Bladder Cancer, Muscle-invasive Bladder Cancer
Conditions
Keywords
mpMRI + same-day biopsy, TURBT
Brief summary
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.
Interventions
DIAGNOSTIC_TESTmpMRI plus a same-day cystoscopic bladder biopsy
mpMRI plus a same-day cystoscopic bladder biopsy
PROCEDURETURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (18+ years of age) * Clinically suspected MIBC * No lymph node or distant metastases * Written informed consent
Exclusion criteria
* Unable or unwilling to undergo mpMRI * Unfit for TURBT * Unfit for definitive treatment with curative intent * A history of cancer, including bladder cancer, except: non-melanoma skin cancer, prostate cancer on active surveillance or a solid malignant tumor ≥5 years disease-free since last treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to definitive treatment | 2 years | 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. |
| Health-related quality of life | 2 years | 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. |
| Hospital-related healthcare costs | 2 years | 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. |
| Cost-effectiveness | 2 years | 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). |
| Circulating tumor cells | Before (at least on same day) and after (max. 60 minutes) TURBT | 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. |
| Metastatic potential of CTC-positive samples | Before (at least on same day) and after (max. 60 minutes) TURBT | 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. |
Countries
Netherlands
Contacts
Primary ContactA. G. van der Heijden, Dr.
Outcome results
None listed