Preclinical evaluation of the Versius surgical system: A next-generation surgical robot for use in minimal access prostate surgery.

Objectives: To evaluate the Versius surgical system for robot-assisted prostatectomy in a preclinical cadaveric model using varying system setups and collect surgeon feedback on the performance of the system and instruments, in line with IDEAL-D recommendations. Materials and methods: Procedures were performed in cadaveric specimens by consultant urological surgeons to evaluate system performance in completing the surgical steps required for a prostatectomy. Procedures were conducted using either a 3-arm or 4-arm bedside unit (BSU) setup. Optimal port placements and BSU layouts were determined and surgeon feedback collected. Procedure success was defined as the satisfactory completion of all steps of the procedure, according to the operating surgeon. Results: All four prostatectomies were successfully completed; two were completed with a 3-arm BSU setup and two using a 4-arm BSU setup. Small adjustments were made to the port and BSU positioning, according to surgeon preference, in order to complete the surgical steps. The surgeons noted some instrument difficulties with the Monopolar Curved Scissor tip and the Needle Holders, which were subsequently refined between the first and second sessions of the study, in line with surgeon feedback. Three cystectomies were also successfully completed, demonstrating the capability of the system to perform additional urological procedures. Conclusions: This study provides a preclinical assessment of a next-generation surgical robot for prostatectomies. All procedures were completed successfully, and port and BSU positions were validated, thus supporting the progression of the system to further clinical development according to the IDEAL-D framework.

A Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer: Preclinical Evaluation and Interim Results From a Multicenter Clinical Trial.

PURPOSE: This study evaluated the performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node dissection (SLND) in a pelvic phantom, porcine model, and in PCa patients as part of an ongoing prospective multicenter clinical trial. METHODS: Two design variants of the drop-in gamma probe (SENSEI; Lightpoint Medical Ltd) were assessed in the pelvic phantom, and the preferred design was evaluated in a porcine model with clinically representative volumes and 99mTc activities. In the clinical trial, radical prostatectomy, SLND, and extended pelvic lymph node dissection were performed the day after 99mTc-nanocolloid injection and imaging. Sentinel lymph nodes (SLNs) were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). An interim analysis was performed after 10 patients were recruited. RESULTS: The narrow field of view probe design outperformed the wide field of view design in the pelvic phantom (detection rate, 100% vs 50%). In the porcine model, all activity concentrations could be successfully detected. The drop-in gamma probe successfully detected SLNs in all 10 patients (detection rate, 100%). Two of the SLNs identified by the drop-in gamma probe could not be found with the RLGP. No false-negative cases and no adverse events related to the SLND procedure or the drop-in gamma probe occurred. CONCLUSION: The drop-in gamma probe meets the usability and performance requirements for SLND in PCa and provides performance advantages over the RLGP. The final clinical study results will confirm the performance of the technique across multiple sites.

Neurovascular structure-adjacent frozen-section examination robotic-assisted radical prostatectomy: outcomes from 500 consecutive cases in the UK.

The purpose is to report the United Kingdom's largest single-centre experience of robotically assisted laparoscopic radical prostatectomies (RALP), using the neurovascular structure-adjacent frozen-section (NeuroSAFE) technique. We describe the utilisation and outcomes of this technique. This is a retrospective study from 2012 to 2019 on 520 patients undergoing NeuroSAFE RALP at our Institution. Our Institution's database was analysed for false-positive frozen-section (FS) margins as confirmed on paraffin histopathological analysis: functional outcomes of potency, continence, and biochemical recurrence (BCR). The median (range) of console time was 145 (90-300) min. In our cohort, positive FS was seen in 30.7% (160/520) of patients, with a confirmatory paraffin analysis in 91.8% of our patients' cohort (147/160). The neurovascular bundles (NVBs) that underwent secondary resection contained tumour in 26.8% (43/160) of the cases. Biochemical recurrence (BCR) was 6.7% (35/520), of which FS was positive in 40% (14/35) of those cases. There were insufficient evidence of a statistical association of urinary incontinence and positive surgical margin rates according to NS or NVB resection. NeuroSAFE enables intraoperative confirmation of the oncologic safety of a NS procedure. Patients with a positive FS on NeuroSAFE can be converted to a negative surgical margin (NSM) by ipsilateral wide resection. This spared 1 in 4 men from positive margins posterolaterally in our series. Limitations are the absence of a matched contemporary cohort of NS RALP without NeuroSAFE in our centre.

Single tertiary cancer center experience on the management of pT3b prostate cancer after robotic-assisted laparoscopic prostatectomy.

Background: Pathological involvement of the seminal vesicle poses a treatment dilemma following robotic prostatectomy. Margin status plays an important role in deciding further management. A wide range of treatment options are available, including active monitoring, adjuvant radiotherapy, salvage radiotherapy, and occasionally androgen deprivation therapy. Patients undergoing postoperative radiotherapy tend to have higher risk of urinary and bowel morbidities. The recent RADICALS-RT concluded that adjuvant radiotherapy did not have any benefit compared with salvage radiotherapy. We aim to audit the incidence, margin status, and management of T3b cancer cases at our center. Materials and methods: A retrospective analysis was conducted of all patients diagnosed with pathological T3b (pT3b) prostate cancer following robotic-assisted laparoscopic prostatectomy from January 2012 to July 2020. Preoperative parameters analyzed included prostate-specific antigen (PSA), T stage, and age. A chi-square test and 2-tailed t test were used to determine the relationship between categorical and continuous variables, respectively. Kaplan-Meier survival curves were generated to assess overall survival in patients with pT3b prostate cancer and used to compare unadjusted progression-free survival among those who underwent adjuvant and salvage radiotherapy. Results: A total of 83 (5%) of 1665 patients who underwent robotic prostatectomy were diagnosed with pT3b prostate cancer between January 2012 and July 2020. Among these, 36 patients (44%) did not receive any radiotherapy during follow-up, compared with 26 patients (31%) who received adjuvant radiotherapy and 21 (25%) who received salvage radiotherapy. The median age of our cohort was 64 (SD, 6.4) years. Mean PSA at presentation was 12.7 µg/L. Positive margins were seen in 36 patients (43%); however, there was no statistically significant difference between treatment groups (p = 0.49). The median overall survival was 96%. There was no significant difference between the adjuvant and salvage groups in terms of biochemical progression-free survival (p = 0.66). Five-year biochemical progression-free survival was 94% for those in the adjuvant radiotherapy group and 97% for those in the salvage radiotherapy group. Conclusions: Our audit corroborates with the recently concluded RADICALS-RT study, although we had fewer patients with positive margins. Radiotherapy can be avoided in patients with T3b prostate cancer, even if margin is positive, until there is definitive evidence of PSA recurrence. In keeping with the conclusion of RADICALS-RT, salvage radiotherapy may be preferable to adjuvant radiotherapy.

The clinical and financial implications of a decade of prostate biopsies in the NHS: analysis of Hospital Episode Statistics data 2008-2019.

OBJECTIVE: To evaluate the clinical and financial implications of a decade of prostate biopsies performed in the UK National Health Service (NHS) through the transrectal (TR) vs the transperineal (TP) route. METHODS: We conducted an evaluation of the TR vs the TP biopsy approach in the context of 28 days post-procedure complications and readmissions. A secondary evaluation of burden of expenditure in NHS hospitals over the entire decade (2008-2019) was conducted through examination of national Hospital Episode Statistics (HES) data. RESULTS: In this dataset of 486 467 prostate biopsies (387 879 TR and 98 588 TP biopsies), rates of infection and sepsis were higher for the TR compared to the TP cohort (0.53% vs 0.31%; P < 0.001, confidence interval 99% ). Rates of sepsis have more than doubled for TR biopsies in the last 2 years compared to the previous decade (1.12% vs 0.53%). Infective complications were the main reasons for readmissions in the TR cohort, whereas urinary retention was the predominant reason for readmission in the TP cohort. Over the last decade, non-elective (NEL) readmissions seem higher for the TP group; however, in the last 2 years these have reduced compared to the TR group (3.54% vs 3.74%). The cost estimates for NEL readmissions for the entire decade were £33,589,527.00 and £7,179,926.00 respectively, for TR and TP cohorts (P < 0.001). Estimated costs per patient readmission were £2,225.00 and £1,758.00 in the TR and TP groups (P < 0.001). CONCLUSIONS: Evaluation of nearly half a million prostate biopsies in the NHS over the entire decade gives sufficient evidence for the distinct advantages of the TP route over the TR route in terms of reduced infections and burden of expenditure. In addition, there is a potential for savings both in upstream and downstream costs if biopsy is performed under a local anaesthetic.

Robot-assisted vs open radical cystectomy for bladder cancer in adults.

BACKGROUND: It has been suggested that, in comparison with open radical cystectomy (ORC), robot-assisted radical cystectomy (RARC) results in less blood loss, shorter convalescence and fewer complications, with equivalent short-term oncological and functional outcomes; however, uncertainty remains as to the magnitude of these benefits. OBJECTIVES: To assess the effects of RARC vs ORC in adults with bladder cancer. SEARCH METHODS: We conducted a comprehensive search, with no restrictions on language of publication or publication status, for randomized controlled trials (RCTs) that compared RARC with ORC. The date of the last search was 1 July 2018. Databases searched included the Cochrane Central Register of Controlled Trials, MEDLINE (1999 to July 2018), PubMed Embase (1999 to July 2018), Web of Science (1999 to July 2018), Cancer Research UK (www.cancerresearchuk.org/), and the Institute of Cancer Research (www.icr.ac.uk/). We also searched the following trial registers: ClinicalTrials.gov (clinicaltrials.gov/); BioMed Central International Standard Randomized Controlled Trials Number (ISRCTN) Registry (www.isrctn.com); and the World Health Organization International Clinical Trials Registry Platform. The review was based on a published protocol. Primary outcomes of the review were recurrence-free survival and major postoperative complications (Clavien grade III to V). Secondary outcomes were minor postoperative complications (Clavien grades I and II), transfusion requirement, length of hospital stay (days), quality of life, and positive surgical margins (%). Three review authors independently assessed relevant titles and abstracts of records identified by the literature search to determine which studies should be assessed further. Two review authors assessed risk of bias using the Cochrane risk-of-bias tool and rated the quality of evidence according to GRADE. We used Review Manager 5 to analyse the data. RESULTS: We included in the review five RCTs comprising a total of 541 participants. Total numbers of participants included in the ORC and RARC cohorts were 270 and 271, respectively. We found that RARC and ORC may result in a similar time to recurrence (hazard ratio 1.05, 95% confidence interval [CI] 0.77 to 1.43; two trials, low-certainty evidence). In absolute terms at 5 years of follow-up, this corresponds to 16 more recurrences per 1000 participants (95% CI 79 fewer to 123 more) with 431 recurrences per 1000 participants for ORC. We downgraded the certainty of evidence because of study limitations and imprecision. RARC and ORC may result in similar rates of major complications (risk ratio [RR] 1.06, 95% CI 0.76 to 1.48; five trials, low-certainty evidence). This corresponds to 11 more major complications per 1000 participants (95% CI 44 fewer to 89 more). We downgraded the certainty of evidence because of study limitations and imprecision. We were very uncertain whether RARC reduces minor complications (very-low-certainty evidence). We downgraded the certainty of evidence because of study limitations and very serious imprecision. RARC probably results in substantially fewer transfusions than ORC (RR 0.58, 95% CI 0.43 to 0.80; two trials, moderate-certainty evidence). This corresponds to 193 fewer transfusions per 1000 participants (95% CI 262 fewer to 92 fewer) based on 460 transfusion per 1000 participants for ORC. We downgraded the certainty of evidence because of study limitations. RARC may result in a slightly shorter hospital stay than ORC (mean difference -0.67, 95% CI -1.22 to -0.12; five trials, low-certainty evidence). We downgraded the certainty of evidence because of study limitations and imprecision. RARC and ORC may result in a similar quality of life (standardized mean difference 0.08, 95% CI 0.32 lower to 0.16 higher; three trials, low-certainty evidence). We downgraded the certainty of evidence because of study limitations and imprecision. RARC and ORC may result in similar positive surgical margin rates (RR 1.16, 95% CI 0.56 to 2.40; five trials, low-certainty evidence). This corresponds to eight more (95% CI 21 fewer to 67 more) positive surgical margins per 1000 participants, based on 48 positive surgical margins per 1000 participants for ORC. We downgraded the certainty of evidence because of study limitations and imprecision. CONCLUSIONS: We conclude that RARC and ORC may have similar outcomes with regard to time to recurrence, rates of major complications, quality of life, and positive surgical margin rates (all low-certainty evidence). We are very uncertain whether the robotic approach reduces rates of minor complications (very-low-certainty evidence), although it probably reduces the risk of blood transfusions substantially (moderate-certainty evidence) and may reduce hospital stay slightly (low-certainty evidence). We were unable to conduct any of the preplanned subgroup analyses to assess the impact of patient age, pathological stage, body habitus, or surgeon expertise on outcomes. This review did not address issues of cost-effectiveness.

The role of extended venous thromboembolism prophylaxis for major urological cancer operations.

OBJECTIVES: Venous thromboembolism (VTE), consisting of both pulmonary embolism (PE) and deep vein thromboses (DVT), remains a well-recognised complication of major urological cancer surgery. Several international guidelines recommend extended thromboprophylaxis (ETP) with LMWH, whereby the period of delivery is extended to the post-discharge period, where the majority of VTE occurs. In this literature review we investigate whether ETP should be indicated for all patients undergoing major urological cancer surgery, as well procedure specific data that may influence a clinician's decision. METHODS: We performed a search of six databases (PubMed, Cochrane, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and British Nursing Index (BNI)) from inception to June 2019, for studies looking at adult patients who received VTE prophylaxis after surgery for a major urological malignancy. RESULTS: Eighteen studies were analysed. VTE risk is highest in open and robotic Radical Cystectomy (RC) (2.6-11.6%) and ETP demonstrates a significant reduction in risk of VTE, but not a significant difference in Pulmonary Embolism (PE) or mortality. Risk of VTE in open Radical Prostatectomy (RP) (0.8-15.7%) is comparable to RC, but robotic RP (0.2-0.9%), open partial/radical nephrectomy (1.0-4.4%) and robotic partial/radical nephrectomy (0.7-3.9%) were lower risk. It has not been shown that ETP reduces VTE risk specifically for RP or nephrectomy. CONCLUSION: The decision to use ETP is a fine balance between variables such as VTE incidence, bleeding risk and perioperative morbidity/mortality. This balance should be assessed for each specific procedure type. While ETP still remains of net benefit for open RP as well as open and robotic RC, the balance is closer for minimally invasive RP as well as radical and partial nephrectomy. Due to a lack of procedure specific evidence for the use of ETP, adherence with national guidelines remains poor. Therefore, we advocate further studies directly comparing ETP vs standard prophylaxis, for specific procedure types, in order to allow clinicians to make a more informed decision in future.

NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy for men with localised prostate cancer (NeuroSAFE PROOF): protocol for a randomised controlled feasibility study.

INTRODUCTION: Robot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of 'standard of practice' RALP. METHODS: NeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life. ETHICS AND DISSEMINATION: NeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03317990.

Robotic versus open radical cystectomy for bladder cancer in adults.

BACKGROUND: It has been suggested that in comparison with open radical cystectomy, robotic-assisted radical cystectomy results in less blood loss, shorter convalescence, and fewer complications with equivalent short-term oncological and functional outcomes; however, uncertainty remains as to the magnitude of these benefits. OBJECTIVES: To assess the effects of robotic-assisted radical cystectomy versus open radical cystectomy in adults with bladder cancer. SEARCH METHODS: Review authors conducted a comprehensive search with no restrictions on language of publication or publication status for studies comparing open radical cystectomy and robotic-assisted radical cystectomy. The date of the last search was 1 July 2018 for the Cochrane Central Register of Controlled Trials, MEDLINE (1999 to July 2018), PubMed Embase (1999 to July 2018), Web of Science (1999 to July 2018), Cancer Research UK (www.cancerresearchuk.org/), and the Institute of Cancer Research (www.icr.ac.uk/). We searched the following trials registers: ClinicalTrials.gov (clinicaltrials.gov/), BioMed Central International Standard Randomized Controlled Trials Number (ISRCTN) Registry (www.isrctn.com), and the World Health Organization International Clinical Trials Registry Platform. SELECTION CRITERIA: We searched for randomised controlled trials that compared robotic-assisted radical cystectomy (RARC) with open radical cystectomy (ORC). DATA COLLECTION AND ANALYSIS: This study was based on a published protocol. Primary outcomes of the review were recurrence-free survival and major postoperative complications (class III to V). Secondary outcomes were minor postoperative complications (class I and II), transfusion requirement, length of hospital stay (days), quality of life, and positive margins (%). Three review authors independently assessed relevant titles and abstracts of records identified by the literature search to determine which studies should be assessed further. Two review authors assessed risk of bias using the Cochrane risk of bias tool and rated the quality of evidence according to GRADE. We used Review Manager 5 to analyse the data. MAIN RESULTS: We included in the review five randomised controlled trials comprising a total of 541 participants. Total numbers of participants included in the ORC and RARC cohorts were 270 and 271, respectively.Primary outomesTime-to-recurrence: Robotic cystectomy and open cystectomy may result in a similar time to recurrence (hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.77 to 1.43); 2 trials; low-certainty evidence). In absolute terms at 5 years of follow-up, this corresponds to 16 more recurrences per 1000 participants (95% CI 79 fewer to 123 more) with 431 recurrences per 1000 participants for ORC. We downgraded the certainty of evidence for study limitations and imprecision.Major complications (Clavien grades 3 to 5): Robotic cystectomy and open cystectomy may result in similar rates of major complications (risk ratio (RR) 1.06, 95% CI 0.76 to 1.48); 5 trials; low-certainty evidence). This corresponds to 11 more major complications per 1000 participants (95% CI 44 fewer to 89 more). We downgraded the certainty of evidence for study limitations and imprecision.Secondary outcomesMinor complications (Clavien grades 1 and 2): We are very uncertain whether robotic cystectomy may reduce minor complications (very low-certainty evidence). We downgraded the certainty of evidence for study limitations and for very serious imprecision.Transfusion rate: Robotic cystectomy probably results in substantially fewer transfusions than open cystectomy (RR 0.58, 95% CI 0.43 to 0.80; 2 trials; moderate-certainty evidence). This corresponds to 193 fewer transfusions per 1000 participants (95% CI 262 fewer to 92 fewer) based on 460 transfusion per 1000 participants for ORC. We downgraded the certainty of evidence for study limitations.Hospital stay: Robotic cystectomy may result in a slightly shorter hospital stay than open cystectomy (mean difference (MD) -0.67, 95% CI -1.22 to -0.12); 5 trials; low-certainty evidence). We downgraded the certainty of evidence for study limitations and imprecision.Quality of life: Robotic cystectomy and open cystectomy may result in a similar quality of life (standard mean difference (SMD) 0.08, 95% CI 0.32 lower to 0.16 higher; 3 trials; low-certainty evidence). We downgraded the certainty of evidence for study limitations and imprecision.Positive margin rates: Robotic cystectomy and open cystectomy may result in similar positive margin rates (RR 1.16, 95% CI 0.56 to 2.40; 5 trials; low-certainty evidence). This corresponds to 8 more (95% CI 21 fewer to 67 more) positive margins per 1000 participants based on 48 positive margins per 1000 participants for ORC. We downgraded the certainty of evidence for study limitations and imprecision. AUTHORS' CONCLUSIONS: Robotic cystectomy and open cystectomy may have similar outcomes with regard to time to recurrence, rates of major complications, quality of life, and positive margin rates (all low-certainty evidence). We are very uncertain whether the robotic approach reduces rates of minor complications (very low-certainty evidence), although it probably reduces the risk of blood transfusions substantially (moderate-certainty evidence) and may reduce hospital stay slightly (low-certainty evidence). We were unable to conduct any of the preplanned subgroup analyses to assess the impact of patient age, pathological stage, body habitus, or surgeon expertise on outcomes. This review did not address issues of cost-effectiveness.

Single-centre Experience of Use of Radium 223 with Clinical Outcomes Based on Number of Cycles and Bone Marrow Toxicity.

BACKGROUND: Bone is the most common site of metastatic disease in advanced prostate cancer. Radium-223 (223Ra) is a calcium-mimetic alpha-particle emitter, which has been shown to have activity in prostate cancer with clinical benefit in patients with symptomatic bone metastasis. The recommended schedule is six cycles of 223Ra, 5 kBq/kg, at 4-weekly intervals. Although previous studies have assessed clinical outcomes in patients who received six cycles of Ra223, there is very little information about outcomes of patients receiving fewer courses of treatment. PATIENTS AND METHODS: Patients with hormone-refractory metastatic prostate cancer treated from May 2014 to August 2016 were included in this retrospective study. A total of 113 patients were identified with a median age of 76 (range=52-92) years. The median number of cycles administered was 5 (range=1-6) with 54 (48%) completing six cycles of treatment. Eighty-five patients (75%) received 223Ra prior to docetaxel chemotherapy and 28 (25%) received it after receiving docetaxel. RESULTS: Eleven patients developed grade 2/3 thrombocytopenia, and none of these received further 223Ra. Only 25% of patients who had a haemoglobin level of 10 g/dl or below at the start of the treatment were able to complete six courses of 223Ra. Of the patients who completed fewer than six cycles of 223Ra (1-5 cycles), the survival was 121 days, compared to 398 days in men who received six cycles (odds ratio(OR)=4.767, 95% confidence internal(CI)=1.07-21.25; p=0.0005). CONCLUSION: Careful selection of patients is essential to obtain good clinical outcomes from 223Ra therapy. When fewer than six cycles were delivered then a beneficial survival effect was not seen.

National implementation of multi-parametric magnetic resonance imaging for prostate cancer detection - recommendations from a UK consensus meeting.

OBJECTIVES: To identify areas of agreement and disagreement in the implementation of multi-parametric magnetic resonance imaging (mpMRI) of the prostate in the diagnostic pathway. MATERIALS AND METHODS: Fifteen UK experts in prostate mpMRI and/or prostate cancer management across the UK (involving nine NHS centres to provide for geographical spread) participated in a consensus meeting following the Research and Development Corporation and University of California-Los Angeles (UCLA-RAND) Appropriateness Method, and were moderated by an independent chair. The experts considered 354 items pertaining to who can request an mpMRI, prostate mpMRI protocol, reporting guidelines, training, quality assurance (QA) and patient management based on mpMRI levels of suspicion for cancer. Each item was rated for agreement on a 9-point scale. A panel median score of ≥7 constituted 'agreement' for an item; for an item to reach 'consensus', a panel majority scoring was required. RESULTS: Consensus was reached on 59% of items (208/354); these were used to provide recommendations for the implementation of prostate mpMRI in the UK. Key findings include prostate mpMRI requests should be made in consultation with the urological team; mpMRI scanners should undergo QA checks to guarantee consistently high diagnostic quality scans; scans should only be reported by trained and experienced radiologists to ensure that men with unsuspicious prostate mpMRI might consider avoiding an immediate biopsy. CONCLUSIONS: Our consensus statements demonstrate a set of criteria that are required for the practical dissemination of consistently high-quality prostate mpMRI as a diagnostic test before biopsy in men at risk.

The British Association of Urological Surgeons (BAUS) radical prostatectomy audit 2014/2015 - an update on current practice and outcomes by centre and surgeon case-volume.

OBJECTIVES: To describe contemporary radical prostatectomy (RP) practice using the British Association of Urological Surgeons (BAUS) data and audit project and to observe differences in practice in relation to surgeon or centre case-volume. PATIENTS AND METHODS: Data on 13 920 RP procedures performed by 179 surgeons across 86 centres were recorded on the BAUS data and audit platform between 1 January 2014 and 31 December 2015. This equates to ~95% of total RPs performed over this period when compared to Hospital Episode Statistics (HES) data. Centre case-volumes were categorised as 'high' (>200), 'medium' (100-200) and 'low' (<100); surgeon case-volumes were categorised as 'high' (>100) and 'low' (<100). Differences in surgical practice and selected outcome measures were observed between groups. All data and volume categories were for the combined 2-year period. RESULTS: The median number of RPs performed over the 2-year period was 63.5 per surgeon and 164 per centre. Overall, surgical approach was robot-assisted laparoscopic RP (RALP) in 65%, laparoscopic RP (LRP) in 23%, and open RP (ORP) in 12%. The dominant approach in high-case-volume centres and by high-case-volume surgeons was RALP (74.3% and 69.2%, respectively). There was a greater percentage of ORPs reported by low-volume surgeons and centres when compared to higher volume equivalents. In all, 51.6% of all patients in this series underwent RP in high-case-volume centres using robot-assisted surgery (RAS). High-case-volume surgeons performed nerve-sparing (NS) procedures on 57.3% of their cases; low-volume surgeons performing NS on 48.2%. Overall, lymph node dissection (LND) rates were very similar across the groups. An 'extended' LND was more commonly performed in high-volume centres (22.1%). The median length of stay (LOS) was lowest in patients undergoing RALP at high-volume centres (1 day) and highest in ORP across all volume categories (3-4 days). Reported pT2 positive surgical margin (PSM) rate varied by technique, centre volume, and surgeon volume. In general, observed PSM rates were lower when RALP was the surgical approach (14.4%) and when high-volume surgeons were compared to low-volume surgeons (13.6% vs 17.7%). Transfusion rates were highest in ORP across all centres and surgeons (2.96-4.49%) compared to techniques using a minimally-invasive approach (0.25-2.41%). Training cases ranged from 0.5% in low-volume centres to 6.0% in high-volume centres. CONCLUSIONS: Compliance with data registration for centres and surgeons performing RP is high in the present series. Most RPs were performed in high-case-volume centres and by high-case-volume surgeons, with the most common approaches being minimally invasive and specifically RAS. High-case-volume centres and surgeons reported higher rates of extended LND and training cases. Higher-case-volume surgeons reported lower pT2 PSM rates, whilst the most marked differences in transfusion rates and LOS were seen when ORP was compared to minimally invasive approaches. Caution must be applied when interpreting these differences on the basis of this being registry data - causality cannot be assumed.

Is Cryotherapy a Genuine Rival to Robotic-assisted Partial Nephrectomy in the Management of Suspected Renal Malignancy? A Systematic Review and Meta-analysis.

We systematically reviewed the world literature and compare oncological outcomes, morbidity, renal function, and perioperative outcome between cryotherapy and robotic-assisted partial nephrectomy (RAPN) for suspected renal malignancy. There was a statistically significant difference in "recurrence rates" between the 2 techniques, favoring the RAPN cohort. There was no statistically significant difference in overall and ≥Clavien 3a complication rates between the 2 techniques. The quality of evidence for recurrence rates, overall complication, and ≥Clavien 3a were "moderate", "low," and "very low," respectively, on GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. If a nephron sparing approach is indicated, RAPN should be the approach of choice.

Short-term Outcomes and Costs Following Partial Nephrectomy in England: A Population-based Study.

BACKGROUND: The benefits of minimally invasive partial nephrectomy (PN) for localised renal cancers are well established. Outcomes and hospital activity following PN have not been studied for the English National Health System, despite a growing use of robotic-assisted PN (RAPN). OBJECTIVE: To compare 90-d complication rates and 1-yr hospital activity and costs following PN using routinely-collected national data. DESIGN, SETTING, AND PARTICIPANTS: We analysed Hospital Episode Statistics data for 4275 patients undergoing open PN (OPN), laparoscopic PN, or RAPN between October 2008 and September 2014. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Hospital activity and costs estimated using multivariate Generalised Linear Models. Logistic regression was used to model postoperative complications. RESULTS AND LIMITATIONS: Compared with RAPN, OPN experienced more frequent 90-d readmissions for wound-related complications (n=68 vs n=3, p=0.014) and postoperative infections (n=151 vs n=11, p=0.045). One-year inpatient admissions were higher in OPN (incidence rate: 1.628 vs 0.928, p=0.004). Outcomes in laparoscopic PN and RAPN were equivalent. In comparison to OPN, RAPN was associated with lower complication-related costs at 90 d (mean £317.21 vs £129.29, p=0.002) and total costs at 1 yr (mean £2998.55 vs £2089.37, p=0.024). Limitations were the absence of clinical indicators for risk adjustment. CONCLUSIONS: Hospital activity is significantly lower in the year immediately following RAPN compared with OPN. This is driven in part by a reduction in postoperative complications requiring readmission, reflecting lower total costs. PATIENT SUMMARY: We analysed national data for 4275 patients undergoing partial nephrectomy via open, laparoscopic, or robotic assisted laparoscopic surgery in England over a 6-yr period. Robotic assisted laparoscopic surgery was associated with fewer 90-d complications and lower total costs at 1-yr postintervention.

Atypical Small Acinar Proliferation and High Grade Prostatic Intraepithelial Neoplasia: Should We Be Concerned? An Observational Cohort Study with a Minimum Follow-Up of 3 Years.

INTRODUCTION: Atypical small acinar proliferation (ASAP) and high grade prostatic intraepithelial neoplasia (HGPIN) are considered precancerous. We aimed to measure the rate of repeat biopsy and adenocarcinoma in patients with ASAP and HGPIN and identify any clinico-pathologic parameters at diagnosis of ASAP/HGPIN that are predictive of adenocarcinoma. MATERIALS AND METHODS: Patients with a diagnosis of ASAP/HGPIN with no previous or concomitant cancer were identified. Prostate specific antigen (PSA) and magnetic resonance imaging (MRI) changes were monitored. Re-biopsy was at clinician discretion. RESULTS: Nineteen were diagnosed with ASAP and 17 with HGPIN. Seven with ASAP (37%) and 6 with HGPIN (35%) underwent re-biopsy. Three (16%) with ASAP and 5 with HGPIN (29%) were diagnosed with adenocarcinoma. The difference in cancer detection rates between ASAP and HGPIN was not significant (p = 0.35). Five (14%) in total required definitive therapy for adenocarcinoma. Twenty-three (64%) did not undergo repeat biopsy. Parameters at diagnosis of HGPIN and ASAP, including PSA, prostate volume and PSA density, were compared between the cancer and non-cancer cohorts with none found to be predictive of adenocarcinoma. CONCLUSION: By monitoring PSA and MRI changes, we managed to spare re-biopsy in two-thirds of patients. Further evaluation is necessary to characterize a surveillance protocol in these populations.

External validation of four nephrometry scores for trans-peritoneal robotic partial nephrectomy.

INTRODUCTION: External validation of four nephrometry scores (NS): Centrality index (C-index), arterial based complexity (ABC), preoperative aspects and dimensions used for an anatomical (PADUA) and radius expohytic/endophytic nearness anterior/posterior location (RENAL) scoring systems in patients who have undergone trans-peritoneal robotic assisted partial nephrectomy (RAPN). MATERIAL AND METHODS: A prospective database for RAPN has been maintained. Individual NSs were performed on 3-dimensional reconstructions of MDCT/MRI studies retrospectively by a board certified uroradiologist. Univariate Cox Proportional-Hazard Regression Analysis was performed for each NSs to valuate its predictability for the following parameters: Warm Ischemia Time (WIT), Estimated Blood Loss (EBL), Operative Time (OT), Complication Rates and Positive Margin Rates. RESULTS: 78 RAPNs were performed for suspected renal malignancies. The mean OT, EBL and WIT time was 186.5 minutes (SD - 33.8), 125.5 mls (SD - 188.91) and 16.7 minutes (SD - 5.6) respectively. The overall complication rate was 20.5% (16/78) of which only 2.6% (2/78) were Clavien Grade 3 or higher complications. The mean change in creatinine change at Day - 1 was 12.54 µmol/L (SD - 18.05). On the Cox regression analysis only the Centrality index predicted prolonged WIT with statistical significance: C-Index (0.02), ABC (0.2), PADUA (0.2), RENAL (0.9). ABC predicted operative time with statistical significance: C-index (0.45), ABC (0.0004), PADUA (0.25), RENAL (0.3). None of the NSs could predict overall complication: C-index (0.5), ABC (0.2), PADUA (0.13), RENAL (0.5). None of the NSs predicted EBL: C-index (0.3)0, ABC (0.8), PADUA (0.2), RENAL (0.7). None of the NSs predicted Positive Margin Rates: C-index (0.4), ABC (0.4), PADUA (0.9), RENAL (0.8). CONCLUSIONS: C-index was able to predict prolonged WIT. ABC was a strong predictor of OT. PADUA and RENAL were poor predictors for all measured parameters.

Early vs. standard unclamping technique in minimal access partial nephrectomy: a meta-analysis of observational cohort studies and the Lister cohort.

To evaluate if early unclamping (EUC) of the renal pedicle compromises perioperative outcomes in minimally invasive partial nephrectomy (PN). The cohort study includes all robot-assisted PN performed between September 2012 and September 2015 by a single surgeon at the Lister Hospital, Stevenage, UK. The systematic review and meta-analysis was performed according to the PRISMA guidelines identifying studies comparing EUC and standard unclamping (SUC) in either laparoscopic or robot-assisted PN. The Lister cohort prospectively reported 84 cases of robot-assisted PN (SUC = 22, EUC = 62) with a mean age of 58 years (SD = 11). The operative time (OT), estimated blood loss (EBL) and warm ischaemia time (WIT) were 186.5 min (SD = 33.8), 125.5 mls (SD = 188.91) and 16.7 min (SD = 5.6), respectively. The data from the Lister cohort were included in the meta-analysis. The systematic review identified four studies, encompassing 666 cases (313 SUC, 353 EUC), for inclusion in the final analysis. There was a statistically significant difference in WIT in favour of the EUC group [-10.59 min (95% CI -16.58, -4.60)]. Specifically, the reduction in WIT was more pronounced in laparoscopic PN (-15.43 min (95% CI -19.05, -11.81)), when compared with the robotic PN [-5.60 min (95% CI -5.70, -5.50)]. There was no statistical difference in OT [-3.97 min (95% CI -14.22, 6.28)]. EBL was found to be increased in the EUC group [71.39 ml (95% CI -0.78, 143.56)]. There was no statistically significant difference in transfusion rates or complications between the two groups. The EUC technique for robot-assisted PN appears to offer a safe limited period of WIT without compromising perioperative outcomes and morbidity.

The Role of Positron Emission Tomography With (68)Gallium (Ga)-Labeled Prostate-specific Membrane Antigen (PSMA) in the Management of Patients With Organ-confined and Locally Advanced Prostate Cancer Prior to Radical Treatment and After Radical Prostatectomy.

The role of positron emission tomography (PET) with (68)Gallium (Ga)-labeled prostate-specific membrane antigen (PSMA) imaging for prostate cancer is gaining prominence. Current imaging strategies, despite having progressed significantly, have limitations, in particular their ability to diagnose metastatic lymph node involvement. Preliminary results of PET with (68)Ga-labeled PSMA have shown encouraging results, particularly in the recurrent prostate cancer setting. Furthermore, the ability of PET with (68)Ga-labeled PSMA of playing a dual diagnostic and therapeutic setting (theranostics) is currently being investigated as well. PET with (68)Ga-labeled PSMA certainly has a role to play in bridging some of the voids in contemporary prostate cancer imaging tools.