In recent years, the Vesical Imaging-Reporting and Data System (VI-RADS) for multiparametric MRI (mpMRI) has been globally validated as an accurate and reliable diagnostic tool for preoperative staging of bladder cancer (BC). It has been widely demonstrated that VI-RADS Scores 1 and 2 are strong predictors of non-invasive disease at re-TURBT.
According to the European Association of Urology (EAU) Guidelines, a second-look resection (re-TURBT) is recommended 2–6 weeks after the initial TURBT if the first surgery is incomplete, for all T1 tumors, or when no detrusor muscle is collected. Over the years, re-TURBT has served as a form of "emergency rescue" for suboptimal primary surgeries, leading to significant economic, social, and healthcare-related burdens for patients.
Our new study, published in BJU International (2024), introduces the research protocol for a randomized controlled trial (RCT) that will begin in 2025. The primary goal is to combine the diagnostic accuracy of preoperative mpMRI for BC staging with the enhanced intraoperative visualization provided by photodynamic diagnosis (PDD) during the initial TURBT to safely avoid the need for re-TURBT.1
This will be a single-center RCT sponsored by “Sapienza” University of Rome. The study will recruit a cohort of BC patients who undergo preoperative mpMRI with VI-RADS score determination. A total of 327 patients with intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC) will be enrolled over a three-year period. They will be randomized in a 1:1 ratio to either the standard of care (SoC)—consisting of primary white-light (WL) TURBT followed by a second WL re-TURBT—or the experimental arm, which involves primary PDD-TURBT without subsequent re-TURBT. Both groups will receive adjuvant intravesical Bacillus Calmette-Guérin (BCG) therapy based on risk-adjusted schedules.
The study aims to demonstrate that the rate of early BC recurrence (within 4.5 months of follow-up) in the SoC arm is non-inferior to that of the experimental arm. Secondary objectives include evaluating late BC recurrence rates, progression from NMIBC to muscle-invasive bladder cancer (MIBC), and changes in patients’ health-related quality of life (HRQoL). These outcomes will be measured using generic QoL instruments for cost-effectiveness analyses and validated disease-specific questionnaires.
Additionally, the study will conduct health-economic evaluations, including a short-term cost-benefit assessment of the incremental costs avoided per re-TURBT and a longer-term cost-utility analysis per quality-adjusted life year (QALY) gained over a two-year follow-up period and the patient’s lifetime. Sub-analyses will explore total hospital and social healthcare costs.
Given the global significance of BC in terms of clinical management and cost-effectiveness, as well as the complications associated with TURBT and patient perspectives on the procedure and disease, the trial aims to propose a novel NMIBC treatment algorithm. The CUT-less trial seeks to establish the clinical non-inferiority of the new approach, improve HRQoL, and revise the cost-effectiveness framework within the European Union.
By proposing a more personalized, socially, and economically sustainable NMIBC treatment pathway, the CUT-less trial aims to reduce patients' surgical exposure and optimize healthcare expenditures. The study aspires to redefine selection criteria for NMIBC candidates requiring re-TURBT, thereby minimizing the procedural burden on patients while resizing healthcare costs across the EU.
Written by: Roberta Corvino,1 Francesco Del Giudice,1 Valeria Panebianco,2 Tanja Hüsch,3,4 and Ettore De Berardinis1
- Department of Maternal Infant and Urologic Sciences, “Sapienza” University of Rome, Rome, ITA
- Department of Radiology, “Sapienza” University of Rome, Rome, ITA
- Clinical Development and Medical Affairs, Photocure, ASA, Oslo, Norway.
- Department of Urology and Paediatric Urology, University Medical Centre of Johannes-Gutenberg University, Mainz, Germany.
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