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

Primary Purpose

Bladder Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
mpMRI plus a same-day cystoscopic bladder biopsy
TURBT
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring mpMRI + same-day biopsy, TURBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuisgroep Twente
  • Amsterdam UMC, location AMC
  • Amsterdam UMC, location VUmc
  • Antoni van Leeuwenhoek - Netherlands Cancer Institute
  • Maasziekenhuis Pantein
  • Ziekenhuis Gelderse Vallei
  • St. Antonius ziekenhuis
  • Canisius Wilhelmina Ziekenhuis
  • Radboud university medical center
  • Erasmus Medical Center
  • Bernhoven ziekenhuis
  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mpMRI plus a same-day cystoscopic bladder biopsy

TURBT

Arm Description

multiparametric MRI plus same-day cystoscopic bladder biopsy

Transurethral resection of the bladder tumor

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
March 9, 2023
Last Updated
April 5, 2023
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05779631
Brief Title
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm
Acronym
BladParadigm
Official Title
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
mpMRI + same-day biopsy, TURBT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mpMRI plus a same-day cystoscopic bladder biopsy
Arm Type
Experimental
Arm Description
multiparametric MRI plus same-day cystoscopic bladder biopsy
Arm Title
TURBT
Arm Type
Active Comparator
Arm Description
Transurethral resection of the bladder tumor
Intervention Type
Diagnostic Test
Intervention Name(s)
mpMRI plus a same-day cystoscopic bladder biopsy
Intervention Description
mpMRI plus a same-day cystoscopic bladder biopsy
Intervention Type
Procedure
Intervention Name(s)
TURBT
Intervention Description
Transurethral resection of the bladder tumor
Primary Outcome Measure Information:
Title
Progression free survival
Description
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
Secondary Outcome Measure Information:
Title
Time to definitive treatment
Description
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
Title
Health-related quality of life
Description
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
Title
Hospital-related healthcare costs
Description
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
Title
Cost-effectiveness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
A. G. van der Heijden, Dr.
Phone
+31 (0)24 361 37 35
Email
toine.vanderheijden@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. G. van der Heijden, Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuisgroep Twente
City
Almelo
Country
Netherlands
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
Country
Netherlands
Facility Name
Amsterdam UMC, location VUmc
City
Amsterdam
Country
Netherlands
Facility Name
Antoni van Leeuwenhoek - Netherlands Cancer Institute
City
Amsterdam
Country
Netherlands
Facility Name
Maasziekenhuis Pantein
City
Boxmeer
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
St. Antonius ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands
Facility Name
Radboud university medical center
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Bernhoven ziekenhuis
City
Uden
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual patient data are available upon request to other research groups

Learn more about this trial

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

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