"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 a support programme for men with prostate cancer (PRO-ACTIVE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for men with prostate cancer who are having active surveillance. Active surveillance means monitoring the cancer closely and treating it if it starts to grow.
This trial is for men with localised prostate cancer that is low or intermediate risk.
More about this trial
Treatments for prostate cancer have side effects and some of these can be long term problems. So if some men having active surveillance don’t ever need treatment, they avoid these side effects.
But active surveillance can be difficult to cope with. It can be worrying to have cancer, but not have treatment. Research has shown that men on active surveillance experience 3 times as much anxiety as men without prostate cancer. Some men may decide to go ahead with treatment before their cancer has started to grow.
Doctors think that providing the right support could help men cope better with active surveillance. And help to avoid unnecessary treatment in some men.
The trial team have developed a support programme called PRO-ACTIVE. This stands for PROstate Cancer Support Intervention for ACTIVE Surveillance. The programme includes workshops and online support sessions. In this trial, some men will take part in the support programme and others will have care as normal.
The aims of this trial are to find out if men
- are willing to take part in this trial
- take part fully in the support programme
If this trial is successful, the researchers hope to organise a similar trial involving more men. This will then try to find out if the support programme improves quality of life and relieves anxiety.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if are a patient at Southampton University Hospital or University College London Hospital and you have been asked to take part. And all of the following apply.
- Your cancer is contained within the prostate gland (localised prostate cancer) and you have low or intermediate risk disease
- You had a template biopsy of your cancer before you started active surveillance
- You have access to the internet and you are able to speak and write fluent English
You cannot join this trial if any of these apply. You
- Have been on active surveillance for more than 1 year
- Have had an MRI scan since you started active surveillance
- Have any another other cancer, apart from non melanoma skin cancer
- Have a mental health problem that the trial team think could affect you taking part
- Are taking part in similar trial that could interfere with you taking part in this one
The researchers need 60 people to join this trial.
It is a randomised trial. The people taking part are put into 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- one group takes part in the support programme as well as usual care with their consultant and GP
- the other group has usual care with their consultant and GP, this is the
Twice as many people will be in the support programme group.
Support Programme Group
You take part in a group session every 2 weeks for a period of 6 weeks (3 in total). Each session takes about 1 hour and is run by a prostate cancer nurse specialist. The sessions cover different topics including
- prostate cancer, active surveillance and the different treatment options
- diet and nutrition
- goal setting
- relaxation techniques
For the final session you are invited to bring along your partner or a close friend or relative. It’s fine if you would prefer not to bring someone.
The researchers will ask your permission if they can audio record these sessions. This is to help with training the nurses who run these support programmes.
You also take part in 6 online interactive sessions via the trial website. These follow some of the topics above, as well as practical issues such as money and work. They aim to support what you have already learnt during the group sessions, as well as provide some extra information.
You continue with your care as usual, provided by your consultant and GP. At the end of the 12 month trial, you will have full and ongoing access to the trial website. This is the same website used by the other group when they take part in the online sessions.
You are asked to fill out a questionnaire at the start of the trial, then after
- 6 weeks
- 6 months
- 12 months
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You may be asked to take part in 3 telephone interviews over the course of the 12 months. You have the interview with one of the researchers. The conversations are recorded and take between 30 to 60 minutes. The researchers would like to find out what you think about active surveillance and about taking part in the trial.
The nurse and researchers will treat everything you tell them as
Partner, friend or relative study
The researchers will also ask whether someone close to you would fill out questionnaires and take part in interviews. This significant other could be your partner, friend or relative. If they are happy to do this, they have
- 2 telephone interviews with a researcher
- fill out 2 questionnaires
They have 1 interview and complete a questionnaire at the start of the trial. Then up to 4 weeks after the workshops they have another interview and complete the 2nd questionnaire.
It doesn’t matter if you have taken part in the support programme or had usual care. The researchers want to find out how a close friend or relative might influence a man having active surveillance.
If you take part in the support programme, you have 3 extra appointments. These are at hospital or another healthcare setting.
As this is not a treatment trial there are no side effects associated with taking part.
Talking about your experiences with prostate cancer could be upsetting at times. The specialist nurse and researcher will do all they can to make you feel comfortable. You don’t have to answer any questions you don’t want to. They can give you information about further support if you need it.
How to join a clinical trial
Professor G. Lewith
Professor A. Richardson
Prostate Cancer UK
Southampton University Hospital NHS Trust
University of Southampton