Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03664869

Sponsor: Turku University Hospital

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
• Carcinoma in situ with or without a papillary tumour(s)
• Ta tumour(s) of high-grade
• Any T1 tumour(s)
• Written informed consent is required from every eligible patient
• Second resection performed in case of T1 tumour
• Adequate physical and mental condition to participate in the study (as judged by treating physician

Exclusion Criteria:

• Ta low grade tumour(s)
• Muscle invasive (pT≥2) tumors
• Urothelial cancer involving the prostatic urethra or upper urinary tract
• Non-urothelial bladder cancer.
• Prior BCG failure (If the patient has previously been successfully treated with BCG, and duration from the last instillation is >12 months, participation may be considered, if bladder preserving is chosen)
• Prior or concurrent immunotherapy
• Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)
• Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)
• Known allergy to MMC or BCG
• Age < 18 years
• Pregnancy or lactating patient
• Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
• Cardiac pacemaker
• Expected survival time less than one year
• Expected poor compliance

View trial on ClinicalTrials.gov