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Study on the Effectiveness and Safety of Mitomycin C with Electric Current for Treating Non-Muscle Invasive Bladder Cancer in Patients, Compared to Standard Immunotherapy

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying the treatment of non-muscle invasive bladder cancer (NMIBC), a type of bladder cancer that has not spread into the muscle layer of the bladder. The study is comparing two treatments: a supportive treatment using mitomycin C administered with the help of an electric current, known as EMDA-MMC, and the standard treatment using BCG immunotherapy. The purpose of the study is to evaluate how effective and safe these treatments are in managing NMIBC.

Participants in the study will receive either the EMDA-MMC treatment or the standard BCG treatment. Both treatments involve an initial phase of six weekly sessions, followed by a maintenance phase lasting one year. The study also aims to assess the effectiveness of a urinary biomarker called MCM5 ADXBLADDER in detecting the recurrence of tumors. This biomarker will be compared to traditional methods like urinary cytology and cystoscopy, which are procedures used to examine the bladder and detect cancer cells.

The trial will monitor participants over time to see how well the treatments work in preventing the return of cancer and to check for any side effects. The study will also look at how these treatments impact the quality of life of the participants. The findings from this study could help improve the management of high-grade NMIBC and provide insights into more effective ways to detect tumor recurrence.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The initial treatment phase involves the administration of mitomycin through a method called intravesical use. This means the medication is delivered directly into the bladder.
During this phase, the treatment consists of six weekly instillations. Each instillation involves placing the medication into the bladder, where it remains for a specified period before being removed.
Step 2
Maintenance treatment phase
Following the initial treatment phase, a maintenance treatment phase is conducted over the course of one year.
This phase is designed to help prevent the recurrence of cancer by continuing the administration of mitomycin at regular intervals.
Step 3
Comparison with standard treatment
The trial compares the efficacy of the mitomycin treatment with the standard treatment using BCG (Bacillus Calmette-Guérin), which is also administered through six weekly instillations followed by one year of maintenance.
The goal is to determine which treatment is more effective in preventing cancer recurrence.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to detect any recurrence of cancer.
A urinary biomarker called MCM5 ADXBLADDER is used to help detect tumor recurrence. This biomarker is compared with standard methods such as urinary cytology and cystoscopy.
Step 5
Evaluation of outcomes
The primary outcomes being evaluated include disease-free survival and the detection rate of tumor recurrence using the biomarker.
Secondary outcomes include the rate of tumor recurrence, progression, and the impact of treatment on quality of life.

Who can join the trial?

7 criteria

Patients must be older than 18 years and have a life expectancy of at least 5 years.
Patients must be able to give informed consent, meaning they understand the study and agree to participate.
Patients must have a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC), which does not grow into the muscle layer of the bladder. It can be in one or more places in the bladder and be at stages Ta or T1, which are specific stages of cancer growth. The cancer must be classified as High Grade, which means it is more likely to grow and spread.
Patients must have been treated with a procedure called TUR (Transurethral Resection), which is a surgery to remove the tumor from the bladder. If needed, a follow-up procedure called RE-RTU should be done within the first 6 weeks.
Patients must have negative results for Tcis in random bladder biopsies. Tcis refers to a specific type of cancer cell that should not be present.
The presence of the patient's own muscle must be confirmed in the TUR or RE-RTU samples.
A RE-RTU procedure is required for all cases of T1 stage tumors and for Ta stage tumors if the initial TUR was incomplete or if there was no muscle in the sample.

Who cannot join the trial?

3 criteria

Patients with medical conditions other than non-muscle invasive bladder cancer cannot participate. This type of cancer affects the bladder but does not invade the muscle layer.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, such as children or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacio Puigvert
Verified
Barcelona, Spain
Fundacion Instituto Valenciano De Oncologia
Verified
Valencia, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

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Investigated drugs

EMDA-MMC
is a treatment that combines a medical device with a drug. It is used as an additional therapy to help prevent the return of bladder cancer. This treatment involves applying the drug directly to the bladder using a special device, which helps the medication work more effectively. The treatment is given once a week for six weeks, followed by maintenance therapy for one year.
BCG
is a standard treatment for bladder cancer. It involves placing a liquid containing weakened bacteria directly into the bladder. This treatment helps the body's immune system fight cancer cells. It is also given once a week for six weeks, followed by maintenance therapy for one year.

Mitomycin

What is already known about the treatment

Mitomycin C (MMC) – This medication is administered directly into the bladder through a catheter, a method known as intravesical therapy. It is currently used in the treatment of non-muscle invasive bladder cancer, particularly as an adjuvant therapy. Mitomycin C works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading. It is classified as an antineoplastic antibiotic, which means it is used to stop the growth of cancer cells.

Investigated diseases

Non-muscle invasive bladder cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not spread into the muscle layer. It often presents with symptoms such as blood in the urine or frequent urination. The disease can progress by growing into larger tumors or spreading to other parts of the bladder lining. It is typically classified into different grades based on how abnormal the cancer cells look under a microscope. High-grade tumors are more likely to grow quickly and spread compared to low-grade tumors. Regular monitoring is essential to detect any changes in the condition.