The outcome of patients with muscle-invasive bladder cancer (MIBC) is poor. 18F-FDG-PET-CT is superior to CT in detecting lymph nodes and distant metastases and the presence of extra-vesical disease is correlated with worse overall survival (OS). This supports the hypothesis that 18F-FDG-PET-CT is useful in stratifying MIBC patients and that adapting treatments accordingly improves outcomes.

EFFORT-MIBC is a multicentric prospective phase II trial aiming to include 156 patients. Eligible patients have histopathology-proven MIBC, without extra-pelvic metastases on conventional imaging. All patients undergo radical local therapy and if eligible neo-adjuvant chemotherapy. An 18F-FDG-PET-CT will be performed in addition to and at the timing of CT imaging.
In case of extra-pelvic metastasis on 18F-FDG-PET-CT, treatment-intensification with
metastasis-directed therapy (in case of ≤3 metastases) or systemic immunotherapy (> 3 metastases) will be
provided. The primary outcome is the 2-year OS.