A trial of active surveillance for early prostate cancer to decide whether or not treatment is needed
Cancer type:
Status:
Phase:
This trial looked at men having regular monitoring for prostate cancer contained within the prostate gland.
It was open for people to join between 2002 and 2018.
The team published some results in 2013.
More about this trial
The main treatments for localised prostate cancer are surgery and radiotherapy. But treatments have side effects and some prostate cancer can be very slow growing and never cause a problem.
You might have active surveillance for early prostate cancer that doesn’t need treatment straight away. Your doctor keeps a close eye on you to check for any signs that the cancer is growing. If it does, then you and your doctor will decide which treatment is best for you.
The researchers in this trial wanted to find out what happened to the cancer when they observed it instead of giving treatment straight away. To do this the men had the following tests regularly:
- an examination of their prostate
- blood and urine tests
After about 18 months of active surveillance they also had a scan and a sample of a tissue taken from the prostate. This was repeated every 2 years.
Doctors used this information to try and predict if the cancer would grow.
The main aims of the trial were to find out:
- how many people would need treatment in the future because their cancer continued to grow
- how many people would never need treatment because the cancer doesn’t grow
Summary of results
The trial team found that in the medium term it was acceptable to have active surveillance. The researchers found ways to predict whose cancer would grow. They say this needs to be checked in the longer term.
About this trial
The trial team aimed to find about 750 men to take part. Between 2002 and 2011, 471 men with early prostate cancer were suitable to join.
Everyone had active surveillance. They had regular tests to check if the cancer was starting to grow.
Results
The team followed everyone up for about 5 years.
They looked at whose cancer had started to grow again. When they looked at the tissue samples (
) they found this was 117 people. They worked out this was just over 2 out of every 10 people (22%) who took part.
They also looked at who needed treatment in the 5 year period. They found:
- 7 out of every 10 people (70%) didn’t need treatment
- 3 out of every 10 people (30%) did need treatment
This means that 70% of people avoided unnecessary treatment within 5 years of being diagnosed.
The researchers looked at the number of people who had died from prostate cancer. They found this was 2 people. Since this trial was done there have been some changes to the criteria men must fulfil before they can have active surveillance. Now men have an MRI scan to help the doctors decide who is suitable for active surveillance. This means that the people who go on to have active surveillance are less likely to need treatment in the future. And the team think these people have a better .
Conclusion
The team found that active surveillance is a good option for people with localised prostate cancer. In this trial, most avoided having treatment in the medium term.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr C. Parker
Supported by
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
