Patients with T1 nonmuscle-invasive bladder cancer (NMIBC) face substantial risks of recurrence and progression to muscle-invasive disease. However, current risk stratification tools rely on retrospective data with significant heterogeneity in the reporting of adverse pathological features. The ROGUE-1 registry was designed to address the unmet need for a clean, prospective dataset on primary T1 bladder cancer to enable accurate risk stratification and guide clinical decision-making.
ROGUE-1 is a multicentric, international, prospective registry enrolling 700 patients with a pathologically confirmed primary diagnosis of T1 bladder cancer across 18 urology centers in Europe and North America. All patients must have T1 disease confirmed at second-look transurethral resection of bladder tumor (TURB). Clinical, pathological, and epidemiological data are prospectively collected using an electronic case report form on the Castor electronic data capture platform. Central pathology review by expert genitourinary pathologists is performed for all specimens. An optional molecular component includes transcriptome analysis of formalin-fixed paraffin-embedded tumor specimens. The primary endpoints are therapy failure rates (recurrence, high-grade recurrence, and progression to muscle-invasive disease). Follow-up data are collected at 3-mo intervals.
This is a protocol paper; no clinical results are reported. A key limitation is the observational design, which precludes treatment standardization across centers. The optional molecular component may result in variable specimen availability.
ROGUE-1 will provide a prospective, multi-institutional dataset to improve risk stratification in T1 NMIBC and identify patients who may benefit from early aggressive treatment versus conservative management.
ClinicalTrials.gov (NCT05792033).
European urology oncology. 2026 Apr 18 [Epub ahead of print]
David D'Andrea, Francesco Soria, Morgan Rouprêt, Paolo Gontero, Shahrokh F Shariat, ROGUE-1 Investigators
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. Electronic address: ., Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy., Sorbonne University, GRC 5 Predictive Onco-Uro, AP-HP, Urology, Pitié-Salpêtrière Hospital, F-75013 Paris, France., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria; Department of Urology, University of Texas Southwestern, Dallas, TX, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czechia.