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OBJECTIVES To assess the feasibility of local anaesthetic transperineal (LATP) technique using a single-freehand transperineal (TP) access device, and report initial prostate cancer (PCa) detection, infection rates, and tolerability. PATIENTS AND METHODS Observational study of a multicentre prospective cohort, including all consecutive cases. LATP was performed in three settings: (i) first biopsy in suspected PCa, (ii) confirmatory biopsies for active surveillance, and (iii) repeat biopsy in suspected PCa. All patients received pre-procedure antibiotics according to local hospital guidelines. Local anaesthesia was achieved by perineal skin infiltration and periprostatic nerve block without sedation. Ginsburg protocol principles were followed for systematic biopsies including cognitive magnetic resonance imaging-targeted biopsies when needed using the PrecisionPoint™ TP access device. Procedure-related complications and oncological outcomes were prospectively and consecutively collected. A validated questionnaire was used in a subset of centres to collect data on patient-reported outcome measures (PROMs). RESULTS Some 1218 patients underwent LATP biopsies at 10 centres: 55%, 24%, and 21% for each of the three settings, respectively. Any grade PCa was diagnosed in 816 patients (67%), of which 634 (52% of total) had clinically significant disease. Two cases of sepsis were documented (0.16%) and urinary retention was observed in 19 patients (1.6%). PROMs were distributed to 419 patients, with a 56% response rate (n = 234). In these men, pain during the biopsy was described as either 'not at all' or 'a little' painful by 64% of patients. Haematuria was the most common reported symptom (77%). When exploring attitude to re-biopsy, 48% said it would be 'not a problem' and in contrast 8.1% would consider it a 'major problem'. Most of the patients (81%) described the biopsy as a 'minor or moderate procedure tolerable under local anaesthesia', while 5.6% perceived it as a 'major procedure that requires general anaesthesia'. CONCLUSION Our data suggest that LATP biopsy using a TP access system mounted to the ultrasound probe achieves excellent PCa detection, with a very low sepsis rate, and is safe and well tolerated. We believe a randomised controlled trial comparing LATP with transrectal ultrasound-guided biopsy (TRUS) to investigate the relative trade-offs between each biopsy technique would be helpful.

INTRODUCTION AND OBJECTIVE:The prevalence of continence after prostatectomy varies noticeably, with a reported range of 13% to 97.5%, depending on the definition of continence considered. Nine defi...

INTRODUCTION AND OBJECTIVE: A LATP service using PrecisionPoint™ was newly started in July 2019, with procedures performed by both surgeon and nurse practitioners. Initial indications were: repeat biopsy, anterior prostate lesions, and Active Surveillance patients. Service was expanded in March 2020 to all prostate pathway patients according to British Association of Urology COVID guidance. METHODS: All patients underwent prebiopsy MRI and dedicated image-review meetings. Biopsies were performed in PIRADS 3-5, or PSAD>0.15. Systematic Ginsburg protocol biopsies were performed for all patients (each zone sent separately), and PIRADS 3-5 lesions were targeted with ≥3 cores (also sent separately). Alpha-blockers were started for patients with Bladder Outlet Obstruction. No antibiotics were used unless patients were immunocompromised or had a previous history of urinary sepsis. A prospective database at point of care was created detailing patient demographics, MRI and biopsy characteristics. Patient Reported Outcome Measures (PROMs) are collected. Histology and complications are also reported. RESULTS: 750 consecutive patients are analysed. Detection of clinically significant prostate cancer (Gl≥3+4) in PIRADS 1-2, 3, 4, 5 groups was 25%, 40%, 59%, 92% respectively. Systematic biopsy alone detected clinically significant cancer in 36%, whereas systematic plus targeted biopsy achieved 63%. Of Active Surveillance patients;40% with Gl 3+3 were upgraded, and 49% with Gl3+4 were upgraded to Gl≥4+3. n=5 (0.6%) experienced vasovagal episodes causing delayed discharge. Only n=5 patients were readmitted (0.6%): 2 urinary tract infection, 2 acute urinary retention, 1 urinary sepsis. PROMs demonstrated majority favourable results regarding pain (98%), discomfort (97%), embarrassment (96%) and further repeat biopsies (89%). CONCLUSIONS: We have set up a safe, effective, antibiotic free LATP biopsy service, with high cancer detection rates and low complication rates. PROMs data suggests this is well tolerated by patients.

Objective: Studies reporting increased risk of metastases in T3a disease are based on clinical staging (Digital rectal examination) in the pre-multiparametric–magnetic resonance imaging (MRI) (mp-MRI) era. The aim of our study was to assess the rate of positive bone scans in patients ascribed with T3a prostate cancer on a pre-biopsy mp-MRI. Methods: We performed a multicentre, retrospective analysis of all patients with T3a prostate cancer staged by mp-MRI who had a bone scan between January 2017 and April 2020. Results: A total of 586 patients were diagnosed with T3a prostate cancer on mp-MRI, with a median age of 71 years (range: 47–87). The median presenting PSA was 11 ng/mL (range: 1–537); 125 patients (21.3%) had a PSA ⩽ 20 and either grade group (GG) 1 or 2 in their prostate biopsy; none of these patients had bone metastases. Eighteen patients (3.1%) were found to have bone metastases: 11 patients had GG ⩾ 3 disease on biopsy and nodal disease, 6 had GG ⩾ 3 without evidence of nodal disease and 1 had a PSA of 103. Conclusion: The use of bone scans in patients with T3a prostate cancer staged on mp-MRI but without other evidence of high-risk disease (GG ⩾ 3 and PSA > 20 ng/mL) appears to be unnecessary and could be safely avoided. Level of evidence: 2b

CONTEXT:Prebiopsy multiparametric magnetic resonance imaging (mpMRI) is increasingly used in prostate cancer diagnosis. The reported negative predictive value (NPV) of mpMRI is used by some clinicians to aid in decision making about whether or not to proceed to biopsy. OBJECTIVE:We aim to perform a contemporary systematic review that reflects the latest literature on optimal mpMRI techniques and scoring systems to update the NPV of mpMRI for clinically significant prostate cancer (csPCa). EVIDENCE ACQUISITION:We conducted a systematic literature search and included studies from 2016 to September 4, 2019, which assessed the NPV of mpMRI for csPCa, using biopsy or clinical follow-up as the reference standard. To ensure that studies included in this analysis reflect contemporary practice, we only included studies in which mpMRI findings were interpreted according to the Prostate Imaging Reporting and Data System (PIRADS) or similar Likert grading system. We define negative mpMRI as either (1) PIRADS/Likert 1-2 or (2) PIRADS/Likert 1-3; csPCa was defined as either (1) Gleason grade group ≥2 or (2) Gleason grade group ≥3. We calculated NPV separately for each combination of negative mpMRI and csPCa. EVIDENCE SYNTHESIS:A total of 42 studies with 7321 patients met our inclusion criteria and were included for analysis. Using definition (1) for negative mpMRI and csPCa, the pooled NPV for biopsy-naïve men was 90.8% (95% confidence interval [CI] 88.1-93.1%). When defining csPCa using definition (2), the NPV for csPCa was 97.1% (95% CI 94.9-98.7%). Calculation of the pooled NPV using definition (2) for negative mpMRI and definition (1) for csPCa yielded the following: 86.8% (95% CI 80.1-92.4%). Using definition (2) for both negative mpMRI and csPCa, the pooled NPV from two studies was 96.1% (95% CI 93.4-98.2%). CONCLUSIONS:Multiparametric MRI of the prostate is generally an accurate test for ruling out csPCa. However, we observed heterogeneity in the NPV estimates, and local institutional data should form the basis of decision making if available. PATIENT SUMMARY:The negative predictive values should assist in decision making for clinicians considering not proceeding to biopsy in men with elevated age-specific prostate-specific antigen and multiparametric magnetic resonance imaging reported as negative (or equivocal) on Prostate Imaging Reporting and Data System/Likert scoring. Some 7-10% of men, depending on the setting, will miss a diagnosis of clinically significant cancer if they do not proceed to biopsy. Given the institutional variation in results, it is of upmost importance to base decision making on local data if available.

Surgical innovation is necessary to ensure continued improvement in patient care. However, several challenges unique to the surgical craft are encountered during the development and validation of such new technology. This article highlights some of these challenges and gives an overview of existing solutions. A Pubmed review was performed about the “introduction of new technology” to identify challenges. Cross-referencing was used to explore the possible solutions per challenge. Several characteristics of the surgical craft itself limit our ability to establish randomised controlled trials and hence provide clear categorical evidence. Existing certification bodies for new technology often use unstructured regulations and allow fast-track bypassing systems. Consequently the IDEAL framework (innovation, development, exploration, assessment, long-term follow-up) proposes an objective scientific approach whilst defining stakeholder responsibilities. The selection of which new modality to implement is heavily influenced by third parties unrelated to the best patient outcomes and thus professional organisations can aid in this decision-making. Appropriate training of surgeons and their teams until proficiency is achieved is essential prior to credentialling. Finally long-term surveillance of outcomes in the form of registries is an increasing responsibility of the urological community to maintain our role in directing the adoption or rejection of these innovations. Urological innovation is a dynamic and challenging process. Increasing efforts are identified within the urological community to render the process more reliable and transparent.

Summary Background The optimal timing of radiotherapy after radical prostatectomy for prostate cancer is uncertain. We aimed to compare the efficacy and safety of adjuvant radiotherapy versus an observation policy with salvage radiotherapy for prostate-specific antigen (PSA) biochemical progression. Methods We did a randomised controlled trial enrolling patients with at least one risk factor (pathological T-stage 3 or 4, Gleason score of 7–10, positive margins, or preoperative PSA ≥10 ng/mL) for biochemical progression after radical prostatectomy (RADICALS-RT). The study took place in trial-accredited centres in Canada, Denmark, Ireland, and the UK. Patients were randomly assigned in a 1:1 ratio to adjuvant radiotherapy or an observation policy with salvage radiotherapy for PSA biochemical progression (PSA ≥0·1 ng/mL or three consecutive rises). Masking was not deemed feasible. Stratification factors were Gleason score, margin status, planned radiotherapy schedule (52·5 Gy in 20 fractions or 66 Gy in 33 fractions), and centre. The primary outcome measure was freedom from distant metastases, designed with 80% power to detect an improvement from 90% with salvage radiotherapy (control) to 95% at 10 years with adjuvant radiotherapy. We report on biochemical progression-free survival, freedom from non-protocol hormone therapy, safety, and patient-reported outcomes. Standard survival analysis methods were used. A hazard ratio (HR) of less than 1 favoured adjuvant radiotherapy. This study is registered with ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and Dec 30, 2016, 1396 patients were randomly assigned, 699 (50%) to salvage radiotherapy and 697 (50%) to adjuvant radiotherapy. Allocated groups were balanced with a median age of 65 years (IQR 60–68). Median follow-up was 4·9 years (IQR 3·0–6·1). 649 (93%) of 697 participants in the adjuvant radiotherapy group reported radiotherapy within 6 months; 228 (33%) of 699 in the salvage radiotherapy group reported radiotherapy within 8 years after randomisation. With 169 events, 5-year biochemical progression-free survival was 85% for those in the adjuvant radiotherapy group and 88% for those in the salvage radiotherapy group (HR 1·10, 95% CI 0·81–1·49; p=0·56). Freedom from non-protocol hormone therapy at 5 years was 93% for those in the adjuvant radiotherapy group versus 92% for those in the salvage radiotherapy group (HR 0·88, 95% CI 0·58–1·33; p=0·53). Self-reported urinary incontinence was worse at 1 year for those in the adjuvant radiotherapy group (mean score 4·8 vs 4·0; p=0·0023). Grade 3–4 urethral stricture within 2 years was reported in 6% of individuals in the adjuvant radiotherapy group versus 4% in the salvage radiotherapy group (p=0·020). Interpretation These initial results do not support routine administration of adjuvant radiotherapy after radical prostatectomy. Adjuvant radiotherapy increases the risk of urinary morbidity. An observation policy with salvage radiotherapy for PSA biochemical progression should be the current standard after radical prostatectomy. Funding Cancer Research UK, MRC Clinical Trials Unit, and Canadian Cancer Society.

Background Multiparametric magnetic resonance imaging (mpMRI) is now recommended prebiopsy in numerous healthcare regions based on the findings of high-quality studies from expert centres. Concern remains about reproducibility of mpMRI to rule out clinically significant prostate cancer (csPCa) in real-world settings. Objective To assess the diagnostic performance of mpMRI for csPCa in a real-world setting. Design, setting, and participants A multicentre, retrospective cohort study, including men referred with raised prostate-specific antigen (PSA) or an abnormal digital rectal examination who had undergone mpMRI followed by transrectal or transperineal biopsy, was conducted. Patients could be biopsy naive or have had previous negative biopsies. Outcome measurements and statistical analysis The primary definition for csPCa was International Society of Urological Pathology (ISUP) grade group (GG) ≥2 (any Gleason ≥7); the accuracy for other definitions was also evaluated. Results and limitations Across ten sites, 2642 men were included (January 2011–November 2018). Mean age and PSA were 65.3 yr (standard deviation [SD] 7.8 yr) and 7.5 ng/ml (SD 3.3 ng/ml), respectively. Of the patients, 35.9% had “negative MRI” (scores 1–2); 51.9% underwent transrectal biopsy and 48.1% had transperineal biopsy, with 43.4% diagnosed with csPCa overall. The sensitivity and negative predictive value (NPV) for ISUP GG ≥ 2 were 87.3% and 87.5%, respectively. The NPVs were 87.4% and 88.1% for men undergoing transrectal and transperineal biopsy, respectively. Specificity and positive predictive value of MRI were 49.8% and 49.2%, respectively. The sensitivity and NPV increased to 96.6% and 90.6%, respectively, when a PSA density threshold of 0.15 ng/ml/ml was used in MRI scores 1–2; these metrics increased to 97.5% and 91.2%, respectively, for PSA density 0.12 ng/ml/ml. ISUP GG ≥ 3 (Gleason ≥4 + 3) was found in 2.4% (15/617) of men with MRI scores 1–2. They key limitations of this study are the heterogeneity and retrospective nature of the data. Conclusions Multiparametric MRI when used in real-world settings is able to rule out csPCa accurately, suggesting that about one-third of men might avoid an immediate biopsy. Men should be counselled about the risk of missing some significant cancers. Patient summary Multiparametric magnetic resonance imaging (MRI) is a useful tool for ruling out prostate cancer, especially when combined with prostate-specific antigen density (PSAD). Previous results published from specialist centres can be reproduced at smaller institutions. However, patients and their clinicians must be aware that an early diagnosis of clinically significant prostate cancer could be missed in nearly 10% of patients by relying on MRI and PSAD alone.

Upper tract urothelial carcinoma represents a small proportion (5%–10%) of all urothelial cancers. Although there are several management options, in undifferentiated or high-risk cases, surgery in the form of nephroureterectomy is the gold standard. Horseshoe kidney is the most common congenital renal fusion anomaly affecting 1 in 400–600 patients. We present the case of a smoker in her mid-50s with an incidental finding of a papillary lesion in the right renal pelvis of her horseshoe kidney on CT scan. She went on to have endoscopic assessment confirming no other foci of disease. She was definitively managed with a robotic nephroureterectomy.

Objective: To report our experience of a contemporary series of patients who underwent radical orchidectomy for non-palpable testicular masses, in order to comment on their malignant potential and identify any factors predictive of a malignant outcome. Materials and Methods: We reviewed the case-notes of patients who underwent radical inguinal orchidectomy over a 22-month period between January 2010 and October 2011. Results: A total of 71 patients were analysed, with a mean (range) age of 45 years (17 - 82). Overall, 41 (57.7%) orchidectomies were malignant and 30 (42.3%) were benign. There were 20 (28%) non-palpable testicular masses found incidentally on ultrasound, and of these 40% were malignant and 60% were benign. In total 6 of these non-palpable lesions were

Prostate-specific antigen (PSA) is a well-known and -utilized tumor marker for prostate cancer. Elevated PSA values are not specific for prostate cancer as they may be caused by other benign conditions. PSA testing is widely used by urologists and non-urologists. Interpretation of test results is difficult but important. Referral of patients for further work-up on suspicion of prostate diseases is mainly done by general practitioners (GPs). As the GP remains the gatekeeper between the patient and the urologist in terms of diagnosing prostate diseases, basic knowledge of PSA testing is crucial. The purpose of this study was to evaluate the basic use and knowledge of PSA testing and to give an estimate of the need for further education in PSA testing amongst GPs in our area.A questionnaire regarding PSA testing and associated needs for education was mailed to all GPs in the Northern County of Denmark. Non-respondents were contacted by mail.Of the contacted GPs, 90% responded. Only 28% of GPs measured PSA in all males complaining of lower urinary tract symptoms (LUTS). Of patients seen as part of a general health check-up, PSA testing was done in 10%. The median PSA value for referral to urologists for further work-up was 5 ng/ml, but the decision was influenced by PSA value (79%), age (65%) and findings on digital rectal examination (DRE) (87%). Opportunistic screening for prostate cancer was done by 14% of GPs. Of the GPs who responded, 24% stated that they did not need any further education regarding PSA testing.The results of this study demonstrate that PSA testing is not standardized in our area. GPs do not test patients on the basis of recommendations provided by national or international societies. PSA testing is not used as a standard test in men with LUTS, and patients are not referred to urologists at a sufficiently low PSA level to improve the early diagnosis and work-up of patients with suspected prostate cancer. However, the decision of many GPs to refer patients to urologists for further work-up is influenced by the findings of a DRE, the age of the patient and the PSA value itself. Further education regarding PSA testing amongst GPs in our area would seem to be appropriate.

OBJECTIVE: To assess risk factors and predictors of failure of the Hem-o-lok(TM) vascular clip (Weck Closure Systems, Research Triangle Park, NC, USA) using vessels harvested from a porcine model. MATERIALS AND METHODS: Vessels of various diameters were harvested from a porcine model, clipped at 90 degrees or 45 degrees using the Hem-o-lok clip and then cut either flush or with a 1-mm cuff. The vessels were then connected to a burst-pressure device and pressures required to burst the clip or to cause it to leak were measured. RESULTS: The Hem-o-lok clip leaked or burst when the vessel to which it was applied was cut flush. The clip became even more likely to fail if the angle of application of the clip was not at 90 degrees to the vessel surface. CONCLUSION: The Hem-o-lok vascular clip is safe if it is applied at 90 degrees to the vessel surface and, more importantly, if a 1-mm cuff is left between the clip and the point at which the vessel is divided. We would therefore discourage the practice of not leaving this cuff of tissue, in an attempt to maximize vessel length during laparoscopic donor nephrectomy.

Disseminated intravascular coagulation (DIC) is a pathological systemic condition resulting from aberrant activation of the coagulation system. It is characterised by the release and activation of procoagulants into the blood, with an associated consumption coagulopathy. Its association with solid and haematological malignancies is well described in literature. This case describes an elderly man, known to have prostate cancer, who following transurethral resection of the prostate developed DIC with haematuria, spontaneous ecchymoses and mucosal bleeding. Subsequent investigations revealed a prostate-specific antigen (PSA) >1000 µg/L, and staging CT showed multiple sclerotic metastatic lesions affecting the thoracic and lumbar vertebra, as well as infiltration into his left femur. Coagulation normalised with blood products and vitamin K within 1 week, and the patient responded to antiandrogen therapy with a reduction in pain and PSA on discharge.