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Background and Objective: Bladder cancer (BC) represents a significant health care challenge and is frequently detected during evaluations for haematuria in emergency departments (EDs). Our aim was to evaluate the clinical performance and economic implications of the Xpert BC Detection (BCD) test for patients presenting to the ED with haematuria to address the pressing need for more efficient and accurate diagnostic tools in this setting., Methods: We conducted a prospective single-centre observational study in the ED of a tertiary university hospital. Patients presenting with gross haematuria as the primary reason for their visit were enrolled. Urine samples collected in the ED were analysed using the Xpert BCD test. The primary outcomes were sensitivity, specificity, and a cost analysis for the Xpert BCD test in comparison to standard diagnostic methods such as urine cytology (UC) and white-light cystoscopy (WLC)., Key Findings and Limitations: The Xpert BCD test exhibited superior sensitivity to UC, particularly in identifying high-grade tumours. Importantly, Xpert BCD implementation has the potential to significantly reduce the number of unnecessary WLC procedures and streamline diagnostic pathways. The cost analysis also highlighted potential cost savings for Xpert BCD adoption in the ED setting., Conclusions and Clinical Implications: Our findings underscore the promise of Xpert BCD for revolutionising the diagnostic approach to BC in the ED for patients with gross haematuria. Its greater sensitivity and efficiency mean that Xpert BCD has the potential to improve patient care, optimise resource use, and alleviate the economic burden associated with unnecessary procedures., Patient Summary: Xpert Bladder Cancer Detection is a simple urine test that detects the presence of five genes associated with bladder cancer. We found that for patients visiting the emergency department because of blood in their urine, use of this test could save time and money over urine cell analysis (UCA) for ruling out or diagnosing bladder cancer. The test was also more sensitive in detecting higher-grade cancers. More research is needed to confirm our results., (© 2024 The Author(s).)

Background and Objective: Intermediate-risk (IR) non-muscle-invasive bladder cancer (NMIBC) encompasses a broad spectrum of disease, with heterogeneous outcomes in terms of disease recurrence and progression. The International Bladder Cancer Group (IBCG) recently proposed an updated scoring model for IR substratification that is based on five key risk factors. Our aim was to provide a clinical validation of the IBCG scoring system and substratification model for IR NMIBC., Methods: This was an international multicenter retrospective study. Patients diagnosed with IR NMIBC between 2012 and 2022 and treated with transurethral resection of the bladder and adjuvant intravesical chemotherapy were included. According to the presence or absence of risk factors, patients with IR NMIBC were further categorized in IR-low (no risk factors), IR-intermediate (1-2 risk factors), and IR-high (≥3 risk factors) groups. The 1-yr and 3-yr rates for recurrence-free survival (RFS) and progression-free survival (PFS) were evaluated for each subgroup. Cox regression analyses were used to compare oncological outcomes between the groups., Key Findings and Limitations: Of the 677 patients with IR NMIBC included in the study, 231 (34%), 364 (54%), and 82 (12%) were categorized in the IR-low, IR-intermediate, and IR-high groups, respectively. There were significant differences in RFS and PFS rates between these groups., Conclusions and Clinical Implications: We provide the first clinical validation of the IBCG scoring system and model for substratification of IR NMIBC., Patient Summary: Our study demonstrates that patients with intermediate-risk non-muscle-invasive bladder cancer can be correctly classified into three distinct subgroups according to their risk of both disease recurrence and progression. Our results support use of this scoring system in clinical practice., (Copyright © 2024. Published by Elsevier B.V.)

Background and Objective: High-resolution micro-ultrasound (microUS) is an advanced imaging tool. Our objective was to determine whether systematic microUS use for transrectal biopsy (TRBx) improves the detection rate for clinically significant prostate cancer (csPCa) in comparison to transperineal biopsy (TPBx) performed with magnetic resonance imaging (MRI)/conventional transrectal ultrasound (TRUS) fusion software., Methods: We retrospectively analyzed data for men who underwent prostate biopsies, including those on active surveillance (AS). TRBx was performed under microUS guidance, while MRI/TRUS fusion was consistently used to guide TPBx. Patients were matched according to propensity score matching (PSM). The primary endpoint was comparison of the csPCa detection rate with the two approaches. Secondary endpoints included predictors of csPCa (International Society of Urological Pathology grade group ≥2, assessed via multivariable logistic regression) and complication rates., Key Findings and Limitations: Overall, 1423 patients were enrolled. After applying PSM we identified an analytical cohort of 1094 men, 582 in the TRBx group and 512 in the TPBx group. There was no significant difference in the csPCa detection rate between the TRBx (45%) and TPBx (51%) groups ( p  = 0.07). Complications occurred in nine of 1094 patients (1%). On adjusted multivariable analysis, TPBx had a similar csPCa detection rate to TRBx (adjusted odds ratio [aOR] 1.26; p  = 0.09). Predictors of csPCa detection were a positive family history (aOR 1.68; 95% confidence interval [CI] 1.20-2.35; p  = 0.002); age (aOR 1.04, 95% CI 1.02-1.06; p  < 0.001); positive digital rectal examination (aOR 2.35, 95% CI 1.70-3.25; p  < 0.001); prostate-specific antigen density ≥0.15 ng/ml/cm 3 (aOR 3.23, 95% CI 2.47-4.23; p  < 0.001); and a Prostate Imaging-Reporting and Data System score ≥3 (aOR 2.46; 95% CI 1.83-3.32; p  < 0.001). Limitations include the retrospective nature of the study, the risk of underestimating the complication rate, and the heterogeneity of biopsy indications., Conclusions and Clinical Implications: TRBx using microUS alone showed a comparable csPCa detection rate to TPBx guided by MRI/TRUS fusion software. Given the better visualization and real-time detection of suspicious zones with microUS, the potential for improvement in the csPCa detection rate with greater integration of microUS in the TPBx setting warrants further investigation., Patient Summary: We compared the ability of two different prostate biopsy approaches to detect clinically significant prostate cancer. We found that transrectal biopsy guided by micro-ultrasound had similar detection rates to transperineal biopsy guided by a combination of magnetic resonance imaging and conventional ultrasound. More research is needed to confirm the potential of micro-ultrasound for transperineal biopsy., (© 2024 The Author(s).)

Bladder cancer is a significant global health concern owing to its prevalence, negative impact on quality of life, and high treatment costs. Treatment for metastatic urothelial carcinoma (mUC) traditionally relies on platinum-based chemotherapy regimens. However, clinical trial results have led to the approval of immune checkpoint inhibitors (ICIs) as viable treatment options. We assessed the escalating costs and economic viability of mUC treatment guidelines in Europe. We used a pragmatic approach that involved: (1) collection of the costs of the recommended medications in the five most populous European countries; (2) conversion of the costs into international dollars to account for differences in purchasing power parity among countries; (3) evaluation of the cost trends over time; and (4) comparison of the medication costs to World Health Organization thresholds. Introduction of ICIs in European guidelines substantially increased the cost of medications for mUC. Intriguingly, important differences across European countries emerged: the annual cost of medications was twofold higher in Italy than in France and the UK. Despite limitations, our study sheds light on the escalating costs and economic challenges of mUC treatment, and highlights the need for assessments of sustainable and cost-effective management approaches. PATIENT SUMMARY: We looked at the costs of treatments for metastatic bladder cancer and found that costs have been rising over time, especially with the introduction of new immune therapies, with notable differences among European countries. While these new treatments improve patient outcomes, they also come with a high price tag, which could strain health care budgets. Our results suggest that cost-effectiveness studies will be essential in determining the best and most sustainable treatment strategies in the future., (Copyright © 2023. Published by Elsevier B.V.)

Background: En bloc transurethral resection of the bladder (eTURB) might improve the surgical management of non-muscle-invasive bladder cancer (NMIBC) in comparison to conventional TURB (cTURB)., Objective: To evaluate whether eTURB is superior to cTURB in resection of NMIBC and specimen retrieval., Design, Setting, and Participants: This was a randomized, multicenter trial in patients with up to three cTa-T1 NMIBC tumors of 1-3 cm in size, who were enrolled from January 2019 to January 2022., Intervention: Participants were randomized 1:1 to undergo eTURB (n = 192) or cTURB (n = 192)., Outcome Measurements and Statistical Analysis: The primary outcome was the prevalence of detrusor muscle (DM) in the specimen retrieved. Secondary endpoints included bladder perforation, persistent disease at second-look TURB, positive lateral resection margin, positive deep resection margin, operation time, perforation rate, obturator reflex, conversion from eTURB to cTURB, recurrence-free survival, and disease recurrence at 3 mo., Results and Limitations: A total of 384 patients were randomized to undergo eTURB or cTURB. A total of 452 tumors were resected and analyzed for the primary outcome. eTURB was superior to cTURB in retrieval of DM (80.7% vs 71.1%; mixed-model p = 0.01). Bladder perforation (5.6% vs 12%; difference -6.4%; 95% confidence interval [CI] -12.2% to -0.6%) and obturator reflex (8.4% vs 16%; difference -7.6%; 95% CI -14.3% to -0.9%) were less frequent in the eTURB arm than in the cTURB arm. Operation time did not differ between the two techniques (26 min, interquartile range [IQR] 20-38 for eTURB vs 25 min, IQR 17-35 for cTURB; difference 1 min, 95% CI -25.9 to 4.99). Second-look TURB was performed in 24 patients in the eTURB arm and 34 in the cTURB arm, with no difference in the rate of residual papillary disease (pTa/pT1: 56% vs 55.9%; difference 0.1%, 95% CI -25.5% to 25.7%). At median follow-up of 13 mo (IQR 7-20), 18.4% of the patients in the eTURB arm and 16.7% in the cTURB arm had experienced bladder cancer recurrence (Cox hazard ratio 0.87, 95% CI 0.49-1.52; p = 0.6)., Conclusions: In patients with clinical NMIBC with up to three tumors of 1-3 cm in size, tumor removal via eTURB resulted in a higher rate of DM in the pathologic specimen in comparison to cTURB. Moreover, eTURB was associated with lower frequency of obturator reflex and bladder perforation than cTURB was. While improving on the quality indicators for NMIBC, the long-term differential oncologic benefits of eTURB remain uncertain., Patient Summary: We compared two techniques for removal of bladder tumors and found that tumor removal in a single piece, called en bloc resection, provides a better-quality specimen for pathology analysis and fewer complications in comparison to the conventional method. This trial is registered at ClinicalTrials.gov as NCT03718754., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Active surveillance (AS) has been proposed as a possible management option for patients with recurrent low-grade non-muscle-invasive bladder cancer. Recent studies suggest that AS is a safe and effective management strategy. Nevertheless, a consensus statement is needed to standardize inclusion criteria and follow-up schedules., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Multiparametric magnetic resonance imaging (mpMRI) is an invaluable diagnostic tool in the decision-making for prostate biopsies (PBx). However, a non-negligible proportion of patients with negative MRI (nMRI) may still harbour prostate cancer (PCa)., Objective: To assess whether microultrasound (micro-US) can help in substratifying the presence of PCa and clinically significant PCa (csPCa; ie, any Gleason score ≥7 PCa) in patients with nMRI despite a persistently high clinical suspicion of PCa., Design Setting and Participants: A total of 125 biopsy-naïve patients who underwent micro-US-guided PBx with the ExactVu system for a persistently high suspicion of PCa despite nMRI were prospectively enrolled., Intervention: The Prostate Risk Identification using micro-US (PRI-MUS) protocol was used to identify suspicious areas; PBx included targeted sampling of PRI-MUS ≥3 areas and systematic sampling., Outcome Measurements and Statistical Analysis: The primary endpoint was the assessment of micro-US diagnostic accuracy in detecting csPCa. Secondary endpoints included determining the proportion of patients with nMRI who may avoid PBx after micro-US or transrectal US, presence of cribriform and intraductal patterns on biopsy core examination, predictors of csPCa in patients presenting with nMRI, and comparing micro-US-targeted and systematic PBx in identifying csPCa., Results and Limitations: Considering csPCa detection rate, micro-US showed optimal sensitivity and negative predictive value (respectively, 97.1% and 96.4%), while specificity and positive predictive value were 29.7% and 34.0%, respectively. Twenty-eight (22.4%) patients with a negative micro-US examination could have avoided PBx with one (2.9%) missed csPCa. Cribriform and intraductal patterns were found in 14 (41.2%) and four (11.8%) of csPCa patients, respectively. In multivariable logistic regression models, positive micro-US, age, digital rectal examination, and prostate-specific antigen density ≥0.15 emerged as independent predictors of PCa. Targeted and systematic sampling identified 33 (97.1%) and 26 (76.5%) csPCa cases, respectively. The main limitation of the current study is represented by its retrospective single-centre nature on an operator-dependent technology., Conclusions: Micro-US represents a valuable tool to rule out the presence of csPCa among patients with a persistent clinical suspicion despite nMRI., Patient Summary: According to our results, microultrasound (micro-US) may represent an effective tool for the diagnosis of clinically significant prostate cancer in patients with negative magnetic resonance imaging (nMRI), providing high sensitivity and negative predictive value. Further randomised studies are needed to confirm the potential role of micro-US in the diagnostic pathway of patients with a persistent suspicion of prostate cancer despite nMRI., (© 2022 The Author(s).)

A trend towards greater benefit from adjuvant chemotherapy (ACT) in pN+ bladder cancer (BCa) has been observed in multiple randomized controlled trials. However, it is still unclear which patients might benefit the most from this approach. We retrospectively analyzed a multicenter cohort of 1381 patients with pTany pN1-3 cM0 R0 urothelial BCa treated with radical cystectomy (RC) with or without cisplatin-based ACT. The main endpoint was overall survival (OS) after RC. We performed 1:1 propensity score matching to adjust for baseline characteristics and conducted a classification and regression tree (CART) analysis to assess postoperative risk groups and Cox regression analyses to predict OS. Overall, 391 patients (28%) received cisplatin-based ACT. After matching, two cohorts of 281 patients with pN+ BCa were obtained. CART analysis stratified patients into three risk groups: favorable prognosis (≤pT2 and positive lymph node [PLN] count ≤2; odds ratio [OR] 0.43), intermediate prognosis (≥pT3 and PLN count ≤2; OR 0.92), and poor prognosis (pTany and PLN count ≥3; OR 1.36). Only patients with poor prognosis benefitted from ACT in terms of OS (HR 0.51; p < 0.001). We created the first algorithm that stratifies patients with pN+ BCa into prognostic classes and identified patients with pTany BCa with PLN ≥3 as the most suitable candidates for cisplatin-based ACT. PATIENT SUMMARY: We found that overall survival among patients with bladder cancer and evidence of lymph node involvement depends on cancer stage and the number of positive lymph nodes. Patients with more than three nodes affected by metastases seem to experience the greatest overall survival benefit from cisplatin-based chemotherapy after bladder removal. Our study suggests that patients with the highest risk should be prioritized for cisplatin-based chemotherapy after bladder removal., (Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Literature lacks clear evidence regarding the optimal treatment for non-muscle-invasive micropapillary bladder cancer (MPBC) due to its rarity and the presence of only small sample size and single-centre studies., Objective: To assess cancer-specific mortality (CSM) and overall mortality (OM) between immediate radical cystectomy (RC) and conservative management among T1 high-grade (HG) MPBC., Design, Setting, and Participants: We retrospectively analysed a multicentre dataset including 119 T1 HG MPBC patients treated between 2005 and 2019 at 15 tertiary referral centres. The median follow-up time was 35 mo (interquartile range: 19-64)., Intervention: Patients underwent immediate RC versus conservative management with bacillus Calmette-Guérin., Outcomes Measurements and Statistical Analysis: Cumulative incidence functions and Kaplan-Meier methods were applied to estimate survival outcomes. Multivariable Cox analyses were performed to assess independent predictors of disease recurrence and disease progression after conservative management; covariates consisted of pure MPBC, concomitant lymphovascular invasion (LVI), and carcinoma in situ at initial diagnosis., Results and Limitations: Immediate RC and conservative management were performed in 27% and 73% of patients, respectively. CSM and OM did not differ significantly among patient treated with immediate RC versus conservative management (Pepe-Mori test p = 0.5 and log-rank test p = 0.9, respectively). Overall, 66.7% and 34.5% of patients experienced disease recurrence and disease progression after conservative management, respectively. At multivariable Cox analyses, concomitant LVI was an independent predictor of disease recurrence (p = 0.01) and progression (p = 0.03), while pure MPBC was independently associated with disease progression (p = 0.03). The absence of a centralised re-review and the retrospective design represent the main limitations of our study., Conclusions: Conservative management could achieve satisfactory results among T1 HG MPBC patients with neither pure MPBC nor LVI at initial diagnosis., Patient Summary: Bacillus Calmette-Guérin seems to be an effective therapy for T1 micropapillary bladder cancer patients with neither pure micropapillary disease nor lymphovascular invasion at initial diagnosis., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Active surveillance (AS) has been proposed as an alternative to transurethral resection (TUR) in selected patients with recurrent low-risk non-muscle-invasive bladder cancer (NMIBC). Here we report long-term results for patients on AS and investigate features associated with AS failure. Cases with recurrence after diagnosis of low-grade (LG) pTa/pT1a NMIBC were enrolled in the Bladder Italian Active Surveillance (BIAS) project. Over 251 AS events, we observed 130 failures (51.8%). In these patients, final pathology showed 25 benign lesions (19.2%) and 92 LG Ta (70.7%), 12 high-grade Ta/T1 (9.2%), and one T2 (0.7%) tumor. The treatment-free probability at 12, 18, 24, and 36 mo was 59.7%, 54.5%, 46.3%, and 40.4%, respectively. We identified 95 patients (37.8%) who remained on AS for >18 mo. A multivariable Cox regression model confirmed that patients with a history of multiple TURs (hazard ratio [HR] 1.59, 95% confidence interval [CI] 1.01-2.51) and those with more than one lesion at AS entry (HR 1.63, 95% CI 1.05-2.54) were significantly more likely to experience AS failure. Our results confirm that well-selected patients with NMIBC can safely remain on AS for a long period of time. Multiple TURs and multiple lesions at AS enrollment are associated with a higher risk of AS failure. PATIENT SUMMARY: Active surveillance has been proposed as an alternative to surgery for patients with recurrent low-risk superficial bladder cancer. Our report confirms that well-selected patients can safely avoid or postpone surgery., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Multiparametric magnetic resonance imaging (MRI) represents the gold standard for the diagnosis of clinically significant prostate cancer (csPCa). The search for alternative diagnostic techniques is still ongoing., Objective: To determine the accuracy of microultrasound (microUS) for the diagnosis of csPCa within prospectively collected cohort of patients with a suspicion of prostate cancer (PCa) according to MRI., Design, Setting, and Participants: A total of 320 consecutive patients with at least one Prostate Imaging Reporting and Data System (PIRADS) ≥3 lesion according to MRI were prospectively enrolled., Intervention: All patients received microUS before prostate biopsy using the ExactVu system; the Prostate Risk Identification using microUS (PRI-MUS) protocol was used to identify targets. The urologists were blinded to MRI results until after the microUS targeting was completed. All patients received both targeted (based on either microUS or MRI findings) and randomized biopsies., Outcome Measurements and Statistical Analysis: The sensitivity and specificity of microUS to determine the presence of csPCa (defined as at least one core with a Gleason score ≥7 PCa) were determined. Multivariable logistic regression analysis was fitted to determine the predictors of csPCa., Results and Limitations: Clinically significant PCa was diagnosed in 116 (36.3%) patients. The sensitivity and negative predictive value of microUS for csPCa diagnosis were 89.7% and 81.5%, while specificity and positive predictive value were 26.0% and 40.8%, respectively. A combination of microUS-targeted and randomized biopsies would allow diagnosing the same proportion of csPCa as that diagnosed by an approach combining MRI-targeted and randomized biopsies (n = 113; 97.4%), with only three (2.6%) csPCa cases diagnosed by a microUS-targeted and three (2.6%) by an MRI-targeted approach. In a logistic regression model, an increasing PRI-MUS score was an independent predictor of csPCa (p ≤ 0.005). The main limitation of the current study is represented by the fact that all patients had suspicious MRI., Conclusions: Microultrasound is a promising imaging modality for targeted prostate biopsies. Our results suggest that a microUS-based biopsy strategy may be capable of diagnosing the great majority of cancers, while missing only few patients with csPCa., Patient Summary: According to our results, microultrasound (microUS) may represent an effective diagnostic alternative to magnetic resonance imaging for the diagnosis of clinically significant prostate cancer, providing high sensitivity and a high negative predictive value. Further randomized studies are needed to confirm the potential role of microUS in the diagnostic pathway of patients with a suspicion of prostate cancer., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: The use of a nephron-sparing surgery for the treatment of localized renal masses is being pushed to more challenging cases. However, this procedure is not devoid of risks, and the Radius, Exophytic/Endophytic, Nearness, Anterior/Posterior, Location (RENAL) and Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) classifications are commonly employed in the prediction of complications. Recently, the Simplified PADUA REnal (SPARE) scoring system has been proposed with the aim to provide a more simple system, to improve its reproducibility to predict postoperative risks., Objective: We aim to retrospectively validate and compare the proposed new SPARE system in a multi-institutional population., Design, Setting, and Participants: The Transatlantic Robotic Nephron-sparing Surgery (TRoNeS) study group collected data from 737 patients subjected to robot-assisted partial nephrectomy (RAPN) between 2010 and 2016 at three tertiary care referral centers. Of these patients, 536 presented complete demographic and clinical data., Outcome Measurements and Statistical Analysis: Renal masses were classified according to the SPARE, RENAL, and PADUA nephrometry scores, and surgical success was defined according to the margin, ischemia, and complication scores., Results and Limitations: Of 536 patients, 340 were male; the median age was 61 (53-69) yr and preoperative tumor size was 30 (22-43) mm. The margin, ischemia, and complication score was achieved in 399 of cases (74.4%). All three nephrometry scores were significant predictors of surgical outcomes both in univariate and in adjusted multivariate logistic regression model analysis. In accuracy analysis, the area under the curve (AUC) of the SPARE scoring system (0.73) was significantly higher than those of the PADUA (0.65) and RENAL (0.68) nephrometry scores in predicting surgical success., Conclusions: The SPARE score appears to be a promising and reliable score for the prediction of surgical outcomes of RAPN, showing a higher accuracy relative to the traditional PADUA and RENAL nephrometry scores. Further, prospective studies are warranted before its introduction in clinical practice., Patient Summary: The Simplified PADUA REnal (SPARE) score is a reproducible and simple nephrometry score, offering better predictive capabilities of surgical success and complications., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Positron emission tomography (PET)/computed tomography (CT) with 68 Ga-labeled prostate-specific membrane antigen ligand ( 68 Ga-PSMA) may represent the most promising alternative to multiparametric magnetic resonance imaging (mpMRI) for prostate cancer (PCa) diagnosis., Objective: To test the diagnostic performance of 68 Ga-PSMA PET/CT in this clinical context., Design, Setting, and Participants: From January 2017 to December 2018 we prospectively enrolled 97 patients with persistently elevated prostate-specific antigen and/or Prostate Health Index score, negative digital rectal examination, and previous negative biopsy. We also included patients with either negative mpMRI or contraindications to or positive mpMRI but previous negative biopsy., Intervention: Patients underwent 68Ga-PSMA PET/CT with additional pelvic reconstruction., Outcome Measurements and Statistical Analysis: The primary endpoint of the study was the diagnostic performance of 68 Ga-PSMA PET/CT in detecting malignant lesions and clinically significant PCa (Gleason score [GS] ≥7)., Results and Limitations: 68 Ga-PSMA PET/transrectal ultrasound fusion biopsy was performed in 64 of 97 patients (66%) for 114 regions of interest (ROIs). Forty patients (41%) had already undergone mpMRI with either a negative result for PCa (n = 15; 22 ROIs) or a positive mpMRI result but a previous negative biopsy. According to pathology, 23 patients (36%) had evidence of PCa: eight (16 ROIs) with GS 6, 13 (21 ROIs) with GS 7 (3 + 4 or 4 + 3), one (2 ROIs) with GS 8, and one (2 ROIs) with GS 10. Clinically significant PCa was identified in four patients with previous negative mpMRI (25%). PET/CT demonstrated PCa in seven patients (14 ROIs) with previous positive mpMRI and negative biopsy. The median maximum standardized uptake value (SUVmax) and median SUV ratio were significantly higher for PCa lesions than for benign lesions (p <  0.001). Optimal cutoff points obtained for SUVmax (>5.4) and SUV ratio (>2.2) could identify clinically significant PCa with accuracy of 81% and 90%, respectively., Conclusions: In our cohort of patients with high suspicion of cancer, 68 Ga-PSMA PET/CT was capable of detecting malignancy and accurately identifying clinically relevant PCa., Patient Summary: Positron emission tomography/computed tomography with a 68 Ga-labeled ligand for prostate-specific membrane antigen is capable of detecting prostate cancer in patients with a high suspicion of cancer and a previous negative biopsy., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: En bloc resection (ERBT) is a valid alternative to piecemeal resection for non-muscle-invasive bladder cancer (NMIBC), guaranteeing pathological outcomes. However, very few studies investigated long-term oncological outcomes of ERBT., Objective: To report long-term oncological outcome of ERBT., Design Setting and Participants: This is a retrospective analysis of prospectively collected data. We included patients who underwent ERBT from June 2010 to February 2014, and were diagnosed with NMIBC at pathology evaluation., Outcome Measurements and Statistical Analysis: The primary study endpoint was recurrence-free survival at 5 yr. Secondary outcomes were presence of detrusor muscle, recurrence rate at the first follow-up cystoscopy, progression to muscle-invasive bladder cancer (MIBC) at 5 yr, and factors associated with long-term oncological outcomes. Kaplan-Meier curves were used to describe recurrence-free survival time. A univariate analysis was used to investigate factors associated with recurrence., Results and Limitations: Overall, 74 patients were included in this study. The median age was 71 (66-76) yr. Most of the patients presented with only one bladder tumor, and the median tumor diameter was 2 (interquartile range [IQR] 1-2.5) cm. After histopathological examination, eight, 35, and 31 patients were diagnosed with low-, intermediate-, and high-risk disease, respectively. All the en bloc resected tumors showed the presence of detrusor muscle. The median follow-up was 72 (IQR 66-90) mo. The recurrence rate at the first follow-up cystoscopy was 5.4% (four out of 74 patients). Overall, 57 (77%) patients were free of recurrence at 5 yr. No progression to MIBC was observed: progression-free survival was 100%. Limitations include retrospective design and small size., Conclusions: Our findings showed that ERBT for NMIBC presents an optimal long-term oncological outcome. Further studies with larger cohorts are necessary for confirming our preliminary results and for a direct comparison with the traditional piecemeal resection., Patient Summary: In case of superficial bladder tumors, transurethral resection of the entire tumor and its base in one piece seems to provide good long-term results in terms of recurrence and progression rates., (© 2021 The Author(s).)

Background: The adoption of robotic technology in the treatment of prostate cancer (PCa) could lead to improvement in outcomes., Objective: To evaluate feasibility, to compare functional outcomes, and to assess the economic benefits of removing catheter on the postoperative day (POD) 3 versus POD 5 after robot-assisted radical prostatectomy (RARP)., Design, Setting, and Participants: From September 2016 to May 2017, patients selected to undergo RARP for clinically localized PCa at a high-volume center were prospectively randomized into group 1 (POD 3; n=72) versus group 2 (POD 5, n=74)., Intervention: All patients underwent RARP with anatomical posterior and anterior reconstruction., Outcome Measurements and Statistical Analysis: The primary endpoint was to compare acute urinary retention (AUR) and urinary leakage rate in the two groups. The secondary endpoints were early and mid-term postoperative functional outcomes assessed through questionnaires (ICIQ-MLUTS, IPSS), early continence rate, and postoperative pain/discomfort (visual analog scale score). The economic impact of early catheter removal was also assessed., Results and Limitations: AUR was reported in two (1.4%) cases, one for each study group (p=0.9). One case of vesicourethral leakage was reported (0.7%) in group 1. Urethral discomfort and pain at discharge was significantly higher in group 2 (p=0.03). In our clinical practice, POD 3 catheter removal approach would determine a saving of approximately €80 000 and 405 d of hospitalization yearly. The main limitation is the small sample size., Conclusions: Early catheter removal after RARP does not lead to an increase in perioperative complications. No negative effect on early and mid-term functional outcomes was observed. A significant impact on saving economic resources was reported., Patient Summary: We demonstrated that early catheter removal has no negative effect on spontaneous voiding, complications, or urinary continence recovery after robot-assisted radical prostatectomy., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Multiparametric magnetic resonance imaging (mpMRI) and MRI/ultrasound (US) fusion targeted biopsies are an increasingly popular alternative to randomized biopsies, but adoption of this technique has been limited owing to its additional costs and complexity. High-resolution micro-ultrasound (micro-US) is a real-time US-based imaging modality that allows real-time targeted prostate biopsies using the Prostate Risk Identification Using Micro-Ultrasound risk identification protocol. We compared the diagnostic accuracy of micro-US targeted biopsies (index test) and MRI/US fusion targeted biopsies (reference standard test) in detecting clinically significant prostate cancer (csPC), defined as Gleason ≥7 disease, in a prospectively collected cohort of 104 patients with suspected PC defined according to prostate-specific antigen, digital rectal examination, and the presence of at least one Prostate Imaging-Reporting and Data System ≥3 lesion at mpMRI. PC was diagnosed in 56 patients (54%) and csPC in 35 (34%). Micro-US sensitivity for csPC detection was 94%, with 33/35 csPC cases correctly identified. The negative predictive value was 90%, while the positive predictive value was 40% and the specificity was 28%. Of the 61 targeted zones concordant between micro-US and mpMRI, 24 were csPC. Discordant targeted lesions led to csPC discovery by micro-US in three cases and mpMRI in four cases. Both techniques missed one case for which csPC was diagnosed by systematic biopsies only. PATIENT SUMMARY: According to the results of our preliminary trial, micro-ultrasound may provide additional information regarding the presence or absence of clinically significant prostate cancer (PC) in patients with suspected PC. Further studies are warranted to investigate how this new imaging modality can best be leveraged within the PC diagnostic pathway., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: It has been shown that active surveillance (AS) is feasible and effective in a subset of patients with recurrent low-grade (LG) non-muscle-invasive bladder cancer (NMIBC)., Objective: To update a previous preliminary series and investigate pathological outcomes for patients who failed to remain on AS., Design, Setting, and Participants: Prospective observational cohort study started in February 2008, and currently still active, at a tertiary university hospital, including patients with pathologically confirmed NMIBC who experienced recurrence during follow-up., Intervention: AS monitoring consisted of cytology and in-office flexible cystoscopy every 3 mo for the first year, and every 6 mo thereafter., Outcome Measurements and Statistical Analysis: The primary endpoint was pathological results for patients who failed to remain on AS. The secondary outcome was an update of clinical results from our previous series. Data were complemented by descriptive statistical analysis and univariable and multivariable proportional hazards Cox regression., Results and Limitations: Overall, 167 patients were included. Of 181 AS events, 61 (33.7%) were deemed to require treatment because of positive cytology (n=10), gross haematuria (n=11), and increases in the tumour number (n=15), or size (n=17), or both (n=8). The median time on AS was 12 mo (interquartile range 4-26). Pathological specimens from AS failures did not show any malignancy in 20 cases. Histopathology identified urothelial hyperplasia and oedema, submucosal vascular ectasia, mucosal erosion, polypoid cystitis, von Brunn nest hyperplasia, and squamous metaplasia. The time from first transurethral resection to AS start was inversely associated with recurrence-free survival (hazard ratio 0.97, 95% confidence interval 0.96-1.00; p=0.024). The study lacks statistical subanalyses focusing on patients with failure and negative neoplastic pathological outcomes., Conclusions: AS might be a reasonable strategy in patients presenting with small LG pTa/pT1a recurrent bladder tumours. Approximately 30% of patients deemed to have AS failure did not harbour any neoplastic lesion, strengthening the role of AS., Patient Summary: Patients with small low-grade pTa/pT1a recurrent papillary bladder tumours could benefit from an active surveillance protocol with no significant risk of pathological progression to muscle-invasive cancer., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Serum levels of neutrophils, platelets, and lymphocytes have been recognized as factors related to poor prognosis for many solid tumors, including bladder cancer (BC)., Objective: To evaluate the prognostic role of the combination of the neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR), and lymphocyte/monocyte ratio (LMR) in patients with high-risk non-muscle-invasive urothelial BC (NIMBC)., Design, Setting, and Participants: A total of 1151 NMIBC patients who underwent first transurethral resection of the bladder tumor (TURBT) at 13 academic institutions between January 1, 2002 and December 31, 2012 were included in this analysis. The median follow-up was 48 mo., Intervention: TURBT with intravesical chemotherapy or immunotherapy., Outcome Measurements and Statistical Analysis: Multivariable Cox regression analysis was performed to identify factors predictive of recurrence, progression, cancer-specific mortality, and overall mortality. A systemic inflammatory marker (SIM) score was calculated based on cutoffs for NLR, PLR, and LMR., Results and Limitations: The 48-mo recurrence-free survival was 80.8%, 47.35%, 20.67%, and 17.06% for patients with an SIM score of 0, 1, 2, and 3, respectively (p<0.01, log-rank test) while the corresponding 48-mo progression free-survival was 92.0%, 75.67%, 72.85%, and 63.1% (p<0.01, log-rank test). SIM scores of 1, 2, and 3 were associated with recurrence (hazard ratio [HR] 3.73, 7.06, and 7.88) and progression (HR 3.15, 4.41, and 5.83). Limitations include the lack of external validation and comparison to other clinical risk models., Conclusions: Patients with high-grade T1 stage NMIBC with high SIM scores have worse oncologic outcomes in terms of recurrence and progression. Further studies should be conducted to stratify patients according to SIM scores to identify individuals who might benefit from early cystectomy., Patient Summary: In this study, we defined a risk score (the SIM score) based on the measurement of routine systemic inflammatory markers. This score can identify patients with high-grade bladder cancer not invading the muscular layer who are more likely to suffer from tumor recurrence and progression. Therefore, the score could be used to select patients who might benefit from early bladder removal., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Context: Repeat transurethral resection (reTUR) is advocated as a fundamental step towards complete clearance and appropriate staging of T1 bladder cancer tumors., Objective: To assess the impact of reTUR in T1 bladder cancer via a systematic review of the literature and meta-analysis of available data sets., Evidence Acquisition: After definition of the population and of the outcome, a systematic search of English language articles in the literature from 1980 to 2016 was performed. The pooled prevalence of residual tumor and of upstaging at reTUR were assessed and computed using a random effects model to take into account heterogeneity showed by I 2 and Cochran's Q values. A sensitivity analysis was conducted to exclude excessive influence by a single study., Evidence Synthesis: Among the papers identified, 29 were selected. A total of 3566 and 2556 cases formed the study population for assessment of the prevalence of residual tumor and upstaging, respectively. The corresponding numbers for the subgroup with detrusor muscle involvement at the initial TUR were 1565 and 1187. The pooled prevalence was 0.56 (95% confidence interval [CI] 0.48-0.63) for residual tumor and 0.1 (95% CI 0.06-0.14) for upstaging to T2 at reTUR. The corresponding rates for the detrusor muscle subgroup were 0.47 (95% CI 0.33-0.62) and 0.1 (95% CI 0.06-0.14). The sensitivity analysis excluded an excessive influence of each of the studies examined., Conclusions: Pooled prevalence rates for residual tumor (∼50%) and upstaging to invasive disease (10%) at reTUR in T1 cases were high, and were stable among studies in different decades and for cases with detrusor muscle involvement at the initial TUR. Therefore, reTUR remains a fundamental procedure., Patient Summary: Repeat transurethral resection after a diagnosis of stage T1 bladder cancer is recommended given the high risk of misallocation to the proper treatment., (Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Decision making in T1 high-grade bladder cancer patients remains a challenging issue in urologic practice., Objective: To assess the feasibility and potential prognostic role of three different substaging systems in specimens from both primary and second transurethral resection (TUR) of the bladder in T1 high-grade bladder cancer patients., Design, Setting, and Participants: A total of 250 consecutive, confirmed pure transitional T1 high-grade bladder tumors submitted to second TUR entered the retrospective study., Outcome Measurements and Statistical Analysis: Feasibility of two already clinically tested microstaging systems (anatomy-based T1a/T1b/T1c and micrometric T1m/T1e with 0.5-mm thresholds of invasion) and that of a micrometric substage designed by the authors and based on a 1-mm threshold of invasion (Rete Oncologica Lombarda [ROL] system) was assessed by five independent uropathologists on both first and second TUR specimens. Univariable Cox proportional hazards models were attempted to identify significant independent predictors of recurrence and progression after TUR. Kaplan-Meier curves were plotted to compare different substaging methods analyzing recurrence and progression., Results and Limitations: The ROL system proved to be feasible in nearly all cases at both first and second TUR. Median follow-up was 60 mo. The univariate Cox regression analysis documented the ROL substage (ROL2 vs ROL1) to be the only statistically significant predictor of progression (hazard ratio: 2.01; 95% CI, 1.03-3.79; p<0.03). For the first time to our knowledge, the substage was investigated and used to assess T1 tumors found at second TUR, registering a high rate of feasibility., Conclusions: T1 microstaging using different procedures is feasible on both primary- and second-TUR specimens. A high rate of feasibility may be expected for T1m/T1e and ROL systems. The clinical role of microstaging on second TUR remains to be defined., Patient Summary: The Rete Oncologica Lombarda system showed feasible results in T1 high-grade bladder tumors. Our substratification was predictive of progression of disease., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Context: En-bloc resection of bladder tumors (ERBT) is a promising alternative to conventional transurethral resection of bladder tumor., Objective: To review the current results of ERBT., Evidence Acquisition: A literature search of articles that included the keywords bladder and en bloc was performed on July 15, 2016 using PubMed/Medline. Relevant English-written original articles were considered. Data from the manuscripts were categorized focusing on recent trends on resection techniques, specimens' quality, morbidity, and recurrence., Evidence Synthesis: ERBT provides high rates of detrusor muscle (> 95%) and specimens of high quality for pathological evaluation. It has not been analyzed whether second resections can therefore be avoided. All energy devices (lasers, electric cautery) have been used to perform ERBT with similar perioperative and oncological results. Data show that there is not much difference in respect of perioperative morbidity compared with conventional transurethral resection of bladder tumor; however, only a few publications used a systematic classification system. No conclusions can be drawn regarding the impact of ERBT on recurrence., Conclusions: The major advantage of ERBT is the high rate of detrusor muscle. Based on limited data, no significant differences are observed regarding perioperative morbidity and recurrence rates., Patient Summary: En-bloc resection of bladder tumor is an emerging technique aimed at improving quality of surgical specimens. Available evidences suggest safety and oncologic equivalence compared with the standard transurethral resection of bladder tumor., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)