Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Interventions
- Radiation: Metastasis directed therapy (MDT)Drug: ImmunotherapyProcedure: Standard of care
- Registration Number
- NCT04724928
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oligo-metastatic MIBC on 18F-FDG-PET-CT Metastasis directed therapy (MDT) No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's Poly-metastatic MIBC on 18F-FDG-PET-CT Immunotherapy No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of \> 3 metastasis on 1 or both 18F FDG PET-CT 's Non-metastatic MIBC Standard of care No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's
- Primary Outcome Measures
Name Time Method Overall survival 2 years Defined as the time from diagnosis of MIBC to death from any cause
- Secondary Outcome Measures
Name Time Method Patient reported quality of life as per EORTC-QLQ C30 5 years Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients
Distant metastasis-free survival 5 years Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging.
Disease specific survival 5 years Defined as time of diagnosis until death due to MIBC.
Validation of predictive biomarkers 5 years A biopsy specimen of the bladder, obtained after transurethral resection of the bladder (TURb),as well as urine and blood samples will be collected for validation of predictive biomarkers by evaluating the correlation between response to therapy and outcome (PFS, DMFS, DSS and OS) with in literature reported biomarkers determined on biopsy specimen of the bladder, obtained after TURb.
Patient reported quality of life as per EORTC-QLQ BLM30 5 years Validated questionnaire assessing the health-related QOL of muscle invasive bladder cancer patients
The number of patients with late toxicity 5 years Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Progression-free survival 5 years Defined as appearance of local/locoregional recurrence diagnosed at CT-scan or cystoscopy in case of TMT or appearance of metastasis diagnosed at MIBC or non-MIBC-related imaging.
The number of patients with acute toxicity 3 months Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases 3 months Sensitivity/specificity of 18F-FDG-PET-CT
Trial Locations
- Locations (1)
Ghent University Hospital
🇧🇪Ghent, Belgium