Value of perilesional biopsies in multiparametric magnetic resonance imaging-targeted biopsy and systematic biopsy in detection of prostate cancer: results of a prospective, non-randomized, surgeon-blinded study.

PURPOSE: The goal of this study is to address if detection rates of clinically significant prostate cancer (csPCa) can be increased by additional perilesional biopsies (PB) in magnetic resonance (MR)/ultrasound fusion prostate biopsy in biopsy-naïve men. METHODS: This prospective, non-randomized, surgeon-blinded study was conducted between February 2020 and July 2022. Patients were included with PSA levels < 20 ng/ml and ≥ one PI-RADS lesion (grades 3-5) per prostate lobe. Prostate biopsy was performed by two urologists. The first performed the MR-fusion biopsy with 3-5 targeted biopsies (TB) and 6 PB in a standardized pattern. The second performed the systematic (12-fold) biopsy (SB) without knowledge of the MR images. Primary outcome of this study is absence or presence of csPCa (≥ ISUP grade 2) comparing TB, PB and SB, using McNemar test. RESULTS: Analyses were performed for each PI-RADS lesion (n = 218). There was a statistically significant difference in csPC detection rate of TB + SB between PI-RADS 3, 4 and 5 lesions (18.0% vs. 42.5% vs. 82.6%, p < 0.001) and TB + PB (19.7% vs. 29.1% vs. 78.3%). Comparing only maximum ISUP grade per lesion, even SB plus TB plus PB did not detect more csPCa compared to SB plus TB (41.3% vs. 39.9%, p > 0.05). CONCLUSION: We present prospective study data investigating the role of perilesional biopsy in detection of prostate cancer. We detected no statistically significant difference in the detection of csPCa by the addition of PB. Therefore, we recommend continuing 12-fold bilateral SB in addition to TB.

Individualized center-based analysis of urinary and sexual functional outcome after radical prostatectomy based on the prostate cancer outcome study: a post hoc pathway to patient outcome measurement analysis for quality improvement.

PURPOSE: We evaluate differences of patient-reported outcome measurements (PROM) based urinary continence and sexual function 12 months after radical prostatectomy (RPE) based on perioperative, surgical, and patient-specific characteristics in a large European academic urology center. MATERIALS AND METHODS: All men enrolled in the Prostate Cancer Outcome Study (PCO) study who were treated with RPE between 2017 and 2021 completed EPIC-26 information surveys before and 12 months after RPE. Survey data were linked to clinical data of our institution. Logistic regression analyses were performed to examine the correlation between individual surgeons, patient characteristics, patient clinical data, and their urinary continence and sexual function. RESULTS: In total, data of 429 men were analyzed: unstratified mean (SD) EPIC-26 domain score for urinary function decreased from 93.3 (0.7) to 60.4 (1.5) one year after RPE, respectively for sexual function from 64.95 (1.6) to 23.24 (1.1). Patients with preoperative adequate urinary function (EPIC-26 score > 80) reported significantly different mean urinary function scores between 53.35 (28.88) and 66.25 (25.15), p= 0.001, stratified by surgeons experience. On binary logistic regression analyses, only nerve sparing techniques (OR: 1,83, 95% CI: 1.01;3.21; p = 0.045) and low body mass index (OR: 0.91, CI: 0.85;0.99, p= 0.032) predicted adequate postoperative urinary function. CONCLUSIONS: The results show how using provider-specific data from a larger cohort study enables to develop institution-specific analysis for functional outcomes after RPE. These models can be used for internal quality improvement as well as enhanced and provider-specific patient communication and shared decision making.

Clinical Impact and Management of Incidental Renal Findings on Pre-TAVI CT Scan from the Urologist's Perspective.

INTRODUCTION: The aim of the study was to investigate prevalence and impact of incidental renal masses (IRMs) accompanying increasing computed tomography (CT) work-up for symptomatic aortic valve stenosis (sAVS) of the elderly with regard to the relevance of urological consultation for overall survival (OS). METHODS: A retrospective analysis of pre-transcatheter aortic-valve implantations (TAVIs) CT scans of patients with sAVS (N = 1,253) harboring IRM was performed for 2014-2019. According to the clinical management, groups 1 (urologic consultation) and 2 (findings ignored) were formed and analyzed in terms of OS. RESULTS: The prevalence of IRM was 9% (119/1,253). In 19% (23/119), urological advice was sought (group 1). At baseline, group 1 showed a significantly higher rate of malignancy-specific lesions compared to 2 (p < 0.01). Other clinical parameters (e.g., age, cardiological scores, comorbidities) did not differ between groups (p > 0.05). In group 1, 4 (17%) findings were histologically confirmed, of which 3 (13%) underwent surgery. There was no significant difference in median OS at a median follow-up of 24.7 months between groups 1 and 2 with 35.7 (95% CI, 5.9; 65.4) and 47.4 months (95% CI, 33.0; 61.7), respectively (p = 0.4). In Cox regression analysis, chronic kidney disease but not urologic work-up or chronic obstructive pulmonary disease or heart failure emerged as an independent unfavorable predictor of OS (HR 2.44, 95% CI 1.37; 4.36, p = 0.003). CONCLUSION: For the first time, a TAVI population with IRM was analyzed from the urologist's perspective. Urologic co-evaluation and work-up does not confer a significant benefit in terms of OS in this particular population.

Digital informed consent for urological surgery - randomized controlled study comparing multimedia-supported vs. traditional paper-based informed consent concerning satisfaction, anxiety, information gain and time efficiency.

INTRODUCTION: Due to a lack of time and staff, informed consent (IC) in clinical practice often lacks clarity, comprehensibility and scope of information. Digital media offer great potential to enhance IC. Aim of this study is to evaluate the effectiveness of multimedia-supported compared to traditional paper-based IC. METHODS: In the randomized, controlled, three-arm DICon (Digital Informed Consent for urological surgery) study 70 patients with an indication for prostate biopsy were randomized 1:1:1 to receive traditional paper-based IC vs. multimedia-supported information before IC vs. multimedia-supported information during IC. Patient satisfaction, anxiety and information gain were measured by validated questionnaires 2 weeks and directly before the procedure and time efficiency was recorded. Statistical analysis was performed using Kruskal-Wallis and Dunn's test (one-way ANOVA) and two-way ANOVA (with bonferroni post-test). RESULTS: Multimedia information prior to the consultation saved 32.9% time compared to paper-based (5.3 min. vs. 9.5 min; p < 0.05) and 60.4% time compared to shared multimedia information (5.3 min. vs. 13.9 min.; p < 0.001), with no difference in satisfaction (62.6 vs. 62.7 vs. 68.6 of max. 80; p = 0.07), anxiety (8 vs. 8.1 vs. 7 of max. 16; p = 0.35), or information gain (6.5 vs. 5.7 vs. 6.7 of max. 10; p = 0.23). Results on satisfaction (56.6 vs. 62.6 vs. 66; p = 0.06), anxiety (7.2 vs. 7.2 vs. 6.8; p = 0.84), and information gain (7 vs. 6.4 vs. 5.9; p = 0.43) remained stable over time. CONCLUSIONS: Multimedia-supported IC prior to consultation provided improved time efficiency (33% gain) compared to traditional paper-based IC, with comparable satisfaction, anxiety and information gain. Multimedia-supported information materials should therefore be used more frequently in patient education.

Understanding tumor localization in multiparametric MRI of the prostate-effectiveness of 3D printed models.

Introduction: Understanding tumor localization in multiparametric MRI (mpMRI) of the prostate is challenging for urologists but of great importance in mpMRI-fused prostate biopsy or radical prostatectomy. The aim was to evaluate the effectiveness of 3D printed models of the prostate to help urologists to locate tumors. Methods and Participants: 20 urologists from University Medical Center Mainz (Germany) were asked to plot the location of a cancer suspicious lesion (PI-RADS ≥ 4) on a total of 30 mpMRI on a prostate sector diagram. The following 3 groups (as matched triplets) were divided into: mpMRI only, mpMRI with radiological report and mpMRI with 3D printed model (scaled 1:1). Statistical analysis was performed using one-way and two-way ANOVA (with bonferroni post-test). Results: Overall, localization of the suspicious lesion was superior with the radiological report (median of max. 10 [IQR]: MRI 2 [IQR 1;5], MRI + report: 8 [6.3;9], MRI + 3D model 3 [1.3;5.8]; p < 0.001). Residents with <1 year of experience had a significantly higher detection rate using a 3D printed model [5 (5;5.8)] compared to mpMRI alone [1.5 (1;3.5)] (p < 0.05). Regarding the estimation of index lesion extension, the 3D model showed a significant benefit (mean percentage difference [95% CI]: MRI alone 234% [17.1;451.5], MRI + report 114% [78.5;149.6], MRI + 3D model 17% [-7.4;41.3] (p < 0.01). Conclusion: Urologists still need the written radiological report for a sufficient understanding of tumor localization. The effectiveness of the 3D printed model regarding tumor localization is particularly evident in young residents (<1 year) and leads to a better overall assessment of the tumor extension.

Change in Splenic Volume as a Surrogate Marker for Immunotherapy Response in Patients with Advanced Urothelial and Renal Cell Carcinoma-Evaluation of a Novel Approach of Fully Automated Artificial Intelligence Based Splenic Segmentation.

BACKGROUND: In the treatment of advanced urothelial (aUC) and renal cell carcinoma (aRCC), biomarkers such as PD-1 and PD-L1 are not robust prognostic markers for immunotherapy (IO) response. Previously, a significant association between IO and a change in splenic volume (SV) was described for several tumour entities. To the best of our knowledge, this study presents the first correlation of SV to IO in aUC and aRCC. METHODS: All patients with aUC (05/2017-10/2021) and aRCC (01/2012-05/2022) treated with IO at our academic centre were included. SV was measured at baseline, 3 and 9 months after initiation of IO using an in-house developed convolutional neural network-based spleen segmentation method. Uni- and multivariate Cox regression models for overall survival (OS) and progression-free survival (PFS) were used. RESULTS: In total, 35 patients with aUC and 30 patients with aRCC were included in the analysis. Lower SV at the three-month follow-up was significantly associated with improved OS in the aRCC group. CONCLUSIONS: We describe a new, innovative artificial intelligence-based approach of a radiological surrogate marker for IO response in aUC and aRCC which presents a promising new predictive imaging marker. The data presented implicate improved OS with lower follow-up SV in patients with aRCC.

Single-center, prospective phase 2 trial of high-intensity focused ultrasound (HIFU) in patients with unilateral localized prostate cancer: good functional results but oncologically not as safe as expected.

PURPOSE: Focal therapy (FT) for localized prostate cancer (PCa) is only recommended within the context of clinical trials by international guidelines. We aimed to investigate oncological follow-up and safety data of focal high-intensity focused ultrasound (HIFU) treatment. METHODS: We conducted a single-center prospective study of 29 patients with PCa treated with (focal) HIFU between 2016 and 2021. Inclusion criteria were unilateral PCa detected by mpMRI-US-fusion prostate biopsy and maximum prostate specific antigen (PSA) of 15 ng/ml. Follow-up included mpMRI-US fusion-re-biopsies 12 and 24 months after HIFU. No re-treatment of HIFU was allowed. The primary endpoint was failure-free survival (FFS), defined as freedom from intervention due to cancer progression. RESULTS: Median follow-up of all patients was 23 months, median age was 67 years and median preoperative PSA was 6.8 ng/ml. One year after HIFU treatment PCa was still detected in 13/ 29 patients histologically (44.8%). Two years after HIFU another 7/29 patients (24.1%) were diagnosed with PCa. Until now, PCa recurrence was detected in 11/29 patients (37.93%) which represents an FFS rate of 62%.One patient developed local metastatic disease 2 years after focal HIFU. Adverse events (AE) were low with 70% of patients remaining with sufficient erectile function for intercourse and 97% reporting full maintenance of urinary continence. CONCLUSION: HIFU treatment in carefully selected patients is feasible. However, HIFU was oncologically not as safe as expected because of progression rates of 37.93% and risk of progression towards metastatic disease. Thus, we stopped usage of HIFU in our department.

High-Normal Preoperative Potassium Level Is Associated with Reduced 30-Day Morbidity and Shorter Hospital Stay after Radical Cystectomy.

BACKGROUND: Radical cystectomy has high complication rates and, consequently, a high socioeconomic burden. The association between preoperative electrolyte levels and postoperative outcomes after radical cystectomy has not been investigated. Therefore, we aimed to investigate the association between preoperative potassium level and clinical (30-day morbidity) and economical (length of hospital stay) postoperative outcomes of patients undergoing radical cystectomy. MATERIALS AND METHODS: We retrospectively evaluated clinical data of 317 patients who had undergone radical cystectomy for bladder cancer. Univariate and multivariate logistic regression analyses were performed to determine whether preoperative patient clinical factors influence clinical (30-day morbidity according to the Clavien-Dindo classification) and economical (length of hospital stay) postoperative outcomes. RESULTS: In univariate analysis, low Charlson comorbidity score (p = 0.011), low ASA score (p = 0.015), no aspirin intake (p = 0.048) and high-normal preoperative potassium level (p = 0.034) were associated with reduced 30-day morbidity. In multivariate analysis, only high preoperative potassium remained an independent predictive factor for a reduced risk of postoperative complications (odds ratio 0.67, 95% confidence interval (0.48, 0.92), p = 0.014). Furthermore, high-normal preoperative potassium was the only preoperative factor associated with a shorter hospital stay ≤21 days (p = 0.007). CONCLUSIONS: High-normal preoperative potassium level was associated with better clinical (lower 30-day morbidity) and economical (shorter hospital stay) outcomes in patients undergoing radical cystectomy. We recommend that a randomized controlled trial be performed to investigate whether there is a causal relationship between preoperative potassium supplementation and postoperative complications and length of hospital stay.

Smartglass augmented reality-assisted targeted prostate biopsy using cognitive point-of-care fusion technology.

INTRODUCTION: MRI-guided targeted biopsy has become standard of care for diagnosis of prostate cancer, with establishment of several biopsy techniques and platforms. Augmented reality smart glasses have emerged as novel technology to support image-guided interventions. We aimed to investigate its usage while prostate biopsy. METHODS: MRI with PIRADS-lesions ≥3 was uploaded to smart glasses (Vuzix BladeR ) and augmented reality smart glasses-assisted targeted biopsy (SMART-TB) of the prostate was performed using cognitive fusion technology at the point of care. Detection rates were compared to systematic biopsy. Feasibility for SMART-TB was assessed (10 domains from bad [1] to excellent [10]). RESULTS: SMART-TB was performed for four patients. Prostate cancer detection was more likely for SMART-TB (46%; 13/28) than for systematic biopsy (27%; 13/48). Feasibility scores were high [8-10] for practicality, multitasking, execution speed, comfort and device weight and low [1-4] for handling, battery and image quality. Median execution time: 28 min; Investment cost smart glass: 1017 USD. CONCLUSION: First description of SMART-TB demonstrated convenient feasibility. This novel technology might enhance diagnosis of prostate cancer in future.

Robotic surgery can be safely performed for patients and healthcare workers during COVID-19 pandemic.

OBJECTIVES: To investigate the safety of robotic surgery during COVID-19 pandemic concerning new-acquired COVID-19 infections for patients and healthcare workers. PATIENTS: We performed a retrospective single-centre cohort study of patients undergoing robotic surgery in initial period of COVID-19 pandemic. Patients and healthcare workers COVID-19 infection status was assessed by structured telephone follow-up and/or repeated nasopharyngeal swabs. RESULTS: After 61 robotic surgeries (93,5% cancer surgery), one patient (1.6%) had COVID-19 infection. Sixty healthcare workers cumulatively exposed to 1187 h of robotic surgery had no infection. One patient with postoperative proof of SARS-CoV-2 had complete recovery. After this potentially contagious robotic surgery, eight healthcare workers had no COVID-19 infection after follow-up with each three nasopharyngeal swabs. CONCLUSIONS: Early clinical experience of robotic surgery during COVID-19 pandemic shows that robotic surgery can be safely performed for patients and healthcare workers. Despite our results we recommend elective surgery only for verified COVID-19 negative patients.

Global change of surgical and oncological clinical practice in urology during early COVID-19 pandemic.

OBJECTIVES: While the coronavirus disease 2019 (COVID-19) pandemic captures healthcare resources worldwide, data on the impact of prioritization strategies in urology during pandemic are absent. We aimed to quantitatively assess the global change in surgical and oncological clinical practice in the early COVID-19 pandemic. METHODS: In this cross-sectional observational study, we designed a 12-item online survey on the global effects of the COVID-19 pandemic on clinical practice in urology. Demographic survey data, change of clinical practice, current performance of procedures, and current commencement of treatment for 5 conditions in medical urological oncology were evaluated. RESULTS: 235 urologists from 44 countries responded. Out of them, 93% indicated a change of clinical practice due to COVID-19. In a 4-tiered surgery down-escalation scheme, 44% reported to make first cancellations, 23% secondary cancellations, 20% last cancellations and 13% emergency cases only. Oncological surgeries had low cancellation rates (%): transurethral resection of bladder tumor (27%), radical cystectomy (21-24%), nephroureterectomy (21%), radical nephrectomy (18%), and radical orchiectomy (8%). (Neo)adjuvant/palliative treatment is currently not started by more than half of the urologists. COVID-19 high-risk-countries had higher total cancellation rates for non-oncological procedures (78% vs. 68%, p = 0.01) and were performing oncological treatment for metastatic diseases at a lower rate (35% vs. 48%, p = 0.02). CONCLUSION: The COVID-19 pandemic has affected clinical practice of 93% of urologists worldwide. The impact of implementing surgical prioritization protocols with moderate cancellation rates for oncological surgeries and delay or reduction in (neo)adjuvant/palliative treatment will have to be evaluated after the pandemic.

Telemedicine Online Visits in Urology During the COVID-19 Pandemic-Potential, Risk Factors, and Patients' Perspective.

The current coronavirus disease 2019 (COVID-19) pandemic has placed considerable strain on hospital resources. We explored whether telemedicine (defined as a videoconference) might help. We undertook prospective structured phone interviews of urological patients (n = 399). We evaluated their suitability for telemedicine (judged by a panel of four physicians) and their risks from COVID-19 (10 factors for a poor outcome), and collected willingness for telemedicine and demographic data. Risk factors for an adverse outcome from COVID-19 infection were common (94.5% had one or more) and most patients (63.2%) were judged suitable for telemedicine. When asked, 84.7% of patients wished for a telemedical rather than a face-to-face consultation. Those favouring telemedicine were younger (68 [58-75] vs 76 [70-79.2] yr, p < 0.001). There was no difference in preference with oncological (mean 86%) or benign diagnoses (mean 85%), or with COVID-19 risks factors. In subgroup analysis, men with prostate cancer preferred telemedicine (odds ratio: 2.93 [1.07-8.03], p = 0.037). We concluded that many urological patients have risk factors for a poor outcome from COVID-19 and most preferred telemedicine consultations at this time. This appears to be a solution to offer contact-free continuity of care. PATIENT SUMMARY: Risk factors for a severe course of coronavirus disease 2019 are common (94.5%) in urology patients. Most patients wished for a telemedical consultation (84.7%). This appears to be a solution to offer contact-free continuity of care.

AR-V7 Protein Expression in Circulating Tumour Cells Is Not Predictive of Treatment Response in mCRPC.

INTRODUCTION: Androgen receptor variant 7 (AR-V7) plays an important role in the progression of castration-resistant prostate cancer (CRPC) and has shown potential as a predictive biomarker in circulating tumour cells (CTCs) isolated from the bloodstream in terms of a liquid biopsy. Studies have shown that AR-V7 is a potential surrogate for selecting drug classes for systemic treatment by detecting nuclear AR-V7 by immunofluorescence or measuring AR-V7 messenger RNA by quantitative PCR. Here, we assessed the predictive value of AR-V7 detected by classical immunohistochemistry (IHC) for treatment response. METHODS: CTCs were isolated by cell separation by density gradient centrifugation from patients with metastatic CRPC (n = 26) before, while, and after undergoing a new therapy with chemotherapy (cabazitaxel or docetaxel) or antiandrogen (enzalutamide or abiraterone). CTCs were sequentially cytospun on object slides, and AR-V7 status was then detected by IHC based on a staining regime established on a 22Rv1 cell line with antibodies against CK8/18 und AR-V7. RESULTS: AR-V7 status detected by IHC showed no predictive value for progression-free survival (PFS). Kaplan-Meier analysis revealed that there was no difference in PFS between patients found positive or negative for AR-V7. DISCUSSION/CONCLUSION: AR-V7 detected by classical IHC has no predictive value for treatment response in the described setting. The future role of AR-V7 in CTCs as a biomarker in clinical routine remains elusive.

[Augmented reality and virtual reality in the operating theatre status quo und quo vadis]. / Augmented Reality und Virtual Reality im Operationssaal ­ Status Quo und Quo vadis.

INTRODUCTION: Virtual reality (VR) is an artificially simulated environment permitting interaction. On the other hand, augmented reality (AR) is an enhanced version of reality created by the use of technology to overlay digital information on an image of something being viewed through a device. Both technologies have partially been implemented in clinical daily routine. Surgical applications of VR and AR are currently evaluated. Yet it is still unclear which possibilities these new and versatile applications offer for physicians. INTENTION: The goal of this article was to assess current and future use of AR und VR, with a special focus on surgery. We also summarised obstacles for AR and VR use as well as potential clinical improvements through these new technologies. METHODS: Systematic literature research in PubMed with inclusion of reviews referring to AR and VR, especially focused on articles on surgery. Keywords were Augmented Reality, Virtual Reality, Telementoring and Telesurgery. Furthermore we briefly analysed the investment volume and investment strategy in medicine from the ten largest private technology companies of the USA. RESULTS: The keyword "Augmented Reality" leads to 1222 articles and 119 reviews, while "Virtual Reality" offered 7766 articles and 878 reviews. In recent years, the amount of published articles has increased. 45 articles were included. Multiple AR- and VR-applications are already integrated in surgical daily routine. The next promising applications will concern the possibility of intraoperative overlap with radiological imaging via AR-tools, as well as telementoring and the use of AR and VR in surgical and anatomical education. The expected - but unproven - advantages include cost savings, reduction in complications, comprehensive knowledge acquisition and improvement in surgical results. In addition, we notice enormous financial investment by technology companies in this sector. CONCLUSION: Due to their tremendous potential, AR and VR technologies will be increasingly integrated into surgery. However, the benefit of these new technologies for relevant endpoints are currently unclear. This should be examined in rigorous clinical trials. Physicians should play a key role in this technological revolution to exploit the potential of AR and VR for their patients.