Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Current practises and the future of robotic surgical training.

INTRODUCTION: This study reviews the current state of robotic surgery training for surgeons, including the various curricula, training methods, and tools available, as well as the challenges and limitations of these. METHODS: The authors carried out a literature search across PubMed, MEDLINE, and Google Scholar using keywords related to 'robotic surgery', 'computer-assisted surgery', 'simulation', 'virtual reality', 'surgical training', and 'surgical education'. Full text analysis was performed on 112 articles. TRAINING PROGRAMMES: The training program for robotic surgery should focus on proficiency, deliberation, and distribution principles. The curricula can be broadly split up into pre-console and console-side training. Pre-Console and Console-Side Training: Simulation training is an important aspect of robotic surgery training to improve technical skill acquisition and reduce mental workload, which helps prepare trainees for live procedures. OPERATIVE PERFORMANCE ASSESSMENT: The study also discusses the various validated assessment tools used for operative performance assessments. FUTURE ADVANCES: Finally, the authors propose potential future directions for robotic surgery training, including the use of emerging technologies such as AI and machine learning for real-time feedback, remote mentoring, and augmented reality platforms like Proximie to reduce costs and overcome geographic limitations. CONCLUSION: Standardisation in trainee performance assessment is needed. Each of the robotic curricula and platforms has strengths and weaknesses. The ERUS Robotic Curriculum represents an evidence-based example of how to implement training from novice to expert. Remote mentoring and augmented reality platforms can overcome the challenges of high equipment costs and limited access to experts. Emerging technologies offer promising advancements for real-time feedback and immersive training environments, improving patient outcomes.

Society for Endocrinology guidelines for testosterone replacement therapy in male hypogonadism.

Male hypogonadism (MH) is a common endocrine disorder. However, uncertainties and variations in its diagnosis and management exist. There are several current guidelines on testosterone replacement therapy that have been driven predominantly by single disciplines. The Society for Endocrinology commissioned this new guideline to provide all care providers with a multidisciplinary approach to treating patients with MH. This guideline has been compiled using expertise from endocrine (medical and nursing), primary care, clinical biochemistry, urology and reproductive medicine practices. These guidelines also provide a patient perspective to help clinicians best manage MH.

Feasibility and safety of radical prostatectomy for oligo-metastatic prostate cancer: the Testing Radical prostatectomy in men with prostate cancer and oligo-Metastases to the bone (TRoMbone) trial.

OBJECTIVES: To test the feasibility of randomisation to radical prostatectomy (RP) plus pelvic lymphadenectomy in addition to standard-of-care (SOC) systemic therapy in men with newly diagnosed oligo-metastatic prostate cancer. PATIENTS AND METHODS: A prospective, randomised, non-blinded, feasibility clinical trial with an embedded QuinteT Recruitment Intervention (QRI) to optimise recruitment was conducted in nine nationwide tertiary care centres undertaking high-volume robotic surgery. We aimed to randomise 50 men with synchronous oligo-metastatic prostate cancer within an 18-month recruitment period to SOC systemic therapy vs SOC plus RP (intervention arm). The main outcome measures were: ability to randomise patients, optimised by a QRI; EuroQoL five Dimensions five Levels (EQ-5D-5L) questionnaires to capture quality-of-life (QoL) data at baseline and 3 months post-randomisation; routine clinicopathological assessment to capture adverse events and prostate-specific antigen in both arms, plus standard perioperative parameters in the surgical arm. RESULTS: A total of 51 men were randomised within 14 months (one was subsequently deemed ineligible), with 60-83% accrual rate in centres that recruited at least two patients. All patients completed the trial follow-up; one patient in the intervention arm subsequently did not undergo the surgical intervention and one in the SOC arm refused all therapies. The QRI positively impacted recruitment. QoL data showed similarly high functioning in both study arms. Surgery for men with oligo-metastatic prostate cancer was found to be safe and had similar impact on early functional outcomes as surgery for standard indication. CONCLUSION: It is feasible to randomise men with synchronous oligo-metastatic prostate cancer to a surgical intervention in addition to standard systemic therapies. While surgery appeared safe with no substantial impact on QoL in this feasibility study, a large randomised controlled trial is now warranted to examine treatment effectiveness of this additional component in the multimodality management of oligo-metastatic prostate cancer.

Retzius-Sparing versus Standard Robot-Assisted Radical Prostatectomy: A Comparative Prospective Study of Nearly 500 Patients.

PURPOSE: We compared standard robot-assisted radical prostatectomy and Retzius-sparing robot-assisted radical prostatectomy in a multicenter study using prospective patient reported outcome measures of functional recovery and quality of life plus standard pentafecta outcomes. MATERIALS AND METHODS: Patient and physician reported data on 483 patients who underwent robot-assisted radical prostatectomy and Retzius-sparing robot-assisted radical prostatectomy from August 2017 to April 2020 by 3 experienced surgeons had been prospectively collected. Perioperative and pentafecta outcomes were analyzed using SPSS software. Patient reported outcome measures for urinary function, erectile function and quality of life were reported at baseline and at 7 days and 1, 3, 6, 9 and 12 months postoperatively. RESULTS: A total of 201 patients underwent robot-assisted radical prostatectomy and 282 had Retzius-sparing robot-assisted radical prostatectomy. Patient and tumor characteristics were similar except for fewer low risk and more intermediate risk disease in robot-assisted radical prostatectomy vs Retzius-sparing robot-assisted radical prostatectomy (p <0.001). High risk disease was similar between groups (p=0.071). Immediate urinary continence was higher in Retzius-sparing robot-assisted radical prostatectomy group (70.4% vs 58.1%, p=0.02), with less nocturnal enuresis prevalence (p=0.011) and bother (p=0.009) with no significant differences afterwards. A better quality of life (p=0.004) was reported 1 week after surgery. No other differences in functional or quality of life outcomes, perioperative parameters, complications or margin rates were found. CONCLUSIONS: Retzius-sparing robot-assisted radical prostatectomy is associated with better immediate continence than anterior robot-assisted radical prostatectomy with no differences in longer-term functional recovery, quality of life or other important outcomes. The overall similarity in outcomes between groups lends support to the view that the surgical technique matters less than the surgeon performing it.

Comparative Outcomes of Salvage Retzius-Sparing versus Standard Robotic Prostatectomy: An International, Multi-Surgeon Series.

PURPOSE: Salvage radical prostatectomy is rare due to the risk of postoperative complications. We compare salvage Retzius-sparing robotic assisted radical prostatectomy (SRS-RARP) with salvage standard robotic assisted radical prostatectomy (SS-RARP). MATERIALS AND METHODS: A total of 72 patients across 9 centers were identified (40 SRS-RARP vs 32 SS-RARP). Demographics, perioperative data, and pathological and functional outcomes were compared using Student's t-test and ANOVA. Cox proportional hazard models and Kaplan-Meier curves were constructed to assess risk of incontinence and time to continence. Linear regression models were constructed to investigate postoperative pad use and console time. RESULTS: Median followup was 23 vs 36 months for SRS-RARP vs SS-RARP. Console time and estimated blood loss favored SRS-RARP. There were no differences in complication rates or oncologic outcomes. SRS-RARP had improved continence (78.4% vs 43.8%, p <0.001 for 0-1 pad, 54.1% vs 6.3%, p <0.001 for 0 pad), lower pads per day (0.57 vs 2.03, p <0.001), and earlier return to continence (median 47 vs 180 days, p=0.008). SRS-RARP was associated with decreased incontinence defined as >0-1 pad (HR 0.28, 95% CI 0.10-0.79, p=0.016), although not when defined as >0 pad (HR 0.56, 95% CI 0.31-1.01, p=0.053). On adjusted analysis SRS-RARP was associated with decreased pads per day. Lymph node dissection and primary treatment with stereotactic body radiation therapy were associated with longer console time. CONCLUSIONS: SRS-RARP is a feasible salvage option with significantly improved urinary function outcomes. This may warrant increased utilization of SRS-RARP to manage men who fail nonsurgical primary treatment for prostate cancer.

Outcomes of the RAFT trial: robotic surgery after focal therapy.

OBJECTIVES: To report toxicity of treatment observed in men participating in the Robotic surgery After Focal Therapy (RAFT) clinical trial. PATIENTS AND METHODS: Men were eligible for this prospective single group interventional study if they had histologically confirmed recurrent/residual prostate adenocarcinoma following primary FT. The short-form Expanded Prostate Cancer Index Composite (EPIC-26) measured prior to salvage robotic prostatectomy (S-RARP) and 3-monthly post-operatively together with Clavien-Dindo complications (I-IV). Secondary outcomes included biochemical recurrence-free survival (BCFS) following surgery and need for salvage treatment after surgery. This study is registered with ClinicalTrials.gov NCT03011606. RESULTS: Twenty-four men were recruited between February 2016 and September 2018. 1 patient withdrew from the trial after consenting and before S-RARP. 23 men completed 12-month post S-RARP follow-up. Median EPIC-26 urinary continence scores initially deteriorated after 3 months (82.4 vs 100) but there was no statistically significant difference from baseline at 12 months (100 vs 100, P = 0.31). Median lower urinary tract symptom scores improved after 12 months compared to baseline (93.8 vs 87.5, P = 0.01). At 12 months, 19/23 (83%) were pad-free and 22/23 (96%) required 0/1 pads. Median sexual function subscale scores deteriorated and remained low at 12 months (22.2 vs 58.3, P < 0.001). Utilising a minimally important difference of nine points, at 12 months after surgery 17/23 (74%) reported urinary continence to be 'better' or 'not different' to pre-operative baseline. The corresponding figure for sexual function (utilising a minimally important difference of 12 points) was 7/23 (30%). There was no statistically significant difference on median bowel/hormonal subscale scores. Only a single patient had a post-operative complication (Clavien-Dindo Grade I). BCFS at 12 months after surgery was 82.6% (95% confidence interval [CI]: 60.1-93.1%) while 4/23 (17%) received salvage radiation. CONCLUSIONS: The RAFT clinical trial suggests toxicity of surgery after FT is low, with good urinary function outcomes, albeit sexual function deteriorated overall. Oncological outcomes at 12 months appear acceptable.

Retzius-sparing robot-assisted radical prostatectomy: early learning curve experience in three continents.

OBJECTIVE: To assess the effect of surgical experience on peri-operative, functional and oncological outcomes during the first 50 Retzius-sparing robot-assisted radical prostatectomy (RsRARP) cases performed by surgeons naïve to this novel approach. MATERIALS AND METHODS: We retrospectively evaluated the initial cases operated by 14 surgeons in 12 different international centres. Pre-, peri- and postoperative features of the first 50 patients operated by each surgeon in all the participating centres were collected. The effect of surgical experience on peri-operative, functional and oncological outcomes was firstly evaluated after stratification by level of surgical experience (initial [≤25 cases] and expert [>25 cases]) and after using locally weighted scatterplot smoothing to graphically explore the relationship between surgical experience and the outcomes of interest. RESULTS: We evaluated 626 patients. The median follow-up was 13 months in the initial group and 9 months in the expert group (P = 0.002). Preoperative features overlapped between the two groups. Shorter console time (140 vs 120 min; P = 0.001) and a trend towards lower complications rates (13 vs 5.5%; P = 0.038) were observed in the expert group. The relationship between surgical experience and console time, immediate urinary continence recovery and Clavien-Dindo grade ≥2 complications was linear, without reaching a plateau, after 50 cases. Conversely, a non-linear relationship was observed between surgical experience and positive surgical margins (PSMs). CONCLUSIONS: In this first report of a multicentre experience of RsRARP during the learning curve, we found that console time, immediate urinary continence recovery and postoperative complications are optimal from the beginning and further quickly improve during the learning process, while PSM rates did not clearly improve over the first 50 cases.

Comparing a new risk prediction model with prostate cancer risk calculator apps in a Taiwanese population.

PURPOSE: 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. METHODS: 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 â‰§ 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. RESULTS: 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. CONCLUSION: 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.

Effect of Extended Pelvic Lymph Node Dissection on Oncologic Outcomes in Patients with D'Amico Intermediate and High Risk Prostate Cancer Treated with Radical Prostatectomy: A Multi-Institutional Study.

PURPOSE: 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. MATERIALS AND METHODS: 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 cohorts. Cox regression models were used to test the effect of pelvic lymph node dissection on biochemical recurrence, metastasis and cancer specific mortality. RESULTS: Overall 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). CONCLUSIONS: 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.

The cytoreductive prostatectomy in metastatic prostate cancer: what the individual trials are hoping to answer.

OBJECTIVE: 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. METHODS: PubMed, MEDLINE and clinical trials websites searches were performed to identify currently ongoing trials of CRP in de novo HSPC. RESULTS: 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. CONCLUSION: 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.

Retzius sparing robotic assisted radical prostatectomy vs. conventional robotic assisted radical prostatectomy: a systematic review and meta-analysis.

CONTEXT: 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. OBJECTIVE: To systematically evaluate evidence comparing functional and oncological outcomes of retzius sparing robotic assisted radical prostatectomy and conventional robotic assisted radical prostatectomy. EVIDENCE ACQUISITION: 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. EVIDENCE SYNTHESIS: 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. CONCLUSIONS: 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.

Peri-operative, functional and early oncologic outcomes of salvage robotic-assisted radical prostatectomy after high-intensity focused ultrasound partial ablation.

BACKGROUND: Partial ablation of the prostate using high-intensity focussed ultrasound (HIFU-PA) is a treatment option for localised prostate cancer. When local recurrence occurs, salvage robot-assisted radical prostatectomy is a treatment option for selected patients, but there is a paucity of data on the peri-operative safety, functional and oncologic outcomes of sRARP.. The objective of this study was therefore to describe peri-operative safety, functional and early oncologic outcomes following salvage robot-assisted radical prostatectomy (sRARP) for local recurrence after HIFU-PA. METHODS: Retrospective analysis of a prospective database of 53 consecutive men who underwent sRARP after HIFU-PA from 2012 to 2018. Continence and erectile-function were reported pre-HIFU, pre-sRARP, 3-months post-sRARP and 12-months post-sRARP. Complications, PSMs and need for subsequent ADT/radiotherapy were assessed. RESULTS: 45 men were suitable for inclusion and had sufficient data for analyses. Median duration from HIFU to sRARP was 30.0 months and median follow-up post-sRARP was 17.7 months. Median age, PSA and ISUP group were 63.0 yrs., 7.2 ng/mL and 2; 88.9% were cT2. Median operative-console time, blood loss and hospital stay were 140 min, 200 ml and 1 day respectively. Clavien-Dindo grade 1, 2 and 3 complications < 90 days occurred in 8.9, 6.7 and 2.2%; late (>90d) complications occurred in 13.2%. At sRARP pathology, ISUP 3-5 occurred in 51.1%, pT3a/b in 64.5%, and PSMs in 44.4% (37.5% for pT2, 48.3% for pT3). Of men with > 3-months follow-up after sRARP, 26.3% underwent adjuvant radiotherapy/ADT for residual disease or adverse pathologic features; 5.3% experienced BCR requiring salvage ADT/radiotherapy. Freedom from ADT/radiotherapy was 66.7% at 12-months. Pad-free rates were 100% pre-HIFU, 95.3% post-HIFU, 29.4% 3-months post-sRARP, and 65.5% 12-months post-sRARP. Median IIEF-5 scores pre-HIFU, post-HIFU, 3- and 12-months post-sRARP were 23.5, 16, 5 and 5, respectively. Potency rates were 81.8, 65.5, 0 and 0%, respectively. Bilateral/unilateral nerve sparing were feasible in 7%/22%. CONCLUSION: Salvage RARP was safe with acceptable but sub-optimal continence and poor sexual-function and poor oncologic outcomes. One in three men required additional treatment within 12-months. This information may aid men and urologists with treatment selection and counselling regarding primary HIFU-PA vs primary RARP and when considering salvage RARP.

Prostate Cancer Risk Calculator Apps in a Taiwanese Population Cohort: Validation Study.

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: P<.001) and high-grade PCa (AUC: 0.862 vs 0.758; P<.001) was significantly better for the Rotterdam app. In the prostatectomy cohort, there was no significant difference between both apps (AUC: 0.857 vs 0.777; P=.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.

PEOPLE: PatiEnt prOstate samPLes for rEsearch, a tissue collection pathway utilizing magnetic resonance imaging data to target tumor and benign tissue in fresh radical prostatectomy specimens.

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.

Comparison of Prostate Biopsy with or without Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Detection: An Observational Cohort Study.

PURPOSE: We hypothesized that 1) introducing prebiopsy multiparametric magnetic resonance imaging would increase the diagnostic yield of transrectal prostate biopsy and 2) this would inform recommendations regarding systematic transrectal prostate biopsy in the setting of negative prebiopsy multiparametric magnetic resonance imaging. MATERIALS AND METHODS: A total of 997 biopsy naïve patients underwent transrectal prostate biopsy alone to June 2016 (cohort 1) and thereafter 792 underwent transrectal prostate biopsy following prebiopsy multiparametric magnetic resonance imaging (cohort 2). Patients with lesions on prebiopsy multiparametric magnetic resonance imaging underwent cognitive targeted plus systematic transrectal prostate biopsy. Patients without lesions underwent systematic transrectal prostate biopsy. RESULTS: Cohort 2 comprised younger men (age 68 vs 69 years, p = 0.01) with lower prostate specific antigen (7.6 vs 7.9 ng/ml, p = 0.024) and smaller prostate volume (56.1 vs 62 cc, p = 0.006). In cohort 2 vs cohort 1 there was no increase in overall prostate cancer detection (57.6% vs 56.7%, p = 0.701), the Gleason Grade Group or the number of positive cores (each p >0.05). Increased multifocal prostatic intraepithelial neoplasia, maximum prostate cancer core length (5 mm or greater vs less than 5 mm) and radical surgery/high intensity focused ultrasound (each p <0.05) were observed in cohort 2. For Gleason Grade Group 2-5 prostate cancer negative prebiopsy multiparametric magnetic resonance imaging had 88.1% sensitivity, 59.8% specificity, 67.8% positive predictive value and 84% negative predictive value. For negative prebiopsy multiparametric magnetic resonance images a prostate specific antigen density cutoff of 0.15 ng/ml2 or greater increased clinically significant prostate cancer detection only if the latter was defined as Gleason Grade Group 3-5 disease and/or tumor length 6 mm or greater. CONCLUSIONS: Introducing prebiopsy multiparametric magnetic resonance imaging in our clinical setting increased the diagnostic yield of prostate cancer per biopsy core. Not performing a systematic transrectal prostate biopsy when prebiopsy multiparametric magnetic resonance imaging was negative would have led to under detection of 15.1% of Gleason Grade Group 2 or greater prostate cancer cases (approximately 1 in 6).

Pathological Findings and Magnetic Resonance Imaging Concordance at Salvage Radical Prostatectomy for Local Recurrence following Partial Ablation Using High Intensity Focused Ultrasound.

PURPOSE: We describe the pathological characteristics of recurrence following high intensity focused ultrasound partial ablation in men treated with salvage robot-assisted radical prostatectomy. We assessed the sensitivity of magnetic resonance imaging before salvage robot-assisted radical prostatectomy in these men. MATERIALS AND METHODS: A total of 35 men underwent salvage robot-assisted radical prostatectomy after high intensity focused ultrasound partial ablation from 2012 to 2018. We compared clinicopathological characteristics before ultrasound and before salvage prostatectomy after ultrasound to histopathology on salvage prostatectomy. We assessed infield recurrence, out of field disease, positive surgical margins and magnetic resonance imaging sensitivity before salvage robot-assisted radical prostatectomy. RESULTS: Before high intensity focused ultrasound 55.9% of men had multifocal disease and 47.1% had Gleason 3 + 3 disease outside the treatment field. Median time to salvage prostatectomy was 16 months (IQR 11-26). Indications for salvage prostatectomy were infield recurrence in 55.8% of cases, out of field recurrence in 20.6%, and infield and out of field recurrence in 23.5%. On salvage prostatectomy histopathology revealed significant cancer, defined as ISUP (International Society of Urological Pathology) 2 or greater, infield in 97.1% of cases, out of field in 81.3%, and infield and out of field in 79.4%. Of the cases 82.4% were adversely reclassified at salvage prostatectomy compared to 67.6% before ultrasound. The positive surgical margin rate was 40.0%. Of the positive margins 84.6% were in the region of previous ultrasound despite wide excision, including pT2 in 28.6%, pT3 in 47.6% and size 3 mm or greater, pT3 or multifocal (ie significant) in 31.4%. After ultrasound the sensitivity of magnetic resonance imaging for infield and out of field recurrence was 81.8% and 60.7%, respectively. CONCLUSIONS: Salvage robot-assisted radical prostatectomy may confer a higher risk of positive surgical margins, upgrading and up-staging than primary robot-assisted radical prostatectomy. High intensity focused ultrasound carries a risk of recurrence inside and outside the ablation zone. This information may inform salvage surgical planning and patient counseling regarding the choice of initial therapy and salvage treatment after high intensity focused ultrasound.

Perioperative and oncological outcomes of radical prostatectomy for high-risk prostate cancer in the UK: an analysis of surgeon-reported data.

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.

Differences in trends in the use of robot-assisted and open radical cystectomy and changes over time in peri-operative outcomes among selected centres in North America and Europe: an international multicentre collaboration.

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.

Positive pre-biopsy MRI: are systematic biopsies still useful in addition to targeted biopsies?

PURPOSE: The diagnostic strategy implementing multiparametric magnet resonance tomography (mpMRI) and targeted biopsies (TB) improves the detection and characterization of significant prostate cancer (PCa). We aimed to assess the clinical usefulness of systematic biopsies (SB) in the setting of patients having a pre-biopsy positive MRI. METHODS: A review of the literature was performed in March 2018. All studies investigating the performance of SB in addition to TB (all techniques) were assessed, both in the biopsy-naïve and repeat biopsy setting. RESULTS: Evidence demonstrates that TB improves the detection of index-significant PCa compared with SB alone, in both initial and repeat biopsy settings. However, the combination of both TB and SB improved the overall (around 30%) and significant (around 10%) PCa detection rates as compared with TB alone. Significant differences between both biopsy approaches exist regarding cancer location favoring SB for the far lateral sampling, and TB for the anterior zone. Main current pitfalls of pure TB strategy are the learning curve and experience required for mpMRI reading and biopsy targeting, as well as the precision assessment in TB techniques. CONCLUSION: A pure TB strategy omitting SB leads to the risk of missing up to 15% of significant cancer, due to limitations of mpMRI performance/reading and of precision during lesion targeting. SB remain necessary, in addition to the TB, to obtain the most accurate assessment of the entire prostate gland in this sub-group of patients at risk of significant disease.