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INTRODUCTION AND OBJECTIVE:Patients undergoing Robotic Assisted Radical Prostatectomy (RARP) commonly require 2 group and screen samples pre-operatively. However, literature suggests intra-operativ...

To review the ongoing randomised trials of cytoreductive prostatectomy (CRP) in de novo hormone-sensitive metastatic prostate cancer (HSPC) in order to identify their goals and assess their strengths and weaknesses.PubMed, MEDLINE and clinical trials websites searches were performed to identify currently ongoing trials of CRP in de novo HSPC.Nine randomised clinical trials in CRP were identified and included: Southwest Oncology Group (SWOG) 1802, Surgery in Metastatic Carcinoma of Prostate (SIMCAP), Adjuvant Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms (IP2-ATLANTA), Testing Radical prostatectomy in men with prostate cancer and oligoMetastases to the bone (TRoMbone), Impact of Radical Prostatectomy as Primary Treatment in Patients with Prostate Cancer with Limited Bone Metastases (g-RAMPP), Cytoreductive Prostatectomy vs Cytoreductive Prostate Irradiation as a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial (LoMP II), Androgen-Deprivation Therapy or Androgen-Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) (FUSCC-OMPCa), and the Testing Radical Prostatectomy in Chinese Men with Prostate Cancer and oligoMetastases to the Bone study. Each study was different; assessing various primary outcome measures including overall survival (OS), progression-free survival and feasibility to randomise between standard therapy and CRP or between radiation therapy and CRP in the metastatic setting. In the oligometastatic setting, the trials assess OS, feasibility to randomise and time to castration resistance. Similarly, a number of secondary endpoints ranging from cancer-specific outcomes to quality-of-life outcomes are being investigated. The inclusion criteria in these trials also varied in terms of volume of metastatic disease (oligometastatic to high-volume metastatic disease), diagnosis of metastases (imaging based vs biopsy confirmed), imaging modalities used (conventional to newer modalities), as well as outcomes and follow-up regimes.While there are differences in each protocol, each trial aims to address different aspects of CRP in de novo HSPC. Therefore, the specific goals of each study and the limitations have to be taken into consideration when interpreting the results of these trials.

To develop a novel Taiwanese prostate cancer (PCa) risk model for predicting PCa, comparing its predictive performance with that of two well-established PCa risk calculator apps.1545 men undergoing prostate biopsies in a Taiwanese tertiary medical center between 2012 and 2019 were identified retrospectively. A five-fold cross-validated logistic regression risk model was created to calculate the probabilities of PCa and high-grade PCa (Gleason score ≧ 7), to compare those of the Rotterdam and Coral apps. Discrimination was analyzed using the area under the receiver operator characteristic curve (AUC). Calibration was graphically evaluated with the goodness-of-fit test. Decision-curve analysis was performed for clinical utility. At different risk thresholds to biopsy, the proportion of biopsies saved versus low- and high-grade PCa missed were presented.Overall, 278/1309 (21.2%) patients were diagnosed with PCa, and 181 out of 278 (65.1%) patients had high-grade PCa. Both our model and the Rotterdam app demonstrated better discriminative ability than the Coral app for detection of PCa (AUC: 0.795 vs 0.792 vs 0.697, DeLong's method: P 0.001) and high-grade PCa (AUC: 0.869 vs 0.873 vs 0.767, P 0.001). Using a ≥ 10% risk threshold for high-grade PCa to biopsy, our model could save 67.2% of total biopsies; among these saved biopsies, only 3.4% high-grade PCa would be missed.Our new logistic regression model, similar to the Rotterdam app, outperformed the Coral app in the prediction of PCa and high-grade PCa. Additionally, our model could save unnecessary biopsies and avoid missing clinically significant PCa in the Taiwanese population.

Robot-assisted radical prostatectomy (RARP) for prostate cancer (PCa) treatment has been widely adopted with limited evidence for long-term (5 yr) oncologic efficacy.To evaluate long-term oncologic outcomes following RARP.Prospective cohort study of 885 patients who underwent RARP as monotherapy for PCa between 2002 and 2006 in a single European centre and followed up until 2016.RARP as monotherapy.Biochemical recurrence (BCR)-free survival (BCRFS), salvage therapy (ST)-free survival (STFS), prostate cancer-specific survival (CSS), and overall survival (OS) were estimated using the Kaplan-Meier method, and event-time distributions were compared using the log-rank test. Variables predictive of BCR and ST were identified using Cox proportional hazards models.We identified 167 BCRs, 110 STs, 16 PCa-related deaths, and 51 deaths from other/unknown causes. BCRFS, STFS, CSS, and OS rates were 81.8%, 87.5%, 98.5%, and 93.0%, respectively, at median follow-up of 10.5 yr. On multivariable analysis, the strongest independent predictors of both BCR and ST were preoperative Gleason score, pathological T stage, positive surgical margins (PSMs), and preoperative prostate-specific antigen. PSM3mm/multifocal but not ≤3mm independently affected the risk of both BCR and ST. Study limitations include a lack of centralised histopathologic reporting, lymph node and post-operative tumour volume data in a historical cohort, and patient-reported outcomes.RARP appears to confer effective long-term oncologic efficacy. The risk of BCR or ST is unaffected by ≤3mm PSM, but further follow-up is required to determine any impact on CSS.Robot-assisted surgery for prostate cancer is effective 10 yr after treatment. Very small (3mm) amounts of cancer at the cut edge of the prostate do not appear to impact on recurrence risk and the need for additional treatment, but it is not yet known whether this affects the risk of death from prostate cancer.

Background Whether surgeons perform better utilising a robot-assisted laparoscopic technique compared with an open approach during prostate cancer surgery is debatable. Objective To report erectile function and early oncologic outcomes for both surgical modalities, stratified by prostate cancer risk grouping. Design, setting, and participants In a prospective nonrandomised trial, we recruited 2545 men with prostate cancer from seven open ( n =753) and seven robot-assisted ( n =1792) Swedish centres (2008–2011). Outcome measurements and statistical analysis Clinometrically-validated questionnaire-based patient-reported erectile function was collected before, 3 mo, 12 mo, and 24 mo after surgery. Surgeon-reported degree of neurovascular-bundle preservation, pathologist-reported positive surgical margin (PSM) rates, and 2-yr prostate-specific antigen-relapse rates were measured. Results and limitations Among 1702 preoperatively potent men, we found enhanced erectile function recovery for low/intermediate-risk patients in the robot-assisted group at 3 mo. For patients with high-risk tumours, point estimates for erectile function recovery at 24 mo favoured the open surgery group. The degree of neurovascular bundle preservation and erectile function recovery were greater correlated for robot-assisted surgery. In pT2 tumours, 10% versus 17% PSM rates were observed for open and robot-assisted surgery, respectively; corresponding rates for pT3 tumours were 48% and 33%. These differences were associated with biochemical recurrence in pT3 but not pT2 disease. The study is limited by its nonrandomised design and relatively short follow-up. Conclusions Earlier recovery of erectile function in the robot-assisted surgery group in lower-risk patients is counterbalanced by lower PSM rates for open surgeons in organ-confined disease; thus, both open and robotic surgeons need to consider this trade-off when determining the plane of surgical dissection. Robot-assisted surgery also facilitates easier identification of nerve preservation planes during radical prostatectomy as well as wider dissection for pT3 cases. Patient summary For prostate cancer surgery, an open operation reduces erection problems in high-risk cancers but has higher relapse rates than robotic surgery. Relapse rates appear similar in low/intermediate-risk cancers and the robot appears better at preserving erections in these cases.

Purpose: This study sought to test the acceptability and feasibility of a nurse-led psycho-educational intervention (NLPI) delivered in primary care to prostate cancer survivors, and to provide preliminary estimates of the effectiveness of the intervention. Methods: Men who reported an ongoing problem with urinary, bowel, sexual or hormone-related functioning/ vitality on a self-completion questionnaire were invited to participate. Participants were randomly assigned to the NLPI plus usual care, or to usual care alone. Recruitment and retention rates were assessed. Prostate-related quality of life, self-efficacy, unmet needs, and psychological morbidity were measured at baseline and 9 months. Health-care resource use data was also collected. An integrated qualitative study assessed experiences of the intervention. Results: 61% eligible men (83/136) participated in the trial, with an 87% (72/83) completion rate. Interviews indicated that the intervention filled an important gap in care following treatment completion, helping men to self-manage, and improving their sense of well-being. However, only a small reduction in unmet needs and small improvement in self-efficacy was observed, and no difference in prostate-related quality of life or psychological morbidity. Patients receiving the NLPI recorded more primary care visits, while the usual care group recorded more secondary care visits. Most men (70%; (21/30)) felt the optimal time for the intervention was around the time of diagnosis/before the end of treatment. Conclusions: Findings suggest a nurse-led psycho-educational intervention in primary care is feasible, acceptable and potentially useful to prostate cancer survivors.

Background: The high degree of genomic diversity in cancer represents a challenge for identifying objective prognostic markers. We aimed to examine the extent of tumour heterogeneity and its effect on the evaluation of a selected prognostic marker using prostate cancer as a model. Methods: We assessed Gleason Score (GS), DNA ploidy status and phosphatase and tensin homologue (PTEN) expression in radical prostatectomy specimens (RP) from 304 patients followed for a median of 10 years (interquartile range 6–12). GS was assessed for every tumour-containing block and DNA ploidy for a median of four samples for each RP. In a subgroup of 40 patients we assessed DNA ploidy and PTEN status in every tumour-containing block. In 102 patients assigned to active surveillance (AS), GS and DNA ploidy were studied in needle biopsies. Results: Extensive heterogeneity was observed for GS (89% of the patients) and DNA ploidy (40% of the patients) in the cohort, and DNA ploidy (60% of the patients) and PTEN expression (75% of the patients) in the subgroup. DNA ploidy was a significant prognostic marker when heterogeneity was taken into consideration. In the AS cohort we found heterogeneity in GS (24%) and in DNA ploidy (25%) specimens. Conclusions: Multi-sample analysis should be performed to support clinical treatment decisions.

There is some evidence to suggest that radical treatment of the primary tumour in patients diagnosed with metastatic prostate cancer can reduce symptomatic progression and increase survival. In this article, the author describes a pilot study to investigate whether a large study looking at survival benefit in early metastatic disease is feasible in the UK and calls for recruits.

BACKGROUND Mobile health apps have emerged as useful tools for patients and clinicians alike, sharing health information or assisting in clinical decision-making. Prostate cancer (PCa) risk calculator mobile apps have been introduced to assess risks of PCa and high-grade PCa (Gleason score ≥7). The Rotterdam Prostate Cancer Risk Calculator and Coral–Prostate Cancer Nomogram Calculator apps were developed from the 2 most-studied PCa risk calculators, the European Randomized Study of Screening for Prostate Cancer (ERSPC) and the North American Prostate Cancer Prevention Trial (PCPT) risk calculators, respectively. A systematic review has indicated that the Rotterdam and Coral apps perform best during the prebiopsy stage. However, the epidemiology of PCa varies among different populations, and therefore, the applicability of these apps in a Taiwanese population needs to be evaluated. This study is the first to validate the PCa risk calculator apps with both biopsy and prostatectomy cohorts in Taiwan. OBJECTIVE The study’s objective is to validate the PCa risk calculator apps using a Taiwanese cohort of patients. Additionally, we aim to utilize postprostatectomy pathology outcomes to assess the accuracy of both apps with regard to high-grade PCa. METHODS All male patients who had undergone transrectal ultrasound prostate biopsies in a single Taiwanese tertiary medical center from 2012 to 2018 were identified retrospectively. The probabilities of PCa and high-grade PCa were calculated utilizing the Rotterdam and Coral apps, and compared with biopsy and prostatectomy results. Calibration was graphically evaluated with the Hosmer-Lemeshow goodness-of-fit test. Discrimination was analyzed utilizing the area under the receiver operating characteristic curve (AUC). Decision curve analysis was performed for clinical utility. RESULTS Of 1134 patients, 246 (21.7%) were diagnosed with PCa; of these 246 patients, 155 (63%) had high-grade PCa, according to the biopsy results. After confirmation with prostatectomy pathological outcomes, 47.2% (25/53) of patients were upgraded to high-grade PCa, and 1.2% (1/84) of patients were downgraded to low-grade PCa. Only the Rotterdam app demonstrated good calibration for detecting high-grade PCa in the biopsy cohort. The discriminative ability for both PCa (AUC: 0.779 vs 0.687; DeLong’s method: PPP=.128). CONCLUSIONS The Rotterdam and Coral apps can be applied to the Taiwanese cohort with accuracy. The Rotterdam app outperformed the Coral app in the prediction of PCa and high-grade PCa. Despite the small size of the prostatectomy cohort, both apps, to some extent, demonstrated the predictive capacity for true high-grade PCa, confirmed by the whole prostate specimen. Following our external validation, the Rotterdam app might be a good alternative to help detect PCa and high-grade PCa for Taiwanese men.

Background High-intensity focused ultrasound (HIFU) is a novel therapy for prostate cancer. Owing to a lack of long-term data, HIFU is recommended for use only in the context of research. Objective To examine the trend for HIFU use nationally and rates of strictures and fistulae. Design, setting, and participants Patients undergoing HIFU for prostate cancer between April 2007 and March 2018 were studied in an English national database (Hospital Episode Statistics). Data on complications were included for patients with a minimum of 1-yr follow-up. Analysis of complications was controlled for other interventions. Outcome measures and statistical analysis Descriptive analyses of HIFU rates and the incidence of strictures and fistulae were carried out. Cox and logistic regression models were built for urethral stricture incidence. Results and limitations A total of 2320 HIFU treatments among 1990 patients were identified. The median age was 67 yr (interquartile range 61–72). Some 1742 patients met the criteria for follow-up analysis. The highest-volume centre performed 1513 HIFU procedures, followed by 194 at the second highest. The number of HIFU procedures increased annually, rising from 196 to 283 per year. There were 208 patients (11.9%) who went on to have radiotherapy and 102 (5.9%) radical prostatectomy after HIFU. Following HIFU, stricture developed in 133/1290 patients (10.3%) and urinary fistula in 16/1240 (1.3%) before any further intervention. More recent years for HIFU were associated with a lower likelihood of stricture formation (2016/2017 vs 2007/2008: hazard ratio 0.30, 95% confidence interval 0.11–0.79; p = 0.015). Limitations include the lack of staging information and unknown rates of HIFU outside of publicly funded health care. Conclusions HIFU is performed at a large number of low-volume centres and complication rates do not differ from those for established therapies. Patient summary This report highlights the trend for provision of high-intensity focused ultrasound treatment for prostate cancer in England. The results suggest that the rate of urethral structural complications may not be lower than that for established prostate cancer treatments.

Pelvic lymph node dissection represents the gold standard of lymph node staging in patients with prostate cancer. We sought to assess the effect of extended pelvic lymph node dissection on oncologic outcomes in patients with characteristics of D'Amico intermediate or high risk prostate cancer treated with radical prostatectomy.In a multi-institutional database of 4 centers we identified 9,742 patients who underwent radical prostatectomy from 2000 to 2017 with or without pelvic lymph node dissection. Only patients with a greater than 5% probability of lymph node invasion according to the Briganti nomogram were included in study. We performed 2:1 propensity score matching to account for potential differences between the 2 cohortsOverall 707 patients (7.3%) did not undergo pelvic lymph node dissection, of whom 520 and 187 harbored D'Amico intermediate and high risk characteristics, respectively. A median of 14 lymph nodes (IQR 8-21) were removed in the pelvic lymph node dissection cohort and 1,714 of these cases (19.0%) harbored lymph node metastasis. After propensity score matching the biochemical recurrence-free, metastasis-free and cancer specific mortality-free survival rates were 60.4% vs 65.6% (p=0.07), 87.0% vs 90.0% (p=0.06) and 95.2% vs 96.4% (p=0.2) for pelvic lymph node dissection vs no pelvic lymph node dissection 120 months after radical prostatectomy. Multivariable Cox regression models adjusted for postoperative and preoperative tumor characteristics revealed that pelvic lymph node dissection performed at radical prostatectomy was no independent predictor of biochemical recurrence, metastasis or cancer specific mortality (all p ≥0.1).There was no significant difference in oncologic outcomes in patients with D'Amico high or intermediate risk prostate cancer in whom pelvic lymph node dissection was or was not performed at radical prostatectomy. The therapeutic value of pelvic lymph node dissection remains unclear.

ObjectiveTo describe how clinicians conceptualised equipoise in the PART (Partial prostate Ablation vs Radical prosTatectomy in intermediate‐risk unilateral clinically localised prostate cancer) feasibility study and how this affected recruitment.Subjects and MethodsPART included a QuinteT Recruitment Intervention (QRI) to optimise recruitment. Phase I aimed to understand recruitment, and included: scrutinising recruitment data, interviewing the trial management group and recruiters (n = 13), and audio‐recording recruitment consultations (n = 64). Data were analysed using qualitative content and thematic analysis methods. In Phase II, strategies to improve recruitment were developed and delivered. ResultsInitially many recruiters found it difficult to maintain a position of equipoise and held preconceptions about which treatment was best for particular patients. They did not feel comfortable about approaching all eligible patients, and when the study was discussed, biases were conveyed through the use of terminology, poorly balanced information, and direct treatment recommendations. Individual and group feedback led to presentations to patients becoming clearer and enabled recruiters to reconsider their sense of equipoise. Although the precise impact of the QRI alone cannot be determined, recruitment increased (from a mean [range] of 1.4 [0–4] to 4.5 [0–12] patients/month) and the feasibility study reached its recruitment target.ConclusionAlthough clinicians find it challenging to recruit patients to a trial comparing different contemporary treatments for prostate cancer, training and support can enable recruiters to become more comfortable with conveying equipoise and providing clearer information to patients.

INTRODUCTION AND OBJECTIVES:The STAMPEDE trial has shown a survival benefit for local radiation therapy in men with oligo-metastatic prostate cancer. Observational studies have suggested such benef...

INTRODUCTION AND OBJECTIVES:To assess the effect of extended pelvic lymph node dissection (PLND) on oncologic outcomes in prostate cancer (PCa) patients with D'Amico intermediate- or high-risk char...

INTRODUCTION AND OBJECTIVES:In the last 15 years robotic surgery became the leading approach for treatment of prostate and kidney cancer. Following the success of these procedures, robotic system has been more recently applied to treat bladder cancer (BCa) but sparse data exists regarding the diffusion of robotic radical cystectomy (RARC) and its trend in contemporary patients. Aim of our study is comparing utilization trends and time-changes in perioperative outcomes of RARC using data from a large multicenter collaboration.METHODS:We retrospectively evaluated data from 2,713 patients treated with open radical cystectomy (ORC) and RARC for BCa at 16 American and European institutions between 2006 and 2018. All patients had completed data regarding pre-, intra- e post-operative characteristics. The Kruskal-Wallis test and Chi-square test evaluated differences between continuous and categorical variables, respectively.RESULTS:Overall, 971 (36%) patients underwent RARC and 1,705 (64%) ORC. RARC became the m...

Retzius sparing robotic assisted radical prostatectomy appears to have better continence rates when compared to conventional robotic assisted radical prostatectomy, however, concern with high positive surgical margin rates exist. To systematically evaluate evidence comparing functional and oncological outcomes of retzius sparing robotic assisted radical prostatectomy and conventional robotic assisted radical prostatectomy. The systematic review was performed in accordance with the Cochrane guidelines and the preferred reporting items for systematic reviews and meta-analyses (PRISMA). Bibliographic databases searched were PubMed/MEDLINE, Cochrane central register of controlled trials—CENTRAL (in The Cochrane library—issue 1, 2018). We used the GRADE approach to assess the quality of the evidence. The search retrieved 137 references through electronic searches of various databases. Six were included in the review. RS-RALP was associated with better early continence rates (≤ 1 month) (moderate quality evidence) (RR 1.72, 95% CI 1.27, 2.32, p 0.0005) and at 3 months (low quality evidence) (RR 1.39, 95% CI 1.03, 1.88, p 0.03). Time to continence recovery, number of pads used and pad weight are better with RS-RALP. Based on very low quality evidence, RS-RALP did not alter 6 and 12 months continence rates. Based on very low quality evidence, RS-RALP did not alter T2 positive margin rates (RR 1.67, 95% CI 0.91, 3.06, p 0.10) and T3 positive margin rates (RR 1.08, 95% CI 0.68, 1.70, p = 0.75). Short-term biochemical free survival appears to be similar between the two approaches. Based on low-quality evidence, RS-RALP did not alter overall and major complication rates. RS-RARP appears to have earlier continence recovery when compared to Con-RARP which does not come at a significant oncologic cost. Whilst there was a trend towards higher PSM rates with RS-RALP, this did not achieve statistical significance. Furthermore this trend appeared to be less pronounced with T3 disease, where the PSM rates are almost similar.

Prostate cancer is the most common solid organ malignancy in men. Despite the implementation of PSA screening, the incidence of metastatic prostate cancer in Spain is still around 4%. In this clinical scenario, systemic treatment is the gold standard. Cytoreductive surgery is a standard approach for some solid organ metastatic tumours. Recently there isinterest in exploring the clinical benefit of local treatment (LT) to the primary site in oligometastatic prostate cancer.Review of the relevant literature to evaluate the benefit of local treatment (LT) in metastatic prostate cancer.Local treatment of the primary tumour has demonstrated oncological and symptomatic benefit in other malignancies. Multimodal therapies have demonstrated oncological and symptomatic benefit in locally advanced prostate cancer. Furthermore, surgery has been shown to reduce symptomatic progression in metastatic prostate cancer.The role of surgery to the primary site or metastasis directed treatment is currently being investigated, in the context of oligometastatic prostate cancer. Retrospective data provide a rationale for ongoing randomized controlled trials in this area. New imaging modalities might have a great impact in this conceptual change. Further data is still needed to recommend this approach as a standard of care.INTRODUCCIÓN: El cáncer de próstata es el tumor maligno más frecuente en varones. A pesar de la implementación del cribado con PSA, la incidenciade cáncer de próstata metastásico en España está en torno al 4%. En este escenario clínico, el tratamiento sistémico es el patrón de referencia. La cirugía citoreductora es un abordaje estándar para algunos tumores metastásicos de órganos sólidos. Recientemente, hay interés en explorar los beneficios clínicos del tratamiento local (TL) en el sitio primario en el cáncer de próstataoligometastásico.MATERIAL Y MÉTODOS: Revisión de la literatura relevante para evaluar el beneficio del tratamiento local en el cáncer de próstata metastásico.RESULTADOS: El tratamiento local del tumor primario ha demostrado beneficios oncológicos y sintomáticos en otros tumores malignos. Los tratamientos multimodales han demostrado beneficios en cáncer de próstata localmente avanzado. Además, la cirugía se ha demostrado que reduce la progresión sintomática en el cáncer de próstata metastásico.CONCLUSIONES: El papel de la cirugía del sitio primario o tratamiento dirigido a las metastasis está actualmente siendo investigado en el contexto del cáncer depróstata oligometastásico. Los datos retrospectivos dan una justificación para los ensayos clínicos aleatorizados en marcha en esta área. Las nuevas modalidades de imagen podrían tener un gran impacto en este cambio conceptual. Todavía son necesarios más datos para recomendar este abordaje como un tratamiento estándar.

Objectives To analyse the perioperative and oncological outcomes of all radical prostatectomies (RPs) performed for high-risk prostate cancer in the British Association of Urological Surgeons (BAUS) national registry from 2014 to 2015. Patients and methods We identified and analysed outcomes of all RPs performed for high-risk prostate cancer (clinical stage >T2 and/or biopsy Gleason grade >7 and/or preoperative prostate-specific antigen level ≥20 ng/mL) in the national registry for 2014 and 2015. Surgeon reporting of data was mandated during this period. Institution and individual surgeon volume-outcome relationships were assessed. Results In total, 3671/13 947 (26.3%) patients underwent RP for high-risk prostate cancer over the 2-year period. Robot-assisted RP was the most prevalent approach (60.7%). In all, 39% of men received an extended pelvic lymph node dissection (LND), but over one-third (33.8%) had no LND. Minimally invasive techniques were associated with a significantly shorter length of stay. The reported rates of Clavien-Dindo ≥III complications within the dataset were low (2.0%), regardless of surgical modality or surgeon volume. No statistically significant surgeon volume-outcome relationships were identified when surgeon volume was stratified into tertiles. Conclusion RP for high-risk prostate cancer in the UK appears safe, regardless of modality used or surgeon volume. No clear evidence that surgeon volume impacts on early perioperative outcomes was seen. Quality assurance of the surgeon-reported BAUS dataset is now required to drive quality improvement in national practice.

Introduction We evaluated patient, hospital, and cancer-specific factors associated with positive surgical margin (PSM) variability after radical prostatectomy in pT2 prostate cancer in the United States. Patients and Methods A total of 45,426 men from 1152 hospitals with pT2 prostate cancer and known margin status after radical prostatectomy were identified using the National Cancer Database (2010-2015). Data on patient, cancer, hospital factors, and surgical approach were extracted. A mixed effects logistic regression model was computed to examine factors associated with PSM and partial R2 values to assess the relative contributions of patient, cancer, and hospital variables to PSM status. Results Median PSM rate of 8.5% (interquartile range, 5.2%-13.0%). Robotic (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.83-0.99) and laparoscopic (OR, 0.74; 95% CI, 0.64-0.90) surgical approach, academic institution (OR, 0.87; 95% CI, 0.76-1.00) and high hospital surgical volume (>297 cases [OR], 0.83; 95% CI, 0.70-0.99) were independently associated with a lower PSM. Black men (OR, 1.13; 95% CI, 1.01-1.26) and adverse cancer-specific features (prostate-specific antigen [PSA], 10-20; PSA >20; cT3 stage; Gleason 7, 8, 9-10; all P > .01) were independently associated with a higher PSM. Patient-specific, hospital-specific, and cancer-specific factors had a contribution of 2.3%, 3.9%, and 15.2%, respectively, to the variation in PSM. Facility had a contribution of 23.7% to the variation in PSM. Conclusion Cancer-specific factors account for 15.2% of PSM variation with the remaining 84.8% of PSM variation due to patient, hospital, and other factors not accounted within the model. Noncancer-specific factors represent addressable factors that are important for policy-makers in efforts to improve patient outcome.

Objectives: To compare trends in the use of robot-assisted radical cystectomy (RARC) and changes over time in peri-operative outcomes in selected North American and European centres. Materials and Methods: We conducted a retrospective evaluation of 2401 patients treated with open radical cystectomy (ORC) or RARC for bladder cancer at 12 centres in North America and Europe between 2006 and 2018. We used the Kruskal–Wallis and chi-squared test to evaluate differences between continuous and categorical variables. Results: Overall, 49.5% of patients underwent RARC and 51.5% ORC. RARC became the most commonly performed procedure in contemporary patients, with an increase from 29% in 2006–2008 to 54% in 2015–2018 (P < 0.001). In the North American centres the use of RARC was higher than that of ORC from 2006, and remained stable over time, whereas in the European centres its use increased exponentially from 2% to 50%. In both groups patients who underwent RARC had less advanced T stages (P < 0.001), lower American Society of Anesthesiologists scores (P < 0.05), lower blood loss (P = 0.001) and shorter length of hospital stay (P < 0.05). No differences were found in early complications. Early readmission and re-operation rates were worse for patients treated with RARC in the European centres; however, when contemporary patients only were considered, the statistical significance was lost. Conclusion: The present study shows that the use of RARC has constantly increased since its introduction, overtaking ORC in the most contemporary series. While RARC was more frequently performed than ORC since its introduction in the North American centres and its use remained substantially stable over time, its use increased exponentially in the European centres. The different trends in use of RARC/ORC and changes over time in peri-operative outcomes between the North American and European centres can be attributed to the earlier introduction and spread of RARC in the former compared with the latter.

Background: To assess the differential effect of robotic assisted radical cystectomy (RARC) versus open radical cystectomy (ORC) on survival outcomes in matched analyses performed on a large multicentric cohort. Methods: The study included 9757 patients with urothelial bladder cancer (BCa) treated in a consecutive manner at each of 25 institutions. All patients underwent radical cystectomy with bilateral pelvic lymphadenectomy. To adjust for potential selection bias, propensity score matching 2:1 was performed with two ORC patients matched to one RARC patient. The propensity-matched cohort included 1374 patients. Multivariable competing risk analyses accounting for death of other causes, tested association of surgical technique with recurrence and cancer specific mortality (CSM), before and after propensity score matching. Results: Overall, 767 (7.8%) patients underwent RARC and 8990 (92.2%) ORC. The median follow-up before and after propensity matching was 81 and 102 months, respectively. In the overall population, the 3-year recurrence rates and CSM were 37% vs. 26% and 34% vs. 24% for ORC vs. RARC (all p values &gt, 0.1), respectively. On multivariable Cox regression analyses, RARC and ORC had similar recurrence and CSM rates before and after matching (all p values &gt, 0.1). Conclusions: Patients treated with RARC and ORC have similar survival outcomes. This data is helpful in consulting patients until long term survival outcomes of level one evidence is available.

Background: Active surveillance (AS) has been increasingly proposed as the preferential initial management strategy for low-risk prostate cancer (PC), while in high-risk PC the indication for surgery has widened. Objective: To evaluate the development of risk group distribution of patients undergoing radical prostatectomy (RP). Design, setting, and participants: Retrospective database review of combined RP databases (2000-2015) of four large European centers (Créteil, Paris; San Rafaele, Milan; Martini Klinik, Hamburg; NKI, AvL, Amsterdam). Outcome measurements and statistical analysis: Clinical and pathological characteristics per year of surgery. Eligibility for AS was defined according to Prostate Cancer Research International Active Surveillance criteria: cT. ≤. 2c, cN0/X, cM0/X, PSA ≤10. ng/ml, prostate-specific antigen density 20. ng/ml, and/or Gleason ≥8. Results and limitations: In total, 28. 572 patients had complete clinical and 24. 790 complete pathological data available. The absolute number of RPs increased: 401, 975, 2344, and 2504 in 2000, 2005, 2010, and 2015, respectively. The proportion of cases considered suitable for AS decreased: 31%, 32%, 18%, and 5%, while the cases considered high risk increased: 10%, 8%, 16%, and 30%. The percentage of patients having only localized Gleason 6 disease after RP decreased: 46%, 34%, 14%, and 8% for all patients (p< 0.01), as well as for AS-suitable patients: 70%, 54%, 41%, and 38% (p

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To review the anatomical facts of urethral sphincter (US) innervation discovered over the last three decades and to determine the implications for continence recovery after radical prostatectomy (RP). Using the PubMed® database, we searched for peer-reviewed articles in English between January 1985 and September 2015, with the following terms: ‘urethral sphincter,’ ‘urethral rhabdosphincter,’ ‘urinary continence and nerve supply’ and ‘neuroanatomy and nerve sparing.’ The anatomical methodology, number of bodies examined, data, figures, relevant facts and text were analyzed. Seventeen articles on 254 anatomical subjects were reviewed. Coexisting pathways were described in every article. Dissection, histology, simulation or electron microscopy evidence supported arguments for somatic and autonomic pathways. From the most to the least substantiated, somatic sphincteric fibers were described extra- or intrapelvic as: direct from the distal pudendal nerve (PuN), recurrent from the dorsal nerve of the penis, from the proximal PuN with an intrapelvic course, extrapudendal somatic fibers dispersed among autonomic pelvic fibers. From the pelvic plexus, or from the neurovascular bundles, autonomic fibers to the US have been described in 13 of the reviewed articles, with at least each of the available anatomical methods. Because continence depends on a number of factors, it is challenging to delineate the specific impact of periprostatic nerve sparing on continence, but the anatomical data suggest that RP surgeons should steer toward the preservation and protection of these nerves whenever possible.

Positive surgical margins (PSM) after radical prostatectomy (RP) are a predictor of biochemical recurrence (BCR), and highly dependent on surgeon, experience, and skill. The length and location PSMs are important, with significant differences between open and robotic RP. The impact of PSMs on BCR remains secondary to other clinico-pathologic variables: Gleason Score, pathologic stage, and baseline PSA. However, lower PSM rates are associated with reduced use of secondary interventions and patient anxiety of cancer recurrence.

Contains fulltext : 171441.pdf (Publisher’s version ) (Open Access) Most prostate cancers (PC) are currently found on the basis of an elevated PSA, although this biomarker has only moderate accuracy. Histological confirmation is traditionally obtained by random transrectal ultrasound guided biopsy, but this approach may underestimate PC. It is generally accepted that a clinically significant PC requires treatment, but in case of an non-significant PC, deferment of treatment and inclusion in an active surveillance program is a valid option. The implementation of multiparametric magnetic resonance imaging (mpMRI) into a screening program may reduce the risk of overdetection of non-significant PC and improve the early detection of clinically significant PC. A mpMRI consists of T2-weighted images supplemented with diffusion-weighted imaging, dynamic contrast enhanced imaging, and/or magnetic resonance spectroscopic imaging and is preferably performed and reported according to the uniform quality standards of the Prostate Imaging Reporting and Data System (PIRADS). International guidelines currently recommend mpMRI in patients with persistently rising PSA and previous negative biopsies, but mpMRI may also be used before first biopsy to improve the biopsy yield by targeting suspicious lesions or to assist in the selection of low-risk patients in whom consideration could be given for surveillance.? MpMRI may be used to detect or exclude significant prostate cancer. ? MpMRI can guide targeted rebiopsy in patients with previous negative biopsies. ? In patients with negative mpMRI consideration could be given for surveillance. ? MpMRI may add valuable information for the optimal treatment selection.

The Human Tissue Act 2004, in England, Wales and Northern Ireland set out a legal framework for regulating the storage and use of human tissue with the aim of restoring public confidence in medical research after the media fuelled storm of the 1990s relating to the use of human tissue for research. It consolidated previous legislation and created the Human Tissue Authority to regulate these activities. It was fully implemented on 1 September 2006. There are two main requirements of the Act: consent and licensing. This article will summarise this legislation with the aim of helping junior researchers understand the regulations and, in particular, which samples require consent and licensing.

Background Over 1 million men are diagnosed with prostate cancer each year worldwide, with a wide range of research programs requiring access to patient tissue samples for development of improved diagnoses and treatments. A random sampling of prostate tissue is sufficient for certain research studies; however, there is growing research need to target areas of the aggressive tumor as fresh tissue. Here we set out to develop a new pathway “PEOPLE: PatiEnt prOstate samPLes for rEsearch” to collect high‐quality fresh tissue for research use, using magnetic resonance imaging (MRI) to target areas of tumor and benign tissue. Methods Prostate tissue was sampled following robotic radical prostatectomy, using MRI data to target areas of benign and tumor tissue. Initially, 25 cases were sampled using MRI information from clinical notes. A further 59 cases were sampled using an optimized method that included specific MRI measurements of tumor location along with additional exclusion criteria. All cases were reviewed in batches with detailed clinical and histopathological data recorded. For one subset of samples, DNA was extracted and underwent quality control. Ex vivo culture was carried out using the gelatin sponge method for an additional subset. Results Tumor was successfully fully or partially targeted in 64% of the initial cohort and 70% of the optimized cohort. DNA of high quality and concentration was isolated from 39 tumor samples, and ex vivo culture was successfully carried out in three cases with tissue morphology, proliferation, and apoptosis remaining comparable before and after 72 hours culture. Conclusion Here we report initial data from the PEOPLE pathway; using a method for targeting areas of tumor within prostate samples using MRI. This method operates alongside the standard clinical pathway and minimizes additional input from surgical, radiological, and pathological teams, while preserving surgical margins and diagnostic tissue.

Introduction The use of robotic-assisted radical cystectomy (RARC) is becoming more widespread. While its safety is accepted, its oncological efficacy as compared to the current standard, open radical cystectomy (ORC), remains debatable. Materials and methods The aim of this study is to compare the rates of positive soft tissue surgical margins (STSM), between patients treated with RARC or ORC, using a large contemporaneous collaborative database. We included 2,536 patients with urothelial carcinoma of the bladder treated at 26 institutions. A propensity-score matching 1:1 was performed with 3 ORC patients matched to 1 RARC patient. The final cohort included 1,614 patients. Uni- and multivariable logistic regression analyses tested the impact of surgical technique on STSM status, before and after propensity-score matching. Results Overall, 870 (34%) patients underwent RARC and 1,666 (66%) ORC. The overall STSM rate was 11%; 10% in the ORC group and 13% in the RARC group. Within the propensity-score-matched cohort, the positive STSM rate were 14% and 13% in the ORC and RARC group, respectively (P = 0.1). In multivariable analysis, after propensity match RARC approach was not associated with the risk of a positive STSM (P = 0.1). These results were confirmed in the subgroup of patients with pathologic non–organ-confined or organ-confined diseases. Conclusions While treatment with RARC is associated with a higher absolute rate of STSM, the difference did not remain after adjustment for the effects of other established prognostic factors. Results from ongoing trials are awaited to assess the validity of these findings.

Objectives To determine whether replacement of protocol-driven repeat prostate biopsy (PB) with multiparametric magnetic resonance imaging (mpMRI) ± repeat targeted prostate biopsy (TB) when evaluating men on active surveillance (AS) for low-volume, low- to intermediate-risk prostate cancer (PCa) altered the likelihood of or time to treatment, or reduced the number of repeat biopsies required to trigger treatment. Patients and methods A total of 445 patients underwent AS in the period 2010-2016 at our institution, with a median (interquartile range [IQR]) follow-up of 2.4 (1.2-3.7) years. Up to 2014, patients followed a 'pre-2014' AS protocol, which incorporated PB, and subsequently, according to the 2014 National Institute for Health and Care Excellence (NICE) guidelines, patients followed a '2014-present' AS protocol that included mpMRI. We identified four groups of patients within the cohort: 'no mpMRI and no PB'; 'PB alone'; 'mpMRI ± TB'; and 'PB and mpMRI ± TB'. Kaplan-Meier plots and log-rank tests were used to compare groups. Results Of 445 patients, 132 (30%) discontinued AS and underwent treatment intervention, with a median (IQR) time to treatment of 1.55 (0.71-2.4) years. The commonest trigger for treatment was PCa upgrading after mpMRI and TB (43/132 patients, 29%). No significant difference was observed in the time at which patients receiving a PB alone or receiving mpMRI ± TB discontinued AS to undergo treatment (median 1.9 vs 1.33 years; P = 0.747). Considering only those patients who underwent repeat biopsy, a greater proportion of patients receiving TB after mpMRI discontinued AS compared with those receiving PB alone (29/66 [44%] vs 32/87 [37%]; P = 0.003). On average, a single set of repeat biopsies was needed to trigger treatment regardless of whether this was a PB or TB. Conclusions Replacing a systematic PB with mpMRI ±TB as part of an AS protocol increased the likelihood of re-classifying patients on AS and identifying men with clinically significant disease requiring treatment. mpMRI ±TB as part of AS thereby represents a significant advance in the oncological safety of the AS protocol.

Objective, Patients and Methods: To develop a novel tool to increase the number of patients with prostate cancer eligible for active surveillance (AS) without increasing the risk of unfavourable pathological features (i.e., misclassification) at radical prostatectomy (RP). Overall, 16049 patients with low- or intermediate-risk prostate cancer treated with RP were identified. Misclassification was defined as non-organ confined or grade group 3 disease at RP. The coefficients of a logistic regression model predicting misclassification were used to develop a risk score. We then performed a systematic analysis of different thresholds to discriminate between patients with or without unfavourable disease and we compared it to available AS criteria. Results and Conclusions: Overall, 5289 (33.0%) patients had unfavourable disease. At multivariable analyses, PSA level, clinical stage, biopsy grade group, the number of positive cores, and PSA density were associated with the risk of unfavourable disease (all P < 0.001). The Prostate Cancer Research International: Active Surveillance (PRIAS) criteria were associated with a lower risk of misclassification (13%) compared to other criteria. Overall, 3303 (20.6%) patients were eligible according to the PRIAS protocol. The adoption of an 18% threshold according to the risk score increased the proportion of eligible patients from 20.6% to 29.4% without increasing the risk of misclassification as compared to the PRIAS criteria. The use of a novel risk score for AS selection would result in an absolute increase of 10% in the number of patients eligible for this approach without increasing the risk of misclassification.

The creation of the urinary diversion is a challenging surgical part after radical cystectomy and holds a special place in the development of urological practice. Following cystectomy, urine can either be diverted into an incontinent stoma, into a continent urinary reservoir catheterised by the patient or controlled by the anal sphincter, or into an orthotopic bladder substitute so that the patient voids per urethra.

Purpose Guidelines and recommendations become increasingly important in clinical urologic practice. This study aims to inform clinicians using guidelines on how to evaluate the quality of the methodology and transparency of these documents. Methods The guidelines on management of castration-resistant prostate cancer of the American Urology Association, European Association of Urology, National Comprehensive Cancer Network, National Institute for Health and Care Excellence, European Society of Medical Oncology were reviewed using the AGREE-II tool (Appraisal of Guidelines for Research and Evaluation). We reported and compared the domain scores for the domains 1 scope and purpose, 2 stakeholder involvement, 3 rigor of development, 4 clarity of presentation, 5 applicability, and 6 editorial independence (100% indicates highest-best quality score). Results The domains evaluated highest and with lowest variability were 'editorial independence' (92% {88-95%}) and 'clarity of presentation' (83% {72-90%}), while the domains with the lowest scores and most variability were 'stakeholder involvement' (56% {36-79%}) and 'applicability' (40% {30-63%}). Length and extent of detail of guidelines vary considerably, each with its own strengths and limitations and adapted to target users. Standard external review using AGREE criteria may be preferable. A formal search strategy was not performed. Findings may be outdated by guidelines' updates. Conclusions Clinicians using practice guidelines need to be aware of the different domains of methodology and transparency used to assess the quality of guidelines contents and recommendations. Patient summary Urologists increasingly use guidelines for support in evidence-based recommendations in clinical practice. It is very important to know how to assess these documents. This study applies standard criteria to compare the design and background of different available guidelines on prostate cancer no longer responding to hormonal treatment.

© 2015 The Authors BJU International © 2015 BJU International. Objective To explore ongoing symptoms, unmet needs, psychological wellbeing, self-efficacy and overall health status in survivors of prostate cancer. Patients and Methods An invitation to participate in a postal questionnaire survey was sent to 546 men, diagnosed with prostate cancer 9-24 months previously at two UK cancer centres. The study group comprised men who had been subject to a range of treatments: surgery, radiotherapy, hormone therapy and active surveillance. The questionnaire included measures of prostate-related quality of life (Expanded Prostate cancer Index Composite 26-item version, EPIC-26); unmet needs (Supportive Care Needs Survey 34-item version, SCNS-SF34); anxiety and depression (Hospital Anxiety and Depression Scale, HADS), self-efficacy (modified Self-efficacy Scale), health status (EuroQol 5D, EQ-5D) and satisfaction with care (questions developed for this study). A single reminder was sent to non-responders after 3 weeks. Data were analysed by age, co-morbidities, and treatment group. Results In all, 316 men completed questionnaires (64.1% response rate). Overall satisfaction with follow-up care was high, but was lower for psychosocial than physical aspects of care. Urinary, bowel, and sexual functioning was reported as a moderate/big problem in the last month for 15.2% (n = 48), 5.1% (n = 16), and 36.5% (n = 105) men, respectively. The most commonly reported moderate/high unmet needs related to changes in sexual feelings/relationships, managing fear of recurrence/uncertainty, and concerns about the worries of significant others. It was found that 17% of men (51/307) reported potentially moderate-to-severe levels of anxiety and 10.2% (32/308) reported moderate-to-severe levels of depression. The presence of problematic side-effects was associated with higher psychological morbidity, poorer self-efficacy, greater unmet needs, and poorer overall health status. Conclusion While some men report relatively few problems after prostate cancer treatment, this study highlights important physical and psycho-social issues for a significant minority of survivors of prostate cancer. Strategies for identifying those men with on-going problems, alongside new interventions and models of care, tailored to individual needs, are needed to improve quality of life.

Objectives To assess the ability of multiphoton microscopy (MPM) to visualise, differentiate and track periprostatic nerves in an in vivo rat model, mimicking real-time imaging in humans during RP and to investigate the tissue toxicity and reproducibility of in vivo MPM on prostatic glands in the rat after imaging and final histological correlation study. Materials and Methods In vivo prostatic rat imaging was carried out using a custom-built bench-top MPM system generating real-time three-dimensional histological images, after performing survival surgery consisting of mini-laparotomies under xylazine/ketamine anaesthesia exteriorising the right prostatic lobe. The acquisition time and the depth of anaesthesia were adjusted for collecting multiple images in order to track the periprostatic nerves in real-time. The rats were then monitored for 15 days before undergoing a new set of imaging under similar settings. After humanely killing the rats, their prostates were submitted for routine histology and correlation studies. Results In vivo MPM images distinguished periprostatic nerves within the capsule and the prostatic glands from fresh unprocessed prostatic tissue without the use of exogenous contrast agents or biopsy sample. Real-time nerve tracking outlining the prostate was feasible and acquisition was not disturbed by motion artefacts. No serious adverse event was reported during rat monitoring; no tissue damage due to laser was seen on the imaged lobe compared with the contralateral lobe (control) allowing comparison of their corresponding histology. Conclusions For the first time, we have shown that in vivo tracking of periprostatic nerves using MPM is feasible in a rat model. Development of a multiphoton endoscope for intraoperative use in humans is currently in progress and must be assessed.

Starting and conducting clinical trials in England can be a complicated and time-consuming process. Before your study can begin it is necessary to gain approval from the appropriate regulatory bodies. Prior to March 2016, studies required National Health Service (NHS) permission (also referred to as Research and Development (R&D) approval) obtained via the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP). Since March 2016, a new streamlined system has been introduced with the aim of making it easier to gain regulatory approvals. Now studies must go through the process of Health Research Authority (HRA) approval. In this article we review the process of gaining HRA approval in England. The article is aimed at junior researchers to help them understand the application process, and to give tips on how to succeed in gaining approval.

Purpose To determine the effect of comorbidity on prostate cancer (PCa)–specific mortality across treatment types. Patients and Methods These are the results of a population-based observational study in Sweden from 1998 to 2012 of 118,543 men who were diagnosed with PCa with a median follow-up of 8.3 years (interquartile range, 5.2 to 11.5 years) until death from PCa or other causes. Patients were categorized by patient characteristics (marital status, educational level) and tumor characteristics (serum prostate-specific antigen, tumor grade and clinical stage) and by treatment type (radical prostatectomy, radical radiotherapy, androgen deprivation therapy, and watchful waiting). Data were stratified by Charlson comorbidity index (0, 1, 2, or ≥ 3). Mortality from PCa and other causes and after stabilized inverse probability weighting adjustments for clinical patient and tumor characteristics and treatment type was determined. Kaplan-Meier estimates and Cox proportional hazards regression models were used to calculate hazard ratios. Results In the complete unadjusted data set, we observed an effect of increased comorbidity on PCa-specific and other-cause mortality. After adjustments for patient and tumor characteristics, the effect of comorbidity on PCa-specific mortality was lost but maintained for other-cause mortality. After additional adjustment for treatment type, we again failed to observe an effect for comorbidity on PCa-specific mortality, although it was maintained for other-cause mortality. Conclusion This large observational study suggests that comorbidity affects other cause–mortality but not PCa-specific– mortality after accounting for patient and tumor characteristics and treatment type. Regardless of radical treatment type (radical prostatectomy or radical radiotherapy), increasing comorbidity does not seem to significantly affect the risk of dying from PCa. Consequently, differences in oncologic outcomes that were observed in population-based comparative effectiveness studies of PCa treatments may not be a result of the varying distribution of comorbidity among treatment groups.