Active not recruitingPHASE3INTERVENTIONAL

BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer

This study is investigating a new way to treat bladder cancer that is high-risk but hasn't grown into the bladder muscle. After keyhole surgery to remove the cancer, people sometimes receive a treatment called BCG, which is put directly into the bladder. While BCG helps reduce the cancer coming back, it can still return in over 30% of patients. Researchers believe that adding another medicine called Mitomycin to the BCG treatment might improve these results. This study aims to confirm if this combined approach, using both Mitomycin and BCG, is more effective at preventing the cancer from returning than BCG alone. They are doing a large-scale study to get clear answers.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Nottingham University Hospitals NHS Trust

Enrolment target

500

Start

10 Dec 2020

Estimated completion

01 Dec 2026

Transitional Cell Carcinoma Transurethral Resection

What is this study about?

This study is about a type of bladder cancer that, while serious, has not yet spread deeply into the bladder muscle. This is often called 'non-muscle-invasive bladder cancer'. After finding and removing this cancer with an operation, doctors try to stop it from coming back. One common treatment involves putting a liquid medicine called BCG into your bladder.

While BCG is good at reducing the chances of the cancer returning, it doesn't work for everyone, and the cancer can still come back in many people. Researchers have been looking for ways to make this treatment even better. They have some early evidence suggesting that if you add another medicine called Mitomycin to the BCG treatment, it might be more successful at keeping the cancer away.

This study, called a 'Phase 3' trial, is a crucial step. It's a large, carefully organised study designed to get a clear answer: does combining BCG and Mitomycin work better than BCG alone for this type of bladder cancer? The aim is to find out if this combination can significantly reduce the risk of the cancer coming back for more people.

Key takeaways

Targets high-risk bladder cancer that hasn't spread into the muscle.
Combines two existing treatments, BCG and Mitomycin, put directly into the bladder.
Aims to see if the combination works better than BCG alone to stop cancer from returning.
It's a large, important study (Phase 3) to get clear answers.
Participation involves treatments into the bladder, regular check-ups, and questionnaires.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with a high-risk type of bladder cancer that has not spread into the muscle. This diagnosis needs to be confirmed by looking at tissue samples under a microscope. Importantly, your doctor must feel that all visible cancer has been removed from your bladder before you can join.

You should be generally well enough to take part, as assessed by your doctor, and have healthy organ function (like your kidneys and liver). The study treatment needs to be able to start within four weeks of agreeing to join. You can't have had certain other bladder treatments before, including previous rounds of BCG or Mitomycin, and you shouldn't have had cancer that has spread to the bladder muscle or to the upper urinary tract.

There are also some health conditions that would prevent you from taking part, such as certain immune system problems, active tuberculosis, or if you've had radiation treatment to your pelvis before. You also shouldn't have severe bladder problems that would make it difficult to receive the treatment directly into your bladder.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with high-risk, non-muscle-invasive bladder cancer?
Has your doctor removed all visible cancer from your bladder recently?
Have you had certain other bladder treatments (like previous BCG or Mitomycin) in the past?
Do you have any serious immune system problems or active infections?
Are you able to receive medication directly into your bladder without severe discomfort?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form. You'll have some blood tests to check your general health. You will then receive treatment directly into your bladder, which involves both BCG and Mitomycin. The study will explain exactly how often and for how long these medicines will be given.

You will have regular check-ups with your medical team, which will likely include looking inside your bladder (a procedure called a cystoscopy) to check for any signs of the cancer returning. You might also be asked to fill in questionnaires about your quality of life. The doctors will monitor you closely over a period of time to see how well the treatment is working and to keep an eye on any side effects. The total duration of your participation, including treatment and follow-up, will be clearly explained by your study team.

Potential risks and benefits

By taking part, you might benefit from a treatment that could be more effective at stopping your bladder cancer from coming back. However, there's no guarantee the treatment will work for you, and it might not be better than standard care. Like all medical treatments, there can be risks and side effects from the medicines used, such as irritation or infections in your bladder, or flu-like symptoms. These will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Nottingham University Hospitals
Verified postcode
Nottingham, United Kingdom

Common questions

What type of bladder cancer is this study for?

This study is for a high-risk type of bladder cancer that has not yet grown into the muscle of the bladder wall.

What is 'intravesical administration'?

This means the medicine is put directly into your bladder through a small tube, rather than taken by mouth or injected.

Are the treatments, BCG and Mitomycin, new drugs?

No, both BCG and Mitomycin are established treatments that are already used for bladder cancer. This study is looking at using them together.

What is a 'Phase 3' study?

A Phase 3 study is a large study designed to find out if a new treatment, or a new combination of existing treatments, is better than the current standard treatment.

Will I know if I'm getting both treatments or just one?

This is a 'randomised' study, meaning you would likely be put into either the group receiving both treatments or the group receiving only BCG by chance. This allows doctors to compare the two approaches fairly, so you probably won't know which one you are getting.