Randomized trial of urinary tumor DNA (utDNA) testing-guided repeat transurethral resection (re-TURBT) in non-muscle-invasive bladder cancer (NMIBC): TRUCE-LB01.

Abstract

TPS910 Background: Repeat transurethral resection of bladder tumor (re-TURBT) is a standard procedure for selected patients with non–muscle-invasive bladder cancer (NMIBC) to ensure complete tumor removal and accurate pathological staging. Although this approach improves diagnostic precision, a substantial proportion of patients are found to be tumor-free at re-TURBT, raising concerns about overtreatment. As an invasive intervention, re-TURBT is associated with bleeding, bladder perforation, and urinary tract infection, as well as psychological stress, hospitalization, and financial burden. These limitations emphasize the need for more precise and individualized strategies to identify patients who can safely omit re-TURBT. Liquid biopsy provides a dynamic and non-invasive means of detecting minimal residual disease. Because bladder tumors shed DNA directly into urine, urinary tumor DNA (utDNA) testing offers a sensitive and repeatable approach for assessing molecular residual disease after surgery. Incorporating utDNA testing to guide re-TURBT may help avoid unnecessary procedures while maintaining oncologic safety. The TRUCE-LB01 trial was initiated and is currently ongoing to evaluate the clinical utility, safety, and cost-effectiveness of utDNA-guided re-TURBT in patients with NMIBC. Methods: TRUCE-LB01 is an open-label, multicenter, randomized controlled trial assessing the role of utDNA testing in guiding repeat transurethral resection (re-TURBT) for NMIBC. Eligible participants are adults (≥18 years) with pathologically confirmed NMIBC, without evidence of muscle-invasive or metastatic disease, and meeting at least one indication for re-TURBT, such as incomplete initial TURBT, absence of detrusor muscle in the specimen (except for low-grade Ta or CIS), or stage T1 disease. A total of 196 patients are randomized 1:1 to either a standard re-TURBT arm, in which patients undergo re-TURBT within 2–6 weeks after the initial procedure, or a utDNA-guided arm, where re-TURBT is performed only if utDNA testing is positive and omitted when utDNA is negative. All patients receive standard intravesical therapy and follow-up per guideline recommendations. The primary endpoint is 2-year recurrence-free survival (RFS). Secondary endpoints include progression-free survival (PFS) and pathological outcomes of re-TURBT (residual tumor rate, upstaging, and CIS detection). Exploratory endpoints include diagnostic and prognostic performance of utDNA, patient compliance, cost-effectiveness, and patient-reported outcomes (PROs). The study is conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Patient enrollment is ongoing across multiple centers in China. Clinical trial information: NCT07187635 .