Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer

• Status: Recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Disease recurrence and progression is a major issue in high risk non-muscle-invasive bladder cancer (NMIBC).

The current study compares two adjuvant instillation therapies in the treatment of high risk NMIBC. After resection of the tumour(s), patients will receive either traditional regimen of Bacillus Calmette-Guérin (BCG) instillations or combination treatment consisting of sequential BCG-instillations and mitomycin C instillations administered with electromotive drug administration (EMDA) device.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Collaborator: Finnbladder
• Treatments: BCG Vaccine; Mitomycin; Mitomycins

Criteria

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