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We determined the early efficacy of bipolar radiofrequency ablation with a coil design for focal ablation of clinically significant localized prostate cancer visible at multiparametric magnetic resonance imaging.A prospective IDEAL phase 2 development study (Focal Prostate Radiofrequency Ablation, NCT02294903) recruited treatment-naïve patients with a single focus of significant localized prostate cancer (Gleason 7 or 4 mm or more of Gleason 6) concordant with a lesion visible on multiparametric magnetic resonance imaging. Intervention was a focal ablation with a bipolar radiofrequency system (Encage™) encompassing the lesion and a predefined margin using nonrigid magnetic resonance imaging-ultrasound fusion. Primary outcome was the proportion of men with absence of significant localized disease on biopsy at 6 months. Trial followup consisted of serum prostate specific antigen, multiparametric magnetic resonance imaging at 1 week, and 6 and 12 months post-ablation. Validated patient reported outcome measures for urinary, erectile and bowel functions, and adverse events monitoring system were used. Analyses were done on a per-protocol basis.Of 21 patients recruited 20 received the intervention. Baseline characteristics were median age 66 years (IQR 63-69) and preoperative median prostate specific antigen 7.9 ng/ml (5.3-9.6). A total of 18 patients (90%) had Gleason 7 disease with median maximum cancer 7 mm (IQR 5-10), for a median of 2.8 cc multiparametric magnetic resonance imaging lesions (IQR 1.4-4.8). Targeted biopsy of the treated area (median number of cores 6, IQR 5-8) showed absence of significant localized prostate cancer in 16/20 men (80%), concordant with multiparametric magnetic resonance imaging. There was a low profile of side effects at patient reported outcome measures analysis and there were no serious adverse events.Focal therapy of significant localized prostate cancer associated with a magnetic resonance imaging lesion using bipolar radiofrequency showed early efficacy to ablate cancer with low rates of genitourinary and rectal side effects.

Background: Multiparametric MRI of the prostate followed by targeted biopsy is recommended for patients at risk of prostate cancer. However, multiparametric ultrasound is more readily available than multiparametric MRI. Data from paired-cohort validation studies and randomised, controlled trials support the use of multiparametric MRI, whereas the evidence for individual ultrasound methods and multiparametric ultrasound is only derived from case series. We aimed to establish the overall agreement between multiparametric ultrasound and multiparametric MRI to diagnose clinically significant prostate cancer. Methods: We conducted a prospective, multicentre, paired-cohort, confirmatory study in seven hospitals in the UK. Patients at risk of prostate cancer, aged 18 years or older, with an elevated prostate-specific antigen concentration or abnormal findings on digital rectal examination underwent both multiparametric ultrasound and multiparametric MRI. Multiparametric ultrasound consisted of B-mode, colour Doppler, real-time elastography, and contrast-enhanced ultrasound. Multiparametric MRI included high-resolution T2-weighted images, diffusion-weighted imaging (dedicated high B 1400 s/mm2 or 2000 s/mm2 and apparent diffusion coefficient map), and dynamic contrast-enhanced axial T1-weighted images. Patients with positive findings on multiparametric ultrasound or multiparametric MRI underwent targeted biopsies but were masked to their test results. If both tests yielded positive findings, the order of targeting at biopsy was randomly assigned (1:1) using stratified (according to centre only) block randomisation with randomly varying block sizes. The co-primary endpoints were the proportion of positive lesions on, and agreement between, multiparametric MRI and multiparametric ultrasound in identifying suspicious lesions (Likert score of ≥3), and detection of clinically significant cancer (defined as a Gleason score of ≥4 + 3 in any area or a maximum cancer core length of ≥6 mm of any grade [PROMIS definition 1]) in those patients who underwent a biopsy. Adverse events were defined according to Good Clinical Practice and trial regulatory guidelines. The trial is registered on ISRCTN, 38541912, and ClinicalTrials.gov, NCT02712684, with recruitment and follow-up completed. Findings: Between March 15, 2016, and Nov 7, 2019, 370 eligible patients were enrolled; 306 patients completed both multiparametric ultrasound and multiparametric MRI and 257 underwent a prostate biopsy. Multiparametric ultrasound was positive in 272 (89% [95% CI 85–92]) of 306 patients and multiparametric MRI was positive in 238 patients (78% [73–82]; difference 11·1% [95% CI 5·1–17·1]). Positive test agreement was 73·2% (95% CI 67·9–78·1; κ=0·06 [95% CI –0·56 to 0·17]). Any cancer was detected in 133 (52% [95% CI 45·5–58]) of 257 patients, with 83 (32% [26–38]) of 257 being clinically significant by PROMIS definition 1. Each test alone would result in multiparametric ultrasound detecting PROMIS definition 1 cancer in 66 (26% [95% CI 21–32]) of 257 patients who had biopsies and multiparametric MRI detecting it in 77 (30% [24–36]; difference –4·3% [95% CI –8·3% to –0·3]). Combining both tests detected 83 (32% [95% CI 27–38]) of 257 clinically significant cancers as per PROMIS definition 1; of these 83 cancers, six (7% [95% CI 3–15]) were detected exclusively with multiparametric ultrasound, and 17 (20% [12–31]) were exclusively detected by multiparametric MRI (agreement 91·1% [95% CI 86·9–94·2]; κ=0·78 [95% CI 0·69–0·86]). No serious adverse events were related to trial activity. Interpretation: Multiparametric ultrasound detected 4·3% fewer clinically significant prostate cancers than multiparametric MRI, but it would lead to 11·1% more patients being referred for a biopsy. Multiparametric ultrasound could be an alternative to multiparametric MRI as a first test for patients at risk of prostate cancer, particularly if multiparametric MRI cannot be carried out. Both imaging tests missed clinically significant cancers detected by the other, so the use of both would increase the detection of clinically significant prostate cancers compared with using each test alone.

OBJECTIVE: To investigate whether patients with Gleason 3 + 4 cancer on transrectal biopsy are upgraded after undergoing transperineal magnetic resonance imaging (MRI)-targeted biopsy and whether this has implications for current clinical practice. PATIENTS AND METHODS: In this retrospective analysis we examined 107 consecutive patients presenting at a single tertiary referral centre (July 2012 to July 2016) with prostate cancer of Gleason score 3 + 4 on transrectal ultrasonography (TRUS)-guided systematic non-targeted biopsy who then underwent a multiparametric MRI followed by MRI-targeted transperineal prostate biopsy for accurate risk stratification and localization. RESULTS: The patients' mean (sd) age was 67.0 (8.0) years, and they had a median (interquartile range) PSA concentration of 6.2 (4.7-9.6) ng/mL. Of the 107 patients, 84 (78.5%) had Gleason 3 + 4 on both transrectal systematic biopsy and transperineal MRI-targeted biopsy. Nineteen patients (17.8%) were upgraded to Gleason 4 + 3, three patients (3.0%) to Gleason 4 + 4 and one patient (1.0%) to Gleason 4 + 5. These differences were significant (P = 0.0006). Likewise, 23/107 patients (22%) had higher-risk disease based on their targeted biopsies. CONCLUSION: The use of targeted biopsy in men with impalpable cancer, ultimately upgraded one in five patients from favourable-intermediate- to unfavourable-intermediate-risk disease or worse. This has significant clinical implications for men considering active surveillance or radical treatment. Our risk calculators must now be validated using these data from targeted biopsy as the technique becomes widely adopted.

Purpose To determine whether the interactive visualisation of patient-specific virtual 3D models of the renal anatomy influences the pre-operative decision-making process of urological surgeons for complex renal cancer operations. Methods Five historic renal cancer patient pre-operative computed tomography (CT) datasets were retrospectively selected based on RENAL nephrectomy score and variety of anatomy. Interactive virtual 3D models were generated for each dataset using image segmentation software and were made available for online visualisation and manipulation. Consultant urologists were invited to participate in the survey which consisted of CT and volume-rendered images (VRI) for the control arm, and CT with segmentation overlay and the virtual 3D model for the intervention arm. A questionnaire regarding anatomical structures, surgical approach, and confidence was administered. Results Twenty-five participants were recruited (54% response rate), with 19/25 having > 5 years of renal surgery experience. The median anatomical clarity score increased from 3 for the control to 5 for the intervention arm. A change in planned surgical approach was reported in 19% of cases. Virtual 3D models increased surgeon confidence in the surgical decisions in 4/5 patient datasets. There was a statistically significant improvement in surgeon opinion of the potential utility for decision-making purposes of virtual 3D models as compared to VRI at the multidisciplinary team meeting, theatre planning, and intra-operative stages. Conclusion The use of pre-operative interactive virtual 3D models for surgery planning influences surgical decision-making. Further studies are needed to investigate if the use of these models changes renal cancer surgery outcomes. Electronic supplementary material The online version of this article (10.1007/s11548-019-01913-5) contains supplementary material, which is available to authorized users.

OBJECTIVE: To analyse the impact of the COVID-19 pandemic on a centralized specialist kidney cancer care pathway. MATERIALS AND METHODS: We conducted a retrospective analysis of patient and pathway characteristics including prioritization strategies at the Specialist Centre for Kidney Cancer located at the Royal Free London NHS Foundation Trust (RFH) before and during the surge of COVID-19. RESULTS: On 18 March 2020 all elective surgery was halted at RFH to redeploy resources and staff for the COVID-19 surge. Prioritizing of patients according to European Association of Urology guidance was introduced. Clinics and the specialist multidisciplinary team (SMDT) meetings were maintained with physical distancing, kidney surgery was moved to a COVID-protected site, and infection prevention measurements were enforced. During the 7 weeks of lockdown (23 March to 10 May 2020), 234 cases were discussed at the SMDT meetings, 53% compared to the 446 cases discussed in the 7 weeks pre-lockdown. The reduction in referrals was more pronounced for small and asymptomatic renal masses. Of 62 low-priority cancer patients, 27 (43.5%) were deferred. Only one (4%) COVID-19 infection occurred postoperatively, and the patient made a full recovery. No increase in clinical or pathological upstaging could be detected in patients who underwent deferred surgery compared to pre-COVID practice. CONCLUSION: The first surge of the COVID-19 pandemic severely impacted diagnosis, referral and treatment of kidney cancer at a tertiary referral centre. With a policy of prioritization and COVID-protected pathways, capacity for time-sensitive oncological interventions was maintained and no immediate clinical harm was observed.

OBJECTIVE: To compare the proportion of clinically significant prostate cancers (PCa) found in lesions detected by multiparametric MRI (mpMRI) with that found in lesions detected by multiparametric ultrasound (mpUSS), in men at risk. PATIENTS AND METHODS: CADMUS (Cancer Detection by Multiparametric Ultrasound of the prostate) is a prospective, multi-centre paired cohort diagnostic utility study with built-in randomisation of order of biopsies. The trial is registered ISRCTN38541912. All patients will undergo the index test under evaluation (mpUSS±biopsies), as well as the standard test (mpMRI±biopsies). Eligible men will be those at risk of harbouring prostate cancer usually recommended for prostate biopsy, either for the first time or as a repeat, who have not had any prior treatment for prostate cancer. Men in need of repeat biopsy will include those with prior negative results but ongoing suspicion, and those with an existing prostate cancer diagnosis but a need for accurate risk stratification. Both scans will be reported blind to the results of the other and the order in which the targeted biopsies derived from the two different imaging modalities are taken will be randomised. Comparison will be drawn between biopsy results of lesions detected by mpUSS with those lesions detected by mpMRI. Agreement over position between the two imaging modalities will be studied. DISCUSSION: CADMUS will provide level one evidence on the performance of mpUSS derived targeted biopsies in the identification of clinically significant prostate cancer in comparison to mpMRI targeted biopsies. Recruitment is underway and expected to complete in 2018.

The on-demand digital healthcare ecosystem is on the near horizon. It has the potential to extract a wealth of information from “big data” collected at the population level, to enhance preventive and precision medicine at the patient level. This may improve efficiency and quality while decreasing cost of healthcare delivered by professionals. However, there are still security and privacy issues that need to be addressed before algorithms, data, and models can be mobilized safely at scale. In this paper we discuss how distributed ledger technologies can play a key role in advancing electronic health, by ensuring authenticity and integrity of data generated by wearable and embedded devices. We demonstrate how the Masked Authenticated Messaging extension module of the IOTA protocol can be used to securely share, store, and retrieve encrypted activity data using a tamper-proof distributed ledger. Keywords: Activity data, Blockchain, Distributed ledger technologies, eHealth, Medical sensors, Remote monitoring, Wearable devices

background: Transrectal prostate biopsy has limited diagnostic accuracy. Prostate Imaging Compared to Transperineal Ultrasound-guided biopsy for significant prostate cancer Risk Evaluation (PICTURE) was a paired-cohort confirmatory study designed to assess diagnostic accuracy of multiparametric magnetic resonance imaging (mpMRI) in men requiring a repeat biopsy. methods: All underwent 3 T mpMRI and transperineal template prostate mapping biopsies (TTPM biopsies). Multiparametric MRI was reported using Likert scores and radiologists were blinded to initial biopsies. Men were blinded to mpMRI results. Clinically significant prostate cancer was defined as Gleason greater than or equal to4+3 and/or cancer core length greater than or equal to6 mm. results: Two hundred and forty-nine had both tests with mean (s.d.) age was 62 (7) years, median (IQR) PSA 6.8 ng ml (4.98–9.50), median (IQR) number of previous biopsies 1 (1–2) and mean (s.d.) gland size 37 ml (15.5). On TTPM biopsies, 103 (41%) had clinically significant prostate cancer. Two hundred and fourteen (86%) had a positive prostate mpMRI using Likert score greater than or equal to3; sensitivity was 97.1% (95% confidence interval (CI): 92–99), specificity 21.9% (15.5–29.5), negative predictive value (NPV) 91.4% (76.9–98.1) and positive predictive value (PPV) 46.7% (35.2–47.8). One hundred and twenty-nine (51.8%) had a positive mpMRI using Likert score greater than or equal to4; sensitivity was 80.6% (71.6–87.7), specificity 68.5% (60.3–75.9), NPV 83.3% (75.4–89.5) and PPV 64.3% (55.4–72.6). conclusions: In men advised to have a repeat prostate biopsy, prostate mpMRI could be used to safely avoid a repeat biopsy with high sensitivity for clinically significant cancers. However, such a strategy can miss some significant cancers and overdiagnose insignificant cancers depending on the mpMRI score threshold used to define which men should be biopsied.

BACKGROUND Distributed ledger technology (DLT) holds great potential to improve health information exchange. However, the immutable and transparent character of this technology may conflict with data privacy regulations and data processing best practices. OBJECTIVE The aim of this paper is to develop a proof-of-concept system for immutable, interoperable, and General Data Protection Regulation (GDPR)–compliant exchange of blood glucose data. METHODS Given that there is no ideal design for a DLT-based patient-provider data exchange solution, we proposed two different variations for our proof-of-concept system. One design was based purely on the public IOTA distributed ledger (a directed acyclic graph-based DLT) and the second used the same public IOTA ledger in combination with a private InterPlanetary File System (IPFS) cluster. Both designs were assessed according to (1) data reversal risk, (2) data linkability risks, (3) processing time, (4) file size compatibility, and (5) overall system complexity. RESULTS The public IOTA design slightly increased the risk of personal data linkability, had an overall low processing time (requiring mean 6.1, SD 1.9 seconds to upload one blood glucose data sample into the DLT), and was relatively simple to implement. The combination of the public IOTA with a private IPFS cluster minimized both reversal and linkability risks, allowed for the exchange of large files (3 months of blood glucose data were uploaded into the DLT in mean 38.1, SD 13.4 seconds), but involved a relatively higher setup complexity. CONCLUSIONS For the specific use case of blood glucose explored in this study, both designs presented a suitable performance in enabling the interoperable exchange of data between patients and providers. Additionally, both systems were designed considering the latest guidelines on personal data processing, thereby maximizing the alignment with recent GDPR requirements. For future works, these results suggest that the conflict between DLT and data privacy regulations can be addressed if careful considerations are made regarding the use case and the design of the data exchange system.

Aims Multi-parametric magnetic resonance imaging (mpMRI) may identify radio-recurrent intra-prostatic cancer accurately. We aimed to compare visually directed MRI-targeted biopsies (MRI-TB) to an accurate reference standard – transperineal prostate mapping (TPM) biopsies with 5 mm sampling – in the detection of clinically significant cancer in men with biochemical failure after radiotherapy. Materials and methods A retrospective registry analysis between 2006 and 2014 identified 77 men who had undergone mpMRI followed by MRI-TB and TPM. Clinical significance was set at two definitions of disease. Definition 1 was Gleason ≥ 4+3 and/or maximum cancer core length ≥ 6 mm. Definition 2 was Gleason ≥ 3+4 and/or maximum cancer core length ≥ 4 mm. Results Of the 77 patients included, the mean age was 70 years (range 61–82; standard deviation 5.03). The median prostate-specific antigen (PSA) at the time of external beam radiotherapy (EBRT) was 14 ng/ml (interquartile range 7.83–32.50). The most frequent EBRT dose given was 74 Gy over 37 fractions. Eight patients had iodine-seed implant brachytherapy or high dose rate brachytherapy. Neoadjuvant/adjuvant hormonal therapy use was reported in 38. The time from EBRT to biochemical recurrence was a median of 60 months (interquartile range 36.75–85.00). The median PSA at the time of mpMRI was 4.68 ng/ml (interquartile range 2.68–7.60). The median time between mpMRI and biopsy was 2.76 months (interquartile range 1.58–4.34). In total, 2392 TPM and 381 MRI-TB cores were taken with 18% and 50% cancer detection, respectively. Detection rates of definition 1 clinically significant cancer were 52/77 (68%) versus 55/77 (71%) for MRI-TB and TPM, respectively. MRI-TB was more efficient requiring 1 core versus 2.8 cores to detect definition 2 cancer. Conclusion MRI-TB seems to have encouraging detection rates for clinically significant cancer with fewer cores compared with TPM, although TPM had higher detection rates for smaller lower grade lesions.

Objectives To determine the diagnostic accuracy and interobserver concordance of whole-body (WB)-MRI, vs. 99mTc bone scintigraphy (BS) and 18fluoro-ethyl-choline (18F-choline) PET/CT for the primary staging of intermediate/high-risk prostate cancer. Methods An institutional review board approved prospective cohort study carried out between July 2012 and November 2015, whereby 56 men prospectively underwent 3.0-T multiparametric (mp)-WB-MRI in addition to BS (all patients) ± 18F-choline PET/CT (33 patients). MRI comprised pre- and post-contrast modified Dixon (mDixon), T2-weighted (T2W) imaging, and diffusion-weighted imaging (DWI). Patients underwent follow-up mp-WB-MRI at 1 year to derive the reference standard. WB-MRIs were reviewed by two radiologists applying a 6-point scale and a locked sequential read (LSR) paradigm for the suspicion of nodal (N) and metastatic disease (M1a and M1b). Results The mean sensitivity/specificity of WB-MRI for N1 disease was 1.00/0.96 respectively, compared with 1.00/0.82 for 18F-choline PET/CT. The mean sensitivity and specificity of WB-MRI, 18F-choline PET/CT, and BS were 0.90/0.88, 0.80/0.92, and 0.60/1.00 for M1b disease. ROC-AUC did not show statistically significant improvement for each component of the LSR; mean ROC-AUC 0.92, 0.94, and 0.93 (p

Background National Health Service England recently oversaw a whole-scale reconfiguration of cancer services in London, UK, for a number of different cancer pathways. Centralisation of cancer surgery has occurred with prostate cancer (PCa) surgery only being commissioned at a single designated pelvic cancer surgical centre. This process has required surgeons to work in teams providing a hub-and-spoke model of care. Objective To report the extent to which the initiation of a quality assurance programme (QAP) can improve the quality of PCa surgical care during reorganisation of cancer services in London. Design, setting, and participants A pre- and postintervention study was initiated with 732 men undergoing robot-assisted radical PCa surgery over a 3-yr period, 396 men before the introduction of the QAP and 336 afterwards. Intervention Image-based surgical planning of cancer surgery and monthly peer review of individual surgeon outcomes incorporating rating and assessment of edited surgical video clips. Outcome measurements and statistical analysis We observed margin status (positive/negative), complication rate of surgery, 3-mo urinary continence, use of nerve-sparing surgery, and potency at 12 mo after surgery. Multivariable logistic regression modelling was used to compare outcomes before and after initiation of the QAP. Cox regression analysis was used to evaluate the return of potency over time. Results and limitations Demographics of patients undergoing surgery did not change following the reorganisation of cancer services. Patient-reported 3-mo urinary continence improved following the initiation of the QAP, both in terms of requirement for incontinence pads (57% continent vs 67% continent; odds ratio [OR]: 2.19; 95% confidence interval [CI], 1.08–4.46; p =0.02) and International Consultation on Incontinence Questionnaire score (5.6 vs 4.2; OR: 0.82; 95% CI, 0.70–0.95; p =0.009). Concurrently, use of nerve-sparing surgery increased significantly (OR: 2.99; 95% CI, 2.14–4.20; p p =0.04). Interaction was noted between surgeon and 3-mo urinary continence. On regression analysis, incontinence scores improved significantly for all but one surgeon who had low incontinence rates at study initiation. Conclusions The implementation of a QAP improved quality of care in terms of consistency of patient selection and outcomes of surgery during a period of major reorganisation of cancer services in London. The QAP framework presented could be adopted by other organisations providing complex surgical care across a large network of referring hospitals. Patient summary The introduction of a quality assurance programme improved the quality of prostate cancer care in terms of consistency of patient selection and outcomes of surgery during a period of major reorganisation of cancer services.

Multiparametric magnetic resonance imaging (mp-MRI) is increasingly advocated for prostate cancer detection. There are limited reports of its use in the setting of radiorecurrent disease. Our aim was to assess mp-MRI for detection of radiorecurrent prostate cancer and examine the added value of its functional sequences. Thirty-seven men with mean age of 69.7 (interquartile range, 66–74) with biochemical failure after external beam radiotherapy underwent mp-MRI (T2-weighted, high b-value, multi-b-value apparent diffusion coefficient (ADC) and dynamic contrast-enhanced (DCE) imaging); then transperineal systematic template prostate mapping (TPM) biopsy. Using a locked sequential read paradigm (with the sequence order above), two experienced radiologists independently reported mp-MRI studies using score 1–5. Radiologist scores were matched with TPM histopathology at the hemigland level (n=74). Accuracy statistics were derived for each reader. Interobserver agreement was evaluated using kappa statistics. Receiver–operator characteristic area under curve (AUC) for readers 1 and 2 increased from 0.67 (95% confidence interval (CI), 0.55–0.80) to 0.80 (95% CI, 0.69–0.91) and from 0.67 (95% CI, 0.55–0.80) to 0.84 (95% CI, 0.76–0.93), respectively, between T2-weighted imaging alone and full mp-MRI reads. Addition of ADC maps and DCE imaging to the examination did not significantly improve AUC for either reader (P=0.08 and 0.47 after adding ADC, P=0.90 and 0.27 after adding DCE imaging) compared with T2+high b-value review. Inter-reader agreement increased from k=0.39 to k=0.65 between T2 and full mp-MRI review. mp-MRI can detect radiorecurrent prostate cancer. The optimal examination included T2-weighted imaging and high b-value DWI; adding ADC maps and DCE imaging did not significantly improve the diagnostic accuracy.

A collaboration between clinicians at UCLH and the Dept of Computer Science at UCL is giving students of computer science the opportunity to undertake real healthcare computing projects as part of their education. This is enabling the creation of a significant research computing platform within the Trust, based on open source components and hosted in the cloud, while providing a large group of students with experience of the specific challenges of health IT.

INTRODUCTION: Focal therapy may reduce the toxicity of current radical treatments while maintaining the oncological benefit. Irreversible electroporation (IRE) has been proposed to be tissue selective and so might have favourable characteristics compared to the currently used prostate ablative technologies. The aim of this trial is to determine the adverse events, genito-urinary side effects and early histological outcomes of focal IRE in men with localised prostate cancer. METHODS: This is a single centre prospective development (stage 2a) study following the IDEAL recommendations for evaluating new surgical procedures. Twenty men who have MRI-visible disease localised in the anterior part of the prostate will be recruited. The sample size permits a precision estimate around key functional outcomes. Inclusion criteria include PSA ≤ 15 ng/ml, Gleason score ≤ 4 + 3, stage T2N0M0 and absence of clinically significant disease outside the treatment area. Treatment delivery will be changed in an adaptive iterative manner so as to allow optimisation of the IRE protocol. After focal IRE, men will be followed during 12 months using validated patient reported outcome measures (IPSS, IIEF-15, UCLA-EPIC, EQ-5D, FACT-P, MAX-PC). Early disease control will be evaluated by mpMRI and targeted transperineal biopsy of the treated area at 6 months. DISCUSSION: The NEAT trial will assess the early functional and disease control outcome of focal IRE using an adaptive design. Our protocol can provide guidance for designing an adaptive trial to assess new surgical technologies in the challenging landscape of health technology assessment in prostate cancer treatment.

Background: Distributed ledger technology (DLT) holds great potential to improve health information exchange. However, the immutable and transparent character of this technology may conflict with data privacy regulations and data processing best practices. Objective: The aim of this paper is to develop a proof-of-concept system for immutable, interoperable, and General Data Protection Regulation (GDPR)–compliant exchange of blood glucose data. Methods: Given that there is no ideal design for a DLT-based patient-provider data exchange solution, we proposed two different variations for our proof-of-concept system. One design was based purely on the public IOTA distributed ledger (a directed acyclic graph-based DLT) and the second used the same public IOTA ledger in combination with a private InterPlanetary File System (IPFS) cluster. Both designs were assessed according to (1) data reversal risk, (2) data linkability risks, (3) processing time, (4) file size compatibility, and (5) overall system complexity. Results: The public IOTA design slightly increased the risk of personal data linkability, had an overall low processing time (requiring mean 6.1, SD 1.9 seconds to upload one blood glucose data sample into the DLT), and was relatively simple to implement. The combination of the public IOTA with a private IPFS cluster minimized both reversal and linkability risks, allowed for the exchange of large files (3 months of blood glucose data were uploaded into the DLT in mean 38.1, SD 13.4 seconds), but involved a relatively higher setup complexity. Conclusions: For the specific use case of blood glucose explored in this study, both designs presented a suitable performance in enabling the interoperable exchange of data between patients and providers. Additionally, both systems were designed considering the latest guidelines on personal data processing, thereby maximizing the alignment with recent GDPR requirements. For future works, these results suggest that the conflict between DLT and data privacy regulations can be addressed if careful considerations are made regarding the use case and the design of the data exchange system.

We describe the case of a man aged 43 years who presented with a 2-week history of a palpable lump in the right proximal penile shaft. This was preceded by a 6-month history of perineal pain, accompanied by erectile dysfunction. An urgent MRI scan of his penis identified a thrombus within the right crus and corpus of the penis. His thrombophilia screen was normal. The patient was started on oral anticoagulation and a phosphodiesterase inhibitor (PDE-5i) to prevent thrombus progression and maintain erectile function. At 5 months, the patients9 symptoms had resolved and an MRI showed a reduction in the thrombus size. MRI is a useful imaging modality to diagnose a thrombus within the corpus cavernosum in patients presenting with a history of penile and perineal pain together with a palpable lump. The non-enhancement of the lesion helps to differentiate this from alternative rare lesions within the penis and perineum.

Background: Port-site metastases (PSMs) are a rare occurrence after robotic surgery. For robot-assisted radical cystectomy (RARC), isolated cases have been reported but management has not been previously described. We present a case of PSM that occurred after RARC and report the results of our systematic review of previously reported PSMs and describe the treatment options. Search Criteria and Methods: We describe a case of a PSM in a 55-year-old man who had undergone intracorporeal RARC. We performed a systematic review of MEDLINE and Embase databases for previously reported PSMs, detailing the stage and grade of the primary tumor, time to presentation of PSM, treatment offered, and outcomes for the identified cases. Results: We identified 4 cases of PSMs after RARC in published studies and also included our case for analysis. All 5 patients had muscle-invasive bladder cancer at cystectomy (stage ≥ T2) and 3 had local lymph node-positive disease. Our aggressive treatment of chemotherapy, wide surgical excision of PSM, and radiotherapy provided our patient with a 2-year disease-free status. Conclusion: PSMs are a rare event in RARC, with only 4 other cases reported in published studies. The outcomes have not been well reported for these cases. We propose that multimodality treatment consisting of salvage chemotherapy, surgery, and radiotherapy should be considered, although concessions could be needed after consideration of patient factors.

Abdominal evaluation of the critically-ill patient is challenging. The patient may have a vague presentation, sometimes with a poor clinical history, few localizing signs, multiple co-morbidities and multi-organ involvement. Often the patient will require resuscitation prior to diagnostic work-up, and support devices such as mechanical ventilators and haemofilters may hamper assessment. Such unreliability of clinical indicators and the myriad of abdominal pathologies in a critically-ill patient may lead to diagnostic uncertainty with consequent delays in treatment. These challenges make imaging one of the most critical steps in the management of such patients. The optimal imaging pathway should be sensitive, specific, and minimize delay in therapy, but should also account for the patient’s clinical state and overall radiation dose. The modalities that have a role in abdominal evaluation of the critically ill are covered in this chapter.

volume (V) of each stone, calculated by a special software of CT or by approximation calculation by urologists. After insertion of a ureteral access sheath, Videoscope (FlexXC Storz, Germany) was introduced into the sheath manually. Then the scope was connected to the Roboflex in sterile condition and the time for this procedure had been recorded. Ergonomic chair of Roboflex can be adjusted in a comfortable position, according to the user. Deflection can be performed by manipulating the right handle similar to standart fURS. Precise deflection provided from the thumb wheel on the console. The rotation and forward and backward movement can be controlled by left handle. Fragments smaller than four fold of the laser fiber (means approx. 1 mm) were left for spontaneous passage. The fragmentation time recorded and the Fragmented Volume /per minute was calculated. At the end of the procedures, ureteral j stents were placed whenever indicated. RESULTS: Mean Stone Volume was 1620 cubic mm (98-10600 cubic mm). Mean connection time to the Roboflex was 2 min. Stones were located in upper, middle and lower calices, and renal pelvis. Fragmentation Efficiency (FE) evaluated by fragmentation volume/per minute was 36 and 25 cubic mm /min for manual and robotic fURS respectively, but it increased to 33 cubic mm/min after 42 case. With some improvements of Roboflex FE was increased to 53 cubic mm/min. Stone-free status including fragments up to 2mm as controlled with xray on day 1 was achieved in all cases. We analyzed the CT controls after 1st and 3rd months. Fever not exceeding one day was seen in 2 patients. CONCLUSIONS: Robot assisted fURS using Roboflex has been detected as a safe and efficient treatment method. It offers performing the procedure out of radiation exposure area while sitting. The operative results are also acceptable compared to the literature of manual fURS stone treatment.

426 Background: Sarcopenia is a decrease in skeletal muscle mass and is a quantifiable marker of frailty associated with poor oncological outcomes. Currently there are no studies using sarcopenia as a prognostic indicator for patients with penile cancer. This study investigated the association of sarcopenia with mortality and morbidity outcomes in penile cancer patients in a specialist centre. Methods: A retrospective case-controlled study was performed. Patient cohort comprised 50 patients with metastatic penile cancer ( > pN2 disease) and 50 patients with non-metastatic disease (N0) ; minimum follow-up period of 2 years. Sarcopenia was classified as a skeletal muscle index < 55cm2/m2 and was measured using software and CT imaging. Results: Sarcopenia was present in 31% of our cohort (n = 100). A univariate analysis showed a statistically significant association between the following parameters and patient mortality; sarcopenia (p = 0.005), metastatic disease (p = 0.001), tumour stage (p = 0.001), sarcomatoid squamous cell carcinoma (p = 0.009), CIS (p = 0.034), lymphovascular invasion (LVI) (p = 0.001) and perineural invasion (p = 0.002). Logistic regression analysis found an association between mortality and sarcopenia (p = 0.035) and metastatic disease (p = 0.000) and approached statistical significance with LVI (p = 0.061). Subdividing our cohort into metastatic and non-metastatic groups, showed that sarcopenia was associated with mortality in patients with metastatic disease but was not associated with post-operative complications or chemo-radiotherapy toxicity. Interestingly, sarcopenia was associated with post-operative infection in patients undergoing surgery for non-metastatic disease (p = 0.027). Additionally, for every day remaining in hospital after the 4th post-operative day, there was a 1.275 increase in the risk of death in patients with sarcopenia. Conclusions: Sarcopenia has a potential role as a novel prognostic indicator and could be used as a risk stratification tool in patients with metastatic penile cancer when deciding treatment options. By identifying this subgroup, additional nutritional support and a supervised exercise program can be implemented to improve the morbidity rate.

To determine the threshold waveform characteristics at Doppler ultrasound (DUS) to differentiate between ischaemic and non-ischaemic priapism.Fifty-two patients were categorised into "ischaemic" and "non-ischaemic" types based on clinical and blood-gas findings: 10 patients with non-ischaemic priapism; 20 with ischaemic priapism before surgical shunt placement and 22 with ischaemic priapism after surgical shunt placement. DUS traces were analysed: peak systolic velocity (PSV) and mean velocity (MV) were calculated. Histological samples were obtained at the time of surgery. Three clinical outcome groups were defined: (1) normal, (2) regular use of pharmacostimulation, and (3) refractory dysfunction/penile implant.All non-ischaemic priapism cases had a PSV50 cm/s and all but one had an MV of6.5 cm/s. In pre-surgery ischaemic cases, all men had a PSV50 cm/s and MV6.5 cm/s. Two flow patterns were observed in this group: PSV25 cm/s in all men scanned before needle aspiration; and in 6/14 after needle aspiration, a high velocity/high resistance (low net inflow) pattern, with peak systolic flows22 cm/s but diastolic reversal. In post-surgery ischaemic priapism, flow parameters overlapped with the non-ischaemic group. PSV/MV did not predict clinical outcome or histology.In the present cohort, PSV50 cm/s and MV6.5 cm/s were predictive of ischaemic priapism (pre-shunt; p0.01). Patients with ischaemic priapism may show PSV22 cm/s, but have diastolic reversal and therefore low net perfusion. Post-shunt, DUS findings were extremely variable and did not predict histology or clinical outcome.

Objectifs Les biopsies ciblees sur une lesion en IRMmp ont montre leur interet pour la detection et stratification du cancer de la prostate. La voie transperineale propose comme avantage d’eviter contamination et potentiel sepsis du a la flore rectale par rapport au standard. Reputee necessitant une anesthesie generale, nous etudions les performances de cette technique sous sedation consciente. Methodes Nous avons revu de maniere retrospective le dossier des patients ayant une serie de biopsie ciblee par voie transperineale sous sedation consciente (BCTS) guidee par reconstruction mentale (propofol IV, sans intervention pour maintenir les voies aeriennes permeables) sur 2014–2015. Cette technique est utilisee de maniere systematique dans notre centre. Toutes les IRMmp etaient realisees selon les consensus dans notre centre et interpretees par des radiologues experimentes selon l’echelle de Lickert. Les resultats sont presentes en termes de taux de detection (valeur predictive positive) stratifie par score IRM en analyse par patient et par lesion. Les effets indesirables sont reportes. Resultats Nous reportons 87 patients inclus presentant 105 lesions IRM. Les caracteristiques demographiques et des IRMmp sont reportees dans le Tableau 1 ainsi que l’indication des BCTS. Le taux de detection global de cancer par patient etait de 93 %. Les performances stratifiees sont reportees dans le Tableau 2. Toutes les procedures ont ete realisees en ambulatoire. Il n’est reporte aucun sepsis a point de depart urinaire dans les suites du geste. Conclusion La BCTS est une technique permettant de conserver les performances de l’IRMmp avec un taux de detection global de 93 % dans certaines indications en evitant les risques d’une anesthesie generale et de sepsis inherent a la voie transrectale.

Several lines of evidence suggest that neurotrophin administration may be of some therapeutic benefit in the treatment of peripheral neuropathy. However, a third of sensory neurons do not express receptors for the neurotrophins. These neurons are of small diameter and can be identified by the binding of the lectin IB4 and the expression of the enzyme thiamine monophosphatase (TMP). Here we show that these neurons express the receptor components for glial-derived neurotrophic factor (GDNF) signaling (RET, GFRα-1, and GFRα-2). In lumbar dorsal root ganglia, virtually all IB4-labeled cells express RET mRNA, and the majority of these cells (79%) also express GFRα-1, GFRα-2, or GFRα-1 plus GFRα-2.GDNF, but not nerve growth factor (NGF), can prevent several axotomy-induced changes in these neurons, including the downregulation of IB4 binding, TMP activity, and somatostatin expression. GDNF also prevents the slowing of conduction velocity that normally occurs after axotomy in a population of small diameter DRG cells and the A-fiber sprouting into lamina II of the dorsal horn. GDNF therefore may be useful in the treatment of peripheral neuropathies and may protect peripheral neurons that are refractory to neurotrophin treatment.

The purpose of this study was to establish the contemporaneous frequency of metastases within the kidney as opposed to primary renal tumors in patients with an active primary nonrenal malignancy and to identify the differentiating features.We retrospectively identified all patients with an active primary nonrenal malignancy (group 1) who had also undergone at least 2 contrast-enhanced abdominal CT examinations spaced 1 year apart. The radiologic and pathologic data of these cases were reviewed and the incidence of metastasis to the kidney versus primary renal tumors established. These data were compared with a separate group who presented with primary renal malignancy from the outset (group 2).In the study were 2340 patients with primary nonrenal malignancy (group 1) and 231 patients with a primary renal malignancy (group 2). For group 1, the mean age was 63 years and 51% were men; for group 2, the mean age was 59 years, and 58% were men. The differences were not statistically significant. Thirty-six patients in group 1 had a malignant renal mass; 21 were a result of kidney metastasis and the remaining 15 were a synchronous primary renal tumor (0.9% vs 0.6%). The kidney was the eighth most common site of metastatic spread. Metastases to the kidney were statistically more likely with higher tumor stage of the primary nonrenal malignancy (68% vs 46%, p = 0.0006) and in those with other sites of metastasis (p = 0.012, positive likelihood ratio [LR+] = 6.75). Compared with primary renal tumors, metastases to the kidney were more often solid (86% vs 53%, p = 0.019, LR+ = 3.7) and endophytic (76% vs 33%, p = 0.017, LR+ = 2.29). There were too few cases with calcification and bilateral tumors to reach a statistically significant conclusion. Tumor size, polar predominance, and enhancement pattern were similar in the two groups. The primary renal tumors seen in group 1 versus group 2 were similar regarding age and sex distribution, cell type, median size, and tumor stage.Metastases to the kidney are uncommon in modern radiologic practice (0.9%, 21/2340 in this study), and a renal mass seen in a patient with nonrenal malignancy is nearly as likely to be an incidental primary renal tumor. Metastasis is more likely in those with higher tumor stage or if other viscera are also affected and is usually an asymptomatic, small, endophytic, and solid mass. If a renal mass seen in a patient with primary nonrenal malignancy proves to be a synchronous primary renal tumor, its cell type and stage will be similar to sporadic primary renal tumors.