A trial looking at helping men manage urinary problems after radiotherapy 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 3

This trial is looking at teaching men how to manage urinary problems after having radiotherapy for prostate cancer.

Doctors often treat prostate cancer with radiotherapy. After radiotherapy some men may have ongoing urinary problems, for example

Wanting to pass urine frequently
Needing to pass urine urgently
Needing to urinate more at night
Pain or difficulty passing urine
Leaking urine (incontinence)

For some men these problems can be upsetting and affect their quality of life. If necessary they can take medications to help. But these medications have side effects and are not suitable for everyone.

The aim of this trial is to find out if teaching men certain exercises and skills can help them manage their urinary problems better after radiotherapy.

Who can enter

You can enter this trial if you are attending the Royal Surrey County Hospital, Basingstoke Hospital, Frimley Park Hospital or East Surrey Hospital and

Have localised prostate cancer (stage T1 – T3b)
Have completed external beam radiotherapy in the last 3 to 4 months or have had brachytherapy at least 6 months ago or have had external radiotherapy followed by brachytherapy at least 6 months ago
Had hormone treatment before radiotherapy
Have moderate to severe urinary problems - your doctor can advise about this

You cannot enter this trial if you

Have prostate cancer that has spread to the lymph nodes
Have a urine infection
Have or have had memory problems
Have been referred to a specialist for a mental or emotional condition that could affect you taking part in this trial

Trial design

This is a phase 3 trial. It will recruit 96 men who have had external beam radiotherapy and are attending the Royal Surrey County Hospital, Frimley Park Hospital and East Surrey Hospital.

It is a randomised trial. You will be put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in. Whichever group you are in you will be involved in the trial for 6 months.

If you are in group 1 you continue to see your doctor as usual. On 3 occasions you will be asked to fill in questionnaires at home and return them by post. They will ask you about your quality of life Open a glossary item and any urinary symptoms you have.

If you are in group 2 you will see your doctor as usual. You will also fill in the same questionnaires as above. You will also be asked in the first 2 months to attend 5 training sessions about how to manage your urinary problems. This will include practical advice, problem solving, information and training in exercises and feedback to help improve your problems.

A nurse specialist runs these sessions. Four sessions will be with 4 or 5 other men and 1 session will be with just you and the nurse. In the individual session with the nurse you can talk privately about any problems or issues that are troubling you and the nurse will give you individual advice and coaching. After the sessions you continue using the skills and doing the exercises at home for 4 months. During this time the nurse will phone you to see how you are managing.

Hospital visits

There are no hospital visits involved in the trial. You attend the sessions at the Surrey Sports Centre and meet the nurse individually at the Surrey Clinical Research Centre, both of which are opposite the Royal Surrey County Hospital. Each session will last up to an hour and a half.