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Legislation to control tobacco use in developing countries has lagged behind the dramatic rise in tobacco consumption. India, the third largest grower of tobacco in the world, amassed 1.7 million disability-adjusted life years (DALYs) in 1990 due to disease and injury attributable to tobacco use in a population where 65% of the men and 38% of the women consume tobacco. India's anti-tobacco legislation, first passed at the national level in 1975, was largely limited to health warnings and proved to be insufficient. In the last decade state legislation has increasingly been used but has lacked uniformity and the multipronged strategies necessary to control demand. A new piece of national legislation, proposed in 2001, represents an advance. It includes the following key demand reduction measures: outlawing smoking in public places; forbidding sale of tobacco to minors; requiring more prominent health warning labels; and banning advertising at sports and cultural events. Despite these measures, the new legislation will not be enough to control the demand for tobacco products in India. The Indian Government must also introduce policies to raise taxes, control smuggling, close advertising loopholes, and create adequate provisions for the enforcement of tobacco control laws.

Abstract Background Randomized trials have long been the gold-standard for evaluating clinical practice. There is growing recognition that rigorous studies are similarly needed to assess the effects of policy. However, these studies are rarely conducted. We report on the Quality Improvement Demonstration Study (QIDS), an example of a large randomized policy experiment, introduced and conducted in a scientific manner to evaluate the impact of large-scale governmental policy interventions. Methods In 1999 the Philippine government proposed sweeping reforms in the National Health Sector Reform Agenda. We recognized the unique opportunity to conduct a social experiment. Our ongoing goal has been to generate results that inform health policy. Early on we concentrated on developing a multi-institutional collaborative effort. The QIDS team then developed hypotheses that specifically evaluated the impact of two policy reforms on both the delivery of care and long-term health status in children. We formed an experimental design by randomizing matched blocks of three communities into one of the two policy interventions plus a control group. Based on the reform agenda, one arm of the experiment provided expanded insurance coverage for children; the other introduced performance-based payments to hospitals and physicians. Data were collected in household, hospital-based patient exit, and facility surveys, as well as clinical vignettes, which were used to assess physician practice. Delivery of services and health status were evaluated at baseline and after the interventions were put in place using difference-in-difference estimation. Results We found and addressed numerous challenges conducting this study, namely: formalizing the experimental design using the existing health infrastructure; securing funding to do research coincident with the policy reforms; recognizing biases and designing the study to account for these; putting in place a broad data collection effort to account for unanticipated findings; introducing sustainable policy interventions based on the reform agenda; and providing results in real-time to policy makers through a combination of venues. Conclusion QIDS demonstrates that a large, prospective, randomized controlled policy experiment can be successfully implemented at a national level as part of sectoral reform. While we believe policy experiments should be used to generate evidence-based health policy, to do this requires opportunity and trust, strong collaborative relationships, and timing. This study nurtures the growing attitude that translation of scientific findings from the bedside to the community can be done successfully and that we should raise the bar on project evaluation and the policy-making process.

Abstract Background The extent of clinical exposure needed to ensure quality care has not been well determined during internal medicine training. We aimed to determine the association between clinical exposure (number of cases seen), self- reports of clinical competence, and type of institution (predictor variables) and quality of care (outcome variable) as measured by clinical vignettes. Methods Cross-sectional study using univariate and multivariate linear analyses in 11 teaching hospitals in Japan. Participants were physicians-in-training in internal medicine departments. Main outcome measure was standardized t-scores (quality of care) derived from responses to five clinical vignettes. Results Of the 375 eligible participants, 263 (70.1%) completed the vignettes. Most were in their first (57.8%) and second year (28.5%) of training; on average, the participants were 1.8 years (range = 1–8) after graduation. Two thirds of the participants (68.8%) worked in university-affiliated teaching hospitals. The median number of cases seen was 210 (range = 10–11400). Greater exposure to cases (p = 0.0005), higher self-reports of clinical competence (p = 0.0095), and type of institution (p < 0.0001) were significantly associated with higher quality of care, using a multivariate linear model and adjusting for the remaining factors. Quality of care rapidly increased for the first 100 to 200 cases seen and tapered thereafter. Conclusion The amount of clinical exposure and levels of self-reports of clinical competence, not years after graduation, were positively associated with quality of care, adjusting for the remaining factors. The learning curve tapered after about 200 cases.

Background: Optimal postsurgical management of prostate cancer (PCa) patients with nodal metastasis at the time of radical prostatectomy remains unclear. We sought to examine the role of postoperative PSA kinetics and pathologic tumor characteristics in guiding additional hormonal therapy use in pN1 men., Methods: In total, 297 pN1 PCa patients treated with radical prostatectomy and ePLND between 2002 and 2018 were identified within our prospectively maintained institutional cancer data-registry. Following surgery, these patients were managed with either immediate androgen deprivation therapy (iADT) or observation with deferred ADT (dADT). The former was defined as ADT given within ≤6 months of surgery and the latter as >6 months. The primary outcome was metastasis. Regression-tree analysis was used to stratify patients into novel risk-groups based on post-prostatectomy tumor characteristics and PSA kinetics and the corresponding metastasis risk. Multivariable Cox regression analyses tested the impact of iADT versus observation ± dADT on metastasis, cancer-specific mortality, and overall mortality within each risk-group separately., Results: The median follow-up was 6.1 years (IQR 3.2-9.0). Regression-tree analysis stratified patients into 3 novel risk-groups (Harrell's C-index 0.79) based on PSA-nadir and time to biochemical failure: group 1 (low-risk) included patients with time to biochemical recurrence >6 months (n = 115), while groups 2 and 3 included patients with biochemical failure within ≤6 months with a postoperative PSA-nadir <1.05 ng/mL (group 2 [intermediate-risk], n = 125) or ≥1.05 ng/mL (group 3 [high-risk], n = 57), respectively. No other patient or tumor characteristics were significant for risk stratification. Within each risk-group, the 10-year metastasis-free survival rates with iADT versus observation ± dADT use were: group 1, 100% versus 95.4% (Log-rank p = 0.738), group 2, 80.6% versus 53.5% (Log-rank p = 0.016), and group 3, 41.5% versus 0% (Log-rank p = 0.015), respectively. Adjusted Cox regression analyses confirmed the benefit of iADT utilization in reducing metastasis in group 2 (p = 0.029) and group 3 (p = 0.008) patients, with no benefit for group 1 patients (p = 0.918). Similar results were noted for cancer-specific and overall mortality., Conclusions: Following radical prostatectomy, early postoperative PSA kinetics may provide valuable information for guiding the timing of ADT initiation-this may reduce over- and undertreatment of pN1 PCa men., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

Objective: To assess the incidence, cumulative healthcare burden, and financial impact of inpatient admissions for radiation cystitis (RC), while exploring practice differences in RC management between teaching and nonteaching hospitals., Methods: We focused on 19,613 patients with a diagnosis of RC within the National Inpatient Sample (NIS) from 2008 to 2014. ICD-9 diagnosis and procedure codes were used. Complex-survey procedures were used to study the descriptive characteristics of RC patients and the procedures received during admission, stratified by hospital teaching status. Inflation-adjusted cost and cumulative annual cost were calculated for the study period. Multivariable logistic regression was used to study the impact of teaching status on the high total cost of admission., Results: Median age was 76 (interquartile range 67-82) years. Most of the patients were males (73%; P < .001). 59,571 (61%) patients received at least one procedure, of which, 24,816 (25.5%) received more than one procedure. Median length of stay was 5days (interquartile range 2-9). Female patients and patients with a higher comorbidity score were more frequently treated at teaching hospitals. A higher proportion of patients received a procedure at a teaching hospital (64% vs 59%; P < .001). The inflation-adjusted cost was 9207 USD and was higher in teaching hospitals. The cumulative cost of inpatient treatment of RC was 63.5 million USD per year and 952.2 million USD over the study period., Conclusion: The incidence of RC-associated admissions is rising in the US. This disease is a major burden to US healthcare. The awareness of the inpatient economic burden and healthcare utilization associated with RC may have funding implications., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: There are not other Declarations of interest If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: An informed decision regarding a treatment option requires data on its long-term efficacy and side-effect profile. While the side-effects of robotic radical prostatectomy have been well-quantified, the data on its long-term efficacy are lacking. We here provide 15-year oncological outcomes of clinically-localized prostate cancer (CLPCa) patients treated with robot-assisted laparoscopic prostatectomy (RALP)., Methods: We treated 1,807 men with CLPCa with RALP between 2001 and 2005 and prospectively collected follow-up data through 2020. We examined the rates of biochemical failure (BCF), metastatic progression, secondary therapy use, PCa-specific mortality (PCSM), and overall survival (OS) using Kaplan-Meier and competing-risk cumulative incidence methods as appropriate., Results: The median follow-up was 14.1 years. Six hundred eight and 312 men had D'Amico intermediate- and high-risk disease, respectively. Overall, the 15-year rates of BCF, metastasis, secondary therapy use, PCSM, and OS were 28.1%, 4.0%, 16.3%, 2.5%, and 82.1%, respectively. The rates of oncologic failure increased with increasing D'Amico (preoperative) and Diaz (postoperative) risk scores - BCF, metastasis, and PCSM rates in D'Amico low-, intermediate-, and high-risk groups at 15-years were 15.2%, 38.3%, and 44.1% [BCF], 1.1%, 4.1%, and 13.0% [metastasis], and 0.5%, 3.4%, and 6.6% [PCSM], respectively, and in Diaz risk groups 1, 2, 3, 4, and 5 were 5.5%, 20.6%, 41.8%, 66.9%, and 89.2% [BCF], 0%, 0.5%, 3.2%, 20.5%, and 60.0% [metastasis], and 0%, 0.8%, 0.6%, 13.5%, and 37.5% [PCSM], respectively. The OS rates in D'Amico low-to-high and Diaz 1-to-5 risk groups at 15-years were 85.9%, 78.6%, and 75.2%, and 89.4%, 83.2%, 80.6%, 67.2%, and 23.4%, respectively., Conclusions: Men diagnosed with clinically-localized prostate cancer in the contemporaneous PSA-screening era and treated with RALP achieve durable long-term oncological control. The data reported here (in a risk-stratified manner) represent the longest follow-up after robotic radical prostatectomy, and as such, should be of value when counseling patients regarding expected oncologic outcomes from RALP., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)

Introduction and Objective: The prognostic significance of a "second" biochemical recurrence (sBCR) after salvage radiation therapy (sRT) with/without hormonal therapy following primary radical prostatectomy in men with prostate cancer has not been examined. We hypothesized that a shorter time to sBCR will be associated with worse cancer control outcomes., Methods: The RTOG 9601 study included 760 patients with tumor stage pT2/T3, pN0, who had either persistently elevated prostate-specific antigen (PSA) postradical prostatectomy or developed subsequent biochemical recurrence with PSA levels between 0.2 and 4.0 ng/ml. All patients received sRT (with or without 2 years of Bicalutamide) from 1998 to 2015. For our study, we focused on 421 patients who had sBCR after sRT-which was defined as a PSA increase of at least 0.3 ng/ml over the first nadir. Patients were divided into two categories: early sBCR (n = 210) and late sBCR (n = 211) using median time to sBCR (3.51 years). All patients who experienced sBCR received salvage hormonal therapy. Competing-risk analysis was used to examine the impact of early versus late sBCR on prostate cancer specific mortality (CSM), after accounting for available covariates., Results: The majority of patients were age 60 years or older (75.8%), had pT3 disease (74.8%), and Gleason score 7 (75.2%). Overall, 13.8% had persistent PSA initially after surgery. At 10 years, starting at the time of sBCR, CSM rate was 31.3% in the early sBCR group versus 20.0% in the late sBCR group. In competing-risk analysis, time to sBCR was an independent predictor of CSM, where patients with early sBCR had 1.7-fold higher CSM risk (p = 0.026) than their counterparts with late sBCR., Conclusions: Time to sBCR after sRT (with or without concomitant Bicalutamide) is a significant predictor of CSM following initial radical prostatectomy. This information can be used to guide subsequent treatments, and to counsel patients., (© 2022 Wiley Periodicals LLC.)

Objective: To identify trends in complications following robot-assisted radical cystectomy (RARC) using a multi-institutional database, the International Robotic Cystectomy Consortium (IRCC)., Methods: A retrospective review of the IRCC database was performed (2976 patients, 26 institutions from 11 countries). Postoperative complications were categorized as overall or high grade (≥ Clavien Dindo III) and were further categorized based on type/organ site. Descriptive statistics was used to summarize the data. Multivariate analysis (MVA) was used to identify variables associated with overall and high-grade complications.  Cochran-Armitage trend test was used to describe the trend of complications over time., Results: 1777 (60%) patients developed postoperative complications following RARC, 51% of complications occurred within 30 days of RARC, 19% between 30-90 days, and 30% after 90 days. 835 patients (28%) experienced high-grade complications. Infectious complications (25%) were the most prevalent, while bleeding (1%) was the least. The incidence of complications was stable between 2002-2021. Gastrointestinal and neurologic postoperative complications increased significantly (P < .01, for both) between 2005 and 2020 while thromboembolic (P = .03) and wound complications (P < .01) decreased. On MVA, BMI (OR 1.03, 95%CI 1.01-1.05, P < .01), prior abdominal surgery (OR 1.26, 95%CI 1.03-1.56, P = .03), receipt of neobladder (OR 1.52, 95%CI 1.17-1.99, P < .01), positive nodal disease (OR 1.33, 95%CI 1.05-1.70, P = .02), length of inpatient stay (OR 1.04, 95%CI 1.02-1.05, P < .01) and ICU admission (OR 1.67, 95%CI 1.36-2.06, P < .01) were associated with high-grade complications., Conclusion: Overall and high-grade complications after RARC remained stable between 2002-2021. GI and neurologic complications increased, while thromboembolic and wound complications decreased., (Published by Elsevier Inc.)

Background: It is unknown whether the addition of anti-androgen therapy (AAT) to late salvage radiation therapy (sRT) can lead to oncological outcomes equivalent to that of early sRT in men with recurrent prostate cancer (CaP) after surgery., Methods: Data on 670 men who participated in the Radiation Therapy Oncology Group (RTOG)-9601 trial and who experienced biochemical recurrence were extracted using the National Clinical Trials Network (NCTN) data archive platform. Patients were stratified into four treatment groups: early sRT (pre-sRT prostate-specific antigen [PSA] < 0.7 ng/mL) and late sRT (pre-sRT PSA ≥ 0.7 ng/mL) with/without concomitant AAT, based on cut-offs reported in the original trial. Time-varying Cox proportional hazards and Fine-Gray competing-risk regression analyses assessed the adjusted hazards of overall mortality, CaP-specific mortality, and metastasis among the four treatment groups., Results: At 15-years (median follow-up of 14.7 years), for patients treated with early sRT, early sRT with AAT, late sRT, and late sRT with AAT, the overall mortality, CaP-specific mortality, and metastasis rates were 22.9, 22.8, 40.1, and 22.9% (log-rank p = 0.0039), 12.1, 3.9, 22.7, and 8.0% (Gray's p = 0.0004), and 18.8, 14.6, 35.9, and 19.5% (Gray's p = 0.0004), respectively. Time-varying multivariable adjusted analysis demonstrated increased hazards of overall mortality in patients receiving delayed sRT versus early sRT (hazards ratio [HR] 1.49, 95% confidence interval [CI] 1.02-2.17); however, no difference remained after the addition of concomitant AAT to late sRT (HR 0.85, 95% CI 0.55-1.32, referent early sRT). Likewise, the hazards of cancer-specific mortality and metastatic progression were worse for late sRT when compared with early sRT, but were no different after the addition of AAT to late sRT., Conclusions: Poorer outcomes associated with late sRT in men with recurrent CaP may be rescued by delivery of concomitant AAT., (© 2022. Society of Surgical Oncology.)

Objectives: To investigate the oncologic outcomes of pT0 after robot-assisted radical cystectomy (RARC)., Methods: A retrospective review of the International Robotic Cystectomy Consortium database was performed. Patients with pT0 after RARC were identified and analyzed. Data were reviewed for demographics and pathologic outcomes. Kaplan-Meier curves were used to depict recurrence-free survival (RFS), disease-specific survival (DSS), and overall survival (OS). Multivariate stepwise Cox regression models were used to identify variables associated with RFS and OS., Results: Four hundred seventy-one patients (18%) with pT0 were identified. Median age was 68 years (interquartile range (IQR) 60-73), with a median follow up of 20 months (IQR 6-47). Thirty-seven percent received neoadjuvant chemotherapy and 5% had pN+ disease. Seven percent of patients experienced disease relapse; 3% had local and 5% had distant recurrence. Most common sites of local and distant recurrences were pelvis (1%) and lungs (2%). Five-year RFS, DSS, and OS were 88%, 93%, and 79%, respectively. Age (hazards ratio [HR] 1.05, 95% confidence interval [CI] 1.01-1.09, P = 0.02), pN+ve (HR 11.48, 95% CI 4.47-29.49, P < .01), and reoperations within 30 days (HR 5.53, 95% CI 2.08-14.64, P < .01) were associated with RFS. Chronic kidney disease (HR 3.24, 95% CI 1.45-7.23, P < .01), neoadjuvant chemotherapy (HR 0.41, 95% CI 0.18-0.92, P = .03), pN+ve (HR 4.37, 95% CI 1.46-13.06, P < .01), and reoperations within 30 days (HR 2.64, 95% CI, 1.08-6.43, P = .03) were associated with OS., Conclusions: Despite pT0 status at RARC, 5% had pN+ disease and 7% of patients relapsed. Node status was the variable strongest associated with RFS and OS in pT0., (Copyright © 2022. Published by Elsevier Inc.)

Purpose: Clinical node-positive urothelial carcinoma of the bladder (cN+UCaB) is a rapidly fatal disease with limited information on comparative-effectiveness of available treatment options. We sought to examine the impact of high-intensity vs. conservative local treatment (LT) regimens in management of these patients alongside systemic chemotherapy., Materials and Methods: We identified 3,227 patients within the National Cancer Data Base who underwent multiagent systemic chemotherapy along with either high-intensity or conservative LT for primary cN+UCaB between 2004-2016. Patients who received no LT, TURBT alone, or <50 Gy radiation therapy to the bladder were included in the conservative group, while patients that received radical cystectomy with pelvic lymphadenectomy or ≥50 Gy radiation therapy with TURBT were included in the high-intensity group. Inverse probability of treatment weighting (IPTW) adjusted Kaplan-Meier and Cox regression analyses were used to assess overall survival (OS). Additionally, to assess whether the benefit of high-intensity LT differs by baseline mortality risk, we tested an interaction between 5-year predicted life-expectancy and the LT type., Results: Overall, 784 (24.3%) and 2,443 (75.7%) cN+UCaB patients underwent high-intensity and conservative LT, respectively. IPTW-adjusted Kaplan-Meier analysis demonstrated OS to be significantly higher in the high-intensity group compared to the conservative group: 5-year OS 28.4% vs. 18.3%, respectively (Log-rank P<0.001). IPTW-adjusted multivariable Cox regression analysis confirmed the benefit of high-intensity LT in prolonging OS (HR 0.63, P<0.001). Interaction analysis showed that high-intensity LT approach was associated with longer OS in all patients regardless of their baseline 5-year life-expectancy (P interaction =0.79)., Conclusion: Eligible patients with cN+UCaB should be considered for aggressive local treatment alongside multiagent systemic chemotherapy. Prospective trials are needed to validate these preliminary findings., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: Ductal adenocarcinoma is considered a rare histological variant of prostate adenocarcinoma (PCa). Given the rarity of this subtype, optimal treatment strategies for men with nonmetastatic ductal PCa is largely unknown. We aimed to describe the impact of surgery, radiotherapy, systemic therapy, and observation on overall survival (OS) in men with nonmetastatic ductal PCa., Materials and Methods: We selected 1,656 cases of nonmetastatic ductal PCa, diagnosed between 2004 and 2015, within the National Cancer Database. Covariates included age, race, Charlson comorbidity score, clinical T stage, clinical lymph node stage, serum prostate specific antigen (PSA), income, hospital type, insurance status, year of diagnosis, and location of residence. Cox regression analysis tested the impact of treatment (surgery, radiotherapy, systemic therapy, and observation) on OS., Results: In men with nonmetastatic ductal PCa, median (interquartile range [IQR]) age and PSA were 67 (60-73) years and 6.2 (4.2-10.7) ng/ml, respectively. Advanced local stage (≥cT3a) was most frequently observed in patients initially treated with systemic therapy (34.8%), followed by those treated with radiotherapy (18.1%), surgery (7.1%) and observation (6.4%, P< 0.001). Serum PSA at presentation was highest in the systemic therapy cohort (median 16.0 ng/ml, IQR: 4.9-37.7), followed by the radiotherapy cohort (median 7.2 ng/ml, IQR: 4.1-12.2), observation cohort (median 7.0 ng/ml, IQR: 4.3-13.3) and surgery cohort (median 5.9 ng/ml, IQR: 4.3-9.2, P< 0.001). Multivariable analysis showed that in comparison to men treated surgically, OS was significantly lower for patients receiving radiotherapy (HR 2.2; 95% CI: 1.5-3.2), under observation (HR 4.6; 95% CI: 2.8-7.6) and receiving systemic therapy (HR 5.2; 95% CI: 3.0-9.1) as an initial course of treatment., Conclusions: While limited by its retrospective nature, our study shows that starting treatment with surgery is associated with more favorable long-term OS outcomes than radiotherapy, systemic therapy or observation., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Prostate cancer is frequently multifocal. Although there may be morphological variation, the genetic underpinnings of each tumor are not clearly understood. To assess the inter and intra tumor molecular heterogeneity in prostate biopsy samples, we developed a combined immunohistochemistry and RNA in situ hybridization method for the simultaneous evaluation of ERG, SPINK1, ETV1, and ETV4. Screening of 601 biopsy cores from 120 consecutive patients revealed multiple alterations in a mutually exclusive manner in 37% of patients, suggesting multifocal tumors with considerable genetic differences. Furthermore, the incidence of molecular heterogeneity was higher in African Americans patients compared with Caucasian American patients. About 47% of the biopsy cores with discontinuous tumor foci showed clonal differences with distinct molecular aberrations. ERG positivity occurred in low-grade cancer, whereas ETV4 expression was observed mostly in high-grade cancer. Further studies revealed correlation between the incidence of molecular markers and clinical and pathologic findings, suggesting potential implications for diagnostic pathology practice, such as defining dominant tumor nodules and discriminating juxtaposed but molecularly different tumors of different grade patterns.

Objective: To compare the perioperative outcomes of intracorporeal (ICUD) vs extracorporeal urinary diversion (ECUD) after robot-assisted radical cystectomy (RARC)., Patients and Methods: We retrospectively reviewed the prospectively maintained International Robotic Cystectomy Consortium (IRCC) database. A total of 972 patients from 28 institutions who underwent RARC were included. Propensity score matching was used to match patients based on age, gender, body mass index (BMI), American Society of Anesthesiologists Score (ASA) score, Charlson Comorbidity Index (CCI) score, prior radiation and abdominal surgery, receipt of neoadjuvant chemotherapy, and clinical staging. Matched cohorts were compared. Multivariate stepwise logistic and linear regression models were fit to evaluate variables associated with receiving ICUD, operating time, 90-day high-grade complications (Clavien-Dindo Classification Grade ≥III), and 90-day readmissions after RARC., Results: Utilisation of ICUD increased from 0% in 2005 to 95% in 2018. The ICUD patients had more overall complications (66% vs 58%, P = 0.01) and readmissions (27% vs 17%, P = 0.01), but not high-grade complications (21% vs 24%, P = 0.22). A more recent RC era and ileal conduit diversion were associated with receiving an ICUD. Higher BMI, ASA score ≥3, and receiving a neobladder were associated with longer operating times. Shorter operating time was associated with male gender, older age, ICUD, and centres with a larger annual average RC volume. Longer intensive care unit stay was associated with 90-day high-grade complications. Higher CCI score, prior radiation therapy, neoadjuvant chemotherapy, and ICUD were associated with a higher risk of 90-day readmissions., Conclusions: Utilisation of ICUD has increased over the past decade. ICUD was associated with more overall complications and readmissions compared to ECUD, but not high-grade complications., (© 2020 The Authors BJU International © 2020 BJU International Published by John Wiley & Sons Ltd.)

Purpose: The American Joint Committee on Cancer recognizes 6 rare histological variants of prostate adenocarcinoma. We describe the contemporary presentation and overall survival of these rare variants., Materials and Methods: We examined 1,345,618 patients who were diagnosed with prostate adenocarcinoma between 2004 and 2015 within the National Cancer Database. We focused on the variants mucinous, ductal, signet ring cell, adenosquamous, sarcomatoid and neuroendocrine. Characteristics at presentation for each variant were compared with nonvariant prostate adenocarcinoma. Cox regression was used to study the impact of histological variant on overall mortality., Results: Few (0.38%) patients presented with rare variant prostate adenocarcinoma. All variants had higher clinical tumor stage at presentation than nonvariant (all p <0.001). Metastatic disease was most common with neuroendocrine (62.9%), followed by sarcomatoid (33.3%), adenosquamous (31.1%), signet ring cell (10.3%) and ductal (9.8%), compared to 4.2% in nonvariant (all p <0.001). Metastatic disease in mucinous (3.3%) was similar to nonvariant (p=0.2). Estimated 10-year overall survival was highest in mucinous (78.0%), followed by nonvariant (71.1%), signet ring cell (56.8%), ductal (56.3%), adenosquamous (20.5%), sarcomatoid (14.6%) and neuroendocrine (9.1%). At multivariable analysis, mortality was higher in ductal (HR 1.38, p <0.001), signet ring cell (HR 1.53, p <0.01), neuroendocrine (HR 5.72, p <0.001), sarcomatoid (HR 5.81, p <0.001) and adenosquamous (HR 9.34, p <0.001) as compared to nonvariant., Conclusions: Neuroendocrine, adenosquamous, sarcomatoid, signet ring cell and ductal variants more commonly present with metastases. All variants present with higher local stage than nonvariant. Neuroendocrine is associated with the worst and mucinous with the best overall survival.

Purpose: Video assessment is an emerging tool for understanding surgical technique. Patient outcomes after robot-assisted radical prostatectomy (RARP) may be linked to technical aspects of the procedure. In an effort to refine surgical approaches and improve outcomes, we sought to understand technical variation for the key steps of RARP in a surgical collaborative., Methods: The Michigan Urological Surgery Improvement Collaborative (MUSIC) is a statewide quality improvement collaborative with the aim of improving prostate cancer care. MUSIC surgeons were invited to submit representative complete videos of nerve-sparing RARP for blinded analysis. We also analyzed peri-operative outcomes from these surgeons in the registry., Results: Surgical video data from 20 unique surgeons identified many variations in technique and time to complete different steps. Common to all surgeons was a transperitoneal approach and a running urethrovesical anastomosis. Prior to anastomosis, 25% surgeons undertook a posterior reconstruction and 30% employed urethral suspension. 65% surgeons approached the seminal vesicle anteriorly. For control of the dorsal vein complex, suture ligation was used in 60%, and vascular stapler was 15%. The majority (80%) of surgeons employed clips for managing pedicles. In examining patient outcomes for surgeons, peri-operative outcomes were not correlated with surgeon's operative time; however, surgeons with an EBL > 400 ml had significant difference among the five different techniques employed., Conclusions: Despite the worldwide popularity of RARP, the operation is still far from standardized. Correlating variation in technique with clinical outcomes may help provide objective data to support best practices with the goal to improve patient outcomes.

Background and Objective: To determine the effect of multiplicity of prostate imaging reporting and data system assessment category 3 (PI-RADS 3) lesions on cancer detection rate (CDR) of confirmatory targeted biopsy of such lesion in patients diagnosed with prostate cancer and managed with active surveillance., Methods: This study was conducted at a single academic institution. There were 91 men with ≥ 1 PI-RADS 3 lesion detected through magnetic resonance imaging (MRI) after systematic prostate biopsy in the course of management of patients diagnosed with prostate cancer with active surveillance. We compared the CDRs based on targeted biopsy of PI-RADS 3 lesions that occurred (1) as solitary lesions, (2) as 1 of multiple PI-RADS 3 only lesions, or (3) with ≥ 1 higher grade lesion., Results: Median age was 65.0 years (interquartile range 59.5-70.0), median prostate specific antigen was 5.95 ng/ml (interquartile range 4.30-8.83), and median prostate specific antigen density was 0.161 ng/ml 2 (0.071-0.194). Forty-three men had solitary PI-RADS 3 lesions, 22 had multiple PI-RADS 3 only lesions, and 26 had multiple lesions with ≥ 1 higher grade lesion. The overall CDR (Gleason score ≥ 3 + 3) based on confirmatory MRI targeted biopsy in a given PI-RADS 3 lesion in each group was 23%, 45%, and 54%, respectively (P = 0.0274). The CDRs for clinically significant disease (Gleason score ≥ 3 + 4) were 16%, 32%, and 35%, respectively (P = 0.1701)., Conclusions: Coexisting lesions increase the CDR of confirmatory MRI targeted biopsy of PI-RADS 3 lesions in patients managed with active surveillance. Risk stratification algorithms for PI-RADS 3 lesion to guide biopsy and management decisions may consider including multiplicity of lesions., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: To compare local/metastatic disease progression and overall mortality rates in men with node-negative prostate cancer at radical prostatectomy (RP) that experience biochemical recurrence vs. persistence postoperatively and undergo salvage radiation therapy (sRT)., Materials and Methods: Data on 760 men who participated in the RTOG 9601 trial were extracted using the NCTN data archive platform. Patients were stratified into biochemical recurrence (nadir-PSA ≤0.4 ng/ml) or persistence (nadir-PSA >0.4 ng/ml) groups, based on the cut-off reported in the original trial. Inverse probability of treatment weighting (IPTW) methodology was utilized to minimize the baseline differences among groups. Competing-risk and Kaplan-Meier analyses estimated the impact of prostate-specific antigen (PSA) persistence vs. recurrence on local and metastatic disease progression and overall-mortality in the IPTW-adjusted model; a 2-sided P < 0.05 was considered significant., Results: All patients received sRT, and about 50% of the patients in either group received concomitant antiandrogen therapy (P = 0.951). The median follow-up was 12 years. After IPTW, the 2 groups were well-matched with standardized mean differences ∼10%. In the IPTW-adjusted cohort, the 10-year local and metastatic disease occurrence rates were 3.2% vs. 1.4% (Gray's P = 0.0001) and 28.6% vs. 10.1% (Gray's P < 0.0001) in patients with persistent vs. recurrent PSA, respectively. Similarly, the 10-year overall-mortality rates were 24.9% vs. 11.9% (Log-rank P = 0.029), respectively., Conclusions: Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use. These data may facilitate patient counseling and shared treatment selection., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Currently, surveillance guidelines following surgical resection of clinically localized renal cell carcinoma (RCC) are clear within the first 5 yr; however, these lack the same degree of objectivity following this cutoff. We sought to investigate the long-term risk of recurrence in surgically treated RCC in order to determine the utility of long-term surveillance. A post hoc analysis of patients within the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) E2805 trial cohort was performed. The 36-mo cumulative incidence of recurrence was assessed at set intervals following surgery, in order to dynamically assess recurrence through the use of a conditional survival model. Of the 1943 patients included in the original cohort, 730 developed recurrence. The 36-mo cumulative incidences of recurrence were found to be 31%, 26%, 19%, 16%, 19%, and 20% for patients at 0, 12, 24, 36, 48, and 60 mo from surgery, respectively. At 0 mo from surgery, age, pathological T3/4 stage (hazard ratio [HR] = 1.56), pathological N1/2 stage (HR = 2.38), and Fuhrman grades 3 and 4 (HR = 1.36 and HR = 2.41, respectively) were independent predictors of recurrence; however, this was not seen at 60 mo following surgery. These findings support that surveillance imaging should be performed beyond 5 yr following surgical resection of intermediate- to high-risk RCC. PATIENT SUMMARY: : Follow-up for surgically resected localized renal cell carcinoma should be performed beyond 5 yr, for the rates of recurrence remain significant beyond this 5 yr endpoint., (Copyright © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Expression profiles of erythroblast transformation-specific (ETS)-related gene fusions and serine protease inhibitor Kazal-type 1 (SPINK1) in early onset prostate cancer have not been thoroughly explored., Methods: We retrieved 151 radical prostatectomy specimens from young men with prostate cancer (<55 years) and characterized the expression of ETS-related gene (ERG), SPINK1, ETS Variant 1 (ETV1), and ETV4 by dual immunohistochemistry and dual RNA in situ hybridization. Age, race, family history, preoperative prostate-specific antigen, biochemical recurrence, and pathological variables using whole-mount radical prostatectomy tissue were collected., Results: A total of 313 tumor nodules from 151 men including 68 (45%) Caucasians and 61 (40%) African Americans were included in the analysis. Positive family history of prostate cancer was seen in 65 (43%) patients. Preoperative prostate-specific antigen ranged from 0.3 to 52.7 ng/mL (mean = 7.04). The follow-up period ranged from 1 to 123.7 months (mean = 30.3). Biochemical recurrence was encountered in 8 of 151 (5%). ERG overexpression was observed in 85 of 151 (56%) cases, followed by SPINK1 in 61 of 151 (40%), ETV1 in 9 of 149 (6%), and ETV4 in 4 of 141 (3%). There were 25 of 151 (17%) cases showing both ERG and SPINK1 overexpression within different regions of either the same tumor focus or different foci. Higher frequency of ERG overexpression was seen in younger patients (≤45 years old; 76% vs 49%, P = .002), Caucasian men (71% vs 41% P = .0007), organ-confined tumors (64% vs 33%, P = .0008), and tumors of Gleason Grade groups 1 and 2 (62% vs 26%, P = .009). SPINK1 overexpression was more in African American men (68% vs 26%, P = .00008), in tumors with high tumor volume (>20%) and with anterior located tumors. ETV1 and ETV4 demonstrated rare overexpression in these tumors, particularly in the higher-grade tumors., Conclusion: This study expands the knowledge of the clonal evolution of multifocal cancer in young patients and support differences in relation to racial background and genetics of prostate cancer., (© 2019 Wiley Periodicals, Inc.)

We present the functional characterization of a pseudogene associated recurrent gene fusion in prostate cancer. The fusion gene KLK4-KLKP1 is formed by the fusion of the protein coding gene KLK4 with the noncoding pseudogene KLKP1. Screening of a cohort of 659 patients (380 Caucasian American; 250 African American, and 29 patients from other races) revealed that the KLK4-KLKP1 is expressed in about 32% of prostate cancer patients. Correlative analysis with other ETS gene fusions and SPINK1 revealed a concomitant expression pattern of KLK4-KLKP1 with ERG and a mutually exclusive expression pattern with SPINK1, ETV1, ETV4, and ETV5. Development of an antibody specific to KLK4-KLKP1 fusion protein confirmed the expression of the full-length KLK4-KLKP1 protein in prostate tissues. The in vitro and in vivo functional assays to study the oncogenic properties of KLK4-KLKP1 confirmed its role in cell proliferation, cell invasion, intravasation, and tumor formation. Presence of strong ERG and AR binding sites located at the fusion junction in KLK4-KLKP1 suggests that the fusion gene is regulated by ERG and AR. Correlative analysis of clinical data showed an association of KLK4-KLKP1 with lower preoperative PSA values and in young men (<50 years) with prostate cancer. Screening of patient urine samples showed that KLK4-KLKP1 can be detected noninvasively in urine. Taken together, we present KLK4-KLKP1 as a class of pseudogene associated fusion transcript in cancer with potential applications as a biomarker for routine screening of prostate cancer., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: Magnetic resonance imaging is playing an ever-bigger role in the management of prostate cancer. This study investigated barriers to obtaining multi-parametric MRI (mpMRI) in African-American men on active surveillance for prostate cancer in comparison to white men affected by the same type of cancer., Materials and Methods: Retrospective review of prostate mpMRI orders from August 2015 to October 2017 at a single health organization treating a diverse population was performed. Data was extracted from the electronic medical records and cancellations were examined based on the documented reason for mpMRI cancellation, race, median zip code household income, and distance from healthcare facility., Results: Out of 793 prostate mpMRI orders, 201 (25%) went unscanned. Access to care issues accounted for 46% of unscanned orders. Patient cancellations were the most common, followed by difficulty contacting patients, and insurance denials. African-American patients disproportionately went unscanned because institution staff were unable to contact patients (29% vs 10% in white men, P = 0.0015). Median zip code household income was significantly different between racial groups but did not vary between indication for cancellation., Conclusions: African-American prostate cancer patients' access to mpMRI is hindered more by barriers to care than White patients. Urology providers must consider these issues before using prostate mpMRI within their active surveillance pathways., (© 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Interest is growing within the urological surgery community for objective assessments of technical skill. Surgical video review relies on the use of objective assessment tools to evaluate both global and procedure-specific skill. These evaluations provide structured feedback to surgeons with the aim of improving technique, which has been associated with patient outcomes. Currently, skill assessments can be performed by using expert peer-review, crowdsourcing or computer-based methods. Given the relationship between skill and patient outcomes, surgeons might be required in the future to provide empirical evidence of their technical skill for certification, employment, credentialing and quality improvement. Interventions such as coaching and skills workshops incorporating video review might help surgeons improve their skill, with the ultimate goal of improving patient outcomes.

Background: We aimed to develop a structured scoring tool: cystectomy assessment and surgical evaluation (CASE) that objectively measures and quantifies performance during robot-assisted radical cystectomy (RARC) for men., Methods: A multinational 10-surgeon expert panel collaborated towards development and validation of CASE. The critical steps of RARC in men were deconstructed into nine key domains, each assessed by five anchors. Content validation was done utilizing the Delphi methodology. Each anchor was assessed in terms of context, score concordance, and clarity. The content validity index (CVI) was calculated for each aspect. A CVI ≥ 0.75 represented consensus, and this statement was removed from the next round. This process was repeated until consensus was achieved for all statements. CASE was used to assess de-identified videos of RARC to determine reliability and construct validity. Linearly weighted percent agreement was used to assess inter-rater reliability (IRR). A logit model for odds ratio (OR) was used to assess construct validation., Results: The expert panel reached consensus on CASE after four rounds. The final eight domains of the CASE included: pelvic lymph node dissection, development of the peri-ureteral space, lateral pelvic space, anterior rectal space, control of the vascular pedicle, anterior vesical space, control of the dorsal venous complex, and apical dissection. IRR > 0.6 was achieved for all eight domains. Experts outperformed trainees across all domains., Conclusion: We developed and validated a reliable structured, procedure-specific tool for objective evaluation of surgical performance during RARC. CASE may help differentiate novice from expert performances.

Purpose: This study aimed to provide an update and compare perioperative outcomes and complications of intracorporeal and extracorporeal urinary diversion following robot-assisted radical cystectomy using data from the multi-institutional, prospectively maintained International Robotic Cystectomy Consortium database., Materials and Methods: We retrospectively reviewed the records of 2,125 patients from a total of 26 institutions. Intracorporeal urinary diversion was compared with extracorporeal urinary diversion. Multivariate logistic regression models using stepwise variable selection were fit to evaluate preoperative, operative and postoperative predictors of intracorporeal urinary diversion, operative time, high grade complications and 90-day hospital readmissions after robot-assisted radical cystectomy., Results: In our cohort 1,094 patients (51%) underwent intracorporeal urinary diversion. These patients demonstrated shorter operative time (357 vs 400 minutes), less blood loss (300 vs 350 ml) and fewer blood transfusions (4% vs 19%, all p <0.001). They experienced more high grade complications (13% vs 10%, p = 0.02). Intracorporeal urinary diversion use increased from 9% of all urinary diversions in 2005 to 97% in 2015. Complications after this procedure decreased significantly with time (p <0.001). On multivariable analysis higher annual cystectomy volume (OR 1.02, 95% CI 1.01-1.03, p <0.002), year of robot-assisted radical cystectomy (2013-2016 OR 68, 95% CI 44-105, p <0.001) and American Society of Anesthesiologists® score less than 3 (OR 1.75, 95% CI 1.38-2.22, p <0.001) were associated with undergoing intracorporeal urinary diversion. The procedure was associated with a shorter operative time of 27 minutes (p = 0.001)., Conclusions: The use of intracorporeal urinary diversion has increased in the last decade. A higher annual institutional volume of robot-assisted radical cystectomy was associated with intracorporeal urinary diversion as well as with shorter operative time. Although intracorporeal urinary diversion was associated with higher grade complications than extracorporeal urinary diversion, they decreased with time., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the utilization of pelvic lymph node dissection (PLND) and its extent in contemporary US patients, and to correlate it to the detection of pN1 disease., Patients and Methods: A total of 328,710 individuals who received radical prostatectomy between the years 2004 and 2013 were identified within the National Cancer Data Base. The Cochran-Armitage test was used to assess the statistical significance of temporal trends. Logistic regression analysis tested the relationship between the number of lymph nodes removed (LNR) and pN1 rate., Results: Most patients had T2 disease (76.7%) and a Gleason score of 7 (55.9%). Overall, 63.5% of the patients received PLND; this ranged between 58.9% and 72.1% over the study period (P = .8). In patients receiving PLND, mean LNR increased from 6.1 nodes in 2004 to 7.2 nodes in 2013 (P < .001). When stratified by tumor risk, utilization and extent of PLND increased in intermediate- and high-risk tumors, while it decreased in low-risk tumors. Overall pN1 rate was 3.73%, and it increased from 2.9% to 5.3% between 2004 and 2013 (P < .001). In multivariable analysis, LNR was an independent predictor of pN1 (P < .001)., Conclusion: The utilization patterns of PLND in the United States have improved, with an increased focus on patients with intermediate- and high-risk disease. Likewise, the extent of PLND has improved to include more lymph nodes. This seems to translate into more accurate tumor, node, metastasis classification system staging, as more patients are being appropriately diagnosed with pN1 disease., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Contemporary treatment trends for prostate cancer show increased rates of active surveillance. However, nationwide applicability of these reports is limited. Additionally, the effect of Commission on Cancer facility type on prostate cancer treatment patterns is unknown., Patients and Methods: We used the National Cancer Data Base to identify men diagnosed with prostate cancer, between 2004 and 2013. Our cohort was stratified on the basis of the National Comprehensive Cancer Network prostate cancer risk classes. Cochran-Armitage tests were used to evaluate temporal trends. Random effects hierarchical logit models were used to assess treatment variation at Commission on Cancer facility and institution level., Results: In 825,707 men, utilization of radiation therapy declined and utilization of radical prostatectomy increased for all prostate cancer risk groups between 2004 and 2013 (P < .0001). Observation for low-risk prostate cancer increased from 16.3% in 2004 to 2005 to 32.0% in 2012 to 2013 (P < .0001). Significant treatment variation was observed on the basis of Commission on Cancer facility type. Across all risk groups, the lowest rates of radical prostatectomy and highest rates of external beam radiation therapy were observed in community cancer programs. The highest rates of observation for low-risk disease were observed in academic centers. Treatment variation according to institution ranged from 14% (95% confidence interval, 0.12-0.15) for androgen deprivation therapy up to 59% (95% confidence interval, 0.45-0.73) for cryotherapy., Conclusion: The increased utilization of observation in low-risk prostate cancer is an encouraging finding, which appears to be mainly derived by a decrease in radiotherapy utilization in this risk group. Regardless of tumor characteristics, significant variations in treatment modality exist among different facility types and institutions., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: To ascertain 3-year urinary continence (UC) and sexual function (SF) recovery following robot-assisted radical prostatectomy (RARP) for clinically high-risk prostate cancer (PCa)., Methods: Retrospective analyses of a prospectively maintained database for 769 patients with D'Amico high-risk PCa undergoing RARP at two tertiary care centers in the United States and Europe between 2001 and 2014. The association between time since RARP and recovery of UC (defined as 0 pad/one safety liner per day) and SF (defined as sexual health inventory for men (SHIM) score ⩾17) was tested in separate preoperative and post-operative Cox-proportional hazards regression models. Sensitivity analyses were conducted using continence 0 pad per day and erection sufficient for intercourse as end points for UC and SF recovery, respectively., Results: Mean age of the cohort was 62.3 years, and 62.1% harbored ⩾PT3a disease. Nerve sparing (unilateral or bilateral) RARP was performed in 87.7% of patients. Kaplan-Meier estimates of UC recovery at 12, 24 and 36 months after surgery was 85.2%, 89.1% and 91.2%, respectively, while 33.8, 52.3 and 69.0% of preoperatively potent men (preoperative SHIM ⩾17; n=548; 71.3%) recovered SF. Similar results were noted in sensitivity analyses. Patient age and year of surgery were associated with UC and SF recovery; additionally, preoperative SHIM score, degree of nerve sparing, pT3b-T4 disease and surgical margins were associated with SF recovery over the period of observation., Conclusions: Patients with D'Amico high-risk PCa treated with RARP may continue to recover UC and SF beyond 12 months of surgery and show promising outcomes at 3-year follow-up. Appropriate patient selection and counseling may aid in setting realistic expectations for functional recovery post RARP.

Objectives: To design a methodology to predict operative times for robot-assisted radical cystectomy (RARC) based on variation in institutional, patient, and disease characteristics to help in operating room scheduling and quality control., Patients and Methods: The model included preoperative variables and therefore can be used for prediction of surgical times: institutional volume, age, gender, body mass index, American Society of Anesthesiologists score, history of prior surgery and radiation, clinical stage, neoadjuvant chemotherapy, type, technique of diversion, and the extent of lymph node dissection. A conditional inference tree method was used to fit a binary decision tree predicting operative time. Permutation tests were performed to determine the variables having the strongest association with surgical time. The data were split at the value of this variable resulting in the largest difference in means for the surgical time across the split. This process was repeated recursively on the resultant data sets until the permutation tests showed no significant association with operative time., Results: In all, 2 134 procedures were included. The variable most strongly associated with surgical time was type of diversion, with ileal conduits being 70 min shorter (P < 0.001). Amongst patients who received neobladders, the type of lymph node dissection was also strongly associated with surgical time. Amongst ileal conduit patients, institutional surgeon volume (>66 RARCs) was important, with those with a higher volume being 55 min shorter (P < 0.001). The regression tree output was in the form of box plots that show the median and ranges of surgical times according to the patient, disease, and institutional characteristics., Conclusion: We developed a method to estimate operative times for RARC based on patient, disease, and institutional metrics that can help operating room scheduling for RARC., (© 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.)

Objective: To report on the establishment of a unified, electronic patient-reported outcome (PRO) infrastructure and pilot results from the first 5 practices enrolled in the web-based collection system developed by the Michigan Urological Surgery Improvement Collaborative., Materials and Methods: Eligible patients were those undergoing radical prostatectomy of 5 academic and community practices. PRO was obtained using a validated 21-item web-based questionnaire, regarding urinary function, erection function, and sexual interest and satisfaction. Data were collected preoperatively, at 3 months, and 6 months postoperatively. Patients were provided a link via email to complete the surveys. Perioperative and PRO data were analyzed as reports for individual patients and summary performance reports for individual surgeons., Results: Among 773 eligible patients, 688 (89%) were enrolled preoperatively. Survey completion rate was 88%, 84%, and 90% preoperatively, at 3 months, and 6 months. Electronic completion rates preoperatively, at 3 months, and 6 months were 70%, 70%, and 68%, respectively. Mean urinary function scores were 18.3, 14.3, and 16.6 (good function ≥ 17), whereas mean erection scores were 18.7, 7.3, and 9.1 (good erection score ≥ 22) before surgery, at 3 months, and 6 months. Variation was noted for erectile function among the practices., Conclusion: Collection of electronic PRO via this unified, web-based format was successful and provided results that reflect expected recovery and identify opportunities for improvement. This will be extended to more practices statewide to improve outcomes after radical prostatectomy., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: To describe a detailed step-by-step approach of our technique for robot-assisted intracorporeal 'W'-configuration orthotopic ileal neobladder., Patients and Methods: Five patients underwent robot-assisted radical cystectomy (RARC), extended pelvic lymph node dissection and intracorporeal neobladder (ICNB). ICNB was divided into six key steps to facilitate and enable a detailed analysis and auditing of the technique. No conversion to open surgery was required. Timing for each step was noted. All patients had at least 3 months of follow-up., Results: The mean age was 57 years. The mean overall console and diversion times were 357 and 193 min, respectively. None of the patients had any evidence of residual disease after RARC. Four of the five patients had complications; three developed fevers due to urinary tract infections (one required readmission), and one developed myocardial infarction and required coronary angiography and stenting. Looking at the timing for the individual steps, bowel detubularisation and construction of the posterior plate were consistently the longest among the key steps (average 46 min, 13% of the overall operative time), followed by uretero-ileal anastomosis (37 min, 10%), neobladder-urethral anastomosis (23 min, 6%), and identification and fixation of the bowel (26 min, 7%)., Conclusion: We described our step-by-step technique and initial perioperative outcomes of our first five ICNBs with 'W' configuration., (© 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.)

Background: The role of local treatment (LT) in patients with metastatic prostate cancer (mPCa) at diagnosis is controversial., Objective: We set to evaluate the potential impact of LT on overall mortality (OM) in men with mPCa, and how this impact is influenced by tumor and patient characteristics., Design, Settings, and Participants: A total of 15 501 patients with mPCa were identified in the National Cancer Data Base (2004-2012) and categorized in LT (radical prostatectomy or radiation therapy targeted to prostate) versus nonlocal treatment (NLT; all other patients)., Outcome Measurements and Statistical Analysis: The two arms (LT vs NLT) were matched using propensity scores to minimize selection bias. To evaluate LT impact on OM in relation to baseline characteristics, first multivariable Cox regression analysis was used to predict OM in patients treated with NLT, then interaction between predicted OM risk and LT status was tested., Results and Limitations: Overall, 9.5% (n=1470) of patients received LT. In the postpropensity matched cohorts, 3-yr OM-free survival was higher in the LT group versus the NLT group (69% vs 54%; p<0.001). In multivariable Cox regression, the NLT group, age, and Charlson comorbidity index were predictors of OM (all p≤0.03). This model was used to predict the 3-yr OM risk. The interaction between predicted OM and LT status was significant (p<0.001). The benefit of LT on OM decreased progressively as predicted OM risk increased. Specifically, the 3-yr absolute improvement in OM-free survival was 15.7%, for patients with predicted OM risk ≤20% versus 0% for those with predicted OM risk ≥72%., Conclusions: Men with mPCa at diagnosis benefit from LT in terms of OM. This is largely affected by baseline characteristics. Specifically, patients with a relatively low tumor risk and good general health status appear to benefit the most., Patient Summary: We used a large hospital-based database to evaluate which patients might benefit from local therapy when metastasized prostate cancer was present at diagnosis. Local therapy is associated with a survival benefit in men with less aggressive tumors and good general health., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: We sought to investigate the prevalence and variables associated with early oncologic failure., Materials and Methods: We retrospectively reviewed the IRCC (International Radical Cystectomy Consortium) database of patients who underwent robot-assisted radical cystectomy since 2003. The final cohort comprised a total of 1,894 patients from 23 institutions in 11 countries. Early oncologic failure was defined as any disease relapse within 3 months of robot-assisted radical cystectomy. All institutions were surveyed for the pneumoperitoneum pressure used, breach of oncologic surgical principles, and techniques of specimen and lymph node removal. A multivariate model was fit to evaluate predictors of early oncologic failure. The Kaplan-Meier method was applied to depict disease specific and overall survival, and Cox proportional regression analysis was used to evaluate predictors of disease specific and overall survival., Results: A total of 305 patients (22%) experienced disease relapse, which was distant in 220 (16%), local recurrence in 154 (11%), peritoneal carcinomatosis in 17 (1%) and port site recurrence in 5 (0.4%). Early oncologic failure developed in 71 patients (5%) at a total of 10 institutions. The incidence of early oncologic failure decreased from 10% in 2006 to 6% in 2015. On multivariate analysis the presence of any complication (OR 2.87, 95% CI 1.38-5.96, p = 0.004), pT3 or greater disease (OR 3.73, 95% CI 2.00-6.97, p <0.001) and nodal involvement (OR 2.14, 95% CI 1.21-3.80, p = 0.008) was a significant predictor of early oncologic failure. Patients with early oncologic failure demonstrated worse disease specific and overall survival (23% and 13%, respectively) at 1 and 3 years compared to patients who experienced later or no recurrences (log rank p <0.001)., Conclusions: The incidence of early oncologic failure following robot-assisted radical cystectomy has decreased with time. Disease related rather than technical related factors have a major role in early oncologic failure after robot-assisted radical cystectomy., (Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To examine time-to-event data for 19 common postoperative complications within 30 days following radical cystectomy (RC)., Methods: Patients undergoing RC were identified within the American College of Surgeons National Surgical Quality Improvement Program database (2005-2011). The primary end point was time-to-complication; secondary end points included length of stay (LOS), reintervention, readmission, and 30-day mortality. Further, the complications were stratified into pre- and postdischarge, and the predictors were identified. Lastly, the effect of time-to-complication on secondary outcomes was evaluated., Results: Overall, 1118 patients underwent RC. The overall complication rate was 52.1%; the median LOS was 8 days. The vast majority of complications (85.2%) were contained within the first 2 weeks of surgery with a median time-to-complication of 8.5 days; 31.4% of the complications occurred post discharge. In adjusted analyses, increasing age (odds ratio [OR] = 1.02, P < .001), black race (OR = 1.67, P = .001), and creatinine ≥1.2 mg/dL (OR = 1.26, P = .002) were significant predictors of predischarge complications, whereas diabetes (OR = 1.40, P < .001), cardiopulmonary disease (OR = 1.27, P = .005), neoadjuvant therapy (OR = 1.35, P = .007), and continent diversions (OR = 1.30, P = .004) were significant predictors of postdischarge complications. A body mass index of ≥30 was associated with increased odds of pre- as well as postdischarge complications (P < .01). For a given complication, timing did not affect the mortality odds (P = .310), but the risk of reintervention, readmission, and prolonged LOS varied., Conclusion: One in 2 patients suffers a complication within 30 days of undergoing RC. A vast majority of complications occur early on postoperatively, either pre- or post discharge, highlighting the need for rigorous inpatient as well as outpatient surveillance during this period-knowledge regarding the time-to-complications, the effect of time-to-complications, and risk factors may facilitate improved patient-physician communication and allow patient-tailored follow-up., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Cancer patients are at increased risk for postoperative sepsis. However, studies addressing the issue are lacking. We sought to identify preoperative and intraoperative predictors of 30-d sepsis after major cancer surgery (MCS) and derive a postoperative sepsis risk stratification tool., Methods: Patients undergoing one of nine MCSs (gastrointestinal, urological, gynecologic, or pulmonary) were identified within the American College of Surgeons National Surgical Quality Improvement Program (2005-2011, n = 69,169). Multivariable adjusted analyses (MVA) were performed to identify the predictors of postoperative sepsis. A composite sepsis risk score (CSRS) was constructed using the regression coefficients of predictors significant on MVA. The score was stratified into low, intermediate, and high risk, and its predictive accuracy for sepsis, septic shock, and mortality was assessed using the area under the curve analysis., Results: Overall, 4.3% (n = 2954) of patients developed postoperative sepsis. In MVA, Black race (odds ratio [OR] = 1.30, P = 0.002), preoperative hematocrit <30 (OR = 1.40, P = 0.022), cardiopulmonary and cerebrovascular comorbidities (P < 0.010), American Society of Anesthesiologists score >3 (P < 0.05), operative time (OR = 1.002, P < 0.001), surgical approach (OR = 1.81, P < 0.001), and procedure type (P < 0.001) were significant predictors of postoperative sepsis. CSRS demonstrated favorable accuracy in predicting postoperative sepsis, septic shock, and mortality (area under the curve 0.72, 0.75, and 0.74, respectively). Furthermore, CSRS risk stratification demonstrated high concordance with sepsis rates, 1.3% in low-risk patients versus 9.7% in high-risk patients. Similarly, 30-d mortality rate varied from 0.5% to 5.5% (10-fold difference) in low-risk patients versus high-risk patients., Conclusions: Our study identifies the major risk factors for 30-d sepsis after MCS. These risk factors have been converted into a simple, accurate bedside sepsis risk score. This tool might facilitate improved patient-physician interaction regarding the risk of postoperative sepsis and septic shock., (Copyright © 2016 Elsevier Inc. All rights reserved.)

This study evaluates whether a new staff surgeon early in the learning curve can be integrated into a high-volume robotic practice with an established robotic team and mentorship without compromising robot-assisted radical prostatectomy (RARP) outcomes of the practice. We analyzed outcomes of 3064 patients who underwent RARP from 2007 to 2012 at a high-volume tertiary center by a robotic practice comprising three experienced robotic surgeons (2846 patients) and a newly hired surgeon (218 patients) immediately out of training (residency and oncology fellowship with 2 years of RARP exposure). The new surgeon performed RARP with intraoperative mentorship by the senior surgeons during the first year. Complications, biochemical recurrence (BCR), positive surgical margins rate (PSM), operating time (OR time), estimated blood loss (EBL) for the new and senior surgeons were compared. Multivariable linear, logistic and exact logistic regression adjusting for disease and patient characteristics were performed. On regression analyses, case number was the most significant predictor of decrease in probability of major complications (p = 0.025) and BCR (p = 0.004) for the new surgeon. Increasing case number was not associated with decrease in minor complications, PSM, OR time, or EBL (p > 0.05). Inclusion of the new surgeon's outcomes did not adversely impact outcomes of the practice. In conclusion, a new surgeon joining a high-volume robotic prostatectomy program with an established robotic team and mentorship can progress through the learning curve without compromising overall outcomes of the practice. Our results may be relevant for programs hiring newly trained staff to join an established robotic practice.

Background: The potential harms of a prostate cancer (PCa) diagnosis may outweigh its benefits in elderly men., Objective: To assess the use of prostate biopsy in men with limited life expectancy (LE) within the practices comprising the Michigan Urological Surgery Improvement Collaborative (MUSIC)., Design, Setting, and Participants: MUSIC is a consortium of 42 practices and nearly 85% of the urologists in Michigan. From July 2013 to October 2014, clinical data were collected prospectively for all men undergoing prostate biopsy., Outcome Measurements and Statistical Analysis: We calculated comorbidity-adjusted LE in men aged ≥66 yr and identified men with <10 yr LE (limited LE) undergoing a first biopsy. Our LE calculator was not designed for men aged <66 yr; thus these men were excluded. Multivariable models estimated the proportion of all biopsies performed for men with limited LE in each MUSIC practice, adjusting for differences in patient characteristics. We also evaluated what treatments, if any, these patients received., Results and Limitations: Among 3035 men aged ≥66 yr undergoing initial prostate biopsy, 60% had none of the measured comorbidities. Overall, 547 men (18%) had limited LE. Compared with men with a longer LE, these men had significantly higher prostate-specific antigen levels and abnormal digital rectal examination findings. The adjusted proportion of biopsies performed for men with limited LE ranged from 3.8% to 39% across MUSIC practices (p < 0.001). PCa was diagnosed in 69% of men with limited LE; among this group, 74% received any active treatment. Of these men, 46% had high-grade cancer (Gleason score 8-10)., Conclusions: Among a large and diverse group of urology practices, nearly 20% of prostate biopsies are performed in men with limited LE. These data provide useful context for quality improvement efforts aimed at optimizing patient selection for prostate biopsy., Patient Summary: In this report, nearly 2 of every 10 men undergoing prostate biopsy had a life expectancy (LE) <10 yr. Implementing LE calculators in clinical practice may help refine patient selection for prostate biopsy., (Published by Elsevier B.V.)

Objective: To test the feasibility of robotic anatrophic nephrolithotomy (RANL) using near-infrared fluorescence (NIRF) image-guidance for treating staghorn stones, in an in vivo stone surgery model., Methods: We developed a novel technique of RANL in a preclinical setting following guidelines on safe surgical innovation from the Idea, Development, Exploration, Assessment, Long-term monitoring (IDEAL) collaborative. We performed 2 RANL procedures on 2 live Yorkshire porcine females (IDEAL stage 0 study). The robot was docked in the flank position and a mini-GelPOINT was placed periumbilically as an assistant port. A model staghorn "stone" was created in vivo by injecting low-viscosity DenMat precision material into the renal pelvis. NIRF image-guidance, following clamping of the posterior renal artery, was used to determine if an anatrophic plane could be identified. One procedure was assessed under cold ischemia, with ice-slush injected onto the renal surface via the mini-GelPOINT., Results: Both porcine subjects underwent RANL successfully. Replica staghorn models could be created reliably (mean size 5.1 cm; solidification time 2-3 minutes). NIRF image-guidance afforded clear vascular demarcation for precise scoring of an anatrophic plane in both kidneys. The staghorn models were removed in toto through the anatrophic incision in both subjects. Mean blood loss was 160 cc. Mean console and ischemia times were 114 minutes and 34.5 minutes, respectively; ice-slush hypothermia led to a renal surface temperature of 15.4°C., Conclusion: In this IDEAL stage 0 preclinical study, we demonstrated that NIRF image-guidance is able to accurately identify the renal avascular plane, thus permitting an anatrophic approach for robotic excision of staghorn stones., (Copyright © 2016 Elsevier Inc. All rights reserved.)