromising diagnostic accuracy.

Safety profile of robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate.

Introduction: Robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate is a novel and highly accurate procedure. The aim of this study was to evaluate the MonaLisa prostate biopsy system in terms of safety, tolerability, and patient-related outcomes. Methods: This prospective study included 228 patients, who had undergone Robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate at the University Hospital Basel between January 2020 and June 2022. Peri-operative side effects, functional outcomes and patient satisfaction were assessed. Results: Mean pain score on the day of biopsy was 1.3 points on VAS, which remained constant on the day after biopsy. Overall, 32 of 228 patients (14%) developed grade I complications according to Clavien-Dindo classification. No higher-grade complications occurred. Gross haematuria, hematospermia and acute urinary retention occurred in 145/228 (63.6%), 98/228 (43%) and 32/228 (14%) patients, respectively. One patient (0.4%) developed urinary tract infection. Conclusions: Robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate performed under general anesthesia is a safe and well tolerated procedure. This technique allows to omit perioperative prophylaxis and at the same time minimizes the risk of infectious complications. We attribute the favorable risk profile and tolerability to the minimal invasive approach via two entry points.

Initial experience with AI Pathway Companion: Evaluation of dashboard-enhanced clinical decision making in prostate cancer screening.

PURPOSE: Rising complexity of patients and the consideration of heterogeneous information from various IT systems challenge the decision-making process of urological oncologists. Siemens AI Pathway Companion is a decision support tool that provides physicians with comprehensive patient information from various systems. In the present study, we examined the impact of providing organized patient information in comprehensive dashboards on information quality, effectiveness, and satisfaction of physicians in the clinical decision-making process. METHODS: Ten urologists in our department performed the entire diagnostic workup to treatment decision for 10 patients in the prostate cancer screening setting. Expenditure of time, information quality, and user satisfaction during the decision-making process with AI Pathway Companion were recorded and compared to the current workflow. RESULTS: A significant reduction in the physician's expenditure of time for the decision-making process by -59.9% (p < 0,001) was found using the software. System usage showed a high positive effect on evaluated information quality parameters completeness (Cohen's d of 2.36), format (6.15), understandability (2.64), as well as user satisfaction (4.94). CONCLUSION: The software demonstrated that comprehensive organization of information improves physician's effectiveness and satisfaction in the clinical decision-making process. Further development is needed to map more complex patient pathways, such as the follow-up treatment of prostate cancer.

Indication for Active Surveillance in the Era of MRI-Targeted Prostate Biopsies.

INTRODUCTION: Active surveillance (AS) strategies were established to avoid overtreatment of low-risk prostate cancer (PCa) patients. Low tumor volume represents one indication criteria; however, applying this criterion after MRI-targeted prostate biopsies may lead to overestimation of tumor volume; wherefore, patients suitable for AS would be exposed to the risk of overtreatment. METHODS: This retrospective analysis included 318 patients in which PCa was detected by MRI-TRUS fusion prostate biopsy. Classic and extended indication for AS included Gleason 6 and Gleason 3 + 4 cancer, respectively. We assessed the effect of targeted biopsies and temporary rating strategies on eligibility for AS and developed new "composite" algorithms to more accurately assess eligibility for AS. RESULTS: Forty-four (13.8%) and 60 (18.9%) of the 318 patients qualified for AS according to "classic" and "extended" criteria, respectively. Application of the "composite 1" definition led to AS eligibility of 52 of 248 patients (20.97%) in the classic and of 77 of 248 patients (31.05%) in the "extended" group. CONCLUSIONS: We could demonstrate that classic algorithms led to ineligibility of patients for AS. We propose a new rating algorithm to improve tumor assessment for a more accurate indication for AS.

Diagnostic accuracy and clinical implications of robotic assisted MRI-US fusion guided target saturation biopsy of the prostate.

MRI-targeted prostate biopsy improves detection of clinically significant prostate cancer (PCa). However, up to 70% of PCa lesions display intralesional tumor heterogeneity. Current target sampling strategies do not yet adequately account for this finding. This prospective study included 118 patients who underwent transperineal robotic assisted biopsy of the prostate. We identified a total of 58 PCa-positive PI-RADS lesions. We compared diagnostic accuracy of a target-saturation biopsy strategy to accuracy of single, two, or three randomly selected targeted biopsy cores and analysed potential clinical implications. Intralesional detection of clinically significant cancer (ISUP ≥ 2) was 78.3% for target-saturation biopsy and 39.1%, 52.2%, and 67.4% for one, two, and three targeted cores, respectively. Target-saturation biopsies led to a more accurate characterization of PCa in terms of Gleason score and reduced rates of significant cancer missed. Compared to one, two, and three targeted biopsy cores, target-saturation biopsies led to intensified staging procedures in 21.7%, 10.9, and 8.7% of patients, and ultimately to a potential change in therapy in 39.1%, 26.1%, and 10.9% of patients. This work presents the concept of robotic-assisted target saturation biopsy. This technique has the potential to improve diagnostic accuracy and thus individual staging procedures and treatment decisions.

Toward a Platform for Structured Data Acquisition in Oncology: A Pilot Study on Prostate Cancer Screening.

INTRODUCTION: Physicians spend an ever-rising amount of time to collect relevant information from highly variable medical reports and integrate them into the patient's health condition. OBJECTIVES: We compared synoptic reporting based on data elements to narrative reporting in order to evaluate its capabilities to collect and integrate clinical information. METHODS: We developed a novel system to align medical reporting to data integration requirements and tested it in prostate cancer screening. We compared expenditure of time, data quality, and user satisfaction for data acquisition, integration, and evaluation. RESULTS: In a total of 26 sessions, 2 urologists, 2 radiologists, and 2 pathologists conducted the diagnostic work-up for prostate cancer screening with both narrative reporting and the novel system. The novel system led to a significantly reduced time for collection and integration of patient information (91%, p < 0.001), reporting in radiology (44%, p < 0.001) and pathology (33%, p = 0.154). The system usage showed a high positive effect on evaluated data quality parameters completeness, format, understandability, as well as user satisfaction. CONCLUSION: This study provides evidence that synoptic reporting based on data elements is effectively reducing time for collection and integration of patient information. Further research is needed to assess the system's impact for different patient journeys.

Revisiting DCE-MRI: Classification of Prostate Tissue Using Descriptive Signal Enhancement Features Derived From DCE-MRI Acquisition With High Spatiotemporal Resolution.

METHODS: A retrospective study (from January 2016 to July 2019) including 75 subjects (mean, 65 years; 46-80 years) with 2.5-second temporal resolution DCE-MRI and PIRADS 4 or 5 lesions was performed. Fifty-four subjects had biopsy-proven prostate cancer (Gleason 6, 15; Gleason 7, 20; Gleason 8, 13; Gleason 9, 6), whereas 21 subjects had negative MRI/ultrasound fusion-guided biopsies. Voxel-wise analysis of contrast signal enhancement was performed for all time points using custom-developed software, including automatic arterial input function detection. Seven descriptive parameter maps were calculated: normalized maximum signal intensity, time to start, time to maximum, time-to-maximum slope, and maximum slope with normalization on maximum signal and the arterial input function (SMN1, SMN2). The parameters were compared with ADC using multiparametric machine-learning models to determine classification accuracy. A Wilcoxon test was used for the hypothesis test and the Spearman coefficient for correlation. RESULTS: There were significant differences (P < 0.05) for all 7 DCE-derived parameters between the normal peripheral zone versus PIRADS 4 or 5 lesions and the biopsy-positive versus biopsy-negative lesions. Multiparametric analysis showed better performance when combining ADC + DCE as input (accuracy/sensitivity/specificity, 97%/93%/100%) relative to ADC alone (accuracy/sensitivity/specificity, 94%/95%/95%) and to DCE alone (accuracy/sensitivity/specificity, 78%/79%/77%) in differentiating the normal peripheral zone from PIRADS lesions, biopsy-positive versus biopsy-negative lesions (accuracy/sensitivity/specificity, 68%/33%/81%), and Gleason 6 versus ≥7 prostate cancer (accuracy/sensitivity/specificity, 69%/60%/72%). CONCLUSIONS: Descriptive perfusion characteristics derived from high-resolution DCE-MRI using model-free computations show significant differences between normal and cancerous tissue but do not reach the accuracy achieved with solely ADC-based classification. Combining ADC with DCE-based input features improved classification accuracy for PIRADS lesions, discrimination of biopsy-positive versus biopsy-negative lesions, and differentiation between Gleason 6 versus Gleason ≥7 lesions.

Enhancing disease awareness for tuberous sclerosis complex in patients with radiologic diagnosis of renal angiomyolipoma: an observational study.

BACKGROUND: Tuberous Sclerosis Complex (TSC) is a genetic disorder, with renal manifestations like angiomyolipoma (AML) occurring in 70-80% of patients. AML usually cause more complications in TCS patients than in non-TSC patients. However, AML patients are not routinely investigated for TSC. Our aim was to retrospectively assess the correlation between radiologically diagnosed AML and TSC. METHODS: All patients were stratified into AML related vs. unrelated to TSC. Correlations were calculated to determine the association between age, AML, and TSC. RESULTS: Complete data were available for 521 patients with renal AML, in 7 of which the concurrent diagnosis of TSC was found. Younger age significantly positively correlated with the prevalence of TSC in AML patients (p <  0.01). 37 (7%) of the 521 patients were within the age-range of 18-40 years, in which TSC occurred in 6 cases, 4 (66.7%) of which presented with multiple, bilateral renal AML (p <  0.05), and 2 (33.3%) of which with a single, unilateral AML (p <  0.05). In patients with AML but without TSC, unilateral AML was found in 83.9% and bilateral AML in 16.1% (p <  0.05). Simple binary logistic regression analysis revealed bilateral AML (OR 33.0; 95% CI 3.2-344.0; p = 0.003) (but not unilateral AML (OR 0.09; 95% CI 0.01-0.88; p = 0.04)) to be a risk factor for TSC. CONCLUSIONS: The presence of bilateral AML in patients within the age-range of 18-40 years should raise suspicion for TSC as the underlying cause. Therefore, our advice is to refer patients with multiple bilateral renal AML for further investigations regarding TSC.

Efficacy, safety, and perioperative outcomes of holmium laser enucleation of the prostate-a comparison of patients with lower urinary tract symptoms and urinary retention.

Holmium laser enucleation of the prostate (HoLEP) is a valid treatment option to relieve bladder outlet obstruction in patients with large prostate volumes (PV). Its efficacy, tolerability, and safety are comparable to the ones of other laser treatments of the prostate and resection techniques. However, safety and efficacy of HoLEP have not been compared between patients with and without preoperative urinary retention. We included 350 patients (mean age 71.2 years) who had undergone HoLEP due to lower urinary tract symptoms (LUTS) or urinary retention caused by prostatic hyperplasia. We evaluated the differences in peri- and postoperative outcomes and complications between patients with and patients without preoperative urinary retention. The mean PV was 115 cm3. PV was > 100 cm3 in 61.9% and < 100 cm3 in 38.1% of the patients. Perioperative complications occurred in 23 patients (6.6%), 15 of which (4.3%) required operative revision. We found no significant differences in terms of complication rates between patients with PV > 100 cm3 and patients with PV < 100 cm3. Mean catheterization-duration was 3.3 days. Preoperatively, 140 patients (40%) had a suprapubic or transurethral indwelling catheter; they did not differ from patients without preoperative catheter regarding postoperative catheter removal success rate, early postoperative complications, and functional outcomes. Prostate cancer was diagnosed in 43 patients (12.3%). Median postoperative PSA-decline was 6.1 ug/l (89.8% drop). HoLEP is a safe and effective treatment for patients with LUTS or urinary retention and large PV. PV > 100 cm3 was not associated with higher complication rates or successful catheter-removal. Furthermore, functional outcomes were independent of preoperative catheterization.

Autonomous Detection and Classification of PI-RADS Lesions in an MRI Screening Population Incorporating Multicenter-Labeled Deep Learning and Biparametric Imaging: Proof of Concept.

BACKGROUND: Opportunistic prostate cancer (PCa) screening is a controversial topic. Magnetic resonance imaging (MRI) has proven to detect prostate cancer with a high sensitivity and specificity, leading to the idea to perform an image-guided prostate cancer (PCa) screening; Methods: We evaluated a prospectively enrolled cohort of 49 healthy men participating in a dedicated image-guided PCa screening trial employing a biparametric MRI (bpMRI) protocol consisting of T2-weighted (T2w) and diffusion weighted imaging (DWI) sequences. Datasets were analyzed both by human readers and by a fully automated artificial intelligence (AI) software using deep learning (DL). Agreement between the algorithm and the reports-serving as the ground truth-was compared on a per-case and per-lesion level using metrics of diagnostic accuracy and k statistics; Results: The DL method yielded an 87% sensitivity (33/38) and 50% specificity (5/10) with a k of 0.42. 12/28 (43%) Prostate Imaging Reporting and Data System (PI-RADS) 3, 16/22 (73%) PI-RADS 4, and 5/5 (100%) PI-RADS 5 lesions were detected compared to the ground truth. Targeted biopsy revealed PCa in six participants, all correctly diagnosed by both the human readers and AI. CONCLUSIONS: The results of our study show that in our AI-assisted, image-guided prostate cancer screening the software solution was able to identify highly suspicious lesions and has the potential to effectively guide the targeted-biopsy workflow.

Predicting clinically significant prostate cancer from quantitative image features including compressed sensing radial MRI of prostate perfusion using machine learning: comparison with PI-RADS v2 assessment scores.

BACKGROUND: To investigate if supervised machine learning (ML) classifiers would be able to predict clinically significant cancer (sPC) from a set of quantitative image-features and to compare these results with established PI-RADS v2 assessment scores. METHODS: We retrospectively included 201, histopathologically-proven, peripheral zone (PZ) prostate cancer lesions. Gleason scores ≤3+3 were considered as clinically insignificant (inPC) and Gleason scores ≥3+4 as sPC and were encoded in a binary fashion, serving as ground-truth. MRI was performed at 3T with high spatiotemporal resolution DCE using Golden-angle RAdial SParse (GRASP) MRI. Perfusion maps (Ktrans, Kep, Ve), apparent diffusion coefficient (ADC), and absolute T2-signal intensities (SI) were determined in all lesions and served as input parameters for four supervised ML models: Gradient Boosting Machines (GBM), Neural Networks (NNet), Random Forest (RF) and Support Vector Machines (SVM). ML results and PI-RADS scores were compared with the ground-truth. Next ROC-curves and AUC values were calculated. RESULTS: All ML models outperformed PI-RADS v2 assessment scores in the prediction of sPC (RF, GBM, NNet and SVM vs. PI-RADS: AUC 0.899, 0.864, 0.884 and 0.874 vs. 0.595, all P<0.001). CONCLUSIONS: Using quantitative imaging parameters as input, supervised ML models outperformed PI-RADS v2 assessment scores in the prediction of sPC. These results indicate that quantitative imagining parameters contain relevant information for the prediction of sPC from image features.

Feasibility of freehand MRI/US cognitive fusion transperineal biopsy of the prostate in local anaesthesia as in-office procedure-experience with 400 patients.

BACKGROUND: Transrectal (TR) ultrasound-guided prostate biopsy is one of the most commonly performed urologic procedures worldwide. The major drawback of this approach is the associated risk for infectious complications. Sepsis rates are increasing due to rising antibiotic resistance, representing a global issue. The transperineal (TP) approach for prostate biopsy has recently been adopted at many centres as an alternative to the TR biopsy, and it was shown to be associated with a lower risk for sepsis. The aim of this study was to assess safety and tolerability of TP prostate biopsy performed in local anaesthesia. METHODS: We retrospectively analysed data of patients who had undergone office-based TP prostate biopsy in local anaesthesia, performed by a single surgeon between January 2015 and May 2019. We evaluated the patients' acceptance of the procedure by a pain score, as well as its safety and diagnostic performance. RESULTS: Four hundred patients were included. Median age was 66 years [range, 49-86]. Median prostate-specific antigen (PSA) concentration was 6.4 ng/ml [range, 0.3-1400], median PSA density was 0.15 ng/ml2 [range, 0-31.1] and median prostate volume was 40 ml [range, 6-150]. A total of 118 (29.5%) and 105 (26.2%) patients had orally received two and one doses of 500 mg fluoroquinolone, respectively, and 177 (44.3%) patients did not receive any antibiotic prophylaxis. No infectious complications occurred. Median pain score was 2.0 (range, 0-8). Overall cancer detection rate was 64.5% (258/400). CONCLUSIONS: Freehand TP prostate biopsy in local anaesthesia is a safe, effective and well-tolerated outpatient procedure with a high cancer detection rate. The elimination of infectious complications and its high accuracy make this technique a feasible alternative to the TR approach for the urological office. We assume that the single puncture and our trocar-like access sheath introduction technique diminish tissue trauma and bacterial exposition, and thus contribute to these promising results.

Novices in MRI-targeted prostate biopsy benefit from structured reporting of MRI findings.

PURPOSE: The aim of this study was to investigate whether structured reports (SRs) of prostate MRI results are more suitable than non-structured reports (NSRs) for promoting the more accurate assessment of the location of a single prostate cancer lesion by novices in MRI-targeted biopsy. METHODS: 50 NSRs and 50 SRs describing a single prostatic lesion were presented to 5 novices in MRI-targeted biopsy. The participants were asked to plot the tumor location in a two-dimensional prostate diagram and to answer a questionnaire on the quality of the reports. The accuracy of the plotted tumor position was evaluated with a validated 30-point scoring system that distinguished between "major" and "minor" mistakes. RESULTS: The overall mean score for the accuracy of the tumor plotting was significantly higher for SRs than for NSRs (26.4 vs. 20.7, p < 0.01). The mean numbers of major (1.4 vs. 0.48, p < 0.01) and minor (3.05 vs. 1.15, p < 0.01) mistakes were significantly higher for NSRs than for SRs. Compared with NSRs, SRs received significantly higher ratings for the perceived quality of the summary (4.0 vs. 2.4, p < 0.01) as well as for the overall satisfaction with the report (4.1 vs. 2.1, p < 0.01). CONCLUSION: Novices in MRI-targeted biopsy prefer structured reporting of prostate MRI as an information tool. SRs allow for a more accurate assessment of the location of single prostate cancer lesions. Therefore, structured reporting of prostate MRI may help to foster the learning process of novices in MRI-targeted biopsy.

Urinary Calprotectin loses specificity as tumour marker due to sterile leukocyturia associated with bladder cancer.

BACKGROUND: Urinary Calprotectin, a mediator of the innate immune system, has been identified as a biomarker in bladder cancer. Our aim was to investigate the association between sterile leukocyturia and urinary Calprotectin in low-grade and high-grade bladder cancer. MATERIALS AND METHODS: We performed a prospective cross-sectional study including 52 patients with bladder cancer and 40 healthy controls. Definition of sterile leukocyturia was > 5.0 leukocytes per visual field in absence of bacteriuria. RESULTS: The rate of sterile leukocyturia in low-grade (60.0%) and high-grade (62.0%) bladder cancer was comparable (p = 0.87). However, the median absolute urinary leukocyte count in patients with sterile leukocyturia was significantly higher in high-grade than in low-grade bladder cancer (p < 0.01). Spearman correlation revealed a significant correlation between urinary Calprotectin and leucocyte concentration (R = 0.4, p < 0.001). Median urinary Calprotectin concentration was 4.5 times higher in bladder cancer patients with than in patients without sterile leukocyturia (p = 0.03). Subgroup analysis revealed a significant difference in urinary Calprotectin regarding the presence of sterile leukocyturia in high-grade patients (596.8 [91.8-1655.5] vs. 90.4 [28.0-202.3] ng ml-1, p = 0.02). Multivariate analysis identified the leukocyte concentration to be the only significant impact factor for urinary Calprotectin (OR 3.2, 95% CI 2.5-3.8, p = 0.001). Immunohistochemistry showed Calprotectin positive neutrophils and tumour cells in high-grade bladder cancer with sterile leukocyturia. CONCLUSIONS: Urinary Calprotectin cannot be regarded as a specific tumour marker for bladder cancer, but rather as a surrogate parameter for tumour inflammation.