ERBT With One Year of BCG vs Standard TURBT With One Year of BCG for Intermediate- or High-Risk NMIBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-centre randomized trial in bladder cancer patients at intermediate or high risk. Participants are assigned 1:1 to either conventional transurethral resection of bladder tumor (TURBT) or en bloc resection of bladder tumor (ERBT), followed by one year of intravesical BCG therapy and standard follow-up. A single intravesical dose of mitomycin C is given per guidelines unless contraindicated by prior recurrences or risk scores. Surveillance includes periodic cystoscopy and pathology review, with routine second-look TURBT if indicated, and potential biopsy or TURBT for suspicious recurrences. The primary outcome is recurrence-free survival at 2 years.

Why it matters

Who can join: the full rules

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

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting
• North District Hospital
  Sheung Shui, Hong Kong Not yet recruiting

Study contacts

• Principal investigator: Yuen Chun Jeremy TEOH, MD — Chinese University of Hong Kong
• Study coordinator: Yuen Chun Jeremy TEOH, MD
• Email: jeremyteoh@surgery.cuhk.edu.hk
• Phone: 35053933

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.