A Randomised Trial Investigating the Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC

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.

Inclusion criteria

• 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

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