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Intravesical instillation therapy with bacillus Calmette-Guérin (BCG) and sequential BCG and electromotive mitomycin-C (EMDA-MMC) in patients with high-risk non-muscle-invasive bladder carcinoma (FINNBLADDER 10)
EU CTIS ID: 2024-516320-33-00
What this study is testing
The objective of the study is to evaluate the efficacy of intravesical BCG monotherapy and sequential BCG/EMDA-MMC in the treatment of patients with high-risk BC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
- 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
You likely can't join if
- Ta low grade tumour(s)
- 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
See the full eligibility criteria
- Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
- 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
- Ta low grade tumour(s)
- 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
- Muscle invasive (pT≥2) tumors
- Urothelial cancer involving the prostatic urethra or upper urinary tract
- Non‐urothelial bladder cancer
- Prior BCG failure (If 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.