Olivier Cussenot , Yoann Taille , Jean-Jacques Portal , Géraldine Cancel-Tassin , Morgan Rouprêt , Alexandre de la Taille , Guillaume Ploussard , Romain Mathieu , Eric Vicaut
{"title":"Eliciting the Impact of Metformin and Statins on Prostate Cancer Outcomes from a Real-life National Database Analysis","authors":"Olivier Cussenot , Yoann Taille , Jean-Jacques Portal , Géraldine Cancel-Tassin , Morgan Rouprêt , Alexandre de la Taille , Guillaume Ploussard , Romain Mathieu , Eric Vicaut","doi":"10.1016/j.euo.2025.04.024","DOIUrl":"10.1016/j.euo.2025.04.024","url":null,"abstract":"<div><div>Several large analyses have revealed contradictory results regarding the association between prostate cancer (PC) survival and the use of statins prescribed for prevention of dyslipidaemia or atherosclerosis complications, or of metformin prescribed for type 2 diabetes (T2D). Using data collected between 2006 and 2018 in French national health databases for 521 052 men with PC and 1 827 345 men without PC, we evaluated current evidence regarding overall survival for men with PC according to statin and/or metformin use. The highest mortality was observed in PC patients exposed to both statins and metformin (hazard ratio [HR] 2.29, 95% confidence interval [CI] 2.25–2.33). However, for patients whose first PC treatment was androgen deprivation therapy, a protective effect was observed for statin alone exposure (HR 0.91, 95% CI 0.88–0.93) and combined statin and metformin exposure (HR 0.86, 95% CI 0.85–0.87), whereas men with metformin exposure alone had higher mortality (HR 1.07, 95% CI 1.03–1.11) in comparison to non-users. This protective effect of statins was not observed for PC patients treated with radical prostatectomy. The result was confirmed using causal analysis in a Bayesian network, followed by semantic elicitation using generative artificial intelligence that compiles web-based human knowledge and dedicated literature.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 871-874"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reply to Giacomo Gallo, Alessio Guidotti, Riccardo Lombardo, and Cosimo De Nunzio’s Letter to the Editor re: Rosemarijn H. Ettema, Jan-Jaap J. Mellema, Dennie Meijer, et al. Early Oncological Outcomes in Patients Who Underwent Staging Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography Compared with Conventional Imaging Before Radical Prostatectomy and Extended Pelvic Lymph Node Dissection. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2024.11.003","authors":"André N. Vis , Rosemarijn H. Ettema","doi":"10.1016/j.euo.2025.04.019","DOIUrl":"10.1016/j.euo.2025.04.019","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Page 1210"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ming Cao , Guoliang Yang , Tingting Zhao , Lianhua Zhang , Dandan Wang , Yang Cao , Haige Chen , Di Jin , Ruiyun Zhang , Yuping Hao , Longfei Huang , Wei Liu , Yang Zhang , Na Xue , Wei Xue
{"title":"Development and Validation of the UriMee Model: A Methylation-based Diagnostic Tool for Early Diagnosis of Urothelial Carcinoma","authors":"Ming Cao , Guoliang Yang , Tingting Zhao , Lianhua Zhang , Dandan Wang , Yang Cao , Haige Chen , Di Jin , Ruiyun Zhang , Yuping Hao , Longfei Huang , Wei Liu , Yang Zhang , Na Xue , Wei Xue","doi":"10.1016/j.euo.2025.03.004","DOIUrl":"10.1016/j.euo.2025.03.004","url":null,"abstract":"<div><h3>Background and objective</h3><div>Urothelial carcinoma (UC) is a common malignancy that imposes a significant health care burden. Current diagnostic methods are limited by their invasiveness and low sensitivity, particularly for detecting low-grade tumors. Noninvasive, accurate, and reliable diagnostic tests for an early diagnosis of UC are urgently needed.</div></div><div><h3>Methods</h3><div>UC-specific DNA methylation biomarkers were identified by combining public datasets from The Cancer Genome Atlas and Gene Expression Omnibus with a cohort from Renji Hospital (<em>n</em> = 50). Using the Least Absolute Shrinkage and Selection Operator regression, we developed a diagnostic model, termed the UriMee model, by selecting key biomarkers from a model cohort (<em>n</em> = 322) and subsequently validating it in an independent cohort (<em>n</em> = 131). The diagnostic performance of the assay was evaluated and compared with that of urine cytology.</div></div><div><h3>Key findings and limitations</h3><div>At 30% threshold probability, the UriMee model demonstrated high sensitivity (92%) and specificity (92%) in distinguishing UC cases, with particularly strong performance in early-stage tumors (83% sensitivity for Ta, 93% for T1, and 100% for Tis). It significantly outperformed urine cytology, offering greater sensitivity (90% vs 25%, <em>p</em> < 0.001) while maintaining comparable specificity. Additionally, the model was highly effective in identifying upper tract urothelial carcinoma (UTUC), achieving sensitivity of 96%. The study’s limitations include the necessity for larger multicenter studies and long-term follow-up to validate the findings and assess the test’s effectiveness across diverse populations, as well as its utility in monitoring disease progression and recurrence.</div></div><div><h3>Conclusions</h3><div>The UriMee test demonstrated high sensitivity and specificity, particularly in detecting early-stage tumors and UTUC, significantly outperforming traditional methods.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 899-908"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143974603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joep J. de Jong , Peter C. Black , Lars Dyrskjøt , Ewan A. Gibb
{"title":"Long Noncoding RNAs Identify a Subgroup of Patients with Low-grade Non–muscle-invasive Bladder Cancer with Less Favorable Outcomes","authors":"Joep J. de Jong , Peter C. Black , Lars Dyrskjøt , Ewan A. Gibb","doi":"10.1016/j.euo.2025.05.013","DOIUrl":"10.1016/j.euo.2025.05.013","url":null,"abstract":"<div><div>Low-grade (LG) stage Ta non–muscle-invasive bladder cancer (NMIBC) is typically nonaggressive with low progression rates and favorable cancer-specific survival. However, frequent monitoring is required because of the risk of recurrence. In this study, we analyzed RNA sequencing data for 286 LG Ta tumors from the UROMOL consortium. Unsupervised consensus clustering of long noncoding RNA profiles identified a subgroup of patients with significantly worse recurrence-free and progression-free survival. These patients may benefit from intensified intravesical therapy or closer surveillance. Further validation of these molecular subgroups could enhance risk stratification and guide personalized treatment approaches.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 879-882"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fabian Falkenbach , Quynh Chi Le , Mattia Longoni , Andrea Marmiroli , Calogero Catanzaro , Michele Nicolazzini , Federico Polverino , Zhe Tian , Jordan A. Goyal , Riccardo Schiavina , Carlotta Palumbo , Gennaro Musi , Felix K.H. Chun , Alberto Briganti , Fred Saad , Shahrokh F. Shariat , Gunhild von Amsberg , Thomas Steuber , Markus Graefen , Pierre I. Karakiewicz
{"title":"Years of Life Lost in Metastatic and Locally Advanced Prostate Cancer","authors":"Fabian Falkenbach , Quynh Chi Le , Mattia Longoni , Andrea Marmiroli , Calogero Catanzaro , Michele Nicolazzini , Federico Polverino , Zhe Tian , Jordan A. Goyal , Riccardo Schiavina , Carlotta Palumbo , Gennaro Musi , Felix K.H. Chun , Alberto Briganti , Fred Saad , Shahrokh F. Shariat , Gunhild von Amsberg , Thomas Steuber , Markus Graefen , Pierre I. Karakiewicz","doi":"10.1016/j.euo.2025.04.008","DOIUrl":"10.1016/j.euo.2025.04.008","url":null,"abstract":"<div><h3>Background and objective</h3><div>Prostate cancer (PCa) is the second most common cancer-specific cause of death in the USA. However, the effects of metastatic or locally advanced PCa on individual years of life lost (YLL) have not been addressed.</div></div><div><h3>Methods</h3><div>Within the Surveillance, Epidemiology, and End Results (SEER) database 2004–2021, metastatic (cM1) and locally advanced (cT3/4, cN1) PCa patients aged 45–75 yr were included. The Monte Carlo method was used to simulate and illustrate individual survival according to the Social Security Administration life tables. Subsequently, the average YLL until the age of 75 yr between patients and simulated controls were quantified using the Kaplan-Meier method.</div></div><div><h3>Key findings and limitations</h3><div>Overall, 21 488 and 53 506 patients with metastatic and locally advanced PCa, respectively, were included. Metastatic and locally advanced PCa patients lost, respectively, 5.76 and 0.77 yr of life compared with controls (<em>p</em> < 0.001). YLL due to metastatic PCa were most pronounced in younger patients (age 45–60 yr: 12.15 YLL), those diagnosed in more historic years (2004–2009: 6.37 YLL), and Black (6.86 YLL) and unmarried (6.66 YLL) individuals. Similar observations were made in patients with locally advanced PCa, although absolute YLL values were substantially lower. Limitations include the life expectancy estimation method that did not take comorbidities into account.</div></div><div><h3>Conclusions and clinical implications</h3><div>Metastatic and locally advanced PCa resulted in 5.76 and 0.77 YLL values, respectively, relative to controls. Young, Black, and unmarried individuals were affected most. Therefore, these groups represent targets of particular interest for the early detection, treatment intensification, and psychosocial interventions.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 961-967"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ryan M. Phillips , James A. Proudfoot , Elai Davicioni , Yang Liu , Daniel E. Spratt , Jeff M. Simko , Robert B. Den , Alan Pollack , Seth A. Rosenthal , A. Oliver Sartor , Christopher J. Sweeney , Gerhardt Attard , Leslie Longoria , Samir Patel , Michael W. Straza , Jason A. Efstathiou , Amit B. Shah , Karen E. Hoffman , Joseph P. Rodgers , Howard M. Sandler , Phuoc T. Tran
{"title":"Transcriptomic Analysis of Localized High-risk Prostate Cancer Improves Prognostication and Identifies Benefit from Adding Docetaxel to Definitive Radiotherapy with Androgen Suppression in the NRG Oncology/RTOG 0521 Phase 3 Trial","authors":"Ryan M. Phillips , James A. Proudfoot , Elai Davicioni , Yang Liu , Daniel E. Spratt , Jeff M. Simko , Robert B. Den , Alan Pollack , Seth A. Rosenthal , A. Oliver Sartor , Christopher J. Sweeney , Gerhardt Attard , Leslie Longoria , Samir Patel , Michael W. Straza , Jason A. Efstathiou , Amit B. Shah , Karen E. Hoffman , Joseph P. Rodgers , Howard M. Sandler , Phuoc T. Tran","doi":"10.1016/j.euo.2025.04.009","DOIUrl":"10.1016/j.euo.2025.04.009","url":null,"abstract":"<div><h3>Background and objective</h3><div>NRG/RTOG 0521 randomized men with high-risk localized prostate cancer (PC) to androgen suppression (AS) and definitive radiotherapy (RT) ± docetaxel-based chemotherapy (CT). The overall survival (OS) benefit with CT initially reported was lost on longer follow-up. The Decipher genomic classifier (GC) measures multiple transcripts relevant to docetaxel action. Basal/luminal differentiation portends differential response to AS and CT for high-risk localized and metastatic hormone-sensitive PC. We validated the Decipher GC in pretreatment biopsy samples for risk stratification and examined basal-luminal subtyping to predict docetaxel response.</div></div><div><h3>Methods</h3><div>Decipher GC scores and basal-luminal cellular subtypes were generated for specimens from NRG/RTOG 0521. The primary objective was to validate the independent prognostic ability of GC for metastasis-free survival (MFS). Treatment effects in luminal proliferating (LP) and non-LP cell subtypes were examined in relation to MFS, OS, and distant metastasis (DM).</div></div><div><h3>Key findings and limitations</h3><div>Samples were obtained from 283 patients and yielded 183 GC scores. Over median follow-up of 9.9 yr, 67 metastasis events were observed, including 34 DM events. Multivariable analysis revealed that GC was independently associated with DM (subdistribution hazard ratio 1.45) and MFS (hazard ratio 1.20). No biomarker-by-treatment interaction with GC and docetaxel was detected. The 10-yr restricted mean survival time difference in OS with CT was 13.7 mo for LP (<em>p</em> = 0.053) and 2.5 mo for non-LP (<em>p</em> = 0.63) tumors.</div></div><div><h3>Conclusions and clinical implications</h3><div>The Decipher GC score was independently associated with DM and MFS, and LP tumors may benefit from addition of CT. Validation of these findings may allow more effective use of CT in men with localized PC.</div><div>The original NRG/RTOG 0521 trial is registered on ClinicalTrials.gov as NCT00288080.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 968-976"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pierre-Etienne Gabriel , Mathieu Roumiguié , Gautier Marcq , Yves Allory , François Audenet , Anne Sophie Bajeot , Priscilla Leon , Alexandra Masson-Lecomte , Benjamin Pradère , Thomas Seisen , Constance Thibault , Morgan Rouprêt , Evanguelos Xylinas , for the Cancer Committee of The French Association of Urology (CC-AFU)
{"title":"The Evolving Landscape of Systemic Immunotherapy for Bacillus Calmette-Guérin–naïve High-risk Non–muscle-invasive Bladder Cancer: At the Edge of a Tsunami?","authors":"Pierre-Etienne Gabriel , Mathieu Roumiguié , Gautier Marcq , Yves Allory , François Audenet , Anne Sophie Bajeot , Priscilla Leon , Alexandra Masson-Lecomte , Benjamin Pradère , Thomas Seisen , Constance Thibault , Morgan Rouprêt , Evanguelos Xylinas , for the Cancer Committee of The French Association of Urology (CC-AFU)","doi":"10.1016/j.euo.2025.06.003","DOIUrl":"10.1016/j.euo.2025.06.003","url":null,"abstract":"<div><h3>Background and objective</h3><div>Treatment options for high-risk (HR) non–muscle-invasive bladder cancer (NMIBC) are still limited. The addition of systemic immunotherapy to intravesical bacillus Calmette-Guérin (BCG) instillations is currently being explored as an initial strategy for BCG-naïve HR NMIBC patients to enhance treatment effectiveness and decrease the risk of BCG failure.</div></div><div><h3>Methods</h3><div>A collaborative narrative review of the literature by the Cancer Committee of the French Association of Urology (CC-AFU) was carried out to describe ongoing studies assessing systemic immunotherapy in BCG-naïve HR NMIBC patients, focus on the different study designs, and evaluate the clinical pertinence of the endpoints. In total, 37 references published between 2003 and 2025 were included in our review.</div></div><div><h3>Key findings and limitations</h3><div>The ongoing phase 3 trials in BCG-naïve HR NMIBC patients include CREST (sasanlimab; NCT04165317), ALBAN (atezolizumab; NCT03799835), POTOMAC (durvalumab; NCT03528694), KEYNOTE-676 (pembrolizumab; NCT03711032), and SunRISe-3 (cetrelimab; NCT05714202). These five randomized, multicenter, multinational, open-label studies are evaluating the efficacy and safety of systemic intravenous or subcutaneous immunotherapy in combination with intravesical BCG, or in combination with TAR-200 in SunRISe-3, compared with BCG alone in BCG-naïve HR NMIBC patients. Recently, the CREST and POTOMAC studies demonstrated statistically significant and clinically meaningful improvements in event-free and disease-free survival, respectively, heralding a new therapeutic era in this field. Other results from these studies are expected between 2025 and 2030.</div></div><div><h3>Conclusions and clinical implications</h3><div>The combination of systemic immunotherapy with intravesical BCG instillations is being investigated and may become a new therapeutic strategy for BCG-naïve HR NMIBC.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 1174-1181"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Constance Huck , Vérane Achard , Jason Efstathiou , Julien Van Damme , Alexandre R. Zlotta , Evanguelos Xylinas , Ananya Choudhury , Morgan Rouprêt , Bertrand Tombal , Paul Sargos
{"title":"Radiation Therapy in the Management of Muscle-invasive Bladder Cancer with Carcinoma in Situ: Still a No Go?","authors":"Constance Huck , Vérane Achard , Jason Efstathiou , Julien Van Damme , Alexandre R. Zlotta , Evanguelos Xylinas , Ananya Choudhury , Morgan Rouprêt , Bertrand Tombal , Paul Sargos","doi":"10.1016/j.euo.2025.05.028","DOIUrl":"10.1016/j.euo.2025.05.028","url":null,"abstract":"<div><h3>Background and objective</h3><div>This narrative review explores the impact of carcinoma in situ (CIS) on outcomes in muscle-invasive bladder cancer (MIBC) after trimodal therapy (TMT) comprising transurethral resection of bladder tumor, a radiosensitizing agent and radiation therapy (RT). There is limited and inconsistent evidence on the effect of CIS, often considered a contraindication to TMT, on treatment efficacy.</div></div><div><h3>Methods</h3><div>We reviewed studies evaluating the influence of TMT and RT alone on clinical outcomes in CIS-associated MIBC. Endpoints evaluated included complete response (CR) rates, overall survival (OS), disease-specific survival (DSS), and RT protocol variations, such as fractionation schedules, total doses, and the use of image-guided RT.</div></div><div><h3>Key findings and limitations</h3><div>Evidence from studies on RT alone is inconsistent, often because of outdated regimens and inadequate CIS evaluation. Retrospective TMT studies suggest that CIS does not significantly affect CR rates, although its impact on OS and DSS remains uncertain, particularly with suboptimal RT protocols. Emerging evidence supports continuous and moderately hypofractionated RT combined with image-guided RT as potential strategies to improve outcomes. Standardized definitions of extensive CIS and better patient selection are critical for optimizing bladder preservation strategies.</div></div><div><h3>Conclusions and clinical implications</h3><div>CIS presents significant challenges for TMT in MIBC, necessitating precise assessment, advanced RT techniques, and multidisciplinary collaboration. Novel therapies, including immunotherapy and intravesical agents, may further improve outcomes. Research into standardized protocols is essential to optimize treatment strategies.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 1165-1173"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gaëlle Margue , Jean-Christophe Bernhard , Joris Giai , Assilah Bouzit , Solène Ricard , Manon Jaffredo , Bénédicte Guillaume , Eva Jambon , Gaëlle Fiard , Pierre Bigot , Thibaut Waeckel , Louis Surlemont , Stéphane De Vergie , Nicolas Branger , Nicolas Doumerc , Romain Boissier , Hervé Lang , François Audenet , Jean-Baptiste Beauval , Karim Bensalah , Jean-Luc Descotes
{"title":"Clinical Trial Protocol for ACCURATE: A CCafU-UroCCR Randomized Trial: Three-dimensional Image-guided Robot-assisted Partial Nephrectomy for Renal Complex Tumor (UroCCR 99)","authors":"Gaëlle Margue , Jean-Christophe Bernhard , Joris Giai , Assilah Bouzit , Solène Ricard , Manon Jaffredo , Bénédicte Guillaume , Eva Jambon , Gaëlle Fiard , Pierre Bigot , Thibaut Waeckel , Louis Surlemont , Stéphane De Vergie , Nicolas Branger , Nicolas Doumerc , Romain Boissier , Hervé Lang , François Audenet , Jean-Baptiste Beauval , Karim Bensalah , Jean-Luc Descotes","doi":"10.1016/j.euo.2025.03.012","DOIUrl":"10.1016/j.euo.2025.03.012","url":null,"abstract":"<div><h3>Background and objective</h3><div>Renal cancer often requires nephron-sparing surgery for optimal patient outcomes. Despite advances in imaging and robot-assisted surgery, there is a need to enhance surgical precision and renal preservation. This trial evaluates the effectiveness of three-dimensional image-guided robot-assisted partial nephrectomy versus standard methods in improving surgical outcomes.</div></div><div><h3>Clinical trial design and timeframe</h3><div>This trial is a prospective, 1:1 randomized, single-blind phase 3 superiority study conducted across 14 centers within the French Network for Research on Kidney Cancer, aiming to enroll 694 patients over 36 mo.</div></div><div><h3>Endpoints</h3><div>The primary endpoint is a composite trifecta score, including negative surgical margins, no complications, and renal function preservation (estimated glomerular filtration rate >90% at 1 mo). The secondary endpoints include oncological outcomes, conversion rates, perioperative parameters, and economic evaluation.</div></div><div><h3>Data sources and statistical analysis plan</h3><div>Data are collected via the UroCCR database. Logistic regression will analyze the primary endpoint, and various regression methods will address the secondary outcomes. Economic evaluations involve incremental cost-utility and cost-effectiveness ratios.</div></div><div><h3>Strengths and limitations</h3><div>Strengths include the multicenter design and robust randomization. Limitations involve variability in surgeons’ experience with the new three-dimensional technology and logistical challenges in technology adoption.</div></div><div><h3>Patient summary</h3><div>This clinical trial is designed to evaluate a new surgical technique for treating kidney tumors called three-dimensional (3D) image-guided robot-assisted partial nephrectomy. This study aims to determine whether this new method is more effective and safer than the current standard robot-assisted surgery by improving surgical precision and preserving kidney function. Kidney tumors require precise surgical removal to ensure the best outcomes for patients both during and after surgery. While robotic assistance has improved many surgeries, use of advanced 3D imaging during these procedures might enhance the surgeon’s ability to operate with greater accuracy, potentially leading to better patient outcomes and fewer complications. Participants in the trial will undergo surgery using either the conventional robotic-assisted method or the new 3D image-guided technique. The method used for each participant will remain undisclosed to maintain the study’s integrity. All participants will receive the highest standard of care, and their progress will be monitored closely throughout the trial. This study hopes to demonstrate that the 3D image-guided method can improve surgical precision and outcomes for patients undergoing kidney tumor removal. If successful, this technique could set a new standard for kid","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 4","pages":"Pages 914-920"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}