What this Trial Is About

Researchers are evaluating how using 18F-FDG-PET-CT scans affects the staging and treatment planning for patients with muscle-invasive bladder cancer. This Phase II prospective trial aims to improve overall survival by categorizing patients into non-metastatic, oligometastatic, and polymetastatic groups based on two 18F-FDG-PET-CT scans, then adapting treatment accordingly. Patients receive standard care which includes either radical cystectomy with pelvic lymph node dissection or a trimodality therapy consisting of complete transurethral resection of the bladder tumor (TURb) followed by radiochemotherapy. Those with oligometastatic disease receive additional metastasis-directed therapy (MDT) such as stereotactic body radiotherapy or metastasectomy, while patients with polymetastatic disease receive immunotherapy after the standard care treatment. Regular follow-up visits are conducted after treatment to monitor patient progress. Participants undergo staging scans, including thoracic CT and abdominopelvic CT or MRI, and two 18F-FDG-PET-CT scans for risk stratification. The study tracks overall survival over two years as the primary outcome. Patients must provide informed consent and are monitored for treatment adherence and safety throughout the trial period.

Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer