A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
360
mpMRI plus a same-day cystoscopic bladder biopsy
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
RECRUITINGZiekenhuisgroep Twente
Progression free survival
Progression-free survival, defined as the time between randomisation and one of the following events, whichever occurs first: * Diagnosis of distant metastases * Diagnosis of loco-regional nodal recurrence * Death from any cause
Time frame: 2 years
Time to definitive treatment
Definitive treatment is defined as TURBT in case of NMIBC and radical cystectomy with or without neoadjuvant chemotherapy or chemoradiotherapy in case of MIBC. Time to definitive treatment is the time between randomisation and the first of these mentioned treatments.
Time frame: 2 years
Health-related quality of life
Generic health-related quality of life will be assessed at baseline, 6 months, 12 months and 24 months using the EuroQol 5 dimensions 5 levels (EuroQol 5D) questionnaire.
Time frame: 2 years
Hospital-related healthcare costs
Hospital registries will be used to identify all items / procedures / activities related to the management of the bladder cancer and obtain a valid and reliable estimate of the costs. Unit costs will be based on the Dutch manual for costing studies.
Time frame: 2 years
Cost-effectiveness
Unit costs will be based on the Dutch manual for costing studies. Effectiveness will be measured in terms of quality-adjusted life years (QALYs), following the Dutch guideline for economic evaluation (EuroQol 5D).
Time frame: 2 years
Circulating tumor cells
Percentage of patients with CTCs/CTC clusters in the blood sample post-TURBT, among those who were CTC-free pre-TURBT, analysed by blood withdrawal shortly before and after TURBT.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Almelo, Netherlands
Meander MC
Amersfoort, Netherlands
NOT_YET_RECRUITINGAmsterdam UMC, location AMC
Amsterdam, Netherlands
RECRUITINGAmsterdam UMC, location VUmc
Amsterdam, Netherlands
RECRUITINGAntoni van Leeuwenhoek - Netherlands Cancer Institute
Amsterdam, Netherlands
RECRUITINGOLVG
Amsterdam, Netherlands
RECRUITINGRijnstate ziekenhuis
Arnhem, Netherlands
RECRUITINGMaasziekenhuis Pantein
Boxmeer, Netherlands
RECRUITINGZiekenhuis Gelderse Vallei
Ede, Netherlands
RECRUITING...and 9 more locations
Time frame: Before (at least on same day) and after (max. 60 minutes) TURBT
Metastatic potential of CTC-positive samples
Post-TURBT CTC-positive samples of patients that were CTC negative prior to TURBT will be further analyzed for the expression levels of bladder cancer metastasis-associated genes using principal component- and heatmap analysis.
Time frame: Before (at least on same day) and after (max. 60 minutes) TURBT