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A trial comparing surgery, conventional radiotherapy and stereotactic radiotherapy for localised prostate cancer (PACE)
This trial is looking at a type of radiotherapy called stereotactic radiotherapy and comparing it with either conventional radiotherapy or surgery. It is for men who have been diagnosed with prostate cancer that has not grown outside the prostate gland (localised prostate cancer).
The trial is supported by Cancer Research UK.
More about this trial
If prostate cancer is diagnosed before it has spread outside the prostate gland, there are several treatment options including surgery to remove the prostate gland, external radiotherapy and internal radiotherapy (brachytherapy). Some men may now also be offered a new way of having external radiotherapy called stereotactic radiotherapy. You have stereotactic radiotherapy over a shorter period of time than conventional radiotherapy.
All of the treatments listed above work well, but doctors don’t know if one is better than the other or which one has the fewest side effects.
In this trial, some men will have keyhole surgery to remove the prostate gland (laparoscopic prostatectomy), some will have conventional radiotherapy and some will have stereotactic radiotherapy.
The aim of the study is to compare the different treatments to find out
- How long men live after each treatment without any sign of their cancer coming back
- More about the side effects of each treatment
Who can enter
You may be able to enter this trial if you
- Have been diagnosed with prostate cancer by having a prostate biopsy during which the doctor was able to take at least 10 samples from your prostate gland
- Have cancer that is completely contained within your prostate gland (stage T1or T2) and has not spread to
lymph nodesnearby or to other parts of your body
- Have a Gleason score that is no more than 3+4 (your doctor can advise you about this)
- Have a
PSA levelof no more than 20 and your doctors think your cancer is low or intermediate risk
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
You cannot enter this trial if you
- Have had any other type of cancer in the last 2 years apart from non melanoma skin cancer
- Have already had radiotherapy to the area between your hip bones (your
- Have already had hormone therapy
- Have had any other type of treatment for prostate cancer
- Have had both your hips replaced or have had any other type of medical implant that could affect a CT scan
- Have any other medical condition that means your doctors would not recommend you have radiotherapy
- Are having treatment for prostate cancer as part of another clinical trial
This phase 3 trial aims to recruit more than 1,700 men with localised prostate cancer. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Before you agree to join the trial, your doctors will have discussed the different treatment options available to you.
If surgery would be an option for you and you agree to take part in the trial, you will have either surgery or stereotactic radiotherapy.
If you join the trial but you or your doctors don’t think surgery would be an option for you, then you have either conventional radiotherapy or stereotactic radiotherapy. This part of the trial is now closed.
If you have conventional radiotherapy, you have treatment each day (Monday to Friday) for nearly 8 weeks. If you have stereotactic radiotherapy, you have 5 treatments over 1 to 2 weeks.
The trial team will ask you to fill out a questionnaire before you know which treatment group you are in, every 6 months for the 1st year and once a year after that. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. There will also be questionnaires about specific side effects to complete more frequently.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- MRI scan
- Rectal examination and rectal ultrasound (you don’t need to have a rectal ultrasound if you have an MRI scan of your
If you are having surgery, you also have a hospital appointment called a pre assessment. This is to check that you are fit enough to have an operation. When you have your surgery, you stay in hospital for a few days.
If you are going to have either type of radiotherapy, you may have 3 to 4 small grains of gold put into your prostate to monitor the position of the gland during radiotherapy.
Having the gold grains put in is a bit like having a prostate biopsy. The doctor puts a probe into your back passage to guide them when placing the grains. It takes about 20 minutes and you can go home afterwards.
At least 7 days later, you have a CT scan and an MRI scan – both on the same day. Doctors will use images from these scans to plan your radiotherapy.
If you have conventional radiotherapy, you go to hospital everyday for nearly 8 weeks. Each treatments lasts about 15 minutes.
If you have stereotactic radiotherapy, you go to hospital 5 times over 1 to 2 weeks. Each treatment lasts between 20 minutes and an hour.
The most common short term side effects of either conventional or stereotactic radiotherapy to the prostate include
- Loose bowel movements or diarrhoea
- Discomfort in your back passage
- Needing to pass water more frequently or discomfort when passing water
- Red skin
- Temporary loss of your pubic hair
The most common long term side effects of radiotherapy include
- Erection problems
- Inability to have children (infertility)
- Changes to your bowel habit
- Problems passing urine
The side effects of surgery to remove your prostate gland include
- Pain after the operation (this can usually be well controlled with painkillers)
- Erection problems
- Temporary incontinence
We have more information about
How to join a clinical trial
Dr Nicholas van As
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
This is Cancer Research UK trial number CRUKE/12/025.