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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Concurrently, the oligometastasis will be treated with stereotactic body radiotherapy or metastasectomy.
Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards immunotherapy will be initiated and regular follow up will be performed.
Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards regular follow up is performed.
Ghent University Hospital
Ghent, Belgium
RECRUITINGOverall survival
Defined as the time from diagnosis of MIBC to death from any cause
Time frame: 2 years
The number of patients with acute toxicity
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 months
The number of patients with late toxicity
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 5 years
Progression-free survival
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.
Time frame: 5 years
Distant metastasis-free survival
Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging.
Time frame: 5 years
Disease specific survival
Defined as time of diagnosis until death due to MIBC.
Time frame: 5 years
Patient reported quality of life as per EORTC-QLQ C30
Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients
Time frame: 5 years
Patient reported quality of life as per EORTC-QLQ BLM30
Validated questionnaire assessing the health-related QOL of muscle invasive bladder cancer patients
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Time frame: 5 years
Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases
Sensitivity/specificity of 18F-FDG-PET-CT
Time frame: 3 months
Validation of predictive biomarkers
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.
Time frame: 5 years