Clinical trial · Interventional
Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC
A Randomised Trial Investigating the Role of Transurethral En Bloc Resection of Bladder Tumour Plus Intravesical Bacillus Calmette-Guerin Therapy, in Patients With Intermediate-Risk or High-Risk Non-Muscle-Invasive Bladder Cancer
NCT07724886CI-TRIAL-00120239not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, multi-centre randomised trial comparing between cTURBT plus 1-year BCG therapy, and ERBT plus 1-year BCG therapy, in patients with intermediate-risk or high-risk NMIBC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Transurethral Resection of Bladder Tumour | Procedure | — | UNRESOLVED |
| Transurethral En Bloc Resection of Bladder Tumour | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Transurethral Resection of Bladder Tumour (cTURBT)
- interventionNames
- Procedure: Conventional Transurethral Resection of Bladder Tumour
- type
- EXPERIMENTAL
- label
- Transurethral En Bloc Resection of Bladder Tumour (ERBT)
- interventionNames
- Procedure: Transurethral En Bloc Resection of Bladder Tumour
Primary outcomes (1)
- measure
- Rate of recurrence-free survival
- timeFrame
- At Year 2
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or above * Fulfil any one of the following three criteria: 1. Recurrent bladder tumour 2. Multiple bladder tumours 3. Any bladder tumour size of \>1cm Exclusion Criteria: * EAU low-risk NIMBC as intravesical BCG therapy should not be offered (5) * EAU very high-risk NMIBC as upfront radical cystectomy should be offered (5) * Any prior use of intravesical BCG therapy * Presence or prior history of upper urinary tract malignancy * Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) (16) * Presence of GOLD Stage III or IV chronic obstructive pulmonary disease * ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities) (18) * History of bleeding disorder or use of anti-coagulants * Pregnancy * Presence of other active malignancy
References
Publications (5)
- BACKGROUNDTeoh JY, D'Andrea D, Gallioli A, Yanagisawa T, MacLennan S, Nicoletti R, Fai NC, Maffei D, Hurle R, Lusuardi L, Malavaud B, Miki J, Kramer M, Mostafid H, Enikeev D, Babjuk M, Breda A, Shariat S, Gontero P, Herrmann T. En bloc resection of bladder tumour: the rebirth of past through reminiscence. World J Urol. 2023 Oct;41(10):2599-2606. doi: 10.1007/s00345-023-04547-0. Epub 2023 Aug 16. PMID 37584691
- BACKGROUNDTeoh JY, Cheng CH, Tsang CF, Kai-Man Li J, Kwun-Chung Cheng B, Hoi-Chak Chan W, Kwun-Wai Chan W, Churk-Fai Li T, Chiu Y, Law MC, Lok-Hei Leung C, Sze-Ho Ho B, Yue-Kit Lee C, Cheong-Kin Chan R, Shu-Yin Chan E, Chan MT, Hok-Leung Tsu J, Tam HM, Lam KM, So HS, Cho CL, Ng CM, Chan CK, Liu PL, Wing-Hong Chu R, Tsui-Lin Ng A, Chu SK, Yee CH, Yiu MK, Lo KL, Au WH, Ma WK, Ka-Fung Chiu P, Sze-Wan Kwok H, Yip SY, Leung CH, Ng CF; EB-StaR Study Group. Transurethral En Bloc Resection Versus Standard Resection of Bladder Tumour: A Randomised, Multicentre, Phase 3 Trial. Eur Urol. 2024 Aug;86(2):103-111. doi: 10.1016/j.eururo.2024.04.015. Epub 2024 Apr 30. PMID 38692956
- BACKGROUNDTeoh JY, Huang J, Ko WY, Lok V, Choi P, Ng CF, Sengupta S, Mostafid H, Kamat AM, Black PC, Shariat S, Babjuk M, Wong MC. Global Trends of Bladder Cancer Incidence and Mortality, and Their Associations with Tobacco Use and Gross Domestic Product Per Capita. Eur Urol. 2020 Dec;78(6):893-906. doi: 10.1016/j.eururo.2020.09.006. Epub 2020 Sep 21. PMID 32972792
- BACKGROUNDYun EJ, Meng MV, Carroll PR. Evaluation of the patient with hematuria. Med Clin North Am. 2004 Mar;88(2):329-43. doi: 10.1016/S0025-7125(03)00172-X. PMID 15049581
- BACKGROUNDGontero P, Birtle A, Capoun O, Comperat E, Dominguez-Escrig JL, Liedberg F, Mariappan P, Masson-Lecomte A, Mostafid HA, Pradere B, Rai BP, van Rhijn BWG, Seisen T, Shariat SF, Soria F, Soukup V, Wood R, Xylinas EN. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ)-A Summary of the 2024 Guidelines Update. Eur Urol. 2024 Dec;86(6):531-549. doi: 10.1016/j.eururo.2024.07.027. Epub 2024 Aug 17.