Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm

Study Overview
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Brief Summary
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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.

Official Title
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Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)

Conditions
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Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: mpMRI plus a same-day cystoscopic bladder biopsy
* Procedure: TURBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (18+ years of age) with clinically suspected MIBC, without 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 or prostate cancer on active surveillance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mpMRI plus a same-day cystoscopic bladder biopsy<br>multiparametric MRI plus same-day cystoscopic bladder biopsy | Diagnostic Test: mpMRI plus a same-day cystoscopic bladder biopsy<br>* mpMRI plus a same-day cystoscopic bladder biopsy<br>|
| Active Comparator: TURBT<br>Transurethral resection of the bladder tumor | Procedure: TURBT<br>* Transurethral resection of the bladder tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mpMRI + same-day biopsy, TURBT