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

Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial

Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.

Inclusion Criteria:

• Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment
• T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
• Age > 18 years
• WHO 0-2
• Willingness to undergo 18F-FDG-PET-CT
• Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively
• Willingness and ability to provide a signed informed consent according to ICH/GCP and national/local regulations

Exclusion Criteria:

• Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
• Refusal of or having contraindications to 18F-FDG-PET-CT
• Refusal of MDT or immunotherapy
• Prior radiotherapy unabling MDT
• Contraindications to radiotherapy (including active inflammatory bowel disease)
• Contraindications to immunotherapy
• Other primary tumor diagnosed < 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.