Follow-up recommendations for patients with nonmuscle invasive bladder cancer (NMIBC) are largely based upon expert opinion. A growing body of evidence suggests that current follow-up strategies for bladder cancer patients with low and intermediate risk represent overdiagnosis and may lead to overtreatment. The goal of this study is to explore the options of a noninvasive follow-up in patients with pTa G1-2/low-grade NMIBC.
The risks and options for a urine marker-guided, noninvasive follow-up of patients with pTa G1-2/low-grade NMIBC were defined and the study design for a prospective randomized trial (UroFollow) was developed based upon the current literature.
The investigators postulated that follow-up of patients with pTa G1-2/low-grade NMIBC requires a high sensitivity of urinary tumor markers. However, data from prospective studies with prediagnostic urine samples are scarce, even for approved markers, and cross-sectional studies with symptomatic patients overestimate the sensitivity. So far, cell-based markers (e.g., uCyt+ and UroVysion) in urine appeared to have higher sensitivities and specificities in low-grade NMIBC than urine cytology and markers analyzing soluble tumor-associated antigens. Marker panels are more sensitive than single-marker approaches at the expense of a lower specificity. Given a prospective randomized comparison with a marker sensitivity of 80% compared to usual care with cystoscopy, the sample size calculation yielded that 62 to 185 patients under study per arm are needed depending on different recurrence rates.
Based upon these findings the UroFollow trial has been designed as a prospective randomized study comparing a noninvasive marker-based (UroVysion, NMP22, urine cytology, and ultrasound) follow-up with the current standard of care over a period of 3 years.
Urologic oncology. 2020 Mar 18 [Epub ahead of print]
Natalya Benderska-Söder, Jan Hovanec, Beate Pesch, Peter J Goebell, Florian Roghmann, Joachim Noldus, Juri Rabinovich, Katharina Wichert, Jan Gleichenhagen, Heiko U Käfferlein, Christina U Köhler, Georg Johnen, Karoline Kernig, Oliver Hakenberg, Daniela Jahn, Tilman Todenhöfer, Arnulf Stenzl, Jochen Gleissner, Klaus Gerwert, Samir El-Mashtoly, Thomas Behrens, Thomas Brüning, Bernd J Schmitz-Dräger
Urologie 24, Nürnberg, Germany., Institute for Prevention and Occupational Medicine of the German Social Accidence Insurance, Institute of the Ruhr University Bochum (IPA), Bochum, Germany., Department of Urology, Friedrich-Alexander University, Erlangen, Germany., Department of Urology, Marienhospital Herne, Ruhr University Bochum, Bochum, Germany., Department of Urology, University of Rostock, Rostock, Germany., Department of Urology, Eberhard-Karls-University of Tübingen, Tübingen, Germany., Die Gesundheitsunion, Wuppertal, Germany., Ruhr University Bochum, Faculty of Biology and Biotechnology, Department of Biophysics, Bochum, Germany; Ruhr University Bochum, Center for Protein Diagnostics (ProDi), Biospectroscopy, Bochum, Germany., Urologie 24, Nürnberg, Germany; Department of Urology, Friedrich-Alexander University, Erlangen, Germany. Electronic address: .