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

Bladder Cancer Clinical Trial

— BladParadigm  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779631
• Other study ID #: 2022-15859
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: December 2028

Study information

• Verified date: January 2024
• Source: Radboud University Medical Center
• Contact: A. G. van der Heijden, Dr.
• Phone: +31 (0)24 361 37 35
• Email: toine.vanderheijden[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2028
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• mpMRI plus a same-day cystoscopic bladder biopsy
mpMRI plus a same-day cystoscopic bladder biopsy

Procedure:
• TURBT
Transurethral resection of the bladder tumor

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Amsterdam UMC, location AMC	Amsterdam
Netherlands	Amsterdam UMC, location VUmc	Amsterdam
Netherlands	Antoni van Leeuwenhoek - Netherlands Cancer Institute	Amsterdam
Netherlands	Maasziekenhuis Pantein	Boxmeer
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

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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