Using electromotive drug administration with mitomycin C to prevent bladder cancer recurrence
Intravesical Instillation Therapy With Bacillus Calmette-Guérin (BCG) and Sequential BCG and Electromotive Mitomycin-C (EMDA-MCC) in Patients With High-risk Non-muscle-invasive Bladder Carcinoma
PHASE3 · Turku University Hospital · NCT03664869
This study is testing if using a combination of a standard bladder cancer treatment and a special drug delivery method can help prevent bladder cancer from coming back in patients at high risk.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Turku University Hospital (other gov) |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 7 sites (Helsinki and 6 other locations) |
| Trial ID | NCT03664869 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two adjuvant therapies for high-risk non-muscle-invasive bladder cancer (NMIBC) after tumor resection. Participants will receive either the standard Bacillus Calmette-Guérin (BCG) instillations or a combination of BCG and mitomycin C administered via an electromotive drug administration (EMDA) device. The goal is to evaluate the effectiveness of this combination treatment in reducing the risk of cancer recurrence and progression. The study aims to provide insights into the potential benefits of combining these therapies for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with high-grade Ta tumors or T1 tumors confined to the bladder who have not previously failed BCG treatment.
Not a fit: Patients with low-grade tumors, muscle-invasive tumors, or those with contraindications to BCG or mitomycin C will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence rates of high-risk bladder cancer, improving patient survival and quality of life.
How similar studies have performed: Previous studies have shown varying success with BCG and mitomycin C combinations, but this specific approach using EMDA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki and 6 other locations
- HYKS Peijas Hospital — Helsinki, Finland (RECRUITING)
- Jyväskylä Central Hospital — Jyväskylä, Finland (RECRUITING)
- Päijät-Häme Central hospital — Lahti, Finland (RECRUITING)
- Mikkeli Central Hospital — Mikkeli, Finland (RECRUITING)
- Seinäjoki Central Hospital — Seinäjoki, Finland (RECRUITING)
- Tampere University Hospital — Tampere, Finland (RECRUITING)
- Turku University Hospital — Turku, Finland (RECRUITING)
Study contacts
- Study coordinator: Pertti T Nurminen, MD
- Email: pertti.nurminen@tyks.fi
- Phone: +358 2 3135922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Cancer, bladder cancer, recurrence, BCG, mitomycin C, electromotive drug administration