Randomized trial of urinary tumor DNA (utDNA) testing-guided cystoscopy in high-risk/very high-risk non-muscle-invasive bladder cancer (NMIBC): TRUCE-LB02.

Abstract

TPS911 Background: Patients with high-risk or very high-risk non–muscle-invasive bladder cancer (NMIBC) require intensive cystoscopic surveillance after transurethral resection of bladder tumor (TURBT), typically every 3 months for the first 2 years. However, repeated cystoscopy is invasive, costly, and associated with pain, anxiety, and complications such as infection and bleeding. Liquid biopsy has emerged as a promising noninvasive tool for dynamic tumor monitoring. Urinary tumor DNA (utDNA) testing, uniquely suited for urothelial malignancies, offers a sensitive means to detect molecular residual disease and early recurrence. Incorporating utDNA testing to guide cystoscopic surveillance may help optimize follow-up intensity, reduce unnecessary procedures, and improve patient experience. The TRUCE-LB02 trial was initiated and is currently ongoing to evaluate the clinical utility, safety, and cost-effectiveness of utDNA-guided cystoscopy in high-risk/very high-risk NMIBC. Methods: TRUCE-LB02 is an open-label, multicenter, randomized controlled trial assessing the role of utDNA testing in guiding cystoscopic surveillance for NMIBC. Eligible patients are adults (≥18 years) with pathologically confirmed high-risk or very high-risk NMIBC as defined by the 2025 EAU guidelines. Prior to randomization, all patients undergo cystoscopy and urine cytology confirming absence of visible tumor. A total of 360 patients are randomized 1:1 to a utDNA-guided arm or a control arm. In the utDNA-guided arm, patients undergo utDNA testing and cytology every 3 months, with one scheduled cystoscopy per year; additional cystoscopy is performed if utDNA or cytology is positive. A single positive cytology or two consecutive utDNA-positive results with negative cystoscopy trigger computed tomography urography (CTU). In the control arm, patients undergo cystoscopy and cytology every 3 months, with CTU performed if cytology is positive but cystoscopy is negative. The primary endpoints are 2-year recurrence-free survival (RFS) and the mean number of cystoscopies per patient. Secondary endpoints include progression-free survival (PFS) and the diagnostic and prognostic performance of utDNA testing, while exploratory endpoints include patient compliance, cost-effectiveness, and patient-reported outcomes (PROs). All patients receive standard treatment and follow-up per EAU 2025 guidelines. The study is conducted in accordance with the Declaration of Helsinki and ICH-GCP. Patient enrollment is ongoing across multiple centers in China. Clinical trial information: NCT07180212 .