Condition: Non-muscle-invasive Bladder Cancer · Non-Muscle Invasive Bladder Urothelial Carcinoma · High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma · Sponsor: University of Roma La Sapienza
Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy. Methods/Aims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI/VI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by …
This description comes directly from the study's public registry record.
Francesco Del Giudice, MD · +39 3395382464 · francesco.delgiudice@uniroma1.it
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| AOU Policlinico Umberto I Hospital, UOC Urologia SMUC05, Rome, Italy | Rome, Lazio, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05962541