Retrospective analysis of the learning curve in perineal robot-assisted prostate biopsy.

INTRODUCTION: Magnetic resonance imaging-transrectal ultrasound (MRI-TRUS)-fusion biopsy (FBx) of the prostate allows targeted sampling of suspicious lesions within the prostate, identified by multiparametric MRI. Due to its reliable results and feasibility, perineal MRI/TRUS FBx is now the gold standard for prostate cancer (PC) diagnosis. There are various systems for performing FBx on the market, for example, software-based, semirobotic, or robot-assisted platform solutions. Their semiautomated workflow promises high process quality independent of the surgeon's experience. The aim of this study was to analyze how the surgeon's experience influences the cancer detection rate (CDR) via targeted biopsy (TB) and the procedure's duration in robot-assisted FBx. PATIENTS AND METHODS: A total of 1716 men who underwent robot-assisted FBx involving a combination of targeted and systematic sampling between October 2015 and April 2022 were analyzed. We extracted data from the patients' electronic medical records retrospectively. Primary endpoints were the CDR by TB and the procedure's duration. For our analysis, surgeons were divided into three levels of experience: ≤20 procedures (little), 21-100 procedures (intermediate), and >100 procedures (high). Statistical analysis was performed via regression analyses and group comparisons. RESULTS: Median age, prostate-specific antigen level, and prostate volume of the cohort were 67 (±7.7) years, 8.13 (±9.4) ng/mL, and 53 (±34.2) mL, respectively. Median duration of the procedure was 26 (±10.9) min. The duration decreased significantly with the surgeon's increasing experience from 35.1 (little experience) to 28.4 (intermediate experience) to 24.0 min (high experience) (p < 0.001). Using TB only, significant PC (sPC) was diagnosed in 872/1758 (49.6%) of the men. The CDR revealed no significant correlation with the surgeon's experience in either group comparison (p = 0.907) or in regression analysis (p = 0.65). CONCLUSION: While the duration of this procedure decreases with increasing experience, the detection rate of sPC in TB is not significantly associated with the experience of the surgeon performing robot-assisted FBx. This robot-assisted biopsy system's diagnostic accuracy therefore appears to be independent of experience.

Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS.

BACKGROUND: Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) are usually asymptomatic and seek treatments that improve survival but have a low risk of adverse events. Darolutamide, a structurally distinct androgen receptor inhibitor (ARi), significantly reduced the risk of metastasis and death versus placebo in ARAMIS. We assessed the extended safety and tolerability of darolutamide and the time-course profile of treatment-emergent adverse events (TEAEs) related to ARis and androgen-suppressive treatment. PATIENTS AND METHODS: Patients with nmCRPC were randomized 2:1 to darolutamide (n = 955) or placebo (n = 554). After trial unblinding, patients could receive open-label darolutamide. Tolerability and TEAEs were assessed every 16 weeks. Time interval-specific new and cumulative event rates were determined during the first 24 months of the double-blind period. RESULTS: Darolutamide remained well tolerated during the double-blind and open-label periods, with 98.8% of patients receiving the full planned dose. The incidence of TEAEs of interest in the darolutamide group was low and ≤2% different from that in the placebo group, except for fatigue. When incidences were adjusted for exposure time, there were minimal differences between the darolutamide double-blind and double-blind plus open-label periods. The rate of initial onset and cumulative incidence of grade 3/4 TEAEs and serious TEAEs were similar for darolutamide and placebo groups over 24 months. CONCLUSION: Extended treatment with darolutamide was well tolerated and no new safety signals were observed. Most ARi-associated and androgen-suppressive treatment-related TEAEs occurred at low incidences with darolutamide, were similar to placebo, and showed minimal increase over time with continued treatment. TRIAL NUMBER: ClinicalTrials.gov identifier NCT02200614.

Update on PI-RADS Version 2.1 Diagnostic Performance Benchmarks for Prostate MRI: Systematic Review and Meta-Analysis.

Background Prostate MRI for the detection of clinically significant prostate cancer (csPCa) is standardized by the Prostate Imaging Reporting and Data System (PI-RADS), currently in version 2.1. A systematic review and meta-analysis infrastructure with a 12-month update cycle was established to evaluate the diagnostic performance of PI-RADS over time. Purpose To provide estimates of diagnostic accuracy and cancer detection rates (CDRs) of PI-RADS version 2.1 categories for prostate MRI, which is required for further evidence-based patient management. Materials and Methods A systematic search of PubMed, Embase, Cochrane Library, and multiple trial registers (English-language studies published from March 1, 2019, to August 30, 2022) was performed. Studies that reported data on diagnostic accuracy or CDRs of PI-RADS version 2.1 with csPCa as the primary outcome were included. For the meta-analysis, pooled estimates for sensitivity, specificity, and CDRs were derived from extracted data at the lesion level and patient level. Sensitivity and specificity for PI-RADS greater than or equal to 3 and PI-RADS greater than or equal to 4 considered as test positive were investigated. In addition to individual PI-RADS categories 1-5, subgroup analyses of subcategories (ie, 2+1, 3+0) were performed. Results A total of 70 studies (11 686 lesions, 13 330 patients) were included. At the patient level, with PI-RADS greater than or equal to 3 considered positive, meta-analysis found a 96% summary sensitivity (95% CI: 95, 98) and 43% specificity (95% CI: 33, 54), with an area under the summary receiver operating characteristic (SROC) curve of 0.86 (95% CI: 0.75, 0.93). For PI-RADS greater than or equal to 4, meta-analysis found an 89% sensitivity (95% CI: 85, 92) and 66% specificity (95% CI: 58, 74), with an area under the SROC curve of 0.89 (95% CI: 0.85, 0.92). CDRs were as follows: PI-RADS 1, 6%; PI-RADS 2, 5%; PI-RADS 3, 19%; PI-RADS 4, 54%; and PI-RADS 5, 84%. The CDR was 12% (95% CI: 7, 19) for transition zone 2+1 lesions and 19% (95% CI: 12, 29) for 3+0 lesions (P = .12). Conclusion Estimates of diagnostic accuracy and CDRs for PI-RADS version 2.1 categories are provided for quality benchmarking and to guide further evidence-based patient management. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Tammisetti and Jacobs in this issue.

Aquablation versus HoLEP in patients with benign prostatic hyperplasia: a comparative prospective non-randomized study.

PURPOSE: The question of best surgical treatment for lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH) remains controversial. We compared the outcomes of aquablation and holmium laser enucleation of the prostate ("HoLEP") in a prospective cohort. METHODS: Patients with BPH underwent aquablation or HoLEP according to their preference between June 2020 and April 2022. Prostate volume ("PV"), laboratory results, postvoid residual volume, uroflowmetry, IPSS, ICIQ-SF, MSHQ-EjD, EES and IIEF were evaluated preoperatively and at three, six and 12 months postoperatively. We also analyzed perioperative characteristics and complications via the Clavien Dindo ("CD") classification. RESULTS: We included 40 patients, 16 of whom underwent aquablation and 24 HoLEP. Mean age was 67 years (SD 7.4). Baseline characteristics were balanced across groups, except the HoLEP patients' larger PV. IPSS fell from 20.3 (SD 7.1) at baseline to 6.3 (SD 4.2) at 12 months (p < 0.001) without differences between aquablation and HoLEP. HoLEP was associated with shorter operation time (59.5 (SD 18.6) vs. 87.2 (SD 14.8) minutes, p < 0.001) and led to better PV reduction over all timepoints. At three months, aquablation's results were better regarding ejaculatory (p = 0.02, MSHQ-EjD) and continence function (p < 0.001, ICIQ-SF). Beyond three months, erectile, ejaculatory, continence function and LUTS reduction did not differ significantly between aquablation and HoLEP. CD ≥ grade 3b complications were noted in six patients in aquablation group while only one in HoLEP group (p = < 0.01). CONCLUSIONS: While aquablation revealed temporary benefits regarding ejaculation and continence at three months, HoLEP was superior concerning operation time, the safety profile and volumetric results.

Primary Results of Patients with Genitourinary Malignancies Presented at a Molecular Tumor Board.

INTRODUCTION: Personalized medicine poses great opportunities and challenges. While the therapeutic landscape markedly expands, descriptions about status, clinical implementation and real-world benefits of precision oncology and molecular tumor boards (MTB) remain sparse, particularly in the field of genitourinary (GU) cancer. Hence, this study characterized urological MTB cases to better understand the potential role of MTB in uro-oncology. METHODS: We analyzed patients with complete data sets being reviewed at an MTB from January 2019 to October 2022, focusing on results of molecular analysis and treatment recommendations. RESULTS: We evaluated 102 patients with GU cancer with a mean patient age of 61.7 years. Prostate cancer (PCa) was the most frequent entity with 52.9% (54/102), followed by bladder cancer (18.6%, 19/102) and renal cell carcinoma (14.7%, 15/102). On average, case presentation at MTB took place 54.9 months after initial diagnosis and after 2.7 previous lines of therapy. During the study period, 49.0% (50/102) of patients deceased. Additional MTB-based treatment recommendations were achieved in a majority of 68.6% (70/102) of patients, with a recommendation for targeted therapy in 64.3% (45/70) of these patients. Only 6.7% (3/45) of patients - due to different reasons - received the recommended MTB-based therapy though, with 33% (1/3) of patients reaching disease control. Throughout the MTB study period, GU cancer case presentations and treatment recommendations increased, while the time interval between initial presentation and final therapy recommendation were decreasing over time. CONCLUSION: Presentation of uro-oncological patients at the MTB is a highly valuable measure for clinical decision-making. Prospectively, earlier presentation of patients at the MTB and changing legislative issues regarding comprehensive molecular testing and targeted treatment approval might further improve patients' benefits from comprehensive molecular diagnostics.

Prediction of upgrade to clinically significant prostate cancer in patients under active surveillance: Performance of a fully automated AI-algorithm for lesion detection and classification.

BACKGROUND: Multiparametric MRI (mpMRI) improves the detection of aggressive prostate cancer (PCa) subtypes. As cases of active surveillance (AS) increase and tumor progression triggers definitive treatment, we evaluated whether an AI-driven algorithm can detect clinically significant PCa (csPCa) in patients under AS. METHODS: Consecutive patients under AS who received mpMRI (PI-RADSv2.1 protocol) and subsequent MR-guided ultrasound fusion (targeted and extensive systematic) biopsy between 2017 and 2020 were retrospectively analyzed. Diagnostic performance of an automated clinically certified AI-driven algorithm was evaluated on both lesion and patient level regarding the detection of csPCa. RESULTS: Analysis of 56 patients resulted in 93 target lesions. Patient level sensitivity and specificity of the AI algorithm was 92.5%/31% for the detection of ISUP ≥ 1 and 96.4%/25% for the detection of ISUP ≥ 2, respectively. The only case of csPCa missed by the AI harbored only 1/47 Gleason 7a core (systematic biopsy; previous and subsequent biopsies rendered non-csPCa). CONCLUSIONS: AI-augmented lesion detection and PI-RADS scoring is a robust tool to detect progression to csPCa in patients under AS. Integration in the clinical workflow can serve as reassurance for the reader and streamline reporting, hence improve efficiency and diagnostic confidence.

Development of PSMA-PET-guided CT-based radiomic signature to predict biochemical recurrence after salvage radiotherapy.

PURPOSE: To develop a CT-based radiomic signature to predict biochemical recurrence (BCR) in prostate cancer patients after sRT guided by positron-emission tomography targeting prostate-specific membrane antigen (PSMA-PET). MATERIAL AND METHODS: Consecutive patients, who underwent 68Ga-PSMA11-PET/CT-guided sRT from three high-volume centers in Germany, were included in this retrospective multicenter study. Patients had PET-positive local recurrences and were treated with intensity-modulated sRT. Radiomic features were extracted from volumes of interests on CT guided by focal PSMA-PET uptakes. After preprocessing, clinical, radiomics, and combined clinical-radiomic models were developed combining different feature reduction techniques and Cox proportional hazard models within a nested cross validation approach. RESULTS: Among 99 patients, median interval until BCR was the radiomic models outperformed clinical models and combined clinical-radiomic models for prediction of BCR with a C-index of 0.71 compared to 0.53 and 0.63 in the test sets, respectively. In contrast to the other models, the radiomic model achieved significantly improved patient stratification in Kaplan-Meier analysis. The radiomic and clinical-radiomic model achieved a significantly better time-dependent net reclassification improvement index (0.392 and 0.762, respectively) compared to the clinical model. Decision curve analysis demonstrated a clinical net benefit for both models. Mean intensity was the most predictive radiomic feature. CONCLUSION: This is the first study to develop a PSMA-PET-guided CT-based radiomic model to predict BCR after sRT. The radiomic models outperformed clinical models and might contribute to guide personalized treatment decisions.

The heat is on: the impact of excessive temperature increments on complications of laser treatment for ureteral and renal stones.

OBJECTIVE: Technological advancements in the field of urology have led to a paradigm shift in the management of urolithiasis towards minimally invasive endourological interventions, namely ureteroscopy and percutaneous nephrolithotomy. However, concerns regarding the potential for thermal injury during laser lithotripsy have arisen, as studies have indicated that the threshold for cellular thermal injury (43 °C) can be exceeded, even with conventional low-power laser settings. This review aims to identify the factors that contribute to temperature increments during laser treatment using current laser systems and evaluate their impact on patient outcomes. MATERIALS AND METHODS: To select studies for inclusion, a search was performed on online databases including PubMed and Google Scholar. Keywords such as 'temperature' or 'heat' were combined with 'lithotripsy', 'nephrolithotomy', 'ureteroscopy', or 'retrograde intrarenal surgery', both individually and in various combinations. RESULTS: Various strategies have been proposed to mitigate temperature rise, such as reducing laser energy or frequency, shortening the duration of laser activation, increasing the irrigation fluid flow rate, and using room temperature or chilled water for irrigation. It is important to note that higher irrigation fluid flow rates should be approached cautiously due to potential increases in intrarenal pressure and associated infectious complications. The utilization of a ureteral access sheath (UAS) may offer benefits by facilitating irrigation fluid outflow, thereby reducing intrapelvic pressure and intrarenal fluid temperature. CONCLUSION: Achieving a balance between laser power, duration of laser activation, and irrigation fluid rate and temperature appears to be crucial for urologists to minimize excessive temperature rise.

Is day-case surgery feasible for laser endoscopic enucleation of the prostate? A systematic review.

PURPOSE: Laser endoscopic enucleation of the prostate (EEP) for benign prostatic obstruction has become increasingly prevalent worldwide. Considering the medical cost-savings and concomitantly fewer nosocomial infections, the feasibility of same-day postoperative discharge of patients who have undergone laser EEP in terms of its safety and effectiveness has become a subject matter of growing interest. We aimed to review those studies focussing on day-case surgery (DCS) in patients undergoing laser EEP. METHODS: A systematic search was conducted using PubMed-MEDLINE and Web of Science databases until October 2022 with the following search terms: "same day discharge AND laser enucleation of the prostate", "day-case AND laser enucleation of the prostate", "same day surgery AND laser enucleation of the prostate" and "one day surgery AND laser enucleation of the prostate" by combining PICO (population, intervention, comparison, outcome) terms. We identified 15 eligible studies. RESULTS: While 14 of the studies focussed on holmium laser EEP, one focused on thulium laser vapoenucleation of the prostate. We observed an improvement in functional parameters in all studies we reviewed, and DCS success and readmission rates ranged between 35.3-100% and 0-17.8%, respectively. The complication rates varied between 0 and 36.7%, most of the complicatons were Clavien-Dindo (CD) I and II. CD ≥ III complications did not significantly differ between same day discharge (SDD) and non-SDD groups in the studies. CONCLUSION: Laser EEP is feasible and promising DCS treatment option delivering improved functional parameters compared to baseline values, and lower perioperative complication and readmission rates in certain patients.

Assessing critical temperature dose areas in the kidney by magnetic resonance imaging thermometry in an ex vivo Holmium:YAG laser lithotripsy model.

PURPOSE: We aimed to assess critical temperature areas in the kidney parenchyma using magnetic resonance thermometry (MRT) in an ex vivo Holmium:YAG laser lithotripsy model. METHODS: Thermal effects of Ho:YAG laser irradiation of 14 W and 30 W were investigated in the calyx and renal pelvis of an ex vivo kidney with different laser application times (tL) followed by a delay time (tD) of tL/tD = 5/5 s, 5/10 s, 10/5 s, 10/10 s, and 20/0 s, with irrigation rates of 10, 30, 50, 70, and 100 ml/min. Using MRT, the size of the area was determined in which the thermal dose as measured by the Cumulative Equivalent Minutes (CEM43) method exceeded a value of 120 min. RESULTS: In the calyx, CEM43 never exceeded 120 min for flow rates ≥ 70 ml/min at 14 W, and longer tL (10 s vs. 5 s) lead to exponentially lower thermal affection of tissue (3.6 vs. 21.9 mm2). Similarly at 30 W and ≥ 70 ml/min CEM43 was below 120 min. Interestingly, at irrigation rates of 10 ml/min, tL = 10 s and tD = 10 s CEM43 were observed > 120 min in an area of 84.4 mm2 and 49.1 mm2 at tD = 5 s. Here, tL = 5 s revealed relevant thermal affection of 29.1 mm2 at 10 ml/min. CONCLUSION: We demonstrate that critical temperature dose areas in the kidney parenchyma were associated with high laser power and application times, a low irrigation rate, and anatomical volume of the targeted calyx.

Towards Improving the Efficacy of PSMA-Targeting Radionuclide Therapy for Late-Stage Prostate Cancer-Combination Strategies.

PURPOSE OF REVIEW: [177Lu]Lu-PSMA-617 is a radiopharmaceutical that emits beta-minus radiation and targets prostate-specific membrane antigen (PSMA)-positive prostate cancer. Despite its clinical success, there are still patients not showing sufficient response rates. This review compiles latest studies aiming at therapy improvement in [177Lu]Lu-PSMA-617-naïve and -resistant patients by alternative or combination treatments. RECENT FINDINGS: A variety of agents to combine with [177Lu]Lu-PSMA-617 are currently under investigation including alpha radiation-emitting pharmaceuticals, radiosensitizers, taxane chemotherapeutics, androgen receptor pathway inhibitors, immune checkpoint inhibitors, and external beam radiation. Actinium-225 (225Ac)-labeled PSMA-targeting inhibitors are the most studied pharmaceuticals for combination therapy or as an alternative for treatment after progression under [177Lu]Lu-PSMA-617 therapy. Alpha emitters seem to have a potential of achieving a response to PSMA-targeting radionuclide therapy in both initial non-responders or responders to [177Lu]Lu-PSMA-617 later developing treatment resistance. Emerging evidence for immunostimulatory effects of radiopharmaceuticals and first prospective studies support the combination of [177Lu]Lu-PSMA-617 and immune checkpoint inhibition for late-stage prostate cancer.

KEYNOTE-991: pembrolizumab plus enzalutamide and androgen deprivation for metastatic hormone-sensitive prostate cancer.

Current treatment for patients with metastatic hormone-sensitive prostate cancer (mHSPC) delays disease progression and improves survival, but resistance is inevitable. Additional therapies that prolong survival are needed. Androgen deprivation therapy (ADT) combined with next-generation hormonal agents, such as enzalutamide, is standard-of-care for men with mHSPC. Emerging evidence suggests potential synergism between enzalutamide and the PD-1 inhibitor pembrolizumab in prostate cancer. The phase III randomized, placebo-controlled, double-blind KEYNOTE-991 trial will investigate the efficacy and safety of pembrolizumab versus placebo in combination with enzalutamide when initiating ADT in participants with mHSPC naive to next-generation hormonal agents. Approximately 1232 patients will be randomly assigned 1:1 to receive pembrolizumab 200 mg every 3 weeks or placebo every 3 weeks, both with enzalutamide 160 mg once daily and ADT. Dual primary end points are overall survival and radiographic progression-free survival. Secondary end points include time to first subsequent therapy, time to symptomatic skeletal related event, objective response rate and safety and tolerability. Clinical Trial Registration: NCT04191096 (ClinicalTrials.gov).

In vivo Temperature Assessment during Holmium Laser Enucleation of the Prostate.

INTRODUCTION: Holmium laser enucleation of the prostate (HoLEP) has become popular worldwide for the surgical treatment of benign prostate hyperplasia. Holmium laser is considered an ideal transurethral thermomechanical device for enucleating the prostate. Although there is evidence on Ho:YAG laser-related heat generation, the studies mainly investigated ex vivo temperature generation during holmium laser lithotripsy. In this in vivo study, we aimed to assess for the first time the real-time heat generated during HoLEP. METHODS: Fifteen HoLEP procedures were included. The study was conducted over a time period of 16 months. To investigate the temperature generation, a preoperatively inserted rectal temperature probe and a temperature sensor within a suprapubic bladder catheter were used to record the temperature change during enucleation and coagulation. RESULTS: The mean values of the temperature change during the laser enucleation and coagulation were -0.35 ± 0.203 K (IQR: 0.23) and +0.14 ± 0.259 K (IQR: 0.3), respectively, in rectal measurements. Temperature differences during laser use and coagulation were <+1 K and <+5 K, respectively, in bladder measurements. We measured no temperature >37.1°C during the procedures and no temperature values considered harmful to the human body. CONCLUSION: Sufficient irrigation flow rates and irrigation monitoring during HoLEP are obligatory. To prevent a high and uncontrolled temperature rise, the surgeon or operating room staff should pay attention to the irrigation's continuity.

The maximum standardized uptake value in patients with recurrent or persistent prostate cancer after radical prostatectomy and PSMA-PET-guided salvage radiotherapy-a multicenter retrospective analysis.

PURPOSE: This study aims to evaluate the association of the maximum standardized uptake value (SUVmax) in positron-emission tomography targeting prostate-specific membrane antigen (PSMA-PET) prior to salvage radiotherapy (sRT) on biochemical recurrence free survival (BRFS) in a large multicenter cohort. METHODS: Patients who underwent 68 Ga-PSMA11-PET prior to sRT were enrolled in four high-volume centers in this retrospective multicenter study. Only patients with PET-positive local recurrence (LR) and/or nodal recurrence (NR) within the pelvis were included. Patients were treated with intensity-modulated-sRT to the prostatic fossa and elective lymphatics in case of nodal disease. Dose escalation was delivered to PET-positive LR and NR. Androgen deprivation therapy was administered at the discretion of the treating physician. LR and NR were manually delineated and SUVmax was extracted for LR and NR. Cox-regression was performed to analyze the impact of clinical parameters and the SUVmax-derived values on BRFS. RESULTS: Two hundred thirty-five patients with a median follow-up (FU) of 24 months were included in the final cohort. Two-year and 4-year BRFS for all patients were 68% and 56%. The presence of LR was associated with favorable BRFS (p = 0.016). Presence of NR was associated with unfavorable BRFS (p = 0.007). While there was a trend for SUVmax values ≥ median (p = 0.071), SUVmax values ≥ 75% quartile in LR were significantly associated with unfavorable BRFS (p = 0.022, HR: 2.1, 95%CI 1.1-4.6). SUVmax value in NR was not significantly associated with BRFS. SUVmax in LR stayed significant in multivariate analysis (p = 0.030). Sensitivity analysis with patients for who had a FU of > 12 months (n = 197) confirmed these results. CONCLUSION: The non-invasive biomarker SUVmax can prognosticate outcome in patients undergoing sRT and recurrence confined to the prostatic fossa in PSMA-PET. Its addition might contribute to improve risk stratification of patients with recurrent PCa and to guide personalized treatment decisions in terms of treatment intensification or de-intensification. This article is part of the Topical Collection on Oncology-Genitourinary.

Thermal effects of thulium: YAG laser treatment of the prostate-an in vitro study.

PURPOSE: To objectively determine whether there is potential thermal tissue damage during Tm:YAG laser-based LUTS treatment. METHODS: Our experimental model was comprised of a prostatic resection trainer placed in a 37 °C water bath. In a hollowed-out central area simulating the urethral lumen, we placed a RigiFib 800 fibre, irrigation inflow regulated with a digital pump, and a type K thermocouple. A second thermocouple was inserted 0.5/1 cm adjacently and protected with an aluminum barrier to prevent it from urethral fluid. We investigated continuous and intermittent 120 W and 80 W laser application with various irrigation rates in eight measurement sessions lasting up to 14 min. Thermal measurements were recorded continuously and in real-time using MatLab. All experiments were repeated five times to balance out variations. RESULTS: Continuous laser application at 120 W and 125 ml/min caused a urethral ∆T of ~ 15 K and a parenchymal temperature increase of up to 7 K. With 50 ml/min irrigation, a urethral and parenchymal ∆T of 30 K and 15 K were reached, respectively. Subsequently and in absence of laser application, prostatic parenchyma needed over 16 min to reach baseline body temperature. At 80 W lower temperature increases were reached compared to similar irrigation but higher power. CONCLUSIONS: We showed that potentially harming temperatures can be reached, especially during high laser power and low irrigation. The heat generation can also be conveyed to the prostate parenchyma and deeper structures, potentially affecting the neurovascular bundles. Further clinical studies with intracorporal temperature measurement are necessary to further investigate this potentially harming surgical adverse effect.

Experimental ex-vivo performance study comparing a novel, pulsed thulium solid-state laser, chopped thulium fibre laser, low and high-power holmium:YAG laser for endoscopic enucleation of the prostate.

PURPOSE: The aim of this study was to compare the enucleation performances of four different types of laser devices in an ex-vivo experiment: a novel, pulsed Tm:YAG solid-state laser evaluation model (p-Tm:YAG), chopped thulium fibre laser (TFL), low-power Ho:YAG laser (LP-Ho:YAG), and a high-power Ho:YAG laser (HP-Ho:YAG). METHODS: Our primary aim was to endoscopically separate the fascial layers of a porcine belly using laser fibres within a time period of 60 s. The size of a "tissue pocket" was assessed numerically. The enucleation characteristics reflecting the surgeon's experience were evaluated via the NASA Task Load Index (TLX) questionnaire and a questionnaire based on Likert scale. RESULTS: HP-Ho:YAG achieved with the available laser settings the largest overall "tissue pocket" (31.5 cm2) followed by p-Tm:YAG (15 cm2), TFL (12 cm2), and LP-Ho:YAG (6 cm2). The coagulation performances of p-Tm:YAG and TFL were rated the best. In the performance evaluation by the Likert questionnaire, HP-Ho:YAG (average score of 4.06) was rated highest, followed by p-Tm:YAG (3.94), TFL (3.38), and LP-Ho:YAG (3.25). The evaluation of the NASA-TLX performance questionnaire revealed average scores for HP-Ho:YAG, LP-Ho:YAG, TFL and p-Tm:YAG of 4.38, 4.09, 3.92 and 3.90, respectively. CONCLUSION: We are the first to compare different laser devices and settings in an ex-vivo study. We found that the surgeons were most satisfied with the HP-Ho:YAG laser device, followed by the p-Tm:YAG. These findings could be highly relevant for future research and for the practical utilisation of laser systems in endourology.

Temperature assessment study of ex vivo holmium laser enucleation of the prostate model.

PURPOSE: There isscarce evidence to date on how temperature develops during holmium laser enucleation of the prostate (HoLEP). We aimed to determine the potential heat generation during HoLEP under ex vivo conditions. METHODS: We developed two experimental setups. Firstly, we simulated HoLEP ex vivo using narrow-neck laboratory bottles mimicking enucleation cavities and a prostate resection trainer. Seven temperature probes were placed at different locations in the experimental setup, and the heat generation was measured separately during laser application. Secondly, we simulated high-frequency current-based coagulation of the vessels using a roller probe. RESULTS: We observed that the larger the enucleated cavity, the higher the temperature rises, regardless of the irrigation flow rate. The highest temperature difference with an irrigation flow was approximately + 4.5 K for a cavity measuring 100ccm and a 300 ml/min irrigation flow rate. The higher flow rate generates faster removal of the generated heat, thus cooling down the artificial cavity. Furthermore, the temperature differences at different irrigation flow rates (except at 0 ml/min) were consistently below 5 K. Within the resection trainer, the temperature increase with and without irrigation flow was approximately 0.5 K and 3.0 K, respectively. The mean depth of necrosis (1084 ± 176 µm) achieved by the roller probe was significantly greater when using 144 W energy. CONCLUSION: Carefully adjusted irrigation and monitoring during HoLEP are crucial when evacuating the thermal energy generated during the procedure. We believe this study of ours provides evidence with the potential to facilitate clinical studies on patient safety.

Impact of COVID-19 crisis on medical care of patients with metastasized uro-oncologic disease under systemic cancer therapy: a multicenter study in German university hospitals.

PURPOSE: To date, over 4.2 million Germans and over 235 million people worldwide have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Uro-oncology (UO) patients are particularly vulnerable but in urgent need of life-saving systemic treatments. Our multicentric study examined the impact of the COVID-19 crisis on the medical care of UO patients in German university hospitals receiving ongoing systemic anti-cancer treatment and to detect the delay of medical care, defined as deferred medical treatment or deviation of the pre-defined follow-up assessment. METHODS: Data of 162 UO patients with metastatic disease undergoing systemic cancer treatment at five university hospitals in Germany were included in our analyses. The focus of interest was any delay or change in treatment between February 2020 and May 2020 (first wave of the COVID-19 crisis in Germany). Statistical analysis of contingency tables were performed using Pearson's chi-squared and Fisher's exact tests, respectively. Effect size was determined using Cramér's V (V). RESULTS: Twenty-four of the 162 patients (14.8%) experienced a delay in systemic treatment of more than 2 weeks. Most of these received immuno-oncologic (IO) treatments (13/24, 54.2%, p = 0.746). Blood tests were delayed or canceled significantly more often in IO patients but with a small effect size (21.1%, p = 0.042, V = 0.230). Treatment of patients with renal cell carcinoma (12/73, 16.4%) and urothelial carcinoma (7/32, 21.9%) was affected the most. CONCLUSIONS: Our data show that the COVID-19 pandemic impacted the medical care of UO patients, but deferment remained modest. There was a tendency towards delays in IO and ADT treatments in particular.

Distress in hospitalized cancer patients: Associations with personality traits, clinical and psychosocial characteristics.

OBJECTIVE: To improve allocation of psychosocial care and to provide patient-oriented support offers, identification of determinants of elevated distress is needed. So far, there is a lack of evidence investigating the interplay between individual disposition and current clinical and psychosocial determinants of distress in the inpatient setting. METHODS: In this cross-sectional study, we investigated 879 inpatients with different cancer sites treated in a German Comprehensive Cancer Center. Assessment of determinants of elevated distress included sociodemographic, clinical and psychosocial characteristics as well as dimensions of personality. Multiple linear regression was applied to identify determinants of psychosocial distress. RESULTS: Mean age of the patients was M = 61.9 (SD = 11.8), 48.1% were women. In the multiple linear regression model younger age (ß = -0.061, p = 0.033), higher neuroticism (ß = 0.178, p = <0.001), having metastases (ß = 0.091, p = 0.002), being in a worse physical condition (ß = 0.380, p = <0.001), depressive symptoms (ß = 0.270, p = <0.001), not feeling well informed about psychological support (ß = 0.054, p = 0.046) and previous uptake of psychological treatment (ß = 0.067, p = 0.020) showed significant associations with higher psychosocial distress. The adjusted R2 of the overall model was 0.464. CONCLUSION: Controlling for sociodemographic characteristics and dispositional vulnerability, that is neuroticism, current clinical and psychosocial characteristics were still associated with hospitalized patients' psychosocial distress. Psycho-oncologists should address both, the more transient emotional responses, such as depressive symptoms, as well as more enduring patient characteristics, like neuroticism.

A nationwide registry for recurrent urolithiasis in the upper urinary tract - The RECUR study protocol.

BACKGROUND: Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries". METHODS: RECUR builds on the technical infrastructure of Germany's Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel. DISCUSSION: The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry's technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries. TRIAL REGISTRATION: This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923 , date of registration January, 11th 2022.