NCT07724886

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
732

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet 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 Progress2%
Jul 2026Mar 2030

First Submitted

Initial submission to the registry

April 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

3.5 years

First QC Date

April 22, 2026

Last Update Submit

July 21, 2026

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of recurrence-free survival

    At Year 2

Secondary Outcomes (7)

  • Rate of progression-free survival

    At Year 2

  • Cancer-specific survival

    At Year 2

  • Overall survival

    At Year 2

  • Adverse Events

    On Day 30 after operation

  • Detrusor muscle sampling rate

    On Day 30 after operation

  • +2 more secondary outcomes

Study Arms (2)

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

Interventions

Conventional Transurethral Resection of Bladder TumourPROCEDURE

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.

Conventional Transurethral Resection of Bladder Tumour (cTURBT)
Transurethral En Bloc Resection of Bladder TumourPROCEDURE

This surgical technique resects the bladder tumour underneath the submucosal plane, and the bladder tumour can be removed in one piece.

Transurethral En Bloc Resection of Bladder Tumour (ERBT)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

North District Hospital

Sheung Shui, Hong Kong

Location

Related Publications (5)

  • 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.

    PMID: 37584691BACKGROUND

  • Teoh 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: 38692956BACKGROUND

  • Teoh 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: 32972792BACKGROUND

  • Yun 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: 15049581BACKGROUND

  • Gontero 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.

    PMID: 39155194BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yuen Chun Jeremy TEOH, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuen Chun Jeremy TEOH, MD

CONTACT

35053933jeremyteoh@surgery.cuhk.edu.hk

Yuen Chun Jeremy TEOH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are randomised to receive either transurethral ERBT or cTURBT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2026

First Posted

July 24, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

March 31, 2030

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)