A study to find the best treatment for early bladder cancer (BRAVO)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Open

Phase:

Pilot

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).

More about this trial

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 immune system Open a glossary item 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.

Who can enter

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.

  • You have recently been diagnosed with early stage bladder cancer that has not grown into the muscle wall (stage Tis, Ta or T1)
  • Your cancer has a high risk of coming back - you might be able to part if your bladder cancer was low grade and has now changed to high grade
  • You have a type of bladder cancer called urothelial cancer (also known as transitional cell cancer or TCC)
  • You are suitable to have surgery to remove the bladder or BCG treatment into the bladder
  • You have had surgery to remove the tumours from your bladder (a trans urethral resection of bladder tumours or TURBT) in the last 3 months and this confirmed the cancer had not grown into the muscle wall
  • You have had a CT scan of the tummy and area between the hip bones (pelvis) in the last year
  • You have had scans or x –rays of the chest in the 3 months before joining the study
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment if there is any chance that you or your partner could become pregnant
  • You are at least 18 years old

As well as the above, one or more of the following must also apply.

  • You have very early cancer (Tis) in the part of the tube nearest to the prostate that carries urine outside the body (the urethra)
  • There are cancer cells in the blood vessels Open a glossary item
  • There are cancer cells on the lymph vessels Open a glossary item
  • After initial surgery to remove the tumours from the bladder lining, your doctors find you still have high grade cancer after they check your bladder
  • You had more than 3 tumours in your bladder when you had your first surgery to remove them
  • The initial tumours measured more than 3cm across
  • You are under 65 years of age

 You cannot join this study if any of these apply. You

  • Have had high risk bladder cancer or cancer that has grown into the muscle wall (invasive bladder cancer) in the past
  • Have already had BCG treatment into the bladder
  • Have had radiotherapy to the area between your pelvis (hipbones) in the past
  • Have had any other cancer in the past apart from non melanoma skin cancer Open a glossary item prostate or bladder cancer that has a low risk of coming back
  • Are pregnant or breastfeeding

Trial design

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.

  • One group have surgery
  • The other group have BCG treatment into the bladder (immunotherapy)

Neither you nor your doctor will be able to decide which group you are in.

BRAVO Study Diagram

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 urethra Open a glossary item. The treatment is left in the bladder for 1 hour. You then pass urine naturally to get rid of the treatment.

You have:

  • treatment once a week for 6 weeks
  • no treatment for 6 weeks followed by a test to check the inside of your bladder (a cystoscopy)
  • treatment once a week for 3 weeks

You have further treatments into the bladder at:

  • 6 months
  • 1 year

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.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

  • a physical examination
  • blood tests
  • a CT scan or x-ray of your chest

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:

  • 6 weeks
  • 3 months
  • 6 months
  • 1 year

If you are having treatment into the bladder you have regular tests to check the inside of the bladder and a check up at:

  • 3 months
  • 6 months
  • 1 year

Everyone will have a CT scan 1 year after joining the study.

Side effects

The most common side effects of BCG into the bladder are:

  • pain or burning when passing urine
  • having to pass urine more frequently
  • urine infections

The possible side effects of surgery to remove the bladder are:

  • a short delay before the bowels start to work properly
  • needing blood transfusions
  • infections

We have information about:

Location

Bradford
Hull
Leeds
Sheffield

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor James Catto

Supported by

Yorkshire Cancer Research - YCR
Clinical Trials Research Unit (CRTU)
Sheffield Teaching Hospitals NHS Foundation Trust
University of Leeds

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14414

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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