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

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Results

Phase:

Phase 3

This study looked at the possibility of doing a larger trial to compare different ways of treating high risk bladder cancer. High risk bladder cancer is more likely to:

  • come back after treatment or
  • spread further 

The trial was for people whose cancer hadn’t grown into the muscle wall of the bladder. This is called non muscle invasive bladder cancer

It was open for people to join between 2016 and 2018. The team published the results in 2020.

More about this trial

When this trial was done, the usual treatments for high risk non muscle invasive bladder cancer were:

Surgery to remove the bladder is a big operation but it is a safe treatment and works well. Doctors weren’t sure if surgery or BCG worked best in the long term. 

BCG is a vaccine. It seems to help cells of the immune system Open a glossary item to grow and become very active in the bladder lining. These cells probably kill off any cancer cells that might grow back or have been left behind. This is called immunotherapy.

At the time of this trial, some research suggested surgery might be over treatment for some people. So researchers wanted to find out more about the best way to treat this type of cancer. First, they needed to find out if it was possible to do this type of study. To find this out they ran a feasibility study.

The main aim of this study was to see if people were willing to take part.

Summary of results

The team found that it wouldn’t be possible to run a larger trial comparing the treatments. This was because it was difficult to find enough people to take part in this study.

Study design
The team screened 407 people who they thought might be suitable to take part. Of those, 215 people fitted the entry conditions Open a glossary item and the team asked 185 to join. 

51 people were consented Open a glossary item and 50 agreed to be randomised Open a glossary item

Of those, 43 people had their trial treatment:

  • 20 had surgery to remove the bladder
  • 23 had BCG into the bladder

Those who had BCG had it for up to 1 year as long as it was working and the side effects weren’t too bad. 

The team followed the people who took part for up to a year. Those who had BCG had regular tests to look inside the bladder (cystoscopies Open a glossary item). Everyone also had regular scans to check if the cancer had spread. 

Results

Why people didn’t join the study
The team looked at why some people, who had been asked to take part didn’t want to. They gave the following reasons:

  • 77 people preferred to have BCG
  • 39 people preferred to have surgery to remove the bladder
  • 27 people didn’t want to be put into a randomised group
  • 8 people were worried about joining a trial
  • 3 people didn’t say why 

Results for the BCG group
23 people had BCG into the bladder. 

After the first 6 weeks of treatment everyone had a cystoscopy to look inside the bladder. The team:

  • found 4 people had cancer in the lining of the bladder (non muscle invasive bladder cancer)
  • found 18 people had no sign of cancer 
  • didn’t have the results for 1 person

At 4 months they had the results for 16 people. They found:

  • 3 people had cancer in the lining of the bladder (non muscle invasive cancer)
  • 13 people had no sign of cancer 

At 4 months follow up, 4 people went on to have surgery to remove the bladder. 

Everyone had regular CT scans during the trial. At the end of the trial they found that 2 people had bladder cancer that had spread elsewhere in the body. 

Results for people who had surgery
20 people had surgery to remove the bladder. At 12 month follow up, information was available for 9 people and of these 9, everyone was free of cancer. 

Quality of life
The research team asked people taking part to fill out a quality of life questionnaire before, during and after treatment. 

The results showed that there wasn’t much of a change in quality of life for people in either group at 12 months.

For those who had surgery, quality of life went down for a few months afterwards. It then began to improve. At 6 to 12 months it was back to about the same level as before surgery. 

There was little change in quality of life in those who had BCG treatment into the bladder. 

Side effects
The team looked at the side effects of treatment. They say most of them were mild.

  • 15 out of 23 people in the BCG group had at least one side effect
  • 13 out of 20 people in the surgery group had at least one side effect 

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

  • tiredness
  • muscle pain
  • pain or burning when passing urine
  • passing urine frequently 

The most common side effects after surgery included:

  • chest and wound infections
  • a short delay before the bowels started to work properly
  • sepsis Open a glossary item
  • constipation 

Conclusion
The research team concluded that it wouldn’t be possible to run a larger trial comparing these treatments. 

This study wasn’t designed to work out which treatment worked best. The team say some people are best suited to have surgery and others to have BCG treatment. 

The researchers suggest their findings are used to tell people about the risks of each treatment. The researchers hope these findings will help doctors decide the best treatment for each person based on their individual risk. 

All trial results help doctors and researchers understand more about different cancers and the best way to treat them.

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

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

If you have questions about the trial please contact our cancer 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.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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