Bladder CancerNCT07724886
Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC
A study testing Conventional Transurethral Resection of Bladder Tumour and Transurethral En Bloc Resection of Bladder Tumour in people with Bladder Cancer, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Conventional Transurethral Resection of Bladder Tumour and Transurethral En Bloc Resection of Bladder Tumour
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 2 sitesHong Kong
- Study dates
- 19 Oct 2026to 31 Mar 2030
- 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
- Age 18 years or above
- Fulfil any one of the following three criteria:
- Recurrent bladder tumour
- Multiple bladder tumours
- Any bladder tumour size of >1cm
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yuen Chun Jeremy TEOH contact
Hong Kong2 sites, 2 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Jeremy Yuen-Chun TEOH, MBBS, FRCS(Ed), MD, 35052625, jeremyteoh@surgery.cuhk.edu.hk
- Not yet recruiting
North District Hospital
Sheung Shui
Jeremy Yuen Chun TEOH, MBBS, FRCSEd, MD, jeremyteoh@surgery.cuhk.edu.hk
About this study
Official title: 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
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.
Read the detailed description
All patients who are diagnosed to have bladder tumour(s) upon flexible cystoscopy will be screened for study eligibility. Imaging will be arranged to rule out any upper urinary tract malignancy. Patients are randomised to receive either transurethral ERBT or cTURBT with an allocation ratio of 1:1. A single dose of intravesical mitomycin C will be instilled according to the EAU guidelines, i.e. in all patients except those with a prior recurrence rate of more than one recurrence per year, or those with an EORTC recurrence score of ≥5. All patients will be followed up at our outpatient clinic and the pathology results will be reviewed. Routine second-look TURBT will be arranged within 2-6 weeks after the first operation should there be any indications as stated in the EAU guidelines. For patients in the intermediate or high-risk groups, 1-year of intravesical BCG therapy will be offered. Surveillance flexible cystoscopy will be performed at a 3-month interval until 2 years after the index surgery, and then every 6 months for another 3 years. Biopsy will be taken and TURBT will be offered if there is any suspicious tumour recurrence noted during surveillance cystoscopy.Primary outcome is recurrence-free survival at 2 years.
- Conditions
- Bladder Cancer
- Being tested
- Conventional Transurethral Resection of Bladder Tumour, Transurethral En Bloc Resection of Bladder Tumour
- 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.
Conventional Transurethral Resection of Bladder TumourProcedure or surgery
Conventional TURBT is performed by resecting the bladder tumour in a piecemeal manner with a top-down approach. The bladder tumour specimen is fragmented during the procedure and whether a complete resection has been achieved is determined by the operating surgeon's judgment intra-operatively.
Transurethral En Bloc Resection of Bladder TumourProcedure or surgery
This surgical technique resects the bladder tumour underneath the submucosal plane, and the bladder tumour can be removed in one piece.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Transurethral Resection of Bladder Tumour (cTURBT) | Active comparator | Not described Receives: Procedure: Conventional Transurethral Resection of Bladder Tumour |
| Transurethral En Bloc Resection of Bladder Tumour (ERBT) | Experimental | Not described Receives: Procedure: Transurethral En Bloc Resection of Bladder Tumour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence-free survival
Measured: At Year 2
Secondary outcomes (7)
Rate of progression-free survival
Measured: At Year 2
Cancer-specific survival
Measured: At Year 2
Overall survival
Measured: At Year 2
Adverse Events
By CTCAE V5.0
Measured: On Day 30 after operation
Detrusor muscle sampling rate
Measured: On Day 30 after operation
Day of hospital stay
Measured: On Day 30 after operation
Total operation time
Measured: On Day 30 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start19 Oct 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomised to receive either transurethral ERBT or cTURBT
- Masking
- None (open label)
- Enrolment
- 732 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Yuen Chun TEOH, Chinese University of Hong Kong
- Investigators
- Yuen Chun Jeremy TEOH, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724886
- Sponsor's protocol ID
- CRE 2025.055
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teoh 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.
PubMed 37584691Teoh 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.
PubMed 38692956Teoh 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.
PubMed 32972792Yun 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.
PubMed 15049581Gontero 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.
PubMed 39155194
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07724886
- Acronym / sponsor ID
- CRE 2025.055
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 732 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 24 Jul 2026 (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.
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.
Detailed description
All patients who are diagnosed to have bladder tumour(s) upon flexible cystoscopy will be screened for study eligibility. Imaging will be arranged to rule out any upper urinary tract malignancy. Patients are randomised to receive either transurethral ERBT or cTURBT with an allocation ratio of 1:1. A single dose of intravesical mitomycin C will be instilled according to the EAU guidelines, i.e. in all patients except those with a prior recurrence rate of more than one recurrence per year, or those with an EORTC recurrence score of ≥5. All patients will be followed up at our outpatient clinic and the pathology results will be reviewed. Routine second-look TURBT will be arranged within 2-6 weeks after the first operation should there be any indications as stated in the EAU guidelines. For patients in the intermediate or high-risk groups, 1-year of intravesical BCG therapy will be offered. Surveillance flexible cystoscopy will be performed at a 3-month interval until 2 years after the index surgery, and then every 6 months for another 3 years. Biopsy will be taken and TURBT will be offered if there is any suspicious tumour recurrence noted during surveillance cystoscopy.Primary outcome is recurrence-free survival at 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomised to receive either transurethral ERBT or cTURBT
| Arm | Type | Receives |
|---|---|---|
| Conventional Transurethral Resection of Bladder Tumour (cTURBT) | Active comparator | Procedure: Conventional Transurethral Resection of Bladder Tumour |
| Transurethral En Bloc Resection of Bladder Tumour (ERBT) | Experimental | Procedure: Transurethral En Bloc Resection of Bladder Tumour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or above
- Fulfil any one of the following three criteria:
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Conventional Transurethral Resection of Bladder TumourConventional TURBT is performed by resecting the bladder tumour in a piecemeal manner with a top-down approach. The bladder tumour specimen is fragmented during the procedure and whether a complete resection has been achieved is determined by the operating surgeon's judgment intra-operatively. | Procedure or surgery | Conventional Transurethral Resection of Bladder Tumour (cTURBT) |
| Transurethral En Bloc Resection of Bladder TumourThis surgical technique resects the bladder tumour underneath the submucosal plane, and the bladder tumour can be removed in one piece. | Procedure or surgery | Transurethral En Bloc Resection of Bladder Tumour (ERBT) |
Primary outcome
Rate of recurrence-free survival
Time frame: At Year 2
7 secondary outcomes
Rate of progression-free survival
Time frame: At Year 2
Cancer-specific survival
Time frame: At Year 2
Overall survival
Time frame: At Year 2
Adverse Events
Time frame: On Day 30 after operation
Detrusor muscle sampling rate
Time frame: On Day 30 after operation
Day of hospital stay
Time frame: On Day 30 after operation
Total operation time
Time frame: On Day 30 after operation
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 27 Oct 2026.
- Background: PubMed 37584691Teoh 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.
- Background: PubMed 38692956Teoh 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.
- Background: PubMed 32972792Teoh 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.
- Background: PubMed 15049581Yun 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.
- Background: PubMed 39155194Gontero 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.
- Individual participant dataSharing planned: No
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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.
Yuen Chun Jeremy TEOH contact
Yuen Chun Jeremy TEOH, MD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Transurethral Resection of Bladder Tumour and Transurethral En Bloc Resection of Bladder Tumour in people with Bladder Cancer, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 5 inclusion and 10 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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 Yuen Chun Jeremy TEOH, MD (35053933, jeremyteoh@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence-free survival (time frame: At Year 2). 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 NCT07724886, which also lists 5 linked publications.
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 27 Oct 2026.