Results of the Prospective Randomized UroFollow Trial Comparing Marker-guided Versus Cystoscopy-based Surveillance in Patients with Low/Intermediate-risk Bladder Cancer
Schmitz-Dräger B, Bismarck E, Roghmann F, von Landenberg N, Noldus J, Jahn D, Kernig K, Hakenberg OW, Goebell P, Hennenlotter J, Erne E, Stenzl A, Rowinski M, Schiffhorst G, Baranek T, Benderska-Söder N (2025)
Publication Language: English
Publication Type: Journal article
Publication year: 2025
Journal
Book Volume: 8
Pages Range: 1041-1049
Journal Issue: 4
DOI: 10.1016/j.euo.2025.04.020
Abstract
BACKGROUND AND OBJECTIVE: A growing body of evidence suggests that the intensity of current follow-up in non-muscle-invasive bladder cancer (NMIBC) patients greatly exceeds clinical necessities. The UroFollow trial investigated the diagnostic accuracy of marker-based follow-up in patients with low/intermediate-risk NMIBC against the standard of care (SOC) for noninferiority (margin: <20%). METHODS: Patients with Ta low- and high-grade (G1-2) NMIBC were randomized to the SOC or 6-monthly marker-based follow-up (algorithm comprising urine markers and ultrasound; marker-based surveillance regimen [MA]). After a negative 3-mo cystoscopy (white light cystoscopy [WLC]), only patients with a positive algorithm underwent WLC in the MA. End-of-study WLC was recommended at 3 yr to recurrence-free patients. Simultaneously, several innovative urine markers were examined. KEY FINDINGS AND LIMITATIONS: In total, 214 patients were randomized to the SOC (n = 109) and MA (n = 105). The median follow-up was 2.4 yr; 30 and 29 cases of tumor recurrence were diagnosed in the SOC and MA arms, respectively. Sensitivity was 96.5% versus 81.5% (p = 0.1), with one and five Ta low-grade tumors being overlooked in the SOC and MA patients, respectively. No tumor progressing in stage or grade was missed. A total of 589 WLC procedures were performed in the SOC and 148 in the MA arm (p < 0.001). Among five other markers (ADX-Bladder, CellDetect, Bladder EpiCheck, UBC rapid, and Xpert bladder cancer monitor [BC-M]), Bladder EpiCheck and the Xpert BC-M showed similar performance to the algorithm. CONCLUSIONS AND CLINICAL IMPLICATIONS: UroFollow is the first urine marker-based randomized trial in low/intermediate-risk NMIBC patients. We conclude that 6-monthly marker-based follow-up after negative 3-mo WLC is safe in this cohort. Results of contemporary urine markers suggest that their potential for use in marker-based surveillance, however, requires prospective confirmation.
Authors with CRIS profile
Involved external institutions
St. Elisabeth Gruppe GmbH - Katholische Kliniken Rhein-Ruhr
Germany (DE)
Universität Rostock
Germany (DE)
Eberhard Karls Universität Tübingen
Germany (DE)
Hochschule Hannover (HsH) / University of Applied Sciences Hannover
Germany (DE)
IGES Institut
Germany (DE)
Germany (DE)
Universität Rostock
Germany (DE)
Eberhard Karls Universität Tübingen
Germany (DE)
Hochschule Hannover (HsH) / University of Applied Sciences Hannover
Germany (DE)
IGES Institut
Germany (DE)
How to cite
APA:
Schmitz-Dräger, B., Bismarck, E., Roghmann, F., von Landenberg, N., Noldus, J., Jahn, D.,... Benderska-Söder, N. (2025). Results of the Prospective Randomized UroFollow Trial Comparing Marker-guided Versus Cystoscopy-based Surveillance in Patients with Low/Intermediate-risk Bladder Cancer. European Urology Oncology, 8(4), 1041-1049. https://doi.org/10.1016/j.euo.2025.04.020
MLA:
Schmitz-Dräger, Bernd, et al. "Results of the Prospective Randomized UroFollow Trial Comparing Marker-guided Versus Cystoscopy-based Surveillance in Patients with Low/Intermediate-risk Bladder Cancer." European Urology Oncology 8.4 (2025): 1041-1049.
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