Phase II Study of 18F-FDG-PET-CT for Risk Assessment and Personalized Treatment in Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating how 18F-FDG-PET-CT scans affect the staging and treatment plans for patients with muscle invasive bladder cancer MIBC. This phase II trial aims to improve overall survival by using these scans to classify patients into non-metastatic, oligometastatic, or polymetastatic groups and adapting treatment based on this risk stratification. The study is sponsored by University Hospital, Ghent and focuses on adults with confirmed MIBC. Participants receive standard care involving either radical cystectomy with pelvic lymph node removal or a combination of tumor resection and radiochemotherapy. Depending on the PET-CT results, patients with oligometastatic disease may receive metastasis directed therapy like targeted radiotherapy or surgery, while those with polymetastatic disease may be given immunotherapy after standard treatment. Patients without extra-pelvic metastasis continue with standard care and follow-up. The study does not use randomization or blinding. During the study, patients undergo two 18F-FDG-PET-CT scans to assess metastasis, alongside conventional imaging. Researchers monitor various outcomes including overall survival at two years, toxicity at three months and five years, progression-free survival, and quality of life over five years using questionnaires. Additional assessments include biomarker validation and measuring the accuracy of PET-CT in detecting metastases. Participants are followed closely with regular check-ups and monitoring throughout the study period ending in May 2030.

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