Pub Date : 2026-02-06DOI: 10.1016/j.euo.2026.01.010
Roberto Contieri, Marco Paciotti, Alessandro Uleri, Alberto Saita, Gianluigi Taverna, Omid Sedigh, Sabato Barra, Piergiuseppe Colombo, Angelo Porreca, Edoardo Beatrici, Vittorio Fasulo, Pier Paolo Avolio, Nicola Frego, Alessio Finocchiaro, Ludovica Cella, Devis Collura, Miriam Cieri, Giorgio Guazzoni, Nicolò Maria Buffi, Giovanni Lughezzani, Paolo Casale, Massimo Lazzeri, Rodolfo Hurle
Background and objective: Current European Association of Urology guidelines universally recommend a second transurethral resection (ReTUR) for all T1 non-muscle-invasive bladder cancer (NMIBC) cases. However, ReTUR is an invasive and costly procedure that is often negative for residual disease, and may represent overtreatment in appropriately selected patients who have undergone complete initial TUR. Our aim was to report 2-yr oncological outcomes and confirm the safety of a novel, response-guided strategy with selective ReTUR for patients with T1 NMIBC.
Methods: The prospective, observational, multicenter HuNIRe trial enrolled patients with T1 NMIBC from 2020 to 2024. Patients with complete TUR underwent urine cytology at 3-4 wk and cystoscopy at 4-6 wk. ReTUR was performed only if cytology was positive (Paris system 3-6) or disease was detected on cystoscopy; otherwise, patients proceeded directly to bacillus Calmette-Guérin (BCG) induction therapy. The primary endpoints were 2-yr recurrence-free survival (RFS) and progression-free survival (PFS). Secondary endpoints included comparison of outcomes between the groups with and without ReTUR, and between the overall HuNIRe cohort and a retrospective cohort of patients with T1 NMIBC who underwent routine ReTUR. Kaplan-Meier estimates and the log-rank test were used for survival analysis.
Key findings and limitations: A total of 90 patients were prospectively enrolled. The protocol successfully avoided ReTUR in 71% (n = 64) of patients, who proceeded directly to BCG therapy. Only 29% (n = 26) of the patients required ReTUR according to early evaluation; importantly, no patient was upstaged to MIBC at ReTUR. After median follow-up of 26 mo, 2-yr survival rates for the entire cohort were 69% for RFS and 91% for PFS. There were no significant differences between the groups with and without ReTUR in RFS (p = 0.9) or PFS (p = 0.6). Oncological outcomes were also comparable between the HuNIRe cohort and a retrospective cohort that underwent routine ReTUR (2-yr RFS: 74% vs 74%; 2-yr PFS: 91% vs 92%).
Conclusions and clinical implications: Results from the HuNIRe trial confirm that a risk-adapted approach to ReTUR in selected patients with T1 NMIBC after complete initial TUR is feasible, although oncological outcomes should be interpreted with caution owing to the short follow-up. This strategy spared 71% of patients from ReTUR, and could support a tailored, response-guided approach rather than the blanket guideline recommendation for ReTUR.
{"title":"Second Transurethral Resection of Bladder Tumor Can Be Safely Omitted in Selected Patients with T1 Non-muscle-invasive Bladder Cancer: Results from the Prospective HuNIRe Trial.","authors":"Roberto Contieri, Marco Paciotti, Alessandro Uleri, Alberto Saita, Gianluigi Taverna, Omid Sedigh, Sabato Barra, Piergiuseppe Colombo, Angelo Porreca, Edoardo Beatrici, Vittorio Fasulo, Pier Paolo Avolio, Nicola Frego, Alessio Finocchiaro, Ludovica Cella, Devis Collura, Miriam Cieri, Giorgio Guazzoni, Nicolò Maria Buffi, Giovanni Lughezzani, Paolo Casale, Massimo Lazzeri, Rodolfo Hurle","doi":"10.1016/j.euo.2026.01.010","DOIUrl":"https://doi.org/10.1016/j.euo.2026.01.010","url":null,"abstract":"<p><strong>Background and objective: </strong>Current European Association of Urology guidelines universally recommend a second transurethral resection (ReTUR) for all T1 non-muscle-invasive bladder cancer (NMIBC) cases. However, ReTUR is an invasive and costly procedure that is often negative for residual disease, and may represent overtreatment in appropriately selected patients who have undergone complete initial TUR. Our aim was to report 2-yr oncological outcomes and confirm the safety of a novel, response-guided strategy with selective ReTUR for patients with T1 NMIBC.</p><p><strong>Methods: </strong>The prospective, observational, multicenter HuNIRe trial enrolled patients with T1 NMIBC from 2020 to 2024. Patients with complete TUR underwent urine cytology at 3-4 wk and cystoscopy at 4-6 wk. ReTUR was performed only if cytology was positive (Paris system 3-6) or disease was detected on cystoscopy; otherwise, patients proceeded directly to bacillus Calmette-Guérin (BCG) induction therapy. The primary endpoints were 2-yr recurrence-free survival (RFS) and progression-free survival (PFS). Secondary endpoints included comparison of outcomes between the groups with and without ReTUR, and between the overall HuNIRe cohort and a retrospective cohort of patients with T1 NMIBC who underwent routine ReTUR. Kaplan-Meier estimates and the log-rank test were used for survival analysis.</p><p><strong>Key findings and limitations: </strong>A total of 90 patients were prospectively enrolled. The protocol successfully avoided ReTUR in 71% (n = 64) of patients, who proceeded directly to BCG therapy. Only 29% (n = 26) of the patients required ReTUR according to early evaluation; importantly, no patient was upstaged to MIBC at ReTUR. After median follow-up of 26 mo, 2-yr survival rates for the entire cohort were 69% for RFS and 91% for PFS. There were no significant differences between the groups with and without ReTUR in RFS (p = 0.9) or PFS (p = 0.6). Oncological outcomes were also comparable between the HuNIRe cohort and a retrospective cohort that underwent routine ReTUR (2-yr RFS: 74% vs 74%; 2-yr PFS: 91% vs 92%).</p><p><strong>Conclusions and clinical implications: </strong>Results from the HuNIRe trial confirm that a risk-adapted approach to ReTUR in selected patients with T1 NMIBC after complete initial TUR is feasible, although oncological outcomes should be interpreted with caution owing to the short follow-up. This strategy spared 71% of patients from ReTUR, and could support a tailored, response-guided approach rather than the blanket guideline recommendation for ReTUR.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146137373","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 : 2026-02-04DOI: 10.1016/j.euo.2026.01.007
Daniele Amparore, Savio Domenico Pandolfo, Riccardo Bertolo, Selcuk Erdem, Pietro Diana, Laura Marandino, Stijn Muselaers, Carlotta Palumbo, Nicola Pavan, Angela Pecoraro, Alberto Piana, Georges Mjaess, Eduard Roussel, Zhenjie Wu, Giovanni Cacciamani, Riccardo Campi, Michele Marchioni
Background and objective: Inferior vena cava (IVC) tumor thrombus can impact the surgical management of locally advanced renal cell carcinoma (RCC). While open surgery remains the standard for complex thrombi, minimally invasive surgery (MIS) is increasingly adopted. The aim of this review was to compare perioperative outcomes across the different surgical approaches for IVC thrombectomy in nonmetastatic RCC.
Methods: We systematically searched the PubMed, Embase, Scopus, and Web of Science databases from inception to January 10, 2025 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The review protocol was registered on PROSPERO (CRD42022330114). Retrospective and prospective studies reporting operative time (OT), estimated blood loss (EBL), complication rates, or length of stay (LOS) after IVC thrombectomy were included. A meta-analysis of proportions and a network meta-analysis (NMA) of comparative studies were performed using random-effects models.
Key findings and limitations: Sixty-six studies (3241 patients) were included. Conventional meta-analysis revealed that mean OT was similar across approaches (p = 0.07), while mean EBL was significantly lower with MIS (robotic: 918.2 ml; laparoscopic: 253.7 ml) than with open surgery (1488.4 ml; p < 0.001). Overall complication rates were 28.5% with robotic, 12.6% with laparoscopic, and 28.9% with open surgery (p = 0.05), with corresponding major complication rates of 5.1%, 2.8%, and 12.9% (p = 0.02). NMA revealed shorter mean OT for robotic (-58.7 min; p < 0.001) and laparoscopic (-43.3 min; p = 0.01) approaches versus open surgery, and lower odds ratios for overall complications (robotic 0.37, p = 0.01; laparoscopic 0.24, p < 0.001) with MIS. Mean LOS was also shorter with MIS (robotic: -3.8 d; laparoscopic: -4.8 d; p < 0.05). Differences in major complication rates were not significant on NMA. Limitations include the retrospective design of the studies included, selection bias favoring open surgery for advanced thrombi, and under-reporting of oncological outcomes.
Conclusions and clinical implications: High-quality comparative evidence on MIS for IVC thrombectomy is limited and affected by substantial selection bias, which restricts robust comparisons to open surgery. Our findings suggest that MIS is associated with favorable perioperative outcomes in carefully selected patients, mainly with Mayo I-II thrombi in experienced centers, but no definitive conclusions on their comparative effectiveness versus open surgery can be drawn.
背景与目的:下腔静脉(IVC)肿瘤血栓影响局部晚期肾细胞癌(RCC)的手术治疗。虽然开放手术仍然是复杂血栓的标准,但微创手术(MIS)越来越多地被采用。本综述的目的是比较不同手术入路对非转移性肾癌下腔静脉血栓切除术的围手术期结果。方法:我们根据系统评价和荟萃分析指南的首选报告项目,系统地检索了PubMed、Embase、Scopus和Web of Science数据库,从成立到2025年1月10日。审查方案已在PROSPERO注册(CRD42022330114)。回顾性和前瞻性研究报告手术时间(OT),估计失血量(EBL),并发症发生率,或下腔静脉血栓切除术后的住院时间(LOS)。采用随机效应模型进行比例荟萃分析和比较研究网络荟萃分析(NMA)。主要发现和局限性:纳入66项研究(3241例患者)。传统的荟萃分析显示,不同入路的平均OT相似(p = 0.07),而MIS(机器人:918.2 ml;腹腔镜:253.7 ml)的平均EBL显著低于开放手术(1488.4 ml)。结论和临床意义:关于MIS用于IVC血栓切除术的高质量比较证据有限,并受到大量选择偏倚的影响,这限制了与开放手术的有力比较。我们的研究结果表明,在精心挑选的患者中,MIS与良好的围手术期预后相关,主要是经验丰富的中心的Mayo I-II血栓,但对于其与开放手术的比较效果没有明确的结论。
{"title":"Surgical Management of Nonmetastatic Renal Cell Carcinoma with Inferior Vena Cava Thrombus: A Systematic Review and Network Meta-analysis.","authors":"Daniele Amparore, Savio Domenico Pandolfo, Riccardo Bertolo, Selcuk Erdem, Pietro Diana, Laura Marandino, Stijn Muselaers, Carlotta Palumbo, Nicola Pavan, Angela Pecoraro, Alberto Piana, Georges Mjaess, Eduard Roussel, Zhenjie Wu, Giovanni Cacciamani, Riccardo Campi, Michele Marchioni","doi":"10.1016/j.euo.2026.01.007","DOIUrl":"https://doi.org/10.1016/j.euo.2026.01.007","url":null,"abstract":"<p><strong>Background and objective: </strong>Inferior vena cava (IVC) tumor thrombus can impact the surgical management of locally advanced renal cell carcinoma (RCC). While open surgery remains the standard for complex thrombi, minimally invasive surgery (MIS) is increasingly adopted. The aim of this review was to compare perioperative outcomes across the different surgical approaches for IVC thrombectomy in nonmetastatic RCC.</p><p><strong>Methods: </strong>We systematically searched the PubMed, Embase, Scopus, and Web of Science databases from inception to January 10, 2025 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The review protocol was registered on PROSPERO (CRD42022330114). Retrospective and prospective studies reporting operative time (OT), estimated blood loss (EBL), complication rates, or length of stay (LOS) after IVC thrombectomy were included. A meta-analysis of proportions and a network meta-analysis (NMA) of comparative studies were performed using random-effects models.</p><p><strong>Key findings and limitations: </strong>Sixty-six studies (3241 patients) were included. Conventional meta-analysis revealed that mean OT was similar across approaches (p = 0.07), while mean EBL was significantly lower with MIS (robotic: 918.2 ml; laparoscopic: 253.7 ml) than with open surgery (1488.4 ml; p < 0.001). Overall complication rates were 28.5% with robotic, 12.6% with laparoscopic, and 28.9% with open surgery (p = 0.05), with corresponding major complication rates of 5.1%, 2.8%, and 12.9% (p = 0.02). NMA revealed shorter mean OT for robotic (-58.7 min; p < 0.001) and laparoscopic (-43.3 min; p = 0.01) approaches versus open surgery, and lower odds ratios for overall complications (robotic 0.37, p = 0.01; laparoscopic 0.24, p < 0.001) with MIS. Mean LOS was also shorter with MIS (robotic: -3.8 d; laparoscopic: -4.8 d; p < 0.05). Differences in major complication rates were not significant on NMA. Limitations include the retrospective design of the studies included, selection bias favoring open surgery for advanced thrombi, and under-reporting of oncological outcomes.</p><p><strong>Conclusions and clinical implications: </strong>High-quality comparative evidence on MIS for IVC thrombectomy is limited and affected by substantial selection bias, which restricts robust comparisons to open surgery. Our findings suggest that MIS is associated with favorable perioperative outcomes in carefully selected patients, mainly with Mayo I-II thrombi in experienced centers, but no definitive conclusions on their comparative effectiveness versus open surgery can be drawn.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124288","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 : 2026-02-02DOI: 10.1016/j.euo.2026.01.008
Andrisha-Jade Inderjeeth, Andrew J Martin, Robert R Zielinski, Stephen Begbie, Leanna Cheung, Simon Chowdhury, Mark Frydenberg, Lisa G Horvath, Anthony M Joshua, Nicola J Lawrence, Gavin Marx, John McCaffrey, Raymond S McDermott, Margaret McJannett, Scott A North, Francis Parnis, Wendy R Parulekar, David W Pook, Martin N Reaume, Shahneen Sandhu, Alvin Tan, Thean H Tan, Alastair H Thomson, Francisco Vera-Badillo, Scott G Williams, Hayley Thomas, Sonia Yip, Alison Y Zhang, Kim N Chi, Martin R Stockler, Christopher J Sweeney, Ian D Davis
Background and objective: ENZAMET randomised 1125 participants with metastatic hormone-sensitive prostate cancer to receive enzalutamide or a standard nonsteroidal antiandrogen (NSAA) combined with testosterone suppression with or without docetaxel. Enzalutamide demonstrated superior progression-free and overall survival (OS). Radiographic progression without prior/concurrent prostate-specific antigen progression (discordant progression; DP) portends poor outcomes. Our aim was to determine the frequency of DP in ENZAMET and the impact of enzalutamide on disease-state transitions.
Methods: A multistate Cox proportional-hazards regression model was used to partition participants into four states: (1) event-free; (2) discordant progression (DP); (3) other types of progression (other progression; OP); and (4) death.
Key findings and limitations: Enzalutamide prolonged OS in the entire cohort of 1125 participants (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.58-0.84; p < 0.0001). Radiographic progression occurred in 388/1125 (34%) participants, and DP in 114/1125 (10%), with similar proportions in the enzalutamide arm (55/114, 48%) and NSAA arm (59/114, 52%). Participant characteristics in the DP group were similar between the treatment arms. Enzalutamide delayed DP (HR 0.66, 95% CI 0.46-0.96; p = 0.03) and OP (HR 0.37, 95% CI 0.31-0.44; p < 0.001). The 5-yr OS rate was lower in the DP group (24%) than in the OP group (42%). Among participants whose cancer had not progressed (495/1125), 51/495 (10%) died of non-prostate cancer causes (median follow-up 68 mo). This exploratory analysis is limited by its post hoc nature.
Conclusions and clinical implications: DP occurred in 10% of participants and accounted for 30% of progression events observed in ENZAMET. DP was associated with worse OS regardless of treatment. Enzalutamide delayed DP and reduced the risk of DP and OP. Regularly scheduled imaging may be preferable to for-cause imaging in metastatic hormone-sensitive prostate cancer.
{"title":"Radiographic Progression Without Prostate-specific Antigen Progression in Metastatic Hormone-sensitive Prostate Cancer: A Retrospective Analysis of the ENZAMET Trial (ANZUP 1304).","authors":"Andrisha-Jade Inderjeeth, Andrew J Martin, Robert R Zielinski, Stephen Begbie, Leanna Cheung, Simon Chowdhury, Mark Frydenberg, Lisa G Horvath, Anthony M Joshua, Nicola J Lawrence, Gavin Marx, John McCaffrey, Raymond S McDermott, Margaret McJannett, Scott A North, Francis Parnis, Wendy R Parulekar, David W Pook, Martin N Reaume, Shahneen Sandhu, Alvin Tan, Thean H Tan, Alastair H Thomson, Francisco Vera-Badillo, Scott G Williams, Hayley Thomas, Sonia Yip, Alison Y Zhang, Kim N Chi, Martin R Stockler, Christopher J Sweeney, Ian D Davis","doi":"10.1016/j.euo.2026.01.008","DOIUrl":"https://doi.org/10.1016/j.euo.2026.01.008","url":null,"abstract":"<p><strong>Background and objective: </strong>ENZAMET randomised 1125 participants with metastatic hormone-sensitive prostate cancer to receive enzalutamide or a standard nonsteroidal antiandrogen (NSAA) combined with testosterone suppression with or without docetaxel. Enzalutamide demonstrated superior progression-free and overall survival (OS). Radiographic progression without prior/concurrent prostate-specific antigen progression (discordant progression; DP) portends poor outcomes. Our aim was to determine the frequency of DP in ENZAMET and the impact of enzalutamide on disease-state transitions.</p><p><strong>Methods: </strong>A multistate Cox proportional-hazards regression model was used to partition participants into four states: (1) event-free; (2) discordant progression (DP); (3) other types of progression (other progression; OP); and (4) death.</p><p><strong>Key findings and limitations: </strong>Enzalutamide prolonged OS in the entire cohort of 1125 participants (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.58-0.84; p < 0.0001). Radiographic progression occurred in 388/1125 (34%) participants, and DP in 114/1125 (10%), with similar proportions in the enzalutamide arm (55/114, 48%) and NSAA arm (59/114, 52%). Participant characteristics in the DP group were similar between the treatment arms. Enzalutamide delayed DP (HR 0.66, 95% CI 0.46-0.96; p = 0.03) and OP (HR 0.37, 95% CI 0.31-0.44; p < 0.001). The 5-yr OS rate was lower in the DP group (24%) than in the OP group (42%). Among participants whose cancer had not progressed (495/1125), 51/495 (10%) died of non-prostate cancer causes (median follow-up 68 mo). This exploratory analysis is limited by its post hoc nature.</p><p><strong>Conclusions and clinical implications: </strong>DP occurred in 10% of participants and accounted for 30% of progression events observed in ENZAMET. DP was associated with worse OS regardless of treatment. Enzalutamide delayed DP and reduced the risk of DP and OP. Regularly scheduled imaging may be preferable to for-cause imaging in metastatic hormone-sensitive prostate cancer.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146112690","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 : 2026-02-01DOI: 10.1016/j.euo.2025.05.023
Nicolas A. Soputro , Carter D. Mikesell , Salim K. Younis , Samarpit Rai , Lin Wang , Adriana M. Pedraza , Jane K. Nguyen , Christopher J. Weight , Jihad Kaouk
<div><h3>Background and objective</h3><div>Introduction of the purpose-built single-port (SP) robotic platform has paved the ways for the advent of novel, regionalized surgical techniques for robot-assisted radical prostatectomy (RARP), including the SP transvesical approach. This study sought to evaluate the perioperative, oncological, and functional outcomes of transvesical SP-RARP, in comparison with the standard multiport (MP) transperitoneal technique.</div></div><div><h3>Methods</h3><div>A retrospective review was performed on the institutional review board–approved, prospectively maintained database to identify all consecutive patients who underwent SP transvesical and MP transperitoneal RARP between 2015 and 2024. A 1:1 propensity-matched analysis was performed to ensure similar baseline clinicodemographic characteristics between the two groups, including prostate volume, preoperative prostate-specific antigen, International Society of Urological Pathology groups, and the clinical T stages.</div></div><div><h3>Key findings and limitations</h3><div>Of the 773 patients included in our series, our propensity score–matched analysis identified 285 cases in each of the SP transvesical and MP transperitoneal cohorts. All SP procedures were completed successfully without conversion or additional ports. Despite the similar preoperative characteristics and intraoperative outcomes, the SP group was associated with a more significant history of previous abdominal surgery, as defined by the Hostile Abdomen Index of 4 (SP 37.3% vs MP 4.3%, <em>p</em> < 0.001). In terms of the postoperative outcomes, the SP approach conferred increased rates of same-day discharges (SP 83.1% vs MP 1.1%, <em>p</em> < 0.001), reduced opioid prescriptions (SP 6.3% vs MP 89.4%, <em>p</em> < 0.001), and shorter postoperative Foley catheter duration (SP 4 d vs MP 7 d, <em>p</em> < 0.001). Furthermore, transvesical SP-RARP provided significant improvements in functional outcomes, with 47% achieving immediate continence, which subsequently grew to 82.8% at 3 mo and 91.7% at 6 mo. These rates were noticeably higher than the 70.5% (<em>p</em> = 0.008) and 89.7% (<em>p</em> = 0.642) continence rates at 3 and 6 mo, respectively, for the MP approach. Both groups were otherwise similar in terms of their sexual potency outcomes, particularly with satisfactory erectile function at 12 mo being reported in 85.7% and 82.1% of the SP and MP patients, respectively (<em>p</em> = 0.742). Limitations of this study included the retrospective, single-institution design, which may limit the generalizability of the findings.</div></div><div><h3>Conclusions and clinical implications</h3><div>Herein, we demonstrated the oncological safety and efficacy of the novel SP transvesical RARP, which remained comparable with the gold-standard MP transperitoneal approach. Albeit the need for further research and long-term follow-up data, the regionalized SP transvesical approach hold a strong promi
背景与目的:专用单口(SP)机器人平台的引入为机器人辅助根治性前列腺切除术(RARP)的新型、区域化手术技术的出现铺平了道路,包括SP经膀胱入路。本研究旨在评估经膀胱SP-RARP与标准多孔(MP)经腹腔技术的围手术期、肿瘤学和功能结果。方法:对机构审查委员会批准的前瞻性维护数据库进行回顾性审查,以确定2015年至2024年间接受SP经膀胱和MP经腹腔RARP的所有连续患者。进行1:1倾向匹配分析,以确保两组患者的基线临床人口学特征相似,包括前列腺体积、术前前列腺特异性抗原、国际泌尿病理学会分组和临床T分期。主要发现和局限性:在我们纳入的773例患者中,我们的倾向评分匹配分析确定了SP经膀胱组和MP经腹腔组各285例。所有SP程序均成功完成,无需转换或附加端口。尽管术前特征和术中结果相似,但SP组有更显著的腹部手术史,如敌对腹部指数为4 (SP 37.3% vs MP 4.3%)。结论和临床意义:在此,我们证明了新型SP经膀胱RARP的肿瘤安全性和有效性,与金标准MP经腹腔入路相当。尽管需要进一步的研究和长期随访数据,但区域化SP经膀胱入路在进一步改善RARP患者舒适度和术后发病率方面具有很强的前景。
{"title":"Propensity-matched Comparison of Single-port Transvesical Versus Standard Multiport Robotic Radical Prostatectomy","authors":"Nicolas A. Soputro , Carter D. Mikesell , Salim K. Younis , Samarpit Rai , Lin Wang , Adriana M. Pedraza , Jane K. Nguyen , Christopher J. Weight , Jihad Kaouk","doi":"10.1016/j.euo.2025.05.023","DOIUrl":"10.1016/j.euo.2025.05.023","url":null,"abstract":"<div><h3>Background and objective</h3><div>Introduction of the purpose-built single-port (SP) robotic platform has paved the ways for the advent of novel, regionalized surgical techniques for robot-assisted radical prostatectomy (RARP), including the SP transvesical approach. This study sought to evaluate the perioperative, oncological, and functional outcomes of transvesical SP-RARP, in comparison with the standard multiport (MP) transperitoneal technique.</div></div><div><h3>Methods</h3><div>A retrospective review was performed on the institutional review board–approved, prospectively maintained database to identify all consecutive patients who underwent SP transvesical and MP transperitoneal RARP between 2015 and 2024. A 1:1 propensity-matched analysis was performed to ensure similar baseline clinicodemographic characteristics between the two groups, including prostate volume, preoperative prostate-specific antigen, International Society of Urological Pathology groups, and the clinical T stages.</div></div><div><h3>Key findings and limitations</h3><div>Of the 773 patients included in our series, our propensity score–matched analysis identified 285 cases in each of the SP transvesical and MP transperitoneal cohorts. All SP procedures were completed successfully without conversion or additional ports. Despite the similar preoperative characteristics and intraoperative outcomes, the SP group was associated with a more significant history of previous abdominal surgery, as defined by the Hostile Abdomen Index of 4 (SP 37.3% vs MP 4.3%, <em>p</em> < 0.001). In terms of the postoperative outcomes, the SP approach conferred increased rates of same-day discharges (SP 83.1% vs MP 1.1%, <em>p</em> < 0.001), reduced opioid prescriptions (SP 6.3% vs MP 89.4%, <em>p</em> < 0.001), and shorter postoperative Foley catheter duration (SP 4 d vs MP 7 d, <em>p</em> < 0.001). Furthermore, transvesical SP-RARP provided significant improvements in functional outcomes, with 47% achieving immediate continence, which subsequently grew to 82.8% at 3 mo and 91.7% at 6 mo. These rates were noticeably higher than the 70.5% (<em>p</em> = 0.008) and 89.7% (<em>p</em> = 0.642) continence rates at 3 and 6 mo, respectively, for the MP approach. Both groups were otherwise similar in terms of their sexual potency outcomes, particularly with satisfactory erectile function at 12 mo being reported in 85.7% and 82.1% of the SP and MP patients, respectively (<em>p</em> = 0.742). Limitations of this study included the retrospective, single-institution design, which may limit the generalizability of the findings.</div></div><div><h3>Conclusions and clinical implications</h3><div>Herein, we demonstrated the oncological safety and efficacy of the novel SP transvesical RARP, which remained comparable with the gold-standard MP transperitoneal approach. Albeit the need for further research and long-term follow-up data, the regionalized SP transvesical approach hold a strong promi","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 45-54"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324911","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 : 2026-02-01DOI: 10.1016/j.euo.2025.01.004
Giorgio Gandaglia , Francesco Barletta , Simone Scuderi , Pietro Scilipoti , Pawel Rajwa , Nicolai A. Huebner , Juan Gomez Rivas , Laura Ibanez , Timo F.W. Soeterik , Lorenzo Bianchi , Agostino Mattei , Claudia Kesch , Christopher Darr , Hongqian Guo , Junlong Zhuang , Fabio Zattoni , Wolfgang P. Fendler , Giancarlo Marra , Armando Stabile , Daniele Robesti , Alberto Briganti
Background and objective
Extended pelvic lymph node dissection (ePLND) is recommended in selected radical prostatectomy (RP) prostate cancer (PCa) patients for staging purposes. We aim to externally validate available tools to predict lymph node invasion (LNI) in men with negative preoperative prostate-specific membrane antigen positron emission tomography (miN0).
Methods
Overall, 282 intermediate- to high-risk PCa patients with miN0 disease undergoing RP and ePLND at ten centers between 2016 and 2023 were identified. The Memorial Sloan Kettering Cancer Center (MSKCC); Amsterdam-Brisbane-Sydney; and Briganti 2017, 2019, and 2023 tools predicting LNI were validated externally using calibration plots, C-indexes, and decision-curve analyses to assess calibration, discrimination, and net benefit.
Key findings and limitations
Overall, 36 (13%) patients had LNI. The C-indexes of the MSKCC, Briganti 2017, Briganti 2019, Amsterdam-Brisbane-Sydney, and Briganti 2023 nomograms were 64%, 69%, 72%, 64%, and 77%, respectively. The Briganti 2023 nomogram exhibited higher net benefit than the other available nomograms, and the use of a 5% cutoff would have spared 47% ePLND procedures (vs 14% and 4.3% for the Briganti 2019 and Amsterdam-Brisbane-Sydney nomograms, respectively) at the cost of missing only five (3.8%) LNI cases. Heterogeneity in patient selection and imaging protocols represents the main limitations.
Conclusions and clinical implications
The Briganti 2023 nomogram outperformed other available tools in predicting LNI in men with miN0 PCa. The use of this tool resulted in a considerable number of unnecessary ePLND procedures spared and optimization of ePLND recommendations in a contemporary clinical setting.
{"title":"External Validation of Nomograms for the Identification of Pelvic Nodal Dissection Candidates Among Prostate Cancer Patients with Negative Preoperative Prostate-specific Membrane Antigen Positron Emission Tomography","authors":"Giorgio Gandaglia , Francesco Barletta , Simone Scuderi , Pietro Scilipoti , Pawel Rajwa , Nicolai A. Huebner , Juan Gomez Rivas , Laura Ibanez , Timo F.W. Soeterik , Lorenzo Bianchi , Agostino Mattei , Claudia Kesch , Christopher Darr , Hongqian Guo , Junlong Zhuang , Fabio Zattoni , Wolfgang P. Fendler , Giancarlo Marra , Armando Stabile , Daniele Robesti , Alberto Briganti","doi":"10.1016/j.euo.2025.01.004","DOIUrl":"10.1016/j.euo.2025.01.004","url":null,"abstract":"<div><h3>Background and objective</h3><div>Extended pelvic lymph node dissection (ePLND) is recommended in selected radical prostatectomy (RP) prostate cancer (PCa) patients for staging purposes. We aim to externally validate available tools to predict lymph node invasion (LNI) in men with negative preoperative prostate-specific membrane antigen positron emission tomography (miN0).</div></div><div><h3>Methods</h3><div>Overall, 282 intermediate- to high-risk PCa patients with miN0 disease undergoing RP and ePLND at ten centers between 2016 and 2023 were identified. The Memorial Sloan Kettering Cancer Center (MSKCC); Amsterdam-Brisbane-Sydney; and Briganti 2017, 2019, and 2023 tools predicting LNI were validated externally using calibration plots, C-indexes, and decision-curve analyses to assess calibration, discrimination, and net benefit.</div></div><div><h3>Key findings and limitations</h3><div>Overall, 36 (13%) patients had LNI. The C-indexes of the MSKCC, Briganti 2017, Briganti 2019, Amsterdam-Brisbane-Sydney, and Briganti 2023 nomograms were 64%, 69%, 72%, 64%, and 77%, respectively. The Briganti 2023 nomogram exhibited higher net benefit than the other available nomograms, and the use of a 5% cutoff would have spared 47% ePLND procedures (vs 14% and 4.3% for the Briganti 2019 and Amsterdam-Brisbane-Sydney nomograms, respectively) at the cost of missing only five (3.8%) LNI cases. Heterogeneity in patient selection and imaging protocols represents the main limitations.</div></div><div><h3>Conclusions and clinical implications</h3><div>The Briganti 2023 nomogram outperformed other available tools in predicting LNI in men with miN0 PCa. The use of this tool resulted in a considerable number of unnecessary ePLND procedures spared and optimization of ePLND recommendations in a contemporary clinical setting.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 133-141"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074417","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 : 2026-02-01DOI: 10.1016/j.euo.2025.02.007
Sunny B. Nalavenkata , Emily Vertosick , Alberto Briganti , Hashim Ahmed , David Eldred-Evans , Steven Gordon , Holly Raghallaigh , Christian Gratzke , Michael O’Callaghan , Michael Liss , Peter Chiu , Michael Müntener , John Yaxley , Cedric Poyet , Matthias Jahnen , Ants Toi , Sangeet Ghai , Daniel Margolis , Donna Ankerst , Behfar Ehdaie , Andrew J. Vickers
<div><h3>Background and objective</h3><div>The quality and reporting of prostate magnetic resonance imaging (MRI) are operator dependent, leading to variations in estimates such as positive predictive value across sites. This impacts patient counseling, risk modeling, and risk calculators. This study assessed variation in Prostate Imaging Reporting and Data System (PI-RADS) score classification and subsequent probability of grade group (GG) ≥2 + prostate cancer.</div></div><div><h3>Methods</h3><div>Data from the Prostate Biopsy Collaborative Group, including multiple sites in North America, Europe, and Asia Pacific, were analyzed. Patients underwent multiparametric MRI (mpMRI) of the prostate followed by prostate biopsy during the years 2010–2023. Only those with MRI-targeted biopsy and PI-RADS score ≥3 were included. The risk of being assigned PI-RADS 4 or 5 and risk of GG ≥2 disease for these scores were estimated using logistic regression.</div></div><div><h3>Key findings and limitations</h3><div>The cohort included 7325 biopsies from 7320 unique patients from 13 sites. A two-fold variation in the probability of PI-RADS 4 or 5 assignment across sites persisted even after adjustment for patient risk (heterogeneity <em>p</em> < 0.001 for both). There were significant differences in the absolute risk of GG ≥2 disease for PI-RADS 4 and 5 (heterogeneity <em>p</em> < 0.001 for both), varying between 23% and 68% and between 49% and 87%, respectively. The use of prostate biopsy as a reference standard has limitations but reflects typical usage of mpMRI in clinical practice.</div></div><div><h3>Conclusions and clinical implications</h3><div>The probability of being assigned PI-RADS 4 or 5 and subsequent detection of GG ≥2 disease varies widely between institutions. This impacts counseling, risk stratification, and clinical practice, necessitating better standardization in the performance and interpretation of mpMRI.</div><div><span><div><span>ADVANCING PRACTICE</span><div><div><strong>What does this study add?</strong></div><div>The quality and reporting of prostate magnetic resonance imaging (MRI) vary significantly between institutions, affecting patient counseling and risk assessment. This study analyzed data from multiple international sites, revealing substantial differences in the scores of the Prostate Imaging Reporting and Data System and the likelihood of detecting high-grade cancer. Even after adjusting for patient risk, the probability of high-grade disease varied widely, highlighting the need for standardized MRI procedures and interpretations.</div><div><strong>Clinical Relevance</strong></div><div>Prostate MRI has hugely changed the prostate cancer diagnostic pathway since the last two decades. However, important variations in terms of operator experience, MRI quality and reporting may significantly alter the diagnostic performance of this MRI-driven pathway. The authors present herein the biopsy results and the cancer grade group 2
{"title":"Variation in Prostate Magnetic Resonance Imaging Performance: Data from the Prostate Biopsy Collaborative Group","authors":"Sunny B. Nalavenkata , Emily Vertosick , Alberto Briganti , Hashim Ahmed , David Eldred-Evans , Steven Gordon , Holly Raghallaigh , Christian Gratzke , Michael O’Callaghan , Michael Liss , Peter Chiu , Michael Müntener , John Yaxley , Cedric Poyet , Matthias Jahnen , Ants Toi , Sangeet Ghai , Daniel Margolis , Donna Ankerst , Behfar Ehdaie , Andrew J. Vickers","doi":"10.1016/j.euo.2025.02.007","DOIUrl":"10.1016/j.euo.2025.02.007","url":null,"abstract":"<div><h3>Background and objective</h3><div>The quality and reporting of prostate magnetic resonance imaging (MRI) are operator dependent, leading to variations in estimates such as positive predictive value across sites. This impacts patient counseling, risk modeling, and risk calculators. This study assessed variation in Prostate Imaging Reporting and Data System (PI-RADS) score classification and subsequent probability of grade group (GG) ≥2 + prostate cancer.</div></div><div><h3>Methods</h3><div>Data from the Prostate Biopsy Collaborative Group, including multiple sites in North America, Europe, and Asia Pacific, were analyzed. Patients underwent multiparametric MRI (mpMRI) of the prostate followed by prostate biopsy during the years 2010–2023. Only those with MRI-targeted biopsy and PI-RADS score ≥3 were included. The risk of being assigned PI-RADS 4 or 5 and risk of GG ≥2 disease for these scores were estimated using logistic regression.</div></div><div><h3>Key findings and limitations</h3><div>The cohort included 7325 biopsies from 7320 unique patients from 13 sites. A two-fold variation in the probability of PI-RADS 4 or 5 assignment across sites persisted even after adjustment for patient risk (heterogeneity <em>p</em> < 0.001 for both). There were significant differences in the absolute risk of GG ≥2 disease for PI-RADS 4 and 5 (heterogeneity <em>p</em> < 0.001 for both), varying between 23% and 68% and between 49% and 87%, respectively. The use of prostate biopsy as a reference standard has limitations but reflects typical usage of mpMRI in clinical practice.</div></div><div><h3>Conclusions and clinical implications</h3><div>The probability of being assigned PI-RADS 4 or 5 and subsequent detection of GG ≥2 disease varies widely between institutions. This impacts counseling, risk stratification, and clinical practice, necessitating better standardization in the performance and interpretation of mpMRI.</div><div><span><div><span>ADVANCING PRACTICE</span><div><div><strong>What does this study add?</strong></div><div>The quality and reporting of prostate magnetic resonance imaging (MRI) vary significantly between institutions, affecting patient counseling and risk assessment. This study analyzed data from multiple international sites, revealing substantial differences in the scores of the Prostate Imaging Reporting and Data System and the likelihood of detecting high-grade cancer. Even after adjusting for patient risk, the probability of high-grade disease varied widely, highlighting the need for standardized MRI procedures and interpretations.</div><div><strong>Clinical Relevance</strong></div><div>Prostate MRI has hugely changed the prostate cancer diagnostic pathway since the last two decades. However, important variations in terms of operator experience, MRI quality and reporting may significantly alter the diagnostic performance of this MRI-driven pathway. The authors present herein the biopsy results and the cancer grade group 2","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 156-163"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976835","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 : 2026-02-01DOI: 10.1016/j.euo.2025.10.003
Robert J. Thomas , Stacey A. Kenfield , Madeleine Williams , Robert U. Newton , Jeffrey Aldous , Anita Mitra , Zahoor Fazili
{"title":"Increasing Phytochemical-rich Foods and Lactobacillus Probiotics in Men with Low-risk Prostate Cancer—A Randomised, Double-blind, Placebo-controlled Trial","authors":"Robert J. Thomas , Stacey A. Kenfield , Madeleine Williams , Robert U. Newton , Jeffrey Aldous , Anita Mitra , Zahoor Fazili","doi":"10.1016/j.euo.2025.10.003","DOIUrl":"10.1016/j.euo.2025.10.003","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 193-198"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145388184","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 : 2026-02-01DOI: 10.1016/j.euo.2025.10.015
Constance Huck , Paul Sargos , Alberto Bossi
{"title":"Re: Markus Graefen, Fabian Falkenbach, Tobias Maurer, et al. Best Systemic Therapy With or Without Radical Prostatectomy in the Management of Men With Oligometastatic Prostate Cancer: The RAMPP Randomised Controlled Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2025.09.4144","authors":"Constance Huck , Paul Sargos , Alberto Bossi","doi":"10.1016/j.euo.2025.10.015","DOIUrl":"10.1016/j.euo.2025.10.015","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 199-200"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145631519","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 : 2026-02-01DOI: 10.1016/j.euo.2025.11.013
Axel Bex , Grant D. Stewart
{"title":"Assessment of Pathologic Response in Kidney Cancer: Back to the Microscope for Now","authors":"Axel Bex , Grant D. Stewart","doi":"10.1016/j.euo.2025.11.013","DOIUrl":"10.1016/j.euo.2025.11.013","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 4-6"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676946","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 : 2026-02-01DOI: 10.1016/j.euo.2025.03.017
Noelia Sanmamed , Ian Dayes , Charles Catton , Amy Liu , Stephane Supiot , Himu Lukka , Glenn Bauman , Zijin Liu , Jean-Paul Bahary , Shahida Ahmed , Patrick Cheung , Matthew Parliament , Michael Sia , Theodorus Tsakiridis , Shankar Siva , Tom Corbett , Colin Tang , Tim Craig , Jarad Martin , Peter Chung
Background and objective
The PROFIT trial was designed to compare moderately hypofractionated (HF) radiotherapy versus conventional fractionation (CF) for patients with intermediate-risk prostate cancer (IR-PC). Similar efficacy and toxicity outcomes were previously reported. The aim of the current analysis was to evaluate differences in long-term patient-reported outcomes (PROs) between the HF and CF arms in PROFIT.
Methods
For the PROFIT phase 3 randomized clinical trial, patients with IR-PC (n = 1206) were enrolled from 14 sites in Canada, 12 in Australia, and one in France and randomized to receive 78 Gy in 39 fractions over 8 wk (CF) or 60 Gy in 20 fractions over 4 wk (HF). PROs were evaluated at baseline and 24 and 48 mo using the Expanded Prostate Cancer Index Composite, American Urological Association Symptom Score (AUASS), and the 12-item Short Form Health Survey (SF-12) comprising a physical component summary (PCS) and a mental component summary (MCS). A minimally important difference (MID) was defined as a deterioration in domain- or subdomain-specific health-related quality of life (HRQoL) score by ≥0.5 times the standard deviation at each time point in comparison to baseline. Statistical significance was set at p < 0.01.
Key findings and limitations
AUASS results were similar and stable over time in both arms (median 5 points, interquartile range 2–9; p > 0.2). There were no significant differences in scores for urinary, bowel, sexual, and hormonal domains or subdomains between the arms at any time point (p > 0.02). The greatest decline over time occurred in sexual domain, with a decrease of ≥10 points from baseline to 24 mo in both arms. SF-12 mean scores for both PSC and MSC were similar in the two arms and remained stable at all time points. The only significant differences in the proportion of patients reporting MIDs were for the bowel subdomains at 48 mo, with significant MID reductions favoring HF for both the bowel summary score (53% vs 44%; p = 0.01) and bowel function score (51% vs 39%; p = 0.001). Overall treatment satisfaction was high in both arms: ≥88% of patients were either satisfied or extremely satisfied with their treatment.
Conclusions and clinical implications
PRO results from the PROFIT trial suggest no significant differences in urinary, bowel, sexual, hormonal, and general HRQoL between CF and HF radiotherapy schedules. This study provides level 1 evidence supporting the use of moderate HF radiotherapy as standard treatment in patients with IR-PC.
This trial is registered on ClinicalTrials.gov as NCT00304759.
背景和目的:PROFIT试验旨在比较中度低分割放疗(HF)与常规分割放疗(CF)对中危前列腺癌(IR-PC)患者的治疗效果。以前报道过类似的疗效和毒性结果。当前分析的目的是评估PROFIT中HF组和CF组长期患者报告结局(PROs)的差异。方法:PROFIT 3期随机临床试验,从加拿大的14个地点、澳大利亚的12个地点和法国的1个地点招募了IR-PC患者(n = 1206),随机分为39组接受78 Gy的8周治疗(CF)或20组接受60 Gy的4周治疗(HF)。使用扩展前列腺癌指数综合、美国泌尿科协会症状评分(AUASS)和包含身体成分摘要(PCS)和精神成分摘要(MCS)的12项简短健康调查(SF-12)在基线和24和48个月时评估PROs。最小重要差异(MID)定义为在每个时间点与基线相比,特定领域或子领域的健康相关生活质量(HRQoL)评分恶化≥0.5倍。主要发现和局限性:随时间推移,两组的AUASS结果相似且稳定(中位数5点,四分位数范围2-9;p > 0.2)。两组在任何时间点的尿、肠、性、激素域或子域评分均无显著差异(p < 0.05)。随着时间的推移,最大的下降发生在性领域,从基线到24个月,双臂下降≥10点。两组PSC和MSC的SF-12平均评分相似,在所有时间点保持稳定。报告MIDs的患者比例的唯一显著差异是在48个月时肠亚域,在肠总评分中,MIDs显著减少有利于HF (53% vs 44%;P = 0.01)和肠功能评分(51% vs 39%;p = 0.001)。两组患者的总体治疗满意度都很高:≥88%的患者对治疗满意或非常满意。结论和临床意义:PROFIT试验的PRO结果显示,CF和HF放疗方案在尿、肠、性、激素和一般HRQoL方面没有显著差异。这项研究提供了一级证据,支持中度HF放疗作为IR-PC患者的标准治疗。该试验在ClinicalTrials.gov上注册为NCT00304759。
{"title":"Patient-reported Quality of Life in PROFIT, a Phase 3 Randomized Clinical Trial Evaluating Moderately Hypofractionated Radiotherapy for Intermediate-risk Prostate Cancer","authors":"Noelia Sanmamed , Ian Dayes , Charles Catton , Amy Liu , Stephane Supiot , Himu Lukka , Glenn Bauman , Zijin Liu , Jean-Paul Bahary , Shahida Ahmed , Patrick Cheung , Matthew Parliament , Michael Sia , Theodorus Tsakiridis , Shankar Siva , Tom Corbett , Colin Tang , Tim Craig , Jarad Martin , Peter Chung","doi":"10.1016/j.euo.2025.03.017","DOIUrl":"10.1016/j.euo.2025.03.017","url":null,"abstract":"<div><h3>Background and objective</h3><div>The PROFIT trial was designed to compare moderately hypofractionated (HF) radiotherapy versus conventional fractionation (CF) for patients with intermediate-risk prostate cancer (IR-PC). Similar efficacy and toxicity outcomes were previously reported. The aim of the current analysis was to evaluate differences in long-term patient-reported outcomes (PROs) between the HF and CF arms in PROFIT.</div></div><div><h3>Methods</h3><div>For the PROFIT phase 3 randomized clinical trial, patients with IR-PC (<em>n</em> = 1206) were enrolled from 14 sites in Canada, 12 in Australia, and one in France and randomized to receive 78 Gy in 39 fractions over 8 wk (CF) or 60 Gy in 20 fractions over 4 wk (HF). PROs were evaluated at baseline and 24 and 48 mo using the Expanded Prostate Cancer Index Composite, American Urological Association Symptom Score (AUASS), and the 12-item Short Form Health Survey (SF-12) comprising a physical component summary (PCS) and a mental component summary (MCS). A minimally important difference (MID) was defined as a deterioration in domain- or subdomain-specific health-related quality of life (HRQoL) score by ≥0.5 times the standard deviation at each time point in comparison to baseline. Statistical significance was set at <em>p</em> < 0.01.</div></div><div><h3>Key findings and limitations</h3><div>AUASS results were similar and stable over time in both arms (median 5 points, interquartile range 2–9; <em>p</em> > 0.2). There were no significant differences in scores for urinary, bowel, sexual, and hormonal domains or subdomains between the arms at any time point (<em>p</em> > 0.02). The greatest decline over time occurred in sexual domain, with a decrease of ≥10 points from baseline to 24 mo in both arms. SF-12 mean scores for both PSC and MSC were similar in the two arms and remained stable at all time points. The only significant differences in the proportion of patients reporting MIDs were for the bowel subdomains at 48 mo, with significant MID reductions favoring HF for both the bowel summary score (53% vs 44%; <em>p</em> = 0.01) and bowel function score (51% vs 39%; <em>p</em> = 0.001). Overall treatment satisfaction was high in both arms: ≥88% of patients were either satisfied or extremely satisfied with their treatment.</div></div><div><h3>Conclusions and clinical implications</h3><div>PRO results from the PROFIT trial suggest no significant differences in urinary, bowel, sexual, hormonal, and general HRQoL between CF and HF radiotherapy schedules. This study provides level 1 evidence supporting the use of moderate HF radiotherapy as standard treatment in patients with IR-PC.</div><div>This trial is registered on ClinicalTrials.gov as NCT00304759.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 26-36"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143974068","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}