{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T19:00:40Z","timestamp":1785006040767,"version":"3.55.0"},"reference-count":38,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,10,13]],"date-time":"2024-10-13T00:00:00Z","timestamp":1728777600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      A second transurethral resection of bladder tumour (Re\u2010TURBT) is recommended by European Association of Urology (EAU) Guidelines on non\u2010muscle\u2010invasive bladder cancers (NMIBCs) due to the risk of understaging and\/or persistent disease following the primary resection. However, in many cases this may be unnecessary, potentially harmful, and significantly expensive constituting overtreatment. The CUT\u2010\n                      <jats:italic>less<\/jats:italic>\n                      trial aims to combine the preoperative staging accuracy of Vesical Imaging\u2010Reporting and Data System (VI\u2010RADS) and the intraoperative enhanced ability of photodynamic diagnosis (PDD) to overcome the primary TURBT pitfalls thus potentially re\u2010defining criteria for Re\u2010TURBT indications.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design<\/jats:title>\n                    <jats:p>Single\u2010centre, non\u2010inferiority, phase IV, open\u2010label, randomised controlled trial with 1:1 ratio.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Endpoints<\/jats:title>\n                    <jats:p>The primary endpoint is short\u2010term BC recurrence between the study arms to assess whether patients preoperatively categorised as VI\u2010RADS Score 1 and\/or Score 2 (i.e., very\u2010low and low likelihood of MIBC) could safely avoid Re\u2010TURBT by undergoing primary PDD\u2010TURBT. Secondary endpoints include mid\u2010 and long\u2010term BC recurrences and progression (i\u2013ii). Also, health\u2010related quality of life (HRQoL) outcomes (iii) and health\u2010economic cost\u2013benefit analysis (iv) will be performed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>All patients will undergo preoperative Multiparametric Magnetic Resonance Imaging of the bladder with VI\u2010RADS score determination. A total of 327 patients with intermediate\u2010\/high\u2010risk NMIBCs, candidate for Re\u2010TURBT according to EAU Guidelines, will be enrolled over a 3\u2010year period. Participants will be randomised (1:1 ratio) to either standard of care (SoC), comprising primary white\u2010light (WL) TURBT followed by second WL Re\u2010TURBT; or the Experimental arm, comprising primary PDD\u2010TURBT and omitting Re\u2010TURBT. Both groups will receive adjuvant intravesical therapy and surveillance according to risk\u2010adjusted schedules. Measure of the primary outcome will be the relative proportion of BC recurrences between the SoC and Experimental arms within 4.5\u2009months (i.e., any \u2018early\u2019 recurrence detected at first follow\u2010up cystoscopy). Secondary outcomes measures will be the relative proportion of late BC recurrences and\/or BC progression detected after 4.5\u2009months follow\u2010up. Additionally, we will compute the HRQoL variation from NMIBC questionnaires modelled over a patient lifetime horizon and the health\u2010economic analyses including a short\u2010term cost\u2013benefit assessment of incremental costs per Re\u2010TURBT avoided and a longer\u2010term cost\u2010utility per quality\u2010adjusted life year gained using 2\u2010year clinical outcomes to drive a lifetime model across the two arms of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrial.gov\">ClinicalTrial.gov<\/jats:ext-link>\n                      identifier (ID): NCT05962541; European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) ID: 2023\u2010507307\u201064\u201000.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.16531","type":"journal-article","created":{"date-parts":[[2024,10,13]],"date-time":"2024-10-13T23:44:06Z","timestamp":1728863046000},"page":"346-354","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["VI\u2010RADS followed by Photodynamic Transurethral Resection of Non\u2010Muscle\u2010Invasive Bladder Cancer vs White\u2010Light Conventional and Second\u2010resection: the \u2018CUT\u2010\n                    <i>less<\/i>\n                    \u2019 Randomised Trial Protocol"],"prefix":"10.1111","volume":"135","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3865-5988","authenticated-orcid":false,"given":"Francesco","family":"Del Giudice","sequence":"first","affiliation":[{"name":"Department of Maternal Infant and Urologic Sciences, \u201cSapienza\u201d University of Rome Policlinico Umberto I Hospital  Rome Italy"},{"name":"Department of Urology Stanford University School of Medicine  Stanford CA USA"},{"name":"Guy's and St. Thomas' NHS Foundation Trust Guys Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annarita","family":"Vestri","sequence":"additional","affiliation":[{"name":"Department of Public Health and Infectious Disease \u201cSapienza\u201d University of Rome  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danilo Alunni","family":"Fegatelli","sequence":"additional","affiliation":[{"name":"Department of Life Sciences, Health and Health Professions Link Campus University  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"H\u00fcsch","sequence":"additional","affiliation":[{"name":"Clinical development and Medical Affairs Photocure, ASA  Oslo Norway"},{"name":"Department of Urology and Paediatric Urology University Medical Centre of Johannes\u2010Gutenberg University  Mainz Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Belsey","sequence":"additional","affiliation":[{"name":"JB Medical Ltd  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajesh","family":"Nair","sequence":"additional","affiliation":[{"name":"Guy's and St. Thomas' NHS Foundation Trust Guys Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eila C.","family":"Skinner","sequence":"additional","affiliation":[{"name":"Department of Urology Stanford University School of Medicine  Stanford CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9660-2732","authenticated-orcid":false,"given":"Benjamin I.","family":"Chung","sequence":"additional","affiliation":[{"name":"Department of Urology Stanford University School of Medicine  Stanford CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Pecoraro","sequence":"additional","affiliation":[{"name":"Department of Radiology, Oncology and Pathology, \u201cSapienza\u201d University of Rome Policlinico Umberto I Hospital  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7899-8056","authenticated-orcid":false,"given":"Alessandro","family":"Sciarra","sequence":"additional","affiliation":[{"name":"Department of Maternal Infant and Urologic Sciences, \u201cSapienza\u201d University of Rome Policlinico Umberto I Hospital  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgio","family":"Franco","sequence":"additional","affiliation":[{"name":"Department of Maternal Infant and Urologic Sciences, \u201cSapienza\u201d University of Rome Policlinico Umberto I Hospital  Rome 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