NCT05779631

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
62mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Dec 2023Jun 2031

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

March 9, 2023

Last Update Submit

January 5, 2026

Conditions

Bladder CancerMuscle-invasive Bladder Cancer

Keywords

mpMRI + same-day biopsyTURBT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Time to definitive treatment

    2 years

  • Health-related quality of life

    2 years

  • Hospital-related healthcare costs

    2 years

  • Cost-effectiveness

    2 years

  • Circulating tumor cells

    Before (at least on same day) and after (max. 60 minutes) TURBT

  • +1 more secondary outcomes

Study Arms (2)

mpMRI plus a same-day cystoscopic bladder biopsy

EXPERIMENTAL

multiparametric MRI plus same-day cystoscopic bladder biopsy

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

TURBT

ACTIVE COMPARATOR

Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT

Procedure: TURBT

Interventions

mpMRI plus a same-day cystoscopic bladder biopsyDIAGNOSTIC_TEST

mpMRI plus a same-day cystoscopic bladder biopsy

mpMRI plus a same-day cystoscopic bladder biopsy
TURBTPROCEDURE

Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT

TURBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (18+ years of age)
  • Clinically suspected MIBC
  • No lymph node or distant metastases
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Jeroen Bosch ziekenhuis

's-Hertogenbosch, Netherlands

RECRUITING

Ziekenhuisgroep Twente

Almelo, Netherlands

RECRUITING

Meander MC

Amersfoort, Netherlands

NOT YET RECRUITING

Amsterdam UMC, location AMC

Amsterdam, Netherlands

RECRUITING

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

RECRUITING

Antoni van Leeuwenhoek - Netherlands Cancer Institute

Amsterdam, Netherlands

RECRUITING

OLVG

Amsterdam, Netherlands

RECRUITING

Rijnstate ziekenhuis

Arnhem, Netherlands

RECRUITING

Maasziekenhuis Pantein

Boxmeer, Netherlands

RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Netherlands

RECRUITING

Treant

Emmen, Netherlands

NOT YET RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

NOT YET RECRUITING

St. Antonius ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

Radboud university medical center

Nijmegen, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

NOT YET RECRUITING

Bernhoven ziekenhuis

Uden, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

VieCuri medisch centrum

Venlo, Netherlands

RECRUITING

Related Publications (1)

  • van Koeverden SW, van Hoogstraten LM, de Rooij M, van der Leest M, Grutters JP; BladParadigm study group; Kiemeney LA, van der Heijden AG. Multiparametric MRI for local staging in patients with suspected muscle-invasive bladder cancer: study protocol for a multicentre, non-inferiority randomised controlled trial (the BladParadigm study). BMJ Open. 2025 Aug 16;15(8):e100002. doi: 10.1136/bmjopen-2025-100002.

    PMID: 40819867DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • A. G. van der Heijden, Dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

A. G. van der Heijden, Dr.

CONTACT

+31 (0)24 361 37 35toine.vanderheijden@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

December 6, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2031

Last Updated

January 8, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual patient data are available upon request to other research groups

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

NL(19)