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: Bladder Cancer
Eligibility Criteria
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
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.