Recruiting

Study comparing BCG and combination of BCG with electromotive mitomycin-C treatment in patients with high-risk non-muscle-invasive bladder cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with high-risk non-muscle-invasive bladder cancer, a type of cancer that affects the inner lining of the bladder without spreading to the muscle layer. The study compares two treatment approaches that are administered directly into the bladder through a catheter. The first treatment uses BCG (bacillus Calmette-Guérin) therapy alone, while the second approach combines BCG with electromotive mitomycin-C (EMDA-MMC).

The purpose of this research is to evaluate how well these treatments work in preventing the cancer from returning or getting worse. BCG is a type of bacteria that helps stimulate the immune system to fight cancer cells, while mitomycin-C is a chemotherapy drug that directly kills cancer cells. Both medications are given as a solution that is placed into the bladder.

The treatment period lasts up to 12 months, during which participants receive either BCG alone or BCG followed by electromotive mitomycin-C treatments. The maximum dose of BCG is 3000 million colony forming units per treatment, while the maximum dose of mitomycin-C is 40 milligrams per treatment. Throughout the study, doctors monitor participants to check if the cancer returns or progresses.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive intravesical therapy (medication delivered directly into the bladder) as part of your treatment for non-muscle-invasive bladder cancer.
The treatment will involve one of two approaches: either BCG therapy alone or BCG combined with mitomycin-C (MMC) using an electric current method called EMDA.
Step 2
Treatment administration
A healthcare professional will insert the medication directly into your bladder through a thin tube.
The medication will be either BCG suspension (a type of bacteria that helps fight cancer cells) or mitomycin solution (a cancer-fighting drug).
Each treatment session will require you to hold the medication in your bladder for a specified time before emptying.
Step 3
Monitoring phase
Your doctor will regularly check for any signs of cancer return through examinations and tissue samples.
These checks will look for two main things: cancer recurrence (return of cancer) and progression (cancer becoming more serious).
The monitoring will continue throughout the study period, which runs until November 2025.
Step 4
Follow-up assessments
Regular bladder examinations will be performed to check your response to treatment.
If needed, tissue samples will be taken to confirm the presence or absence of cancer cells.
Your doctor will track any changes in your condition throughout the treatment period.

Who can join the trial?

7 criteria

Patient must have a confirmed non-muscle-invasive bladder tumor (cancer that has not spread to the muscle layer of the bladder) through tissue examination
Patient must provide written informed consent (a signed document indicating understanding and agreement to participate in the study)
For patients with T1 tumors (cancer that has grown into the connective tissue layer), a second surgical removal of tissue must be performed
Patient must be in suitable physical and mental health to participate in the study, as determined by the treating doctor
Patient can be either male or female
Patient must be an adult (18 years or older)
Patient must not be from a vulnerable population (such as persons unable to give consent)

Who cannot join the trial?

13 criteria

Age below 18 years or above 65 years
Previous or current diagnosis of muscle-invasive bladder cancer (cancer that has grown into the muscle layer of the bladder)
Current urinary tract infection (infection in any part of the urinary system)
History of allergic reactions to BCG (Bacillus Calmette-Guérin) or MMC (Mitomycin C) treatments
Presence of active tuberculosis
Severely weakened immune system
Current pregnancy or breastfeeding
Severe bleeding disorders
Active or untreated urinary tract abnormalities
Major surgery within the last 3 months
Participation in other clinical trials within the last 30 days
Inability to follow study procedures or attend follow-up visits
Serious medical conditions that could interfere with study treatment

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Verified sites

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Verified
Turku University Hospital
Turku, Finland

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Investigated drugs

Bacillus Calmette-Guérin (BCG) is a type of bacteria used as an immunotherapy treatment. It's administered directly into the bladder to stimulate the immune system to fight bladder cancer cells. This treatment helps prevent the cancer from returning or progressing. Mitomycin-C is a chemotherapy medication that is administered directly into the bladder. When combined with electromotive drug administration (EMDA), which uses a mild electric current to help the medication penetrate the bladder wall more effectively, it helps to destroy cancer cells and prevent them from growing back. The combination therapy uses both BCG and Mitomycin-C in sequence, meaning they are given one after the other during the treatment course, to potentially provide better cancer control than using either treatment alone.

Mitomycin

What is already known about the treatment

BCG (Bacillus Calmette-Guérin)
A live attenuated vaccine administered directly into the bladder through intravesical instillation for treating non-muscle-invasive bladder cancer. This immunotherapy medication stimulates the body's immune system to fight cancer cells by triggering an inflammatory response in the bladder lining. It is considered a first-line treatment for high-risk bladder cancer patients after tumor removal, with extensive clinical evidence supporting its effectiveness in preventing cancer recurrence.
Mitomycin-C
An anticancer antibiotic medication delivered into the bladder through electromotive drug administration (EMDA), which uses an electric current to enhance drug absorption. This chemotherapy agent works by interfering with DNA synthesis in cancer cells, preventing them from multiplying and ultimately leading to their death. It is commonly used in combination therapy protocols for non-muscle-invasive bladder cancer, particularly when enhanced drug delivery is desired through electromotive administration.

Investigated diseases

Bladder Cancer - A disease that begins when cells in the bladder start to grow out of control. The bladder is a hollow organ in the lower pelvis that stores urine. Most bladder cancers start in the cells that line the inside of the bladder. The cancer typically begins in the inner layer of the bladder wall and can grow deeper into the bladder tissue over time. Bladder cancer can develop from the transitional epithelium, which is the tissue lining the bladder. As the cancer cells multiply, they can form a tumor and spread through the bladder wall to surrounding areas.