"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A study looking at using rectal balloons in radiotherapy for prostate cancer (BRAD)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at rectal balloons to see if they can help to stop the prostate gland moving and the rectum changing size or shape during radiotherapy.
During treatment, you may also have cone beam scans to make sure the radiotherapy is being accurately aimed at the cancer. A cone beam scan is similar to a CT scan but uses lower energy X-rays.
But your prostate gland moves position slightly on a daily basis. For this reason, the area treated with radiotherapy is slightly larger than the prostate gland. This ensures that the prostate is fully treated, even if it moves a little.
The size and shape of your back passage (your
Radiotherapy to the rectum can cause side effects such as diarrhoea and pain in the rectum.
It may be possible to control the size of the rectum during treatment using a device known as a rectal balloon. This may reduce the amount of radiation the rectum receives, which may reduce some of the side effects men can have after radiotherapy for prostate cancer.
In this study, the researchers want to see if it is possible to use rectal balloons in a small number of men. They want to see if the men find the procedure acceptable and whether the balloon does reduce both the movement of the prostate gland and any changes to the rectum.
The men taking part in this study will not have radiotherapy while the balloon is in place. They will have their radiotherapy as normal so are very unlikely to have any direct benefit from taking part. But results from this study may help to improve radiotherapy for prostate cancer in the future.
Who can enter
You may be able to join this study if all of the following apply. You
- Have been diagnosed with prostate cancer and are going to have radiotherapy with the aim of curing your cancer
- Are having your treatment at the Christie NHS Foundation Trust
- Are well enough to be up and about for at least half the day (performance status 0,1 or 2)
- Are at least 18 years old
You cannot join this study if any of these apply. You
- Have had surgery in the past that involved your back passage (your rectum) or the opening at the end of your back passage (your anus)
- Have any medical condition affecting your rectum or anus, such as piles (haemorrhoids) bleeding, irritation or inflammatory bowel disease
- Have any other serious medical condition or mental health problem that the study team think could affect your taking part
- Have had radiotherapy to area between your hip bones (your
This is a feasibility study. The researchers need 10 men to take part.
You have a CT scan as part of your radiotherapy planning. This takes about 10 minutes. If you are taking part in the study, a rectal balloon will then be put into your back passage (your rectum) and the CT scan will be repeated. The balloon is then removed. Having the balloon put in and the extra CT scan takes about 10 minutes.
As part of your radiotherapy, you have a cone beam scan when you have your first 3 treatments. If there are no differences between the scans, you then have them once a week for the rest of your treatment. If you are taking part in the study, you have a rectal balloon put into your back passage before having another cone beam scan. After the scan, the balloon is removed. Having the extra scan with the balloon in place takes about 10 minutes.
The research team will ask you to fill out a questionnaire once a week. This will ask how you found the procedure.
Taking part in this study does not involve extra hospital visits. But you will have 1 extra CT scan and extra cone beam scans.
The rectal balloon may feel uncomfortable. There is a very small risk of injury to your back passage. But all staff involved have been fully trained in this procedure to reduce the risk of injury.
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.
Experimental Cancer Medicine Centre (ECMC)
The Christie NHS Foundation Trust