A trial looking at circulating tumour cells and exercise in prostate cancer (ExPeCT)

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:

Other

This trial is looking at circulating tumour cells and exercise in men with prostate cancer. It is for men whose prostate cancer has spread elsewhere in the body.

More about this trial

In some men, cancer cells spread beyond the prostate gland and can be found in the blood. These are known as circulating tumour cells, or CTCs. Small blood particles called platelets Open a glossary item can stick on these CTSs and this is known as platelet cloaking. Platelet cloaking may prevent the body’s immune system from finding and killing these cancer cells.

Men who are overweight have stickier platelets than men who are a normal weight. Researchers think that overweight men may have more platelet cloaking and so their prostate cancer may have a better chance of growing more quickly and spreading. This trial wants to find out if this is the case.

The trial team also want to look at the effect of exercise on prostate cancer. Researchers think that exercise may reduce the stickiness and cloaking of platelets. This is turn may slow down the growth of cancer in overweight men.

The aims of this trial are

To find out if platelet cloaking of prostate cancer CTCs is more likely in men who are overweight (compared to men who are a normal weight)
To find out if exercise can reduce platelet cloaking
To see if exercise improves quality of life in men with prostate cancer

Who can enter

The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.

You may be able to join this trial if all of the following apply.

You have a type of prostate cancer called adenocarcinoma
You have prostate cancer that has spread elsewhere in the body (metastatic prostate cancer) and this has been confirmed with either a CT scan , MRI scan or bone scan
Your doctor thinks you are fit and well enough to carry out the exercise programme as part of this trial
You are at least 18 years old

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

Have had an operation to remove your prostate cancer (a radical prostatectomy)
Have had major surgery in the last 4 weeks
Have had another type of cancer, unless it was very early stage and has been successfully treated
Have any serious medical condition or infection that the trial team think could affect you taking part

Trial design

This is an international trial. The researchers need about 67 people to join in the UK.

It is a randomised trial. The people taking part are put into 2 different groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

One group takes part in an exercise programme
The other group does not take part in the exercise programme (this is the control group )

Diagram for ExPeCT

If you are taking part in the exercise programme, you meet the physiotherapist who will design a personal exercise plan that suits your abilities. You then go to an exercise class every week for the next 3 months. This is run by the physiotherapist and you will be with other men with prostate cancer taking part in the trial. Each class lasts about 1 hour.

The physiotherapist will encourage you to continue exercise at home every day and keep an exercise diary. An example of the type of exercise you could do is walking for about 30 minutes.

You will be shown how to use a small monitor for when you exercise at home. This measures your heart rate and helps to guide the intensity of your exercise. The physiotherapist can also use the monitor to download information about your heart rate when you go back to hospital each week.

After 3 months, you no longer go to exercise classes or use the monitor. But you will be asked to continue exercising every day and keep an exercise diary for the next 3 months, at which point your involvement in this trial will finish.

If you are in the other group, you will not take part in the exercise programme.

Men in both groups will have a blood test

At the start of the trial
After 3 months
After 6 months

This blood sample will used by the trial team to look for and measure CTCs and platelet cloaking. You will not be told about the results of these tests and the results will not affect your treatment. You have these blood tests at the same time as one of your routine blood tests.

Your height, weight and waist circumference will be recorded by a member of the trial team at the same time as your blood tests.

All men fill out a questionnaire on 3 different occasions (at the same time as their blood tests for the trial). The questionnaires will ask about

Your diet
How well you are sleeping
What medicines you are taking
Your mood
Your overall quality of life

The trial team will also look at a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item . The trial team will use this to look at the genetic information in your cells.

After 6 months, any appointments you have will be part of your routine care.

Hospital visits

Your planning session with the physiotherapist and your exercise classes will take place at Guy’s hospital in London or St James’s Hospital in Dublin, depending on where you are a patient.

Side effects

You will not be asked to take part in this trial unless your doctor thinks you are fit and well enough. If you take part in the exercise programme, this is run by a physiotherapist and is very safe. It is very unlikely that you will have side effects as a result of taking part in this trial.

If you take part in regular exercise, it may help to improve your symptoms, sleep and overall quality of life.