Research Protocol for an Observational Health Data Analysis on the Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform.

Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in "real-life" patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

Predictive Models for Assessing Patients' Response to Treatment in Metastatic Prostate Cancer: A Systematic Review.

Background and objective: The treatment landscape of metastatic prostate cancer (mPCa) has evolved significantly over the past two decades. Despite this, the optimal therapy for patients with mPCa has not been determined. This systematic review identifies available predictive models that assess mPCa patients' response to treatment. Methods: We critically reviewed MEDLINE and CENTRAL in December 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Only quantitative studies in English were included with no time restrictions. The quality of the included studies was assessed using the PROBAST tool. Data were extracted following the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews criteria. Key findings and limitations: The search identified 616 citations, of which 15 studies were included in our review. Nine of the included studies were validated internally or externally. Only one study had a low risk of bias and a low risk concerning applicability. Many studies failed to detail model performance adequately, resulting in a high risk of bias. Where reported, the models indicated good or excellent performance. Conclusions and clinical implications: Most of the identified predictive models require additional evaluation and validation in properly designed studies before these can be implemented in clinical practice to assist with treatment decision-making for men with mPCa. Patient summary: In this review, we evaluate studies that predict which treatments will work best for which metastatic prostate cancer patients. We found that existing studies need further improvement before these can be used by health care professionals.

How Can We Improve Patient-Clinician Communication for Men Diagnosed with Prostate Cancer?

Background and objective: The ability of health care professionals to communicate with patients compassionately and effectively is crucial for shared decision-making, but little research has investigated patient-clinician communication. As part of PIONEER-an international Big Data Consortium led by the European Association of Urology to answer key questions for men with prostate cancer (PCa), funded through the IMI2 Joint Undertaking under grant agreement 777492- we investigated communication between men diagnosed with PCa and the health care professional(s) treating them across Europe. Methods: We used the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Communication 26, which was shared via the PIONEER and patient organisations on March 11, 2022. We sought men who spoke French, Italian, Spanish, German, Dutch, or English who were diagnosed with PCa and were undergoing or had already received treatment for their PCa. Results and limitations: A total of 372 men reported that they communicated with their clinician during either the diagnostic or the treatment period. Overall, the majority of participants reported positive experiences. However, important opportunities to enhance communication were identified, particularly with regard to correcting misunderstandings, understanding the patient's preferred approach to information presentation, addressing challenging questions, supporting the patient's comprehension of information, attending to the patient's emotional needs, and assessing what information had already been given to patients about their disease and treatment, and how much of it was understood. Conclusions and clinical implications: These results help us to identify gaps and barriers to shared treatment decision making. This knowledge will help devise measures to improve patient-health care professional communication in the PCa setting. Patient summary: As part of the PIONEER initiative, we investigated the communication between men diagnosed with prostate cancer and their health care professionals across Europe. A total of 372 men from six different countries participated in the study. Most participants reported positive experiences, but areas where communication could be improved were identified. These included addressing misunderstandings, tailoring the presentation of information to the patient's preferences, handling difficult questions, supporting emotional needs, and assessing the patient's understanding of their diagnosis and treatment.

PRECISE Version 2: Updated Recommendations for Reporting Prostate Magnetic Resonance Imaging in Patients on Active Surveillance for Prostate Cancer.

BACKGROUND AND OBJECTIVE: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations standardise the reporting of prostate magnetic resonance imaging (MRI) in patients on active surveillance (AS) for prostate cancer. An international consensus group recently updated these recommendations and identified the areas of uncertainty. METHODS: A panel of 38 experts used the formal RAND/UCLA Appropriateness Method consensus methodology. Panellists scored 193 statements using a 1-9 agreement scale, where 9 means full agreement. A summary of agreement, uncertainty, or disagreement (derived from the group median score) and consensus (determined using the Interpercentile Range Adjusted for Symmetry method) was calculated for each statement and presented for discussion before individual rescoring. KEY FINDINGS AND LIMITATIONS: Participants agreed that MRI scans must meet a minimum image quality standard (median 9) or be given a score of 'X' for insufficient quality. The current scan should be compared with both baseline and previous scans (median 9), with the PRECISE score being the maximum from any lesion (median 8). PRECISE 3 (stable MRI) was subdivided into 3-V (visible) and 3-NonV (nonvisible) disease (median 9). Prostate Imaging Reporting and Data System/Likert ≥3 lesions should be measured on T2-weighted imaging, using other sequences to aid in the identification (median 8), and whenever possible, reported pictorially (diagrams, screenshots, or contours; median 9). There was no consensus on how to measure tumour size. More research is needed to determine a significant size increase (median 9). PRECISE 5 was clarified as progression to stage ≥T3a (median 9). CONCLUSIONS AND CLINICAL IMPLICATIONS: The updated PRECISE recommendations reflect expert consensus opinion on minimal standards and reporting criteria for prostate MRI in AS. PATIENT SUMMARY: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations are used in clinical practice and research to guide the interpretation and reporting of magnetic resonance imaging for patients on active surveillance for prostate cancer. An international panel has updated these recommendations, clarified the areas of uncertainty, and highlighted the areas for further research.

Unlocking the Potential of Adequate Bacillus Calmette-Guérin Immunotherapy in Very-high-risk Non-muscle-invasive Bladder Carcinoma: A Multicenter Analysis of Oncological Outcomes and Risk Dynamics.

BACKGROUND: The European Association of Urology (EAU) recommends discussing upfront radical cystectomy for all patients with very high risk (VHR) non-muscle-invasive bladder carcinoma (NMIBC), but the role of bacillus Calmette-Guérin (BCG) treatment remains controversial. OBJECTIVE: To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG. DESIGN, SETTING, AND PARTICIPANTS: A multi-institutional retrospective study involving patients with VHR NMIBC who received adequate BCG therapy from 2007 to 2020 was conducted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A survival analysis estimated recurrence-free survival (RFS), progression-free survival (PFS), and the cumulative incidence of cancer-specific mortality (CSM) after accounting for other causes of mortality as competing risk events and of the overall mortality (OM). Conditional survival probabilities for 0-4 yr without events were computed. Cox regression assessed the predictors of oncological outcomes. RESULTS AND LIMITATION: A total of 640 patients, with a median 47 (32-67) mo follow-up for event-free individuals, were analyzed. High-grade RFS and PFS at 5 yr were 53% (49-57%) and 78% (74-82%), respectively. The cumulative incidence of CSM and OM at 5 yr was 13% (10-16%) and 16% (13-19%), respectively. Conditional RFS, PFS, overall survival, and cancer-specific survival at 4 yr were 91%, 96%, 87%, and 94%, respectively. Cox regression identified tumor grade (hazard ratio [HR]: 1.54; 1.1-2) and size (HR: 1.3; 1.1-1.7) as RFS predictors. Tumor multiplicity predicted RFS (HR: 1.6; 1.3-2), PFS (HR: 2; 1.2-3.3), and CSM (HR: 2; 1.2-3.2), while age predicted OM (HR: 1.48; 1.1-2). CONCLUSIONS: Patients with VHR NMIBC who receive adequate BCG therapy have a more favorable prognosis than predicted by EAU risk groups, especially among those with a sustained response, in whom continuing maintenance therapy emerges as a viable alternative to radical cystectomy. PATIENT SUMMARY: Our research shows that a sustained response to bacillus Calmette-Guérin in patients can lead to favorable outcomes, serving as a viable alternative to cystectomy for select cases.

Awareness and Use of ChatGPT and Large Language Models: A Prospective Cross-sectional Global Survey in Urology.

BACKGROUND: Since its release in November 2022, ChatGPT has captivated society and shown potential for various aspects of health care. OBJECTIVE: To investigate potential use of ChatGPT, a large language model (LLM), in urology by gathering opinions from urologists worldwide. DESIGN, SETTING, AND PARTICIPANTS: An open web-based survey was distributed via social media and e-mail chains to urologists between April 20, 2023 and May 5, 2023. Participants were asked to answer questions related to their knowledge and experience with artificial intelligence, as well as their opinions of potential use of ChatGPT/LLMs in research and clinical practice. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data are reported as the mean and standard deviation for continuous variables, and the frequency and percentage for categorical variables. Charts and tables are used as appropriate, with descriptions of the chart types and the measures used. The data are reported in accordance with the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). RESULTS AND LIMITATIONS: A total of 456 individuals completed the survey (64% completion rate). Nearly half (47.7%) reported that they use ChatGPT/LLMs in their academic practice, with fewer using the technology in clinical practice (19.8%). More than half (62.2%) believe there are potential ethical concerns when using ChatGPT for scientific or academic writing, and 53% reported that they have experienced limitations when using ChatGPT in academic practice. CONCLUSIONS: Urologists recognise the potential of ChatGPT/LLMs in research but have concerns regarding ethics and patient acceptance. There is a desire for regulations and guidelines to ensure appropriate use. In addition, measures should be taken to establish rules and guidelines to maximise safety and efficiency when using this novel technology. PATIENT SUMMARY: A survey asked 456 urologists from around the world about using an artificial intelligence tool called ChatGPT in their work. Almost half of them use ChatGPT for research, but not many use it for patients care. The resonders think ChatGPT could be helpful, but they worry about problems like ethics and want rules to make sure it's used safely.

Docetaxel Provides Oncological Benefits in the Era of New-Generation Androgen Receptor Inhibitors - or Is Three a Crowd?

In recent years, several systemic therapies have been introduced for metastatic hormone-sensitive prostate cancer, including androgen deprivation therapy (ADT) combined with docetaxel (Doc) and/or new-generation androgen receptor signaling inhibitors (ARSI). Trials evaluating ADT + ARSI have consistently demonstrated an overall survival (OS) benefit for doublet therapy over ADT alone. Similarly, the STOPCaP meta-analysis showed an OS benefit in favor of ADT + Doc versus ADT alone. ARSI, Doc, and ADT have different antitumor mechanisms, thus potentiating the effect of combination therapy. Two randomized trials showed that the addition of ARSI to ADT + Doc improves OS, especially for synchronous high-volume disease. However, the real question about triplet therapy remains unanswered: whether combining Doc with ARSI improves outcomes compared to ADT + ARSI. As there are no head-to-head comparisons, this narrative review aims to summarize the current evidence regarding triplet therapy versus doublet therapy including ADT+ ARSI.

Prognostic Significance of Grade Discrepancy Between Primary Tumor and Venous Thrombus in Nonmetastatic Clear-cell Renal Cell Carcinoma: Analysis of the REMEMBER Registry and Implications for Adjuvant Therapy.

BACKGROUND: Further stratification of the risk of recurrence of clear-cell renal cell carcinoma (ccRCC) with venous tumor thrombus (VTT) will facilitate selection of candidates for adjuvant therapy. OBJECTIVE: To assess the impact of tumor grade discrepancy (GD) between the primary tumor (PT) and VTT in nonmetastatic ccRCC on disease-free survival (DFS), overall survival (OS), and cancer-specific survival (CSS). DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective analysis of a multi-institutional nationwide data set for patients with pT3N0M0 ccRCC who underwent radical nephrectomy and thrombectomy. OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS: Pathology slides were centrally reviewed. GD, a bidirectional variable (upgrading or downgrading), was numerically defined as the VTT grade minus the PT grade. Multivariable models were built to predict DFS, OS, and CSS. RESULTS AND LIMITATIONS: We analyzed data for 604 patients with median follow-up of 42 mo (excluding events). Tumor GD between VTT and PT was observed for 47% (285/604) of the patients and was an independent risk factor with incremental value in predicting the outcomes of interest (all p < 0.05). Incorporation of tumor GD significantly improved the performance of the ECOG-ACRIN 2805 (ASSURE) model. A GD-based model (PT grade, GD, pT stage, PT sarcomatoid features, fat invasion, and VTT consistency) had a c index of 0.72 for DFS. The hazard ratios were 8.0 for GD = +2 (p < 0.001), 1.9 for GD = +1 (p < 0.001), 0.57 for GD = -1 (p = 0.001), and 0.22 for GD = -2 (p = 0.003) versus GD = 0 as the reference. According to model-converted risk scores, DFS, OS, and CSS significantly differed between subgroups with low, intermediate, and high risk (all p < 0.001). CONCLUSIONS: Routine reporting of VTT upgrading or downgrading in relation to the PT and use of our GD-based nomograms can facilitate more informed treatment decisions by tailoring strategies to an individual patient's risk of progression. PATIENT SUMMARY: We developed a tool to improve patient counseling and guide decision-making on other therapies in addition to surgery for patients with the clear-cell type of kidney cancer and tumor invasion of a vein.

Research protocol to identify progression and death amongst patients with metastatic hormone-sensitive prostate cancer treated with available treatments: PIONEER IMI's "big data for better outcomes" program.

Androgen deprivation therapy-based with or without first-generation anti-androgens, was the standard of care for patients with metastatic hormone-sensitive prostate cancer (mHSPC) for decades. However, the development of docetaxel chemotherapy and new androgen receptor-targeted agents, abiraterone acetate and prednisolone, apalutamide , enzalutamide and darolutamide (in combination with docetaxel chemotherapy) has proven that combination of treatments is more effective. Recently, intensification therapy, so-called "triplets", have emerged in the armamentarium of mHSPC treatment. Metastatic disease is a clinical state that remains poorly understood. The optimal diagnostic and management of patients with mHSPC are changing thanks to the development of new imaging techniques and therapies. The primary objective of this study is to develop and validate a predictive model for the occurrence of symptomatic progression, initiation of new treatments and death amongst patients with mHSPC treated with one of the approved treatment plans, on characteristics present at admission.

Navigating through the Controversies and Emerging Paradigms in Early Detection of Prostate Cancer: Bridging the Gap from Classic RCTs to Modern Population-Based Pilot Programs.

Over the last three decades, the European Randomized Study of Screening for Prostate Cancer (ERSPC) and the US-based Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening have steered the conversation around the early detection of prostate cancer. These two randomized trials assessed the effect of screening on prostate cancer disease-specific mortality. Elevated PSA levels were followed by a systematic sextant prostate biopsy. Standard repeat testing intervals were applied. After controversies from 2009 to 2016 due to contradicting results of the two trials, the results aligned in 2016 and showed that early PSA detection reduces prostate cancer-specific mortality. However, overdiagnosis rates of up to 50% were reported, and this sparked an intense debate on harms and benefits for almost 20 years. The balance between harms and benefits is highly debated and has initiated further research to investigate new ways of early detection. In the meantime, the knowledge and tools for the diagnostic algorithm improved. This is a continuously ongoing effort which focuses on individual risk-based screening algorithms that preserve the benefits of the purely PSA-based screening algorithms, while reducing the side effects. An important push towards investigating new techniques for early detection came from the European Commission on the 20th of September 2022. The European Commission published its updated recommendation to investigate prostate, lung, and gastric cancer early detection programs. This opened a new window of opportunity to move away from the trial setting to population-based early detection settings. With this review, we aim to review 30 years of historical evidence of prostate cancer screening, which led to the initiation of the 'The Prostate Cancer Awareness and Initiative for Screening in the European Union' (PRAISE-U) project, which aims to encourage the early detection and diagnosis of PCa through customized and risk-based screening programs.

Can the Abdominal Aortic Atherosclerotic Plaque Index Predict Functional Outcomes after Robot-Assisted Partial Nephrectomy?

This study aims to evaluate the abdominal aortic atherosclerotic plaque index (API)'s predictive role in patients with pre-operatively or post-operatively developed chronic kidney disease (CKD) treated with robot-assisted partial nephrectomy (RAPN) for renal cell carcinoma (RCC). One hundred and eighty-three patients (134 with no pre- and post-operative CKD (no CKD) and 49 with persistent or post-operative CKD development (post-op CKD)) who underwent RAPN between January 2019 and January 2022 were deemed eligible for the analysis. The API was calculated using dedicated software by assessing the ratio between the CT scan atherosclerotic plaque volume and the abdominal aortic volume. The ROC regression model demonstrated the influence of API on CKD development, with an increasing effect according to its value (coefficient 0.13; 95% CI 0.04-0.23; p = 0.006). The Model 1 multivariable analysis of the predictors of post-op CKD found that the following are independently associated with post-op CKD: Charlson Comorbidity Index (OR 1.31; p = 0.01), last follow-up (FU) Δ%eGFR (OR 0.95; p < 0.01), and API ≥ 10 (OR 25.4; p = 0.01). Model 2 showed API ≥ 10 as the only factor associated with CKD development (OR 25.2; p = 0.04). The median follow-up was 22 months. Our results demonstrate API to be a strong predictor of post-operative CKD, allowing the surgeon to tailor the best treatment for each patient, especially in those who might be at higher risk of CKD.

Robot-Assisted Radical Prostatectomy by Lateral Approach: Technique, Reproducibility and Outcomes.

BACKGROUND: Radical prostatectomy by lateral approach allows performing a prostatectomy through a buttonhole, with direct access to the seminal vesicle and fully sparing the anterior pubovesical complex. Our aim is to show the results of reproducing the technique of robotic radical prostatectomy by lateral approach, in terms of intraoperative, postoperative, oncological and functional parameters. METHODS: We analyzed 513 patients submitted to robotic radical prostatectomy by lateral approach from January 2015 to March 2021, operated on by two surgeons in our institution. The oncological and functional results of both surgeons were compared. RESULTS: When comparing both surgeons, the rate of positive surgical margins (PSM) was 32.87% and 37.9% and significant surgical margins (PSM > 2 mm) were 5.88% and 7.58% (p = 0.672) for surgeon 1 and surgeon 2, respectively. Immediate continence was 86% and 85% and sexual potency at one year 73% and 72%, with a similar rate of complications for surgeon 1 and 2. CONCLUSIONS: Radical prostatectomy by the lateral approach technique with preservation of the anterior pubovesical complex is reproducible and offers good oncological and functional results.

Oncological Efficacy of Robotic Nephroureterectomy vs. Open and Laparoscopic Nephroureterectomy for Suspected Non-Metastatic UTUC-A Systematic Review and Meta-Analysis.

INTRODUCTION AND AIMS: The optimal approach for nephroureterectomy in patients with suspected UTUC remains a point of debate. In this review, we compare the oncological outcomes of robotic nephroureterectomy (RNU) with open (ONU) or laparoscopic nephroureterectomy (LNU). METHODS: All randomized trials and observational studies comparing RNU with ONU and/or LNU for suspected non-metastatic UTUC are included in this review. The systematic review was performed in accordance with the Cochrane Guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The primary outcome measures were overall survival (OS), cancer-specific survival (CSS), disease-free survival (DFS), and intravesical recurrence-free survival (IV-RFS). The secondary outcome measures were the lymph node dissection (LND) rates, positive margin rates, and the proportion of patients receiving bladder intravesical chemotherapy. RESULTS: We identified 8172 references through our electronic searches and 8 studies through manual searching. A total of 15 studies met the inclusion criteria. The total number of patients in the review was 18,964. RNU had superior OS compared to LNU (HR: 0.81 (95% CI: 0.71, 0.93), p-0.002 (very low certainty)). RNU and ONU had similar OS (HR: 0.83 (95% CI: 0.52, 1.34), p-0.44 (very low certainty)). One study reported an independent association of RNU as a worse predictor of IV-RFS when compared to ONU (HR-1.73 (95% CI: 1.22, 2.45)). The LND rates were higher in the RNU cohort when compared to the LNU cohort (RR 1.24 (95% CI: 1.03, 1.51), p-0.03 (low certainty)). The positive margin rate was lower in the RNU cohort when compared to the ONU cohort (RR 0.29 (95% CI: 0.08, 0.86), p-0.03 (low certainty)). CONCLUSION: RNU offers comparable oncological efficacy to ONU, except for intravesical recurrence-free survival (IV-RFS). RNU has fewer positive surgical margin rates compared to ONU in well-balanced studies. RNU appears to outperform LNU for certain oncological parameters, such as OS and the proportion of patients who receive lymph node dissections. The quality of evidence comparing surgical techniques for UTUC has remained poor in the last decade.

Artificial Intelligence in Surgical Training for Kidney Cancer: A Systematic Review of the Literature.

The prevalence of renal cell carcinoma (RCC) is increasing due to advanced imaging techniques. Surgical resection is the standard treatment, involving complex radical and partial nephrectomy procedures that demand extensive training and planning. Furthermore, artificial intelligence (AI) can potentially aid the training process in the field of kidney cancer. This review explores how artificial intelligence (AI) can create a framework for kidney cancer surgery to address training difficulties. Following PRISMA 2020 criteria, an exhaustive search of PubMed and SCOPUS databases was conducted without any filters or restrictions. Inclusion criteria encompassed original English articles focusing on AI's role in kidney cancer surgical training. On the other hand, all non-original articles and articles published in any language other than English were excluded. Two independent reviewers assessed the articles, with a third party settling any disagreement. Study specifics, AI tools, methodologies, endpoints, and outcomes were extracted by the same authors. The Oxford Center for Evidence-Based Medicine's evidence levels were employed to assess the studies. Out of 468 identified records, 14 eligible studies were selected. Potential AI applications in kidney cancer surgical training include analyzing surgical workflow, annotating instruments, identifying tissues, and 3D reconstruction. AI is capable of appraising surgical skills, including the identification of procedural steps and instrument tracking. While AI and augmented reality (AR) enhance training, challenges persist in real-time tracking and registration. The utilization of AI-driven 3D reconstruction proves beneficial for intraoperative guidance and preoperative preparation. Artificial intelligence (AI) shows potential for advancing surgical training by providing unbiased evaluations, personalized feedback, and enhanced learning processes. Yet challenges such as consistent metric measurement, ethical concerns, and data privacy must be addressed. The integration of AI into kidney cancer surgical training offers solutions to training difficulties and a boost to surgical education. However, to fully harness its potential, additional studies are imperative.

Which Patients with Prostate Cancer and Lymph Node Uptake at Preoperative Prostate-specific Membrane Antigen Positron Emission Tomography/Computerized Tomography Scan Are at a Higher Risk of Prostate-specific Antigen Persistence After Radical Prostatectomy? Identifying Indicators of Systemic Disease by Integrating Clinical, Magnetic Resonance Imaging, and Functional Imaging Parameters.

BACKGROUND: The role of local therapies including radical prostatectomy (RP) in prostate cancer (PCa) patients with clinical lymphadenopathies on prostate-specific membrane antigen (PSMA) positron emission tomography/computerized tomography (PET/CT) has scarcely been explored. Limited data are available to identify men who would benefit from RP; on the contrary, those more likely to benefit already have systemic disease. OBJECTIVE: We aimed to assess the predictors of prostate-specific antigen (PSA) persistence in surgically managed PCa patients with lymphadenopathies on a PSMA PET/CT scan by integrating clinical, magnetic resonance imaging (MRI), and PSMA PET/CT parameters. DESIGN, SETTING, AND PARTICIPANTS: We identified 519 patients treated with RP and extended lymph node dissection, and who received preoperative PSMA PET between 2017 and 2022 in nine referral centers. Among them, we selected 88 patients with nodal uptake at preoperative PSMA PET (miTxN1M0). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The outcome was PSA persistence, defined as a PSA value of ≥0.1 ng/ml at the first measurement after surgery. Multivariable logistic regression models tested the predictors of PSA persistence. Covariates consisted of biopsy International Society of Urological Pathology (ISUP) grade group, clinical stage at MRI, and number of positive spots at a PET/CT scan. A regression tree analysis stratified patients into risk groups based on preoperative characteristics. RESULTS AND LIMITATIONS: Overall, lymph node invasion (LNI) was detected in 63 patients (72%) and 32 (36%) experienced PSA persistence after RP. At multivariable analyses, having more than two lymph nodal positive findings at PSMA PET, seminal vesicle invasion (SVI) at MRI, and ISUP grade group >3 at biopsy were independent predictors of PSA persistence (all p < 0.05). At the regression tree analysis, patients were stratified in four risk groups according to biopsy ISUP grade, number of positive findings at PET/CT, and clinical stage at MRI. The model depicted good discrimination at internal validation (area under the curve 78%). CONCLUSIONS: One out of three miN1M0 patients showed PSA persistence after surgery. Patients with ISUP grade 2-3, as well as patients with organ-confined disease at MRI and a single or two positive nodal findings at PET are those in whom RP may achieve the best oncological outcomes in the context of a multimodal approach. Conversely, patients with a high ISUP grade and extracapsular extension or SVI or more than two spots at PSMA PET should be considered as potentially affected by systemic disease upfront. PATIENT SUMMARY: Our novel and straightforward risk classification integrates currently available preoperative risk tools and should, therefore, assist physician in preoperative counseling of men candidates for radical treatment for prostate cancer with positive lymph node uptake at prostate-specific membrane antigen positron emission tomography.

The Use of Radiomic Tools in Renal Mass Characterization.

The incidence of renal mass detection has increased during recent decades, with an increased diagnosis of small renal masses, and a final benign diagnosis in some cases. To avoid unnecessary surgeries, there is an increasing interest in using radiomics tools to predict histological results, using radiological features. We performed a narrative review to evaluate the use of radiomics in renal mass characterization. Conventional images, such as computed tomography (CT) and magnetic resonance (MR), are the most common diagnostic tools in renal mass characterization. Distinguishing between benign and malignant tumors in small renal masses can be challenging using conventional methods. To improve subjective evaluation, the interest in using radiomics to obtain quantitative parameters from medical images has increased. Several studies have assessed this novel tool for renal mass characterization, comparing its ability to distinguish benign to malign tumors, the results in differentiating renal cell carcinoma subtypes, or the correlation with prognostic features, with other methods. In several studies, radiomic tools have shown a good accuracy in characterizing renal mass lesions. However, due to the heterogeneity in the radiomic model building, prospective and external validated studies are needed.

Prognosis of patients with T1 low-grade urothelial bladder cancer treated with bacillus Calmette-Guérin immunotherapy.

BACKGROUND: The existence and prognosis of T1LG (T1 low-grade) bladder cancer is controversial. Also, because of data paucity, it remains unclear what is the clinical history of bacillus Calmette-Guérin (BCG) treated T1LG tumors and if it differs from other NMIBC (non-muscle-invasive bladder cancer) representatives. The aim of this study was to analyse recurrence-free survival (RFS) and progression-free survival (PFS) in patients with T1LG bladder cancers treated with BCG immunotherapy. METHODS: A multi-institutional and retrospective study of 2510 patients with Ta/T1 NMIBC with or without carcinoma in situ (CIS) treated with BCG (205 T1LG patients) was performed. Kaplan-Meier estimates and log-rank test for RFS and PFS to compare the survival between TaLG, TaHG, T1LG, and T1HG NMIBC were used. Also, T1LG tumors were categorized into EAU2021 risk groups and PFS analysis was performed, and Cox multivariate model for both RFS and PFS were constructed. RESULTS: The median follow-up was 52 months. For the T1LG cohort, the estimated RFS and PFS rates at 5-year were 59.3% and 89.2%, respectively. While there were no differences in RFS between NMIBC subpopulations, a slightly better PFS was found in T1LG NMIBC compared to T1HG (5-year PFS; T1LG vs. T1HG: 82% vs. 89%; P<0.001). A heterogeneous classification of patients with T1LG NMIBC was observed when EAU 2021 prognostic model was applied, finding a statistically significant worse PFS in patients classified as high-risk T1LG (5-year PFS; 81.8%) compared to those in intermediate (5-year PFS; 93,4%), and low-risk T1LG tumors (5-year PFS; 98,1%). CONCLUSIONS: The RFS of T1LG was comparable to other NMIBC subpopulations. The PFS of T1LG tumors was significantly better than of T1HG NMIBC. The EAU2021 scoring model heterogeneously categorized the risk of progression in T1LG tumors and the high-risk T1LG had the worst PFS.

A Systematic Review of New Imaging Technologies for Robotic Prostatectomy: From Molecular Imaging to Augmented Reality.

New imaging technologies play a pivotal role in the current management of patients with prostate cancer. Robotic assisted radical prostatectomy (RARP) is a standard of care for localized disease and through the already imaging-based console subject of research towards combinations of imaging technologies and RARP as well as their impact on surgical outcomes. Therefore, we aimed to provide a comprehensive analysis of the currently available literature for new imaging technologies for RARP. On 24 January 2023, we performed a systematic review of the current literature on Pubmed, Scopus and Web of Science according to the PRISMA guidelines and Oxford levels of evidence. A total of 46 studies were identified of which 19 studies focus on imaging of the primary tumor, 12 studies on the intraoperative tumor detection of lymph nodes and 15 studies on the training of surgeons. While the feasibility of combined approaches using new imaging technologies including MRI, PSMA-PET CT or intraoperatively applied radioactive and fluorescent dyes has been demonstrated, the prospective confirmation of improvements in surgical outcomes is currently ongoing.

Digital Therapeutics in Urology: An Innovative Approach to Patient Care and Management.

Digital therapeutics (DTx) are a new class of intervention involving evidence-based software applications and have been used in neurology and psychiatry. To assess the potential of DTx in urology, we conducted a survey to assess the current prevalence of the digital infrastructure required for DTx, areas of support expected by patients, and requirements for uptake. Between November 2022 and January 2023, we conducted an anonymized survey at two German academic centers among patients with urologic conditions. We found that among patients aged <65 yr versus ≥65 yr, digital devices including smartphones (93.6% vs 77.3%; p < 0.001), computers (80.4% vs 70.1%; p < 0.001), tablets (51.7% vs 38.1%; p < 0.001), and smartwatches (24.7% vs 7.7%; p < 0.001) are already widely used, especially in the younger age group. Apps (95.6% vs 74.4%; p < 0.001) and health apps (57.6% vs 30.4%; p < 0.001) are already frequently used, but certified DTx apps are not (7.3% vs 5.4%; p = 0.25). Patients favor solutions that provide access to validated information (49.6%), give medical advice based on data or symptoms captured by the app (43.0%), or replace a physiotherapist (41.7%). Patients feel that optimization of therapy (78.4%), significant positive health outcomes (76.9%), and better patient autonomy (73.4%) are important requirements for DTx in urology. Regulatory and reimbursement changes mean that DTx might play an increasing role in urology. Patient summary: Patients can use digital therapeutics (DTx), which are mainly smartphone apps, to improve their health status or treat medical conditions. We assessed the current and future use of DTx in urology. Patients are already widely using smartphones and frequently use uncertified health apps, but do not use DTx. Patients would like to use DTx to optimize therapy that provides a significant health improvement.