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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mpMRI plus a same-day cystoscopic bladder biopsy | Experimental | multiparametric MRI plus same-day cystoscopic bladder biopsy |
|
| TURBT | Active Comparator | Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mpMRI plus a same-day cystoscopic bladder biopsy | Diagnostic Test | mpMRI plus a same-day cystoscopic bladder biopsy |
|
| 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:
| 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A. G. van der Heijden, Dr. | Contact | +31 (0)24 361 37 35 | toine.vanderheijden@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| A. G. van der Heijden, Dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch ziekenhuis | Recruiting | 's-Hertogenbosch | Netherlands | |||
| Ziekenhuisgroep Twente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40819867 | Derived | 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. |
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Individual patient data are available upon request to other research groups
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TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
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| TURBT | Procedure | Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT |
|
| 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 |
| Circulating tumor cells | Percentage of patients with CTCs/CTC clusters in the blood sample post-TURBT, among those who were CTC-free pre-TURBT, analysed by blood withdrawal shortly before and after TURBT. | Before (at least on same day) and after (max. 60 minutes) TURBT |
| Metastatic potential of CTC-positive samples | Post-TURBT CTC-positive samples of patients that were CTC negative prior to TURBT will be further analyzed for the expression levels of bladder cancer metastasis-associated genes using principal component- and heatmap analysis. | Before (at least on same day) and after (max. 60 minutes) TURBT |
| Recruiting |
| Almelo |
| Netherlands |
| Meander MC | Not yet recruiting | Amersfoort | Netherlands |
| Amsterdam UMC, location AMC | Recruiting | Amsterdam | Netherlands |
| Amsterdam UMC, location VUmc | Recruiting | Amsterdam | Netherlands |
| Antoni van Leeuwenhoek - Netherlands Cancer Institute | Recruiting | Amsterdam | Netherlands |
| OLVG | Recruiting | Amsterdam | Netherlands |
| Rijnstate ziekenhuis | Recruiting | Arnhem | Netherlands |
| Maasziekenhuis Pantein | Recruiting | Boxmeer | Netherlands |
| Ziekenhuis Gelderse Vallei | Recruiting | Ede | Netherlands |
| Treant | Not yet recruiting | Emmen | Netherlands |
| Medisch Spectrum Twente | Not yet recruiting | Enschede | Netherlands |
| St. Antonius ziekenhuis | Recruiting | Nieuwegein | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Recruiting | Nijmegen | Netherlands |
| Radboud university medical center | Recruiting | Nijmegen | Netherlands |
| Erasmus Medical Center | Not yet recruiting | Rotterdam | Netherlands |
| Bernhoven ziekenhuis | Recruiting | Uden | Netherlands |
| University Medical Center Utrecht | Recruiting | Utrecht | Netherlands |
| VieCuri medisch centrum | Recruiting | Venlo | Netherlands |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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