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Objective: To determine the risk of disease progression and conversion to active treatment following a negative biopsy while on active surveillance (AS) for prostate cancer (PCa). Patients and Methods: Men on an AS programme at a single tertiary hospital (London, UK) between 2003 and 2018 with confirmed low–intermediate‐risk PCa, Gleason Grade Group <3, clinical stage 30% positive cores, magnetic resonance imaging (MRI) Likert score >3/T3 or PSA level of >20 ng/mL. Conversion to treatment included radical or hormonal treatment. Results: Among the 460 eligible patients, 23% had negative follow‐up biopsy findings. The median follow‐up was 62 months, with one to two repeat biopsies and two MRIs per patient during that period. Negative biopsy findings at first repeat biopsy were associated with decreased risk of converting to active treatment (hazard ration [HR] 0.18, 95% confidence interval [CI] 0.09–0.37; P < 0.001), suspicion of disease progression (HR 0.56, 95% CI: 0.34–0.94; P = 0.029), and upgrading (HR 0.48, 95% CI 0.23–0.99; P = 0.047). Data are limited by fewer men with multiple follow‐up biopsies. Conclusion: A negative biopsy finding at the first scheduled follow‐up biopsy among men on AS for PCa was strongly associated with decreased risk of subsequent upgrading, clinical or radiological suspicion of disease progression, and conversion to active treatment. A less intense surveillance protocol should be considered for this cohort of patients. [ABSTRACT FROM AUTHOR]

Objective: To develop a model and methodology for predicting the risk of Gleason upgrading in patients with prostate cancer on active surveillance (AS) and using the predicted risks to create risk‐based personalised biopsy schedules as an alternative to one‐size‐fits‐all schedules (e.g. annually). Furthermore, to assist patients and doctors in making shared decisions on biopsy schedules, by providing them quantitative estimates of the burden and benefit of opting for personalised vs any other schedule in AS. Lastly, to externally validate our model and implement it along with personalised schedules in a ready to use web‐application. Patients and Methods: Repeat prostate‐specific antigen (PSA) measurements, timing and results of previous biopsies, and age at baseline from the world's largest AS study, Prostate Cancer Research International Active Surveillance (PRIAS; 7813 patients, 1134 experienced upgrading). We fitted a Bayesian joint model for time‐to‐event and longitudinal data to this dataset. We then validated our model externally in the largest six AS cohorts of the Movember Foundation's third Global Action Plan (GAP3) database (>20 000 patients, 27 centres worldwide). Using the model predicted upgrading risks; we scheduled biopsies whenever a patient's upgrading risk was above a certain threshold. To assist patients/doctors in the choice of this threshold, and to compare the resulting personalised schedule with currently practiced schedules, along with the timing and the total number of biopsies (burden) planned, for each schedule we provided them with the time delay expected in detecting upgrading (shorter is better). Results: The cause‐specific cumulative upgrading risk at the 5‐year follow‐up was 35% in PRIAS, and at most 50% in the GAP3 cohorts. In the PRIAS‐based model, PSA velocity was a stronger predictor of upgrading (hazard ratio [HR] 2.47, 95% confidence interval [CI] 1.93–2.99) than the PSA level (HR 0.99, 95% CI 0.89–1.11). Our model had a moderate area under the receiver operating characteristic curve (0.6–0.7) in the validation cohorts. The prediction error was moderate (0.1–0.2) in theGAP3 cohorts where the impact of the PSA level and velocity on upgrading risk was similar to PRIAS, but large (0.2–0.3) otherwise. Our model required re‐calibration of baseline upgrading risk in the validation cohorts. We implemented the validated models and the methodology for personalised schedules in a web‐application (http://tiny.cc/biopsy). Conclusions: We successfully developed and validated a model for predicting upgrading risk, and providing risk‐based personalised biopsy decisions in AS of prostate cancer. Personalised prostate biopsies are a novel alternative to fixed one‐size‐fits‐all schedules, which may help to reduce unnecessary prostate biopsies, while maintaining cancer control. The model and schedules made available via a web‐application enable shared decision‐making on biopsy schedules by comparing fixed and personalised schedules on total biopsies and expected time delay in detecting upgrading. [ABSTRACT FROM AUTHOR]

Objectives: To report the study protocol for the first international multicentre randomized controlled trial investigating the effectiveness of simulation‐based surgical training and the development process for an evidence‐based training curriculum, to be delivered as an educational intervention. Participants and Methods: This prospective, international, multicentre randomized controlled clinical and educational trial will recruit urology surgical trainees who must not have performed ≥10 of the selected index procedure, ureterorenoscopy (URS). Participants will be randomized to simulation‐based training (SBT) or non‐simulation‐based training (NSBT), the latter of which is the current sole standard of training globally. The primary outcome is the number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skills (OSATS) assessment scale, for three consecutive operations, without any complications. All participants will be followed up either until they complete 25 procedures or for 18 months. Development of the URS SBT curriculum took place through a two‐round Delphi process. Results: A total of 47 respondents, consisting of trainees (n = 24) with URS experience and urolithiasis specialists (n = 23), participated in round 1 of the Delphi process. Specialists (n = 10) finalized the content of the curriculum in round 2. The developed interventional curriculum consists of initial theoretic knowledge through didactic lectures followed by select tasks and cases on the URO‐Mentor (Simbionix, Lod, Israel) VR Simulator, Uro‐Scopic Trainer (Limbs & Things, Bristol, UK) and Scope Trainer (Mediskills, Manchester, UK) models for both semi‐rigid and flexible URS. Respondents also selected relevant non‐technical skills scenarios and cadaveric simulation tasks as additional components, with delivery subject to local availability. Conclusions: SIMULATE is the first multicentre trial investigating the effect and transferability of supplementary SBT on operating performance and patient outcomes. An evidence‐based training curriculum is presented, developed with expert and trainee input. Participants will be followed and the primary outcome, number of procedures required to proficiency, will be reported alongside key clinical secondary outcomes, (ISCRTN 12260261). [ABSTRACT FROM AUTHOR]

Abbreviations ABC UK Action Bladder Cancer UK BC bladder cancer TURBT transurethral resection of bladder tumour The COVID-19 pandemic has placed unprecedented strain on healthcare systems worldwide with the requirement to treat large influxes of infected patients, many of whom require respiratory support. BC patients were directed to the survey via the ABC UK website (http://actionbladdercanceruk.org/), ABC UK Patient Support Groups, and social media platforms. The outputs of this survey have demonstrated the considerable disruption to the care of BC patients in the UK during the COVID-19 pandemic. Hence, despite a plethora of recommendations from a number of sources outlining reasonable patient prioritization strategies [2,5-7], these strategies may not have been developed and circulated quickly enough or enacted rapidly enough at or around the peak of the UK pandemic to have made a perceivable difference to patients. [Extracted from the article]

Objectives The Movember Foundation launched the Global Action Plan Prostate Cancer Active Surveillance (GAP3) initiative to create a global consensus on the selection and monitoring of men with low-risk prostate cancer (PCa) on active surveillance (AS). The aim of this study is to present data on inclusion and follow-up for AS in this unique global AS database. Patients and Methods Between 2014 and 2016, the database was created by combining patient data from 25 established AS cohorts worldwide (USA, Canada, Australasia, UK and Europe). Data on a total of 15 101 patients were included. Descriptive statistics were used to report patients' clinical and demographic characteristics at the time of PCa diagnosis, clinical follow-up, discontinuation of AS and subsequent treatment. Cumulative incidence curves were used to report discontinuation rates over time. Results At diagnosis, the median (interquartile range [IQR]) patient age was 65 (60-70) years and the median prostate-specific antigen level was 5.4 (4.0-7.3) ng/mL. Most patients had clinical stage T1 disease (71.8%), a biopsy Gleason score of 6 (88.8%) and one tumour-positive biopsy core (60.3%). Patients on AS had a median follow-up time of 2.2 (1.0-5.0) years. After 5, 10 and 15 years of follow-up, respectively, 58%, 39% and 23% of patients were still on AS. The current version of GAP3 has limited data on magnetic resonance imaging (MRI), quality of life and genomic testing. Conclusions GAP3 is the largest worldwide collaboration integrating patient data from men with PCa on AS. The results will allow individual patients and clinicians to have greater confidence in the personalized decision to either delay or proceed with active treatment. Longer follow-up and the evaluation of MRI, new genomic markers and patient-related outcomes will result in even more valuable data and eventually in better patient outcomes. [ABSTRACT FROM AUTHOR]

Objective To identify preoperative factors that predict 30-day mortality in patients undergoing simultaneous cardiac and renal surgery for urological tumours involving the peri-diaphragmatic vena cava and right atrium- The ability to predict mortality and therefore avoid surgery in those patients likely to die would be valuable. Patients and Methods We retrospectively reviewed perioperative outcomes in patients managed between December 2007 and January 2016 by a single team. The relationships of outcome measurements were analysed using Fisher's exact and Mann-Whitney U-tests. Results Of the 46 patients identified, 41 (89%) underwent surgery (20 males and 21 females). The median (range) age was 65 (17-95) years. Histology confirmed 37 renal cell cancers, one adrenal cancer, two primitive neuroectodermal tumours, and one leiomyosarcoma. The overall 30-day mortality rate was 7% (three of 41 patients). The international normalised ratio ( INR), age, and estimated glomerular filtration rate ( eGFR) correlated significantly with 30-day mortality. The mortality rate was high in patients with an INR ≥1.5 and <1.5 (with three of the five patients dying) compared to those with an INR <1.5 (0/36 patients died; 30 day mortality 0%). The INR correlated with serious complications (≥Clavien-Dindo Grade III), which occurred in all five patients with an INR ≥1.5 and <1.5 vs 12/36 (33%) with an INR <1.5 ( P < 0.002). The median (range) eGFR in those that died was 36 (26-37) mL/min/1.73 m2 compared to 52 (24-154) mL/min/1.73 m2 in those that survived ( P = 0.018). Conclusions In patients undergoing combined cardiac and renal tumour surgery raised preoperative INR is associated with a high risk of 30-day mortality when the patient is elderly (>70 years) and of significant post-operative complications in younger patients (<70 years). Surgery in patients with a normal INR is challenging but much safer. [ABSTRACT FROM AUTHOR]

Objectives To investigate the risk of thromboembolic disease ( TED) in men with prostate cancer ( PCa) on androgen deprivation therapy ( ADT), while accounting for known TED risk factors. Materials and Methods We assessed TED risk for 42 263 men with PCa who were receiving ADT compared with a matched cohort of 190 930 without PCa. The associations between ADT and deep vein thrombosis ( DVT) or pulmonary embolism ( PE) were analysed using multivariate Cox proportional hazard regression models, while accounting for previous PCa-related surgeries and the following proxies for disease progression: transurethral resection of the prostate, palliative radiotherapy and nephrostomy. Results Between 1997 and 2013, 11 242 men with PCa received anti-androgen monotherapy, 26 959 men received gonadotropin-releasing hormone (Gn RH) agonists, 1 091 men received combined androgen blockade and 3 789 men underwent orchiectomy. When accounting for previous surgeries and proxies of disease progression, Gn RH agonist users and surgically castrated men had a higher risk of TED than the comparison cohort: hazard ratios ( HRs) 1.67 (95% confidence interval [ CI] 1.40-1.98) and 1.61 (95% CI 1.15-2.28), respectively. Men on anti-androgen monotherapy had a lower risk: HR for DVT 0.49 (95% CI 0.33-0.74). TED risk was highest among those who switched from anti-androgen to Gn RH agonists: HR for PE 2.55 (95% CI 1.76-3.70). This increased from 2.52 (95% CI 1.54-4.12) in year 1, to 4.05 (95% CI 2.51-6.55) in year 2. Conclusion The incidence of TED among men on ADT increased with the duration of therapy and the risk was highest for those who switched regimen, suggesting that disease progression as well as ADT contribute to the propagation of TED risk. Nonetheless, these findings support the hypothesis that only men with a relevant indication should receive systemic ADT. [ABSTRACT FROM AUTHOR]