"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A trial looking at diet and exercise after surgery for prostate cancer (PrEvENT)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
Researchers want to see if certain foods and being physically active may help reduce the risk of prostate cancer coming back after surgery. To do this they will put men into different groups. Some men will continue with their usual activity and eat their usual diet. Other men will increase their physical activity and take dietary supplements or eat more fruit and vegetables.
The main aims of this trial are to find out
- How acceptable the increase in activity and the change to diet is for men
- How many men are willing to join a trial comparing different levels of exercises and changes to diet
Who can enter
There are 3 parts to this trial.
To join the trial you must be a man who is going to the Urology Centre at the Southmead Hospital in Bristol and all of the following apply
- You have prostate cancer that is completely within the prostate gland (localised prostate cancer)
- You are going to have surgery to remove the prostate gland (radical prostatectomy)
- You are at least 18 years old
When you agree to join part 1, the team will ask if you are interested in being contacted to join part 2. You don’t have to agree to this if you only want to join part 1. If you do agree to be contacted, they will send you an information sheet about part 2 when they start recruiting.
You won’t be asked to join part 2 if any of these apply. You
- Have certain heart problems or breathing problems (the trial team can advise you about this)
- Need help with getting around, such as using a walking frame or a wheelchair. You may be able to take part if you use a walking stick
- Routinely do large amounts of vigorous exercise throughout the week (the trial team can advise you what is classed as vigorous exercise)
- Have taken lycopene supplements regularly for more than 3 months before taking part in the trial
- Eat more than 5 or more servings of fruit or vegetables every day
- Are allergic to lycopene
- Have any other medical condition or health problem that the trial team thinks could affect you taking part
If you join part 2, the team will ask if you are interested in being contacted to join part 3. If you agree to this, they will send out an information sheet about part 3 when they start recruiting.
The researchers need 102 men to join this trial.
In part 1, you fill in a questionnaire at Southmead hospital before you have surgery to remove your prostate. This will ask questions about
- Yourself and your lifestyle
- Your general health
- Your eating and exercise habits
- Any problems you may have passing urine
- Your moods and how tired you feel
- Your general
quality of life
You take home a small, light activity monitor to wear for a week. You wear it around your waist as pictured below. It will record your physical activity. After the week, you return it by post in a pre paid envelope.
You then have your surgery as planned. About 4 to 5 weeks afterwards, the team will post you another questionnaire to fill in. You return it to the team in a pre paid envelope.
If you don’t wish to answer any of the questions in either of the questionnaires you don’t have to, you can skip them and move on to the next question.
If you agree that the researchers can contact you about part 2 of the trial, they will send you an information sheet after your surgery. About a week later, a member of the team will phone you to find out if you would like to take part. If you are interested, they will arrange an appointment for you to see the research nurse at Southmead Hospital.
Part 2 is randomised. The men taking part are put into 1 of 6 groups by a computer. Neither you nor the trial team can choose which group you are in.
- Men in group 1 do brisk walking and take a lycopene supplement
- Men in group 2 do brisk walking and increase the amount of fruit and vegetables they eat
- Men in group 3 do brisk walking and eat their normal diet
- Men in group 4 continue their normal physical activity and take a lycopene supplement
- Men in group 5 continue their normal physical activity and increase the amount of fruit and vegetables they eat
- Men in group 6 continue their normal physical activity and eat their normal diet
Whichever group you are in, this continues for 6 months.
Brisk walking is walking at a quick pace for 30 minutes. You do this at least 5 times a week on top of your normal physical activity.
Lycopene supplements are capsules you take every day. Lycopene is a natural substance found in tomatoes and other fruit and vegetables.
To increase your fruit and vegetable intake, you must aim to eat at least 5 servings each day. You must also try and swap cow’s milk for alternatives such as soy milk, almond milk or rice milk, as often as possible.
You fill in a questionnaire similar to those in part 1. For 6 months you wear a smaller, lighter activity monitor as pictured below. It will measure how many steps you do each day. For the last week of the trial you will wear the monitor you wore in stage 1 again, to measure your general activity. You also write down your daily activity and what you eat for 6 months. A member of the trial team will tell you more about this.
If you agree to join part 3, one of the trial team will contact you to arrange an interview. They will ask about any changes you have made to your diet, your physical activity and how this has worked out for you. They will also ask about your experience of taking part in the trial and about how things might be improved.
They will make an audio recording of the interview.
In part 1 before having surgery, you see a research nurse at the hospital. The appointment will last about half an hour. They will take your height, weight, body fat measurement and a blood sample.
In part 2, you see the research nurse at the hospital before you are put into your group. You have the same tests as in part 1. This will take about 30 minutes. You then see a member of the team after 3 months to see how you are doing and at 6 months for a blood sample.
In part 3, the trial team will arrange the interview at a place and time convenient to you. The interview will take about 20 minutes.
You may have some discomfort and bruising from where the blood samples are taken.
Your legs muscles may ache a little bit from the brisk walking.
When taking lycopene supplements, people have reported the following
- Feeling sick (nausea)
- Indigestion, gas and feeling bloated
Increasing the amount of fruit and vegetable in your diet may cause
- A mildly upset stomach
- Feeling bloated
- Feeling sick
How to join a clinical trial
Dr Athene Lane
National Institute for Health Research (NIHR)
University of Bristol
University Hospitals Bristol NHS Foundation Trust