Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.09.004
Stacy Loeb , Mariana Rangel Camacho , Tatiana Sanchez Nolasco , Nataliya Byrne , Adrian Rivera , LaMont Barlow , June M. Chan , Scarlett Gomez , Aisha T. Langford
{"title":"Downstream Impact of Social Media Use and Variable Quality of Online Information About Prostate Cancer","authors":"Stacy Loeb , Mariana Rangel Camacho , Tatiana Sanchez Nolasco , Nataliya Byrne , Adrian Rivera , LaMont Barlow , June M. Chan , Scarlett Gomez , Aisha T. Langford","doi":"10.1016/j.euo.2025.09.004","DOIUrl":"10.1016/j.euo.2025.09.004","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1648-1652"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312742","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.09.003
Emmanuel Seront , Mehdi Bsilat , Karolien Goffin , Anne-Sophie Govaerts , Saskia Litière , Jedelyn Cabrieto , Bert Dhondt , Bertrand Tombal , Laurence Albiges , the EORTC Genito-Urinary Cancer Group
<div><h3>Background and objective</h3><div>Angiogenesis-targeting tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) are standard treatments for metastatic clear-cell renal cell carcinoma (ccRCC). However, therapeutic options remain limited after progression on these agents. Prostate-specific membrane antigen (PSMA) is highly expressed on the surface of endothelial cells in ccRCC, making radioligand therapy with [<sup>177</sup>Lu]Lu-PSMA-617 a promising approach.</div></div><div><h3>Clinical trial design and timeframe</h3><div>RENALUT (NCT06783348) is a single-arm, open-label, phase 2 trial investigating the safety and efficacy of [<sup>177</sup>Lu]Lu-PSMA-617 in metastatic ccRCC after TKI and ICI failure. Eligible patients must have PSMA-positive lesions on PSMA positron emission tomography imaging. Patients will receive four cycles of [<sup>177</sup>Lu]Lu-PSMA-617 every 6 wk, with up to two additional cycles in cases with stable disease or a partial response.</div></div><div><h3>Endpoints</h3><div>The primary endpoint is the objective response rate according to Response Evaluation Criteria in Solid Tumours version 1.1.</div></div><div><h3>Data sources and statistical analysis plan</h3><div>Assuming a PSMA negativity rate of 15%, a total of 56 patients will be screened to achieve the target enrolment of 48 patients. European centres from three countries (Belgium, France, and Spain) will participate. First patient enrolment is expected in September 2025.</div></div><div><h3>Strengths and limitations</h3><div>This is the first multicentre trial to assess PSMA-targeted radioligand therapy for patients with metastatic ccRCC selected on the basis of PSMA expression, which may be a potential biomarker in this setting.</div></div><div><h3>Funding</h3><div>RENALUT is funded by Novartis and is being conducted as a research collaboration trial. The trial is sponsored by the EORTC.</div></div><div><h3>Ethics and trial registration</h3><div>The trial has been approved by the ethics committee of the coordinating institution in the lead country (Belgium) and is registered on ClinicalTrials.gov as NCT06783348. Twelve centres across three countries will be participating. Regulatory submissions are ongoing at all participating sites in compliance with national requirements. Enrolment will begin only after all required approvals are in place.</div></div><div><h3>Patient summary</h3><div>This trial is looking at a new treatment, called [<sup>177</sup>Lu]Lu-PSMA-617, for patients with advanced kidney cancer that has spread and no longer responds to standard inhibitor and immunotherapy treatments. [<sup>177</sup>Lu]Lu-PSMA-617 is a radioactive agent that targets a molecule called PSMA (prostate-specific membrane antigen). Patients who have PSMA detected on a PET (positron emission tomography) scan will receive the treatment every 6 weeks for up to four cycles, with the possibility of two extra cycles if their cancer is stable or shrinking. The
{"title":"Efficacy of [177Lu]Lu-PSMA-617 in Patients with Metastatic Clear-cell Renal Cell Carcinoma: The Multicentre, Single-arm, Phase 2 RENALUT Trial","authors":"Emmanuel Seront , Mehdi Bsilat , Karolien Goffin , Anne-Sophie Govaerts , Saskia Litière , Jedelyn Cabrieto , Bert Dhondt , Bertrand Tombal , Laurence Albiges , the EORTC Genito-Urinary Cancer Group","doi":"10.1016/j.euo.2025.09.003","DOIUrl":"10.1016/j.euo.2025.09.003","url":null,"abstract":"<div><h3>Background and objective</h3><div>Angiogenesis-targeting tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) are standard treatments for metastatic clear-cell renal cell carcinoma (ccRCC). However, therapeutic options remain limited after progression on these agents. Prostate-specific membrane antigen (PSMA) is highly expressed on the surface of endothelial cells in ccRCC, making radioligand therapy with [<sup>177</sup>Lu]Lu-PSMA-617 a promising approach.</div></div><div><h3>Clinical trial design and timeframe</h3><div>RENALUT (NCT06783348) is a single-arm, open-label, phase 2 trial investigating the safety and efficacy of [<sup>177</sup>Lu]Lu-PSMA-617 in metastatic ccRCC after TKI and ICI failure. Eligible patients must have PSMA-positive lesions on PSMA positron emission tomography imaging. Patients will receive four cycles of [<sup>177</sup>Lu]Lu-PSMA-617 every 6 wk, with up to two additional cycles in cases with stable disease or a partial response.</div></div><div><h3>Endpoints</h3><div>The primary endpoint is the objective response rate according to Response Evaluation Criteria in Solid Tumours version 1.1.</div></div><div><h3>Data sources and statistical analysis plan</h3><div>Assuming a PSMA negativity rate of 15%, a total of 56 patients will be screened to achieve the target enrolment of 48 patients. European centres from three countries (Belgium, France, and Spain) will participate. First patient enrolment is expected in September 2025.</div></div><div><h3>Strengths and limitations</h3><div>This is the first multicentre trial to assess PSMA-targeted radioligand therapy for patients with metastatic ccRCC selected on the basis of PSMA expression, which may be a potential biomarker in this setting.</div></div><div><h3>Funding</h3><div>RENALUT is funded by Novartis and is being conducted as a research collaboration trial. The trial is sponsored by the EORTC.</div></div><div><h3>Ethics and trial registration</h3><div>The trial has been approved by the ethics committee of the coordinating institution in the lead country (Belgium) and is registered on ClinicalTrials.gov as NCT06783348. Twelve centres across three countries will be participating. Regulatory submissions are ongoing at all participating sites in compliance with national requirements. Enrolment will begin only after all required approvals are in place.</div></div><div><h3>Patient summary</h3><div>This trial is looking at a new treatment, called [<sup>177</sup>Lu]Lu-PSMA-617, for patients with advanced kidney cancer that has spread and no longer responds to standard inhibitor and immunotherapy treatments. [<sup>177</sup>Lu]Lu-PSMA-617 is a radioactive agent that targets a molecule called PSMA (prostate-specific membrane antigen). Patients who have PSMA detected on a PET (positron emission tomography) scan will receive the treatment every 6 weeks for up to four cycles, with the possibility of two extra cycles if their cancer is stable or shrinking. The","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1592-1597"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274334","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.08.003
Roger Li , Patrick J. Hensley , Marko Babjuk , Laura Bukavina , Sarah P. Psutka , Seth P. Lerner , Michael A. O’Donnell , Yair Lotan , Kelly K. Bree , Joan Palou Redorta , David J. McConkey , Byron H. Lee , Paramananthan Mariappan , Laura S. Mertens , Mark S. Soloway , Robert S. Svatek , Wei Shen Tan , Stephen B. Williams , Shilpa Gupta , Roger Buckley , Ashish M. Kamat
Background and objective
Intermediate-risk (IR) non–muscle-invasive bladder cancer (NMIBC) is a heterogeneous disease, and standardized definitions and risk-guided management are critical for appropriate patient care and clinical trial development.
Methods
A global committee of bladder cancer experts developed IR-NMIBC recommendations. Working groups reviewed literature and drafted recommendations, which were voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During an August 2024 meeting, voting results and evidence were presented, and recommendations were refined. Final recommendations achieved >75% agreement.
Key findings and limitations
The IBCG recommends inclusion of only low-grade (LG; G1 and G2) tumors in the IR-NMIBC category, risk stratified using the IBCG IR-NMIBC risk scoring system. Given the relatively indolent course and treatment burden of IR-NMIBC, therapeutic deintensification with active surveillance or office-based ablation is appropriate for select patients. Morbidity related to transurethral resection of a bladder tumor can be mitigated by forgoing restaging resection in completely resected LG tumors and not mandating muscularis propria sampling. Perioperative chemotherapy reduces recurrences, and additional adjuvant intravesical treatment should be risk stratified. Clinical trials evaluating novel IR-NMIBC therapies, including adjuvant and ablative designs, should incorporate patient-reported outcomes and risk-stratified controls. Ablative trials, as proof-of-concept studies for efficacy, require randomized controlled studies in the adjuvant setting to confirm superiority over the standard of care.
Conclusions and clinical implications
The IBCG consensus recommendations provide practical guidance for clinical care and clinical trial design for patients with IR-NMIBC.
{"title":"Intermediate-risk Non–muscle-invasive Bladder Cancer: Recommendations for Definitions, Risk Stratification, Management Strategies, and Clinical Trial Design from the International Bladder Cancer Group","authors":"Roger Li , Patrick J. Hensley , Marko Babjuk , Laura Bukavina , Sarah P. Psutka , Seth P. Lerner , Michael A. O’Donnell , Yair Lotan , Kelly K. Bree , Joan Palou Redorta , David J. McConkey , Byron H. Lee , Paramananthan Mariappan , Laura S. Mertens , Mark S. Soloway , Robert S. Svatek , Wei Shen Tan , Stephen B. Williams , Shilpa Gupta , Roger Buckley , Ashish M. Kamat","doi":"10.1016/j.euo.2025.08.003","DOIUrl":"10.1016/j.euo.2025.08.003","url":null,"abstract":"<div><h3>Background and objective</h3><div>Intermediate-risk (IR) non–muscle-invasive bladder cancer (NMIBC) is a heterogeneous disease, and standardized definitions and risk-guided management are critical for appropriate patient care and clinical trial development.</div></div><div><h3>Methods</h3><div>A global committee of bladder cancer experts developed IR-NMIBC recommendations. Working groups reviewed literature and drafted recommendations, which were voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During an August 2024 meeting, voting results and evidence were presented, and recommendations were refined. Final recommendations achieved >75% agreement.</div></div><div><h3>Key findings and limitations</h3><div>The IBCG recommends inclusion of only low-grade (LG; G1 and G2) tumors in the IR-NMIBC category, risk stratified using the IBCG IR-NMIBC risk scoring system. Given the relatively indolent course and treatment burden of IR-NMIBC, therapeutic deintensification with active surveillance or office-based ablation is appropriate for select patients. Morbidity related to transurethral resection of a bladder tumor can be mitigated by forgoing restaging resection in completely resected LG tumors and not mandating muscularis propria sampling. Perioperative chemotherapy reduces recurrences, and additional adjuvant intravesical treatment should be risk stratified. Clinical trials evaluating novel IR-NMIBC therapies, including adjuvant and ablative designs, should incorporate patient-reported outcomes and risk-stratified controls. Ablative trials, as proof-of-concept studies for efficacy, require randomized controlled studies in the adjuvant setting to confirm superiority over the standard of care.</div></div><div><h3>Conclusions and clinical implications</h3><div>The IBCG consensus recommendations provide practical guidance for clinical care and clinical trial design for patients with IR-NMIBC.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1685-1695"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274386","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.10.002
Félix Guerrero-Ramos , Carsten Schwenke , Álvaro Pinto , Siobhán Mulhern-Haughey , Marta Pisini , Ali Azough , Astrid Rijken , Sophie Van Beekhuizen , Andreas Freitag , Rhiannon Campden , Ben Mayer
Background and objective
Current guidelines on bladder cancer lack consensus on which outcomes should be used to define cure, the optimal time point for measurement, and which treatments can be given with curative intent in early bladder cancer. Our aim was to determine the optimal definition of cure by assessing cure definitions used in non–muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) studies.
Methods
We conducted a systematic literature review via Embase and Medline on July 10, 2024, to identify real-world evidence (RWE) studies published within the previous 5 yr reporting key effectiveness outcomes (time to recurrence [TTR], overall survival [OS], and recurrence-free survival [RFS]) of NMIBC and MIBC treatments.
Key findings and limitations
Among 83 publications included in the review, median TTR ranged from 10 to 89 mo across seven NMIBC studies, and from 6 to 19 mo across five MIBC studies. RFS was the first and second most commonly reported outcome among the NMIBC and MIBC publications, respectively. OS and RFS were commonly reported at 1, 2, and 5 yr among NMIBC studies, and at 3 and 5 yr among MIBC studies. Limitations include the use of RWE only, the 5-yr cut-off for the publications included, and the scarcity of relevant data.
Conclusions and clinical implications
According to the evidence reviewed, 5-yr RFS appears to be a suitable definition of cure in early bladder cancer. Consensus on this or another surrogate outcome for measurement of cure could support the development of clinical trial designs and inform decision-making in health care from both clinician-patient and reimbursement perspectives.
{"title":"Systematic Review of the Definition of Cure and of Curative-intent Treatments in Early Bladder Cancer","authors":"Félix Guerrero-Ramos , Carsten Schwenke , Álvaro Pinto , Siobhán Mulhern-Haughey , Marta Pisini , Ali Azough , Astrid Rijken , Sophie Van Beekhuizen , Andreas Freitag , Rhiannon Campden , Ben Mayer","doi":"10.1016/j.euo.2025.10.002","DOIUrl":"10.1016/j.euo.2025.10.002","url":null,"abstract":"<div><h3>Background and objective</h3><div>Current guidelines on bladder cancer lack consensus on which outcomes should be used to define cure, the optimal time point for measurement, and which treatments can be given with curative intent in early bladder cancer. Our aim was to determine the optimal definition of cure by assessing cure definitions used in non–muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) studies.</div></div><div><h3>Methods</h3><div>We conducted a systematic literature review via Embase and Medline on July 10, 2024, to identify real-world evidence (RWE) studies published within the previous 5 yr reporting key effectiveness outcomes (time to recurrence [TTR], overall survival [OS], and recurrence-free survival [RFS]) of NMIBC and MIBC treatments.</div></div><div><h3>Key findings and limitations</h3><div>Among 83 publications included in the review, median TTR ranged from 10 to 89 mo across seven NMIBC studies, and from 6 to 19 mo across five MIBC studies. RFS was the first and second most commonly reported outcome among the NMIBC and MIBC publications, respectively. OS and RFS were commonly reported at 1, 2, and 5 yr among NMIBC studies, and at 3 and 5 yr among MIBC studies. Limitations include the use of RWE only, the 5-yr cut-off for the publications included, and the scarcity of relevant data.</div></div><div><h3>Conclusions and clinical implications</h3><div>According to the evidence reviewed, 5-yr RFS appears to be a suitable definition of cure in early bladder cancer. Consensus on this or another surrogate outcome for measurement of cure could support the development of clinical trial designs and inform decision-making in health care from both clinician-patient and reimbursement perspectives.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1696-1706"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145421605","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.05.008
Rod Carlo A. Columbres , Aryan Selokar , Sybil Jones , James Fan Wu , Sruthi Ranganathan , Jenny Chen , Nikko J. Magsanoc , Juan Martin Magsanoc , Jerickson Abbie Flores , Erin Jay G. Feliciano , Frances Dominique V. Ho , Fabio Ynoe Moraes , Enrico D. Tangco , Brandon A. Mahal , Puneeth Iyengar , Himanshu Nagar , Kenrick Ng , Melvin L.K. Chua , Imjai Chitapanarux , Paul L. Nguyen , Edward Christopher Dee
Background and objective
The global burden of genitourinary (GU) cancers is rising; yet, the specific burden on the diverse population of 700 million in Southeast Asia (SEA) remains poorly understood. This study presents the most updated trends in the incidence and mortality of bladder, kidney, prostate, and testicular cancer patients across SEA from 1990 to 2021.
Methods
Data from the Global Burden of Disease 2021 database were analyzed for the incidence, deaths, and age-standardized rates by sex and age of patients with four major GU cancers across 11 SEA countries from 1990 to 2021.
Key findings and limitations
GU cancer incidence and mortality in SEA primarily increased from 1990 to 2021. Kidney cancer showed the greatest rise in incidence and deaths for both sexes, while prostate cancer had the largest absolute increase in male incidence and mortality. In 2021, Brunei had the highest age-standardized incidence rate (ASIR) and age-standardized mortality rate (ASMR) of kidney cancer for both sexes. Singapore had the highest prostate cancer ASIR, with the incidence rising in all countries except in Laos, and the Philippines recorded the highest ASMR. For bladder cancer, Thailand and Brunei recorded the highest ASIR for males and females, respectively, while Malaysia had the highest male ASMR and Brunei the female ASMR. Testicular cancer ASIR was highest in Singapore; however, ASMR in Singapore decreased over the study period, but increased or remained stable across the region.
Conclusions and clinical implications
Broadly, the rising age-standardized incidence of GU cancers in SEA reflects not only the evolving patterns of modifiable and nonmodifiable risk factors, but also the development of cancer diagnostic systems and improvements in reporting infrastructure. For many SEA countries, these increases warrant enhanced resource allocation for cancer system strengthening, to support timely diagnosis and equitable access to affordable, effective treatment. Regional and international collaboration is essential to promote equity in access to cancer care in SEA.
{"title":"The Burden of Genitourinary Malignancies in Southeast Asia from 1990 to 2021","authors":"Rod Carlo A. Columbres , Aryan Selokar , Sybil Jones , James Fan Wu , Sruthi Ranganathan , Jenny Chen , Nikko J. Magsanoc , Juan Martin Magsanoc , Jerickson Abbie Flores , Erin Jay G. Feliciano , Frances Dominique V. Ho , Fabio Ynoe Moraes , Enrico D. Tangco , Brandon A. Mahal , Puneeth Iyengar , Himanshu Nagar , Kenrick Ng , Melvin L.K. Chua , Imjai Chitapanarux , Paul L. Nguyen , Edward Christopher Dee","doi":"10.1016/j.euo.2025.05.008","DOIUrl":"10.1016/j.euo.2025.05.008","url":null,"abstract":"<div><h3>Background and objective</h3><div>The global burden of genitourinary (GU) cancers is rising; yet, the specific burden on the diverse population of 700 million in Southeast Asia (SEA) remains poorly understood. This study presents the most updated trends in the incidence and mortality of bladder, kidney, prostate, and testicular cancer patients across SEA from 1990 to 2021.</div></div><div><h3>Methods</h3><div>Data from the Global Burden of Disease 2021 database were analyzed for the incidence, deaths, and age-standardized rates by sex and age of patients with four major GU cancers across 11 SEA countries from 1990 to 2021.</div></div><div><h3>Key findings and limitations</h3><div>GU cancer incidence and mortality in SEA primarily increased from 1990 to 2021. Kidney cancer showed the greatest rise in incidence and deaths for both sexes, while prostate cancer had the largest absolute increase in male incidence and mortality. In 2021, Brunei had the highest age-standardized incidence rate (ASIR) and age-standardized mortality rate (ASMR) of kidney cancer for both sexes. Singapore had the highest prostate cancer ASIR, with the incidence rising in all countries except in Laos, and the Philippines recorded the highest ASMR. For bladder cancer, Thailand and Brunei recorded the highest ASIR for males and females, respectively, while Malaysia had the highest male ASMR and Brunei the female ASMR. Testicular cancer ASIR was highest in Singapore; however, ASMR in Singapore decreased over the study period, but increased or remained stable across the region.</div></div><div><h3>Conclusions and clinical implications</h3><div>Broadly, the rising age-standardized incidence of GU cancers in SEA reflects not only the evolving patterns of modifiable and nonmodifiable risk factors, but also the development of cancer diagnostic systems and improvements in reporting infrastructure. For many SEA countries, these increases warrant enhanced resource allocation for cancer system strengthening, to support timely diagnosis and equitable access to affordable, effective treatment. Regional and international collaboration is essential to promote equity in access to cancer care in SEA.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1544-1557"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224883","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.02.003
Aleksander Ślusarczyk , Adam Gurwin , Anna Barnaś , Hamza Ismail , Marcin Miszczyk , Piotr Zapała , Mikołaj Przydacz , Wojciech Krajewski , Andrzej Antczak , Marcin Życzkowski , Łukasz Nyk , Giancarlo Marra , Juan G. Rivas , Veeru Kasivisvanathan , Giorgio Gandaglia , Morgan Rouprêt , Guillaume Ploussard , Shahrokh F. Shariat , Bartosz Małkiewicz , Piotr Radziszewski , Paweł Rajwa
Background and objective
Focal therapies (FTs) for localized prostate cancer (PCa) are recommended only within prospective registries or clinical trials. In this systematic review and meta-analysis, we aimed to synthesize data from prospective trials evaluating the efficacy and safety of FTs in patients with clinically localized PCa.
Methods
Systematic searches of the PubMed, Scopus, and Web of Science databases identified prospective studies reporting oncological outcomes of FTs in treatment-naïve, clinically localized PCa patients. The primary endpoint was biopsy-proven clinically significant PCa (csPCa; International Society of Urological Pathology grade group ≥2) recurrence-free survival (csPCa RFS). The secondary endpoints included RFS, radical/systemic treatment–free survival, and adverse event (AE) rates.
Key findings and limitations
Fifty studies including 4615 patients treated with FTs were analyzed; of these 50 studies, 19 were on predominantly intermediate-risk (n = 2800), 16 on mixed low-/intermediate-risk (n = 990), and 15 on low-risk (n = 825) patients. Estimates of 12- and 24-mo csPCa RFS rates were 86% (95% confidence interval [CI] 82–89%) and 81% (95% CI: 74–86%), respectively. In the intermediate-risk subgroup, the 12-mo csPCa RFS rate was 79% (95% CI: 74–83%). Five-year radical and systemic treatment–free survival was 82% (95% CI: 75–88%). The pooled incidence of grade ≥3 AEs was 3% (95% CI: 2–5%). Pad-requiring urinary incontinence increased by 3% (95% CI: 0–6%), with 11% of patients developing new erectile dysfunction (95% CI: 4–18%). The median follow-up of 21 mo (interquartile range 12–34) and the use of surrogate endpoints constitute the major limitations.
Conclusions and clinical implications
The primarily short-term data from prospective studies of FT in clinically localized PCa demonstrate moderate to high cancer control with a favorable safety profile.
{"title":"Outcomes of Focal Therapy for Localized Prostate Cancer: A Systematic Review and Meta-analysis of Prospective Studies","authors":"Aleksander Ślusarczyk , Adam Gurwin , Anna Barnaś , Hamza Ismail , Marcin Miszczyk , Piotr Zapała , Mikołaj Przydacz , Wojciech Krajewski , Andrzej Antczak , Marcin Życzkowski , Łukasz Nyk , Giancarlo Marra , Juan G. Rivas , Veeru Kasivisvanathan , Giorgio Gandaglia , Morgan Rouprêt , Guillaume Ploussard , Shahrokh F. Shariat , Bartosz Małkiewicz , Piotr Radziszewski , Paweł Rajwa","doi":"10.1016/j.euo.2025.02.003","DOIUrl":"10.1016/j.euo.2025.02.003","url":null,"abstract":"<div><h3>Background and objective</h3><div>Focal therapies (FTs) for localized prostate cancer (PCa) are recommended only within prospective registries or clinical trials. In this systematic review and meta-analysis, we aimed to synthesize data from prospective trials evaluating the efficacy and safety of FTs in patients with clinically localized PCa.</div></div><div><h3>Methods</h3><div>Systematic searches of the PubMed, Scopus, and Web of Science databases identified prospective studies reporting oncological outcomes of FTs in treatment-naïve, clinically localized PCa patients. The primary endpoint was biopsy-proven clinically significant PCa (csPCa; International Society of Urological Pathology grade group ≥2) recurrence-free survival (csPCa RFS). The secondary endpoints included RFS, radical/systemic treatment–free survival, and adverse event (AE) rates.</div></div><div><h3>Key findings and limitations</h3><div>Fifty studies including 4615 patients treated with FTs were analyzed; of these 50 studies, 19 were on predominantly intermediate-risk (<em>n</em> = 2800), 16 on mixed low-/intermediate-risk (<em>n</em> = 990), and 15 on low-risk (<em>n</em> = 825) patients. Estimates of 12- and 24-mo csPCa RFS rates were 86% (95% confidence interval [CI] 82–89%) and 81% (95% CI: 74–86%), respectively. In the intermediate-risk subgroup, the 12-mo csPCa RFS rate was 79% (95% CI: 74–83%). Five-year radical and systemic treatment–free survival was 82% (95% CI: 75–88%). The pooled incidence of grade ≥3 AEs was 3% (95% CI: 2–5%). Pad-requiring urinary incontinence increased by 3% (95% CI: 0–6%), with 11% of patients developing new erectile dysfunction (95% CI: 4–18%). The median follow-up of 21 mo (interquartile range 12–34) and the use of surrogate endpoints constitute the major limitations.</div></div><div><h3>Conclusions and clinical implications</h3><div>The primarily short-term data from prospective studies of FT in clinically localized PCa demonstrate moderate to high cancer control with a favorable safety profile.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1653-1672"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965007","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}
Successful fibroblast growth factor receptor alterations (FGFRalt) testing is essential for identifying patients eligible for erdafitinib. This analysis of the global ANNAR biomarker study assessed the proportion of valid fibroblast growth factor receptor (FGFR) test results, reasons for test failure, and proportion of FGFRalt in locally advanced/metastatic urothelial cancer (mUC) and non–muscle-invasive bladder cancer (NMIBC).
Methods
Archival tumor tissue was tested using the QIAGEN therascreen FGFR real-time polymerase chain reaction kit, an approved companion diagnostic for erdafitinib.
Key findings and limitations
A total of 2706 mUC and 962 NMIBC samples were tested. The proportion of valid test results was significantly different between mUC and NMIBC (86% and 66%, respectively; p < 0.001), which declined with older archival sample age for both mUC (<1 yr 89% and ≥3 yr 77%; p < 0.001) and NMIBC (<1 yr 72% and ≥3 yr 43%; p < 0.001). For mUC, the proportion of valid test results was higher for the primary tumor than for metastatic samples (92% and 55%, respectively; p < 0.001) but similar between upper and lower tract disease (87% and 86%, respectively; p = 0.7). Common reasons for test failure were low tumor content and insufficient RNA. FGFRalt were found in 19% of mUC (83% mutations; 15% fusions) and 53% of NMIBC (92% mutations; 6.3% fusions) samples. Limitations include the lack of data on sample collection method.
Conclusions and clinical implications
This is the first and largest report on factors affecting FGFR test results. To ensure valid FGFR test results, adequate tumor sample amount, RNA quality, short archival sample age, and primary tumor samples are important factors.
{"title":"Fibroblast Growth Factor Receptor Alteration Testing for >3600 Patients with Locally Advanced/Metastatic Urothelial Cancer and Non–muscle-invasive Bladder Cancer: An Analysis of the Global ANNAR Biomarker Study","authors":"Nobuaki Matsubara , Yohann Loriot , Severine Banek , Begoña Perez Valderrama , Jason Hwang , Kris Deprince , Spyros Triantos , Shibu Thomas , Jenna Cody Carcione , Sanket Patel , Arlene Siefker-Radtke","doi":"10.1016/j.euo.2025.07.009","DOIUrl":"10.1016/j.euo.2025.07.009","url":null,"abstract":"<div><h3>Background and objective</h3><div>Successful fibroblast growth factor receptor alterations (<em>FGFR</em>alt) testing is essential for identifying patients eligible for erdafitinib. This analysis of the global ANNAR biomarker study assessed the proportion of valid fibroblast growth factor receptor (FGFR) test results, reasons for test failure, and proportion of <em>FGFR</em>alt in locally advanced/metastatic urothelial cancer (mUC) and non–muscle-invasive bladder cancer (NMIBC).</div></div><div><h3>Methods</h3><div>Archival tumor tissue was tested using the QIAGEN <em>therascreen</em> FGFR real-time polymerase chain reaction kit, an approved companion diagnostic for erdafitinib<em>.</em></div></div><div><h3>Key findings and limitations</h3><div>A total of 2706 mUC and 962 NMIBC samples were tested. The proportion of valid test results was significantly different between mUC and NMIBC (86% and 66%, respectively; <em>p</em> < 0.001), which declined with older archival sample age for both mUC (<1 yr 89% and ≥3 yr 77%; <em>p</em> < 0.001) and NMIBC (<1 yr 72% and ≥3 yr 43%; <em>p</em> < 0.001). For mUC, the proportion of valid test results was higher for the primary tumor than for metastatic samples (92% and 55%, respectively; <em>p</em> < 0.001) but similar between upper and lower tract disease (87% and 86%, respectively; <em>p</em> = 0.7). Common reasons for test failure were low tumor content and insufficient RNA. <em>FGFR</em>alt were found in 19% of mUC (83% mutations; 15% fusions) and 53% of NMIBC (92% mutations; 6.3% fusions) samples. Limitations include the lack of data on sample collection method.</div></div><div><h3>Conclusions and clinical implications</h3><div>This is the first and largest report on factors affecting FGFR test results. To ensure valid FGFR test results, adequate tumor sample amount, RNA quality, short archival sample age, and primary tumor samples are important factors.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1558-1565"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130419","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.07.017
Isabel Heidegger
{"title":"Re: Niven Mehra, Emmanuel S. Antonarakis, Se Hoon Park, et al. Patient-reported Outcomes in KEYLYNK-010: Pembrolizumab plus Olaparib Versus Abiraterone or Enzalutamide. EurUrol Oncol. In press. https://doi.org/10.1016/j.euo.2025.04.018","authors":"Isabel Heidegger","doi":"10.1016/j.euo.2025.07.017","DOIUrl":"10.1016/j.euo.2025.07.017","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Page 1707"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145343857","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.08.006
Francesco Barletta , Simone Scuderi , Pietro Scilipoti , Mattia Longoni , Leonardo Quarta , Antony Pellegrino , Donato Cannoletta , Riccardo Leni , Paolo Zaurito , Alfonso Santangelo , Abigail Gettman , Alessandro Viti , Andrea Cosenza , Michele Brancaccio , Armando Stabile , Francesco Montorsi , Giorgio Gandaglia , Alberto Briganti
Background and objective
Several models predicting the lymph node invasion (LNI) risk in radical prostatectomy (RP) patients have been proposed to identify extended pelvic lymph node dissection (ePLND) candidates. We hypothesised that the implementation of these tools in the clinical practice would not hamper nodal staging accuracy, with benefits in perioperative outcomes.
Methods
A total of 7371 patients treated with RP ± ePLND between 2002 and 2023 were identified at a referral centre where the use of preoperative risk tools (Briganti nomograms) was implemented. Differences in pN stage (pNx vs pN0 vs pN1), ePLND-specific complications, and readmission rates (available from 2017, n = 1161) were displayed using the estimated annual percent change (EAPC). Multivariable linear regression tested the association of year of surgery with operative time, among cases performed with a robot-assisted approach by experienced surgeons (n = 1484). Survival analyses focused on biochemical (BCR) and clinical (CR) recurrence risks according to pN status (pNx vs pN0/1) in patients with a Briganti 2012 risk of <5% (n = 3774).
Key findings and limitations
Overall, 5352 (73%) versus1222 (17%) versus 797 (11%) patients were at pN0 versus pNx versus pN1 stage. A total of 509 (6.9%) patients experienced ePLND-specific complications. The rates of pNx and pN1 during the study period ranged from 4.7% to 38% (EAPC: 8.9%, p < 0.001) and from 14% to 15% (EAPC: 1.6%, 95% confidence interval 0.29–3, p = 0.02), respectively. Decreased ePLND-specific complication rates were observed over the study period (EAPC: –4.6%, p = 0.01). Readmission rates decreased from 8% to 2.3% (EAPC: –13%, p = 0.046). Year of surgery was independently associated with reduced operative time (β coefficient –6.3, p < 0.001). In multivariable Cox-regression models, pN0/1 patients exhibited similar BCR (hazard ratio [HR]: 1.1, p = 0.4) and CR (HR: 0.98, p = 0.95) risks to pNx patients. A study limitation is represented by the lack of individual LNI risk data on which the decision to perform ePLND was based.
Conclusions and clinical implications
The implementation of nomograms for preoperative LNI risk did not hamper nodal staging accuracy and reduced the number of ePLND procedures performed, with significant benefits in terms of RP patients’ outcomes.
背景与目的已经提出了几种预测根治性前列腺切除术（RP）患者淋巴结侵袭（LNI）风险的模型，以确定扩展盆腔淋巴结清扫（ePLND）候选人。我们假设在临床实践中使用这些工具不会妨碍淋巴结分期的准确性，并有利于围手术期的预后。方法采用术前风险工具（Briganti nomogram）对2002年至2023年间接受RP±ePLND治疗的7371例患者进行诊断。使用估计的年变化百分比（EAPC）显示pN分期（pNx vs pN0 vs pN1）、eplnd特异性并发症和再入院率（2017年起，n = 1161）的差异。在由经验丰富的外科医生采用机器人辅助入路的病例中，多变量线性回归检验了手术年份与手术时间的关系（n = 1484）。生存分析的重点是生化（BCR）和临床（CR）复发风险，根据pN状态（pNx vs pN0/1）， Briganti 2012风险为5% （n = 3774）的患者。总体而言，5352例（73%）、1222例（17%）和797例（11%）患者处于pN0期、pNx期和pN1期。共有509例（6.9%）患者出现eplnd特异性并发症。在研究期间，pNx和pN1的发生率分别为4.7% ~ 38% （EAPC: 8.9%, p < 0.001）和14% ~ 15% （EAPC: 1.6%， 95%可信区间0.29-3,p = 0.02）。研究期间观察到eplnd特异性并发症发生率下降（EAPC: -4.6%, p = 0.01）。再入院率从8%下降到2.3% （EAPC: -13%, p = 0.046）。手术年份与减少手术时间独立相关（β系数-6.3,p < 0.001）。在多变量cox回归模型中，pN0/1患者的BCR（风险比[HR]: 1.1, p = 0.4）和CR（风险比：0.98,p = 0.95）风险与pNx患者相似。研究的局限性在于缺乏个体LNI风险数据，而这些数据是决定实施ePLND的基础。结论和临床意义采用nomogram诊断术前LNI风险并不影响淋巴结分期的准确性，也减少了ePLND手术的数量，对RP患者的预后有显著的好处。
{"title":"Impact of Implementation of Risk Calculators for the Selection of Extended Pelvic Lymph Node Dissection Candidates: 20-year Experience from a Tertiary Referral Centre","authors":"Francesco Barletta , Simone Scuderi , Pietro Scilipoti , Mattia Longoni , Leonardo Quarta , Antony Pellegrino , Donato Cannoletta , Riccardo Leni , Paolo Zaurito , Alfonso Santangelo , Abigail Gettman , Alessandro Viti , Andrea Cosenza , Michele Brancaccio , Armando Stabile , Francesco Montorsi , Giorgio Gandaglia , Alberto Briganti","doi":"10.1016/j.euo.2025.08.006","DOIUrl":"10.1016/j.euo.2025.08.006","url":null,"abstract":"<div><h3>Background and objective</h3><div>Several models predicting the lymph node invasion (LNI) risk in radical prostatectomy (RP) patients have been proposed to identify extended pelvic lymph node dissection (ePLND) candidates. We hypothesised that the implementation of these tools in the clinical practice would not hamper nodal staging accuracy, with benefits in perioperative outcomes.</div></div><div><h3>Methods</h3><div>A total of 7371 patients treated with RP ± ePLND between 2002 and 2023 were identified at a referral centre where the use of preoperative risk tools (Briganti nomograms) was implemented. Differences in pN stage (pNx vs pN0 vs pN1), ePLND-specific complications, and readmission rates (available from 2017, <em>n</em> = 1161) were displayed using the estimated annual percent change (EAPC). Multivariable linear regression tested the association of year of surgery with operative time, among cases performed with a robot-assisted approach by experienced surgeons (<em>n</em> = 1484). Survival analyses focused on biochemical (BCR) and clinical (CR) recurrence risks according to pN status (pNx vs pN0/1) in patients with a Briganti 2012 risk of <5% (<em>n</em> = 3774).</div></div><div><h3>Key findings and limitations</h3><div>Overall, 5352 (73%) versus1222 (17%) versus 797 (11%) patients were at pN0 versus pNx versus pN1 stage. A total of 509 (6.9%) patients experienced ePLND-specific complications. The rates of pNx and pN1 during the study period ranged from 4.7% to 38% (EAPC: 8.9%, <em>p</em> < 0.001) and from 14% to 15% (EAPC: 1.6%, 95% confidence interval 0.29–3, <em>p</em> = 0.02), respectively. Decreased ePLND-specific complication rates were observed over the study period (EAPC: –4.6%, <em>p</em> = 0.01). Readmission rates decreased from 8% to 2.3% (EAPC: –13%, <em>p</em> = 0.046). Year of surgery was independently associated with reduced operative time (β coefficient –6.3, <em>p</em> < 0.001). In multivariable Cox-regression models, pN0/1 patients exhibited similar BCR (hazard ratio [HR]: 1.1, <em>p</em> = 0.4) and CR (HR: 0.98, <em>p</em> = 0.95) risks to pNx patients. A study limitation is represented by the lack of individual LNI risk data on which the decision to perform ePLND was based.</div></div><div><h3>Conclusions and clinical implications</h3><div>The implementation of nomograms for preoperative LNI risk did not hamper nodal staging accuracy and reduced the number of ePLND procedures performed, with significant benefits in terms of RP patients’ outcomes.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Pages 1583-1591"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145712234","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}
Pub Date : 2025-12-01DOI: 10.1016/j.euo.2025.08.010
Francesco Montorsi , Paolo Zaurito , Giorgio Gandaglia , Alberto Briganti
{"title":"Re: Himanshu Nagar, Marshall A. Diven, Brady Rippon, et al. A Randomized Controlled Phase 2 Trial Comparing Salvage Radiotherapy for Prostate Cancer Delivered in 4 Versus 2 Weeks (SHORTER): Acute Genitourinary and Gastrointestinal Patient-reported Outcomes at a Single Institution. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2025.05.014","authors":"Francesco Montorsi , Paolo Zaurito , Giorgio Gandaglia , Alberto Briganti","doi":"10.1016/j.euo.2025.08.010","DOIUrl":"10.1016/j.euo.2025.08.010","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 6","pages":"Page 1712"},"PeriodicalIF":9.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145712313","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}
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