Daniele Robesti, Ashish M. Kamat, Guillaume Ploussard, Roberto Contieri, Giuseppe Fallara, Alberto Briganti, Francesco Montorsi, Antoine G. van der Heijden, Bernard Malavaud, Kamal Pohar, Neal Shore, Colin P. N. Dinney, Alberto Martini
{"title":"Trial design drives outcomes: harmonising efficacy across BCG ‐unresponsive bladder carcinoma in situ trials","authors":"Daniele Robesti, Ashish M. Kamat, Guillaume Ploussard, Roberto Contieri, Giuseppe Fallara, Alberto Briganti, Francesco Montorsi, Antoine G. van der Heijden, Bernard Malavaud, Kamal Pohar, Neal Shore, Colin P. N. Dinney, Alberto Martini","doi":"10.1111/bju.70463","DOIUrl":"https://doi.org/10.1111/bju.70463","url":null,"abstract":"Objectives To evaluate how heterogeneity in response assessment protocols, including biopsy timing, complete response (CR) assessment, retreatment policies, and the handling of withdrawals, influences reported efficacy outcomes across single‐arm registrational trials of patients with bacillus Calmette Guérin unresponsive (BCG‐U) carcinoma <jats:italic>in situ</jats:italic> (CIS). Patients and Methods We reconstructed survival data from six registrational BCG‐U CIS trials and conducted simulation analyses to test how trial design affects efficacy estimates. Specifically, we: (i) reclassified patients who underwent re‐induction as non‐responders; (ii) adjusted for false‐negative rates of cystoscopy/cytology vs biopsy (as uniquely reported in the nadofaragene firadenovec trial, hence chosen as the analytical reference); (iii) harmonised CR assessment timing across trials. The exact binomial test was utilised for comparisons. Results Re‐induction reclassification reduced the 12‐month <jats:styled-content style=\"fixed-case\">CR</jats:styled-content> rate for nogapendekin alfa inbakicept ( <jats:styled-content style=\"fixed-case\">NAI</jats:styled-content> ) + <jats:styled-content style=\"fixed-case\">BCG</jats:styled-content> from 44% to 33% and for cretostimogene grenadenorepvec from 45% to 38%. After adjusting for an 11% false‐negative rate in trials lacking mandatory biopsies, the pembrolizumab 12‐month <jats:styled-content style=\"fixed-case\">CR</jats:styled-content> rate declined to 17% ( <jats:italic>P</jats:italic> = 0.07), and <jats:styled-content style=\"fixed-case\">NAI</jats:styled-content> , accounting for re‐induction reclassification, achieved a <jats:styled-content style=\"fixed-case\">CR</jats:styled-content> rate of 29% ( <jats:italic>P</jats:italic> = 0.4). <jats:styled-content style=\"fixed-case\">TAR</jats:styled-content> ‐200 outperformed the analytical reference, with a 12‐month <jats:styled-content style=\"fixed-case\">CR</jats:styled-content> rate of 45% under mandatory biopsy protocols ( <jats:italic>P</jats:italic> < 0.01). Conclusions Trial design artefacts significantly impact reported efficacy in BCG‐U CIS studies. Published CR rates are not directly comparable across agents. Future trials should standardise biopsy timing and clearly define retreatment policies to ensure meaningful cross‐study comparisons.","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"91 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149043545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to “Functional and quality of life outcomes of localised prostate cancer treatments (Prostate Testing for Cancer and Treatment [ ProtecT ] study)”","authors":"","doi":"10.1111/bju.70466","DOIUrl":"https://doi.org/10.1111/bju.70466","url":null,"abstract":"","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149019912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kieran Long, Joseph Hutchinson, George Acland, Judith Clarke, Phil Hider, Stephen Mark
{"title":"Patient‐reported outcomes after open and robotic radical prostatectomy: a New Zealand registry study","authors":"Kieran Long, Joseph Hutchinson, George Acland, Judith Clarke, Phil Hider, Stephen Mark","doi":"10.1111/bju.70459","DOIUrl":"https://doi.org/10.1111/bju.70459","url":null,"abstract":"Objectives Our objective was to compare functional outcomes between open radical prostatectomy (ORP) and robotic‐assisted laparoscopic prostatectomy (RALP) in New Zealand. Methods We analysed responses from men in the Prostate Cancer Outcome Registry of New Zealand (PCOR‐NZ) who underwent ORP or RALP as primary treatment for prostate cancer between January 2016 and December 2024. We included men who completed an Expanded Prostate Cancer Index – 26 (EPIC‐26) patient‐reported outcome measure (PROM) questionnaire either at baseline, 12 months after radical prostatectomy or both. EPIC‐26 scores range from 0 to 100 (100 = best score). Established thresholds assessed minimal clinically important differences; urinary incontinence (6–9 points), urinary obstruction (5–7 points), bowel (4–6 points), sexual (10–12 points) and hormonal (4–6 points). Mean differences were calculated using multivariate analysis to adjust for age, prostate‐specific antigen and International Society of Urological Pathology grade. Additional analyses assessed daily pad usage and patient‐reported sexual function. Results Of the 4889 men who completed a questionnaire, 2844 (58.1%) underwent ORP and 2045 (41.8%) underwent RALP. PROM completion rates were 52.3% at baseline and 78.8% at 12 months after treatment. Patients who underwent RALP had higher post‐treatment PROM scores in all domains. Adjusted mean differences for urinary incontinence (6.9 points, 95% confidence interval 4.6–9.2 <jats:italic>P</jats:italic> < 0.001) and sexual (11.4 points, 95% confidence interval 9.1–13.7, <jats:italic>P</jats:italic> < 0.001) domains were above the threshold for minimal clinically important difference. Urinary obstruction, bowel and hormonal domains did not reach clinical significance. At 12 months, RALP had a higher rate of zero pads/day usage (65.1% vs 54.4% <jats:italic>P</jats:italic> < 0.001) and lower two or more pads/day usage (3.9% vs 10.0% <jats:italic>P</jats:italic> < 0.001). More men in the RALP group reported a ‘good’ to ‘very good’ sexual function at 12 months (13.7% vs 5.3%, <jats:italic>P</jats:italic> < 0.001). Conclusion RALP is associated with higher PROMs across all EPIC‐26 domains, with clinically meaningful benefit in sexual function, urinary incontinence and reduced incontinence pad usage at 12 months.","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"44 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149009878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Francesco Di Bello, Andres K Kanashiro, Alejandra Bravo-Balado, Paolo Verri, Paula Izquierdo, Lucio Fila, Oriol Angerri
{"title":"From stone-free to stone-load reduction: a volumetric perspective on surgical and functional outcomes.","authors":"Francesco Di Bello, Andres K Kanashiro, Alejandra Bravo-Balado, Paolo Verri, Paula Izquierdo, Lucio Fila, Oriol Angerri","doi":"10.1111/bju.70453","DOIUrl":"https://doi.org/10.1111/bju.70453","url":null,"abstract":"","PeriodicalId":8985,"journal":{"name":"BJU International","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fredrik Möller, Marianne Månsson, Mikael Hellström, Fredrik Langkilde, Vasiliki Spyratou, Johan Stranne, Jonas Wallström, Jonas Hugosson, Rebecka Arnsrud Godtman
{"title":"The role of PSA density in the follow up of men with a negative MRI in the Göteborg‐2 trial","authors":"Fredrik Möller, Marianne Månsson, Mikael Hellström, Fredrik Langkilde, Vasiliki Spyratou, Johan Stranne, Jonas Wallström, Jonas Hugosson, Rebecka Arnsrud Godtman","doi":"10.1111/bju.70450","DOIUrl":"https://doi.org/10.1111/bju.70450","url":null,"abstract":"Objectives To assess whether prostate‐specific antigen density (PSAD) stratifies long‐term risk of clinically significant prostate cancer (csPCa) after a negative magnetic resonance imaging (MRI; Prostate Imaging‐Reporting and Data System score ≤2) and to evaluate the potential of PSAD to guide follow‐up in a screening setting. Patients and Methods This pre‐specified sub‐analysis of the population‐based, randomised Göteborg‐2 screening trial included 1685 men who underwent PSA testing between October 2015 and June 2021 and had a subsequent negative initial MRI. Follow‐up continued until 30 September 2024. The primary endpoint was cumulative incidence of csPCa (Gleason score ≥3 + 4). Men were categorised by baseline PSAD (<0.10, 0.10 to <0.15, and ≥0.15 ng/mL <jats:sup>2</jats:sup> ). Cumulative incidence was estimated using Kaplan–Meier methods and compared using the log‐rank test. The clinical implications of PSAD‐based follow‐up strategies were explored. Results Over a median follow‐up of 5.5 years, 160 PCas were diagnosed, of which 80 were csPCa, including 22 cases of Gleason score ≥4 + 3. At 7 years, cumulative csPCa incidence was 7.1% overall and 5.5%, 13.8%, and 11.9% in the PSAD <0.10, 0.10 to <0.15, and ≥0.15 ng/mL <jats:sup>2</jats:sup> groups, respectively ( <jats:italic>P</jats:italic> < 0.001 for PSAD <0.10 ng/mL <jats:sup>2</jats:sup> vs both higher groups). Overall, 87% of repeat MRIs remained negative. Although men with baseline PSAD <0.10 ng/mL <jats:sup>2</jats:sup> had the lowest overall risk, 42 csPCas occurred in this group, including 12 Gleason score ≥4 + 3, emphasising the importance of continued regular PSA‐based follow‐up. A PSAD‐guided strategy with biennial PSA testing and repeat MRI triggered by PSAD ≥0.10 ng/mL <jats:sup>2</jats:sup> could reduce MRI use by 60% and biopsies by 46%, halve detection of clinically insignificant PCa, and delay csPCa diagnosis in 17% of cases including 10 men with Gleason score 3 + 4 and one with Gleason score ≥4 + 3. Conclusions The PSAD stratifies long‐term risk of csPCa after a negative MRI and supports risk‐adapted follow‐up in PCa screening.","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"58 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148993734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Richard J. Bryant, Tom Leslie, Marc Laniado, Abhishek Sharma, Alistair Grey, John Withington, Christopher Blick, Edward Streeter, Sanjeev Kotwal, Oliver Hulson, William Cross, Daniel W. Good, Altan Omer, Taimur T. Shah, Nishant Bedi, Luke Stroman, Caroline Moore, Prasanna Sooriakumaran, Hashim U. Ahmed, Simon F. Brewster, Vicki S. Barber, Aimi Hewitt, Clare Calvert, Jessica Scaife, Derek Shepherd, Filipa Landeiro, Jane Wolstenholme, Philip Camilleri, Clare Verrill, Shelagh Lovell, Martin Pirkl, Fergus Gleeson, Roxanne Williams, Jo Cook, Catherine R. Holt, Martyn Hill, Jonathan Cook, James Radford, Ioana R. Marian, Ruth Macpherson, Daisy Elliott, Jenny L. Donovan, Freddie C. Hamdy
{"title":"The PART randomised trial protocol: Partial Ablation versus Radical Treatment for prostate cancer","authors":"Richard J. Bryant, Tom Leslie, Marc Laniado, Abhishek Sharma, Alistair Grey, John Withington, Christopher Blick, Edward Streeter, Sanjeev Kotwal, Oliver Hulson, William Cross, Daniel W. Good, Altan Omer, Taimur T. Shah, Nishant Bedi, Luke Stroman, Caroline Moore, Prasanna Sooriakumaran, Hashim U. Ahmed, Simon F. Brewster, Vicki S. Barber, Aimi Hewitt, Clare Calvert, Jessica Scaife, Derek Shepherd, Filipa Landeiro, Jane Wolstenholme, Philip Camilleri, Clare Verrill, Shelagh Lovell, Martin Pirkl, Fergus Gleeson, Roxanne Williams, Jo Cook, Catherine R. Holt, Martyn Hill, Jonathan Cook, James Radford, Ioana R. Marian, Ruth Macpherson, Daisy Elliott, Jenny L. Donovan, Freddie C. Hamdy","doi":"10.1111/bju.70448","DOIUrl":"https://doi.org/10.1111/bju.70448","url":null,"abstract":"Objectives Primary objective: to determine whether prostate gland partial ablation (PA) has non‐inferior oncological treatment success vs radical treatment (RT) of localised intermediate‐risk prostate cancer (irPCa). Secondary objectives: to compare (i) participant‐reported urinary and sexual dysfunction side effects, (ii) short/medium term serious adverse events, (iii) health‐related quality of life (HRQoL), (iv) cost‐effectiveness; and to report (v) the need for repeat PA, (vi) accuracy of magnetic resonance imaging and biopsy protocols in determining suitability for PA, (vii) disease progression, local spread and metastases, (viii) medium‐term disease‐specific and overall mortality. Participants and Methods The ‘Partial prostate Ablation versus Radical Treatment’ (PART; International Standard Randomised Controlled Trial Number ISRCTN17249875) is a UK‐wide, multicentre, pragmatic, randomised controlled trial investigating whether PA (high‐intensity focused ultrasound [HIFU] or irreversible electroporation [IRE]) is non‐inferior to RT (radical prostatectomy, radical radiotherapy, or low‐dose‐rate brachytherapy [LDR‐B]) in treating localised irPCa. A Qualitative Research Integrated within Trials (QuinteT) Recruitment Intervention is included to optimise recruitment and informed consent. Primary outcome treatment success for PA will be determined by prostate biopsies and imaging, and for RT using standard definitions. Participants will receive treatment according to their randomised allocation, with HIFU or IRE for PA depending on lesion location, and radical prostatectomy, radical radiotherapy, or LDR‐B according to patient and physician preference for RT. Based on 95% and 85% oncological treatment success for RT and PA, respectively, with a non‐inferiority margin of 20%, at median 3 years of follow‐up, PART requires 275 recruited men (137 per group, randomised on a 1:1 basis), for 80% power, with a one‐sided alpha of 0.025. Allowing for a 10% total withdrawal or dropout rate, PART requires 306 recruited and randomised participants. Conclusions The PART trial will provide robust prospective data and high‐level randomised evidence to determine oncological treatment effectiveness of PA vs RT for localised irPCa, along with comparative side effect, HRQoL, and health economics evaluations, to inform clinical decision‐making.","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"47 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148993732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"EXPRESSION OF CONCERN : Small Interference RNA Targeting Heat‐Shock Protein 27 Inhibits the Growth of Prostatic Cell Lines and Induces Apoptosis via Caspase‐3 Activation In Vitro","authors":"","doi":"10.1111/bju.70458","DOIUrl":"https://doi.org/10.1111/bju.70458","url":null,"abstract":"EXPRESSION OF CONCERN : P. Rocchi, P. Jugpal, A. So, S. Sinneman, S. Ettinger, L. Fazli, C. Nelson and M. Gleave, “Small Interference RNA Targeting Heat‐Shock Protein 27 Inhibits the Growth of Prostatic Cell Lines and Induces Apoptosis via Caspase‐3 Activation <jats:italic>In Vitro</jats:italic> ,” <jats:italic>BJU International</jats:italic> 98, no. 5 (2006): 1082–1089, <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" xlink:href=\"https://doi.org/10.1111/j.1464-410X.2006.06425.x\">https://doi.org/10.1111/j.1464-410X.2006.06425.x</jats:ext-link> . This Expression of Concern is for the above article, published online on 09 October 2006 in Wiley Online Library ( <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" xlink:href=\"http://wileyonlinelibrary.com\">wileyonlinelibrary.com</jats:ext-link> ), and its correction <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" xlink:href=\"https://doi.org/10.1111/bju.70026\">https://doi.org/10.1111/bju.70026</jats:ext-link> . It has been issued by agreement between the journal Editor‐in‐Chief, Freddie Hamdy; and John Wiley & Sons Ltd. UK. The Expression of Concern has been issued following concerns raised by a third party. Following an investigation, it was confirmed that the blots in Fig. 2 were taken from earlier publications and were produced using siRNA sequences that differ from those reported in this study. As the figure does not correspond to the experimental conditions described in the study, Fig. 2 cannot be considered a valid representation of the results reported, contrary to the authors' correction. The author's institution was contacted regarding this matter, but no response has been received. As the concerns remain unresolved, the journal has decided to issue an Expression of Concern to alert readers to these issues.","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"18 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148973409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Riccardo Leni, Scott E Eggener, Matthew R Cooperberg, Simpa S Salami, Adam B Weiner, Ming Zhou, Hasan Al-Sattar, Alastair D Lamb, Andrew J Vickers
{"title":"Is Gleason pattern 3 cancer? Molecular features do not distinguish pattern 3 from benign tissue.","authors":"Riccardo Leni, Scott E Eggener, Matthew R Cooperberg, Simpa S Salami, Adam B Weiner, Ming Zhou, Hasan Al-Sattar, Alastair D Lamb, Andrew J Vickers","doi":"10.1111/bju.70433","DOIUrl":"https://doi.org/10.1111/bju.70433","url":null,"abstract":"","PeriodicalId":8985,"journal":{"name":"BJU International","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}