Bladder CancerBladParadigmNCT05779631
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm
A study testing mpMRI plus a same-day cystoscopic bladder biopsy and TURBT in people with Bladder Cancer and Muscle-invasive Bladder Cancer, run by Radboud University Medical Center at 19 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Muscle-invasive Bladder Cancer
- What is being tested?
- mpMRI plus a same-day cystoscopic bladder biopsy and TURBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 19 sitesNetherlands
- Study dates
- 6 Dec 2023to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18+ years of age)
- Clinically suspected MIBC
- No lymph node or distant metastases
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Netherlands19 sites, 19 recruiting
- Recruiting
Jeroen Bosch ziekenhuis
's-Hertogenbosch
- Recruiting
Ziekenhuisgroep Twente
Almelo
- Not yet recruiting
Meander MC
Amersfoort
- Recruiting
Amsterdam UMC, location AMC
Amsterdam
- Recruiting
Amsterdam UMC, location VUmc
Amsterdam
- Recruiting
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Amsterdam
- Recruiting
OLVG
Amsterdam
- Recruiting
Rijnstate ziekenhuis
Arnhem
- Recruiting
Maasziekenhuis Pantein
Boxmeer
- Recruiting
Ziekenhuis Gelderse Vallei
Ede
- Not yet recruiting
Treant
Emmen
- Not yet recruiting
Medisch Spectrum Twente
Enschede
- Recruiting
St. Antonius ziekenhuis
Nieuwegein
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
- Recruiting
Radboud university medical center
Nijmegen
- Not yet recruiting
Erasmus Medical Center
Rotterdam
- Recruiting
Bernhoven ziekenhuis
Uden
- Recruiting
University Medical Center Utrecht
Utrecht
- Recruiting
VieCuri medisch centrum
Venlo
About this study
Official title: Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
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.
- Conditions
- Bladder Cancer, Muscle-invasive Bladder Cancer
- Being tested
- mpMRI plus a same-day cystoscopic bladder biopsy, TURBT
- Keywords
- mpMRI + same-day biopsy, TURBT
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRI plus a same-day cystoscopic bladder biopsyDiagnostic test
mpMRI plus a same-day cystoscopic bladder biopsy
TURBTProcedure or surgery
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
| Study group | Role | What they receive |
|---|---|---|
| mpMRI plus a same-day cystoscopic bladder biopsy | Experimental | multiparametric MRI plus same-day cystoscopic bladder biopsy Receives: 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 Receives: Procedure: TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 2 years
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Before (at least on same day) and after (max. 60 minutes) TURBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start6 Dec 2023
- Primary completionDec 2028 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. G. van der Heijden, Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779631
- Sponsor's protocol ID
- 2022-15859
- Acronym
- BladParadigm
- Status last verified
- Dec 2025
- First submitted
- 9 Mar 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data are available upon request to other research groups
Publications
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.
PubMed 40819867
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
- ClinicalTrials.gov ID
- NCT05779631
- Acronym / sponsor ID
- BladParadigm / 2022-15859
- Conditions
- Bladder Cancer, Muscle-invasive Bladder Cancer
- Keywords
- mpMRI + same-day biopsy, TURBT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
| Arm | Type | Receives |
|---|---|---|
| mpMRI plus a same-day cystoscopic bladder biopsy | Experimental | Diagnostic Test: mpMRI plus a same-day cystoscopic bladder biopsymultiparametric MRI plus same-day cystoscopic bladder biopsy |
| TURBT | Active comparator | Procedure: TURBTTransurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients (18+ years of age)
- Clinically suspected MIBC
- No lymph node or distant metastases
- Written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mpMRI plus a same-day cystoscopic bladder biopsympMRI plus a same-day cystoscopic bladder biopsy | Diagnostic test | mpMRI plus a same-day cystoscopic bladder biopsy |
| TURBTTransurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT | Procedure or surgery | TURBT |
Primary outcome
Progression free survival
Time frame: 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
6 secondary outcomes
Time to definitive treatment
Time frame: 2 years
Health-related quality of life
Time frame: 2 years
Hospital-related healthcare costs
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
Circulating tumor cells
Time frame: Before (at least on same day) and after (max. 60 minutes) TURBT
Metastatic potential of CTC-positive samples
Time frame: Before (at least on same day) and after (max. 60 minutes) TURBT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 40819867van 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.
- Individual participant dataSharing planned: Yes. Individual patient data are available upon request to other research groups
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingObservational study
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma
Active, not recruitingPhase 3
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
Metastatic Bladder Urothelial Carcinoma, Metastatic Urothelial Carcinoma
RecruitingPhase 2
A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
Muscle-invasive Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A. G. van der Heijden, Dr. principal investigator
Radboud University Medical Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mpMRI plus a same-day cystoscopic bladder biopsy and TURBT in people with Bladder Cancer and Muscle-invasive Bladder Cancer, run by Radboud University Medical Center at 19 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A. G. van der Heijden, Dr. (+31 (0)24 361 37 35, toine.vanderheijden@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.