
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at treatment into the bladder or surgery for bladder cancer that has a high risk of coming back. It is for people whose cancer has not grown further than the inside lining of the bladder (early bladder cancer).
Having surgery to remove the bladder (a radical cystectomy) or treatment into the bladder with the BCG vaccine are the usual treatments for high risk early bladder cancer.
Removing the bladder completely is a major operation but it is a safe treatment and works well. Although some research suggests it might be over treatment for some people.
Doctors think that BCG treatment into the bladder works as a type of immunotherapy. It encourages cells of the to grow and become very active in the lining of the bladder. These cells of the immune system probably kill off any cancer cells that might grow back or have been left behind in the bladder lining.
Doctors aren’t sure which treatment works best in the long term and they want to find out more.
But first they need to find out if it is possible to do the study. To find this out they will do a feasibility study.
The main aim of this study is to find out how willing patients are to take part.
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You might be able to join this study if all of the following apply.
As well as the above, one or more of the following must also apply.
You cannot join this study if any of these apply. You
This pilot (feasibility) study is based in the Yorkshire and Newcastle. The researchers need 60 people to take part.
It is a randomised study. You are put into 1 of 2 groups.
Neither you nor your doctor will be able to decide which group you are in.
Having surgery to remove the bladder is a major operation. You will have this at a specialist cancer centre. The operation takes between 3 to 6 hours to do. Your study doctor can tell you more about this.
To have treatment into the bladder you have a tube (catheter) put into your bladder through the . The treatment is left in the bladder for 1 hour. You then pass urine naturally to get rid of the treatment.
You have:
You have further treatments into the bladder at:
You might continue to have treatment for up to 3 years if it is helping you.
Quality of life
The study team ask everyone taking part to complete some questionnaires before treatment starts and then every 3 months during the study. These are called quality of life questionnaires. The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
A small number of people will be invited to take part in a short interview about their experiences of taking part in the study.
You see a doctor and have some tests before you can take part. These include:
You have treatment at the hospital. You shouldn’t have any extra visits as a result of taking part in the study.
If you’re having surgery, you stay in hospital for about 2 weeks. You see the doctor for a routine check ups at:
If you are having treatment into the bladder you have regular tests to check the inside of the bladder and a check up at:
Everyone will have a CT scan 1 year after joining the study.
The most common side effects of BCG into the bladder are:
The possible side effects of surgery to remove the bladder are:
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor James Catto
Yorkshire Cancer Research - YCR
Clinical Trials Research Unit (CRTU)
Sheffield Teaching Hospitals NHS Foundation Trust
University of Leeds
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.