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

Not Applicable

Recruiting

• Conditions: Bladder Cancer
• Interventions: Procedure: TURBT; Diagnostic Test: mpMRI plus a same-day cystoscopic bladder biopsy

• Registration Number: NCT05779631
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Study Start: 2023-12-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-07
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TURBT	TURBT	Transurethral resection of the bladder tumor
mpMRI plus a same-day cystoscopic bladder biopsy	mpMRI plus a same-day cystoscopic bladder biopsy	multiparametric MRI plus same-day cystoscopic bladder biopsy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (15)

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands

Amsterdam UMC, location VUmc; 🇳🇱 Amsterdam, Netherlands

Antoni van Leeuwenhoek - Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands

Rijnstate ziekenhuis; 🇳🇱 Arnhem, Netherlands

Maasziekenhuis Pantein; 🇳🇱 Boxmeer, Netherlands

Jeroen Bosch ziekenhuis; 🇳🇱 Den Bosch, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

St. Antonius ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Bernhoven ziekenhuis; 🇳🇱 Uden, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands

VieCuri medisch centrum; 🇳🇱 Venlo, Netherlands