A trial looking for the best way to make sure your bladder is the same size during each radiotherapy treatment for prostate cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 2

This trial is comparing a new set of instructions with those used at the moment about how to fill your bladder before external radiotherapy for prostate cancer.

More about this trial

If you have prostate cancer that has not spread beyond your prostate, you will usually have radiotherapy to treat it. The prostate is a small gland about the size of a walnut. It surrounds the first part of the tube that carries urine from the bladder to the penis (the urethra).

Because it is so close to the bladder, the prostate’s position can vary from day to day, depending on how much urine is in your bladder. But it is important that your prostate is in the same position for each radiotherapy treatment you have. Having the same amount of fluid in your bladder for each treatment will help this.

Before you have treatment your radiographer may ask you to fill your bladder by drinking some water. Researchers in this trial are comparing a new set of instructions with those staff already use. They want to see if the new guidelines can better help the bladder to be the same size before each treatment.

Sometimes, men have bladder irritation caused by prostate radiotherapy. The amount of urine in the bladder may be linked to this side effect. So researchers will also collect urine samples to see if there are any features (biomarkers) in the urine that could be used to predict who may have this side effect. The main aims of this trial are to

See if a new set of fluid guidelines helps to make the bladder the same size before each radiotherapy session
Assess side effects of men having radiotherapy, and see if biomarkers in the urine could help with this

Who can enter

You may be able to enter this trial if you are being cared for by doctors at the Northern Ireland Cancer Centre in Belfast. To enter the trial you must also

Have prostate cancer
Have cancer that has not spread to another part of your body (stage 1, 2 or 3 prostate cancer)
Be due to have a type of radiotherapy called intensity modulated radiotherapy (IMRT) that aims to cure your cancer rather than control symptoms
Be able to follow instructions on how to fill your bladder before radiotherapy
Be able to complete a series of questionnaires for the trial
Be at least 18 years old

You cannot enter this trial if you

Are having radiotherapy in combination with surgery (adjuvant radiotherapy) or radiotherapy to treat prostate cancer that has come back after earlier treatment (salvage radiotherapy)
Have a plastic tube to drain urine from your bladder (catheter)
Have small harmless pouches in your bladder wall which stop your bladder emptying properly - you can ask your doctor about this
Are taking medication to treat an overactive bladder or symptoms of an enlarged prostate
Are having moderate to severe bladder problems because of your prostate cancer (international prostate symptom score of more than 15)
Pass urine before you reach the toilet (incontinence), or you have any other problems related to passing urine that would stop you being able to follow the instruction sheets for filling your bladder
Have any other condition that could affect the results of the trial - you can ask your doctor about this

Trial design

This trial will recruit 101 men. It is randomised. Everyone taking part will be put into one of 2 groups by a computer. Neither you nor your doctor can decide which group you are in. Each group will be given a set of instructions on how to fill their bladder before radiotherapy.

The first time you follow these instructions will be when you come for your radiotherapy planning.

The instructions will start by telling you how to squirt a small amount of liquid into your back passage (an enema) to clear your bowels. After 10 to 15 minutes, you try to empty your bowels if you can, and pass urine to empty your bladder.

If you are in group 1, you then drink 500ml (about 4 cups) of water 45 minutes before your radiotherapy, which is what happens normally. If you are in group 2 you drink 250 ml (about 2 cups) of water 45 minutes before your radiotherapy.

You then have an ultrasound scan of your bladder, and a CT scan to plan your radiotherapy.

Once a week before radiotherapy you have an ultrasound to measure how full your bladder is.

You will also give blood and urine samples throughout the trial. And, fill out short questionnaires asking about any problems you may have passing urine.