A trial looking at radiotherapy and hormone therapy after surgery for prostate cancer (RADICALS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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This trial is looking at radiotherapy and hormone therapy after surgery for early prostate cancer. This trial is supported by Cancer Research UK.
More about this trial
Doctors usually use surgery to remove the prostate to treat prostate cancer that they think is completely inside the prostate gland (stage T1 or T2). Doctors call this operation a radical prostatectomy.
Depending on your PSA blood test results after surgery, you may not have any more treatment. Or you may have radiotherapy alone or radiotherapy with hormone treatment.
Doctors are not sure if all men should have radiotherapy after surgery or not. And if you do have radiotherapy, they are not sure if you will benefit from hormone therapy or how long you should have it for. All treatments have side effects and it is important that men don’t have treatments they don’t need.
The aim of this study is to find the best way to treat early prostate cancer after surgery. The researchers want to find out
- Whether it is best to give radiotherapy after surgery or wait to see if the PSA level in the blood rises first
- If radiotherapy and hormone therapy together is more effective than radiotherapy alone
- How long men should have hormone therapy for
- More about the side effects
The results of this study may help doctors to improve treatment for prostate cancer in the future.
Who can enter
You can enter this trial if you
- Have prostate cancer
- Have had an operation (radical prostatectomy) to remove your prostate
You cannot enter this trial if you
- Have prostate cancer that has spread to another part of your body (metastasised)
- Have had hormone therapy before your operation to remove your prostate cancer in the last 6 months and you took it for longer than 8 months
- Have already had hormone therapy after your surgery for prostate cancer
- Have had surgery to remove both your testicles (orchidectomy)
- Have had radiotherapy to your lower abdomen (pelvic area) in the past
- Have any other cancer which means that you cannot take part in this trial
Trial design
This is a phase 3 international trial and will recruit about 3,000 men. All the men taking part will have had an operation to remove their prostate.
The men are divided up into groups by a computer. This is called a randomised trial. Neither you nor your doctor will be able to decide which treatment group you are in.
This trial has 2 parts.
Part 1 is divided into 2 groups.
- If you are in group 1 you have radiotherapy straight away.
- If you are in group 2 you won't have radiotherapy to start with. But you may have radiotherapy later on if your PSA level starts to rise.
In part 2 you will be put into 1 of 3 main groups. The first main group will be split into 3 and you will have one of the following
- Radiotherapy alone
- Radiotherapy and 6 months of hormone therapy
- Radiotherapy and 2 years of hormone therapy
The second main group will be divided into 2 and you will have either
- Radiotherapy alone OR
- Radiotherapy and 6 months of hormone therapy
The third main group will be also be divided into 2 and you will have either
- Radiotherapy and 6 months of hormone therapy OR
- Radiotherapy and 2 years of hormone therapy
Depending on your PSA blood test results after surgery, the trial doctor will decide if you can take part in the trial or not. If you can take part and join part 1, and are randomised to have radiotherapy, you may then go into part 2 if you are happy to do so. If the trial doctor decides that you need to have radiotherapy, you will join part 2 straight away. But the trial doctor can tell you more about this.
If you are in part 1 and not having radiotherapy, you will have regular PSA blood tests. If your PSA rises and the doctor decides you need treatment, you may then join part 2 of the trial.
If the trial doctor decides you do not need treatment after surgery, you will not join the trial, but if your PSA rises in the future you may join part 2.
If you have radiotherapy, you will fill out a questionnaire before the trial begins, and 1 year, 5 years and 10 years after starting treatment. The questionnaire will ask you about any side effects you have and about how you have been feeling. This is called a quality of life study.
Hospital visits
Before you can take part in the trial, a doctor will examine you and you will have some blood tests and a bone scan.
If you are in part 1 and not having any treatment, you will go to the hospital to have regular PSA blood tests and check ups with the doctor.
If you have radiotherapy, you will have a CT scan of your lower abdomen (pelvic area) before you start treatment. And then you will go to the hospital every weekday for between 4 and 7 weeks for radiotherapy. Each treatment lasts about 5 to 10 minutes and you have this as an outpatient.
If you have hormone therapy, you have it as a tablet or an injection for 6 months or 2 years. The trial doctor will tell you how often you need to go to the hospital for treatment and check ups.
When you finish treatment, you will go to the hospital to see the doctor
- Every 4 months for 2 years
- Every 6 months for 5 years
- Every year for 5 years
At each appointment you will have some standard tests including a PSA blood test.
Side effects
All treatments have side effects. The short term side effects of radiotherapy to the prostate include
- Bladder irritation
- Diarrhoea
- Sore skin
The longer term side effects of radiotherapy to the prostate include
- The feeling of wanting to strain and bleeding from your back passage (proctitis)
- Difficulty passing urine or leaking urine (incontinence)
- Difficulty getting an erection (impotence)
The most common side effects of hormone therapy include
- Difficulty getting an erection (impotence)
- Breast tenderness
- Hot flushes and sweating
- Pain caused by ‘tumour flare’
You can read more about the side effects of radiotherapy to the prostate and hormone therapy on CancerHelp UK.
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 Chris Parker
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
Other information
This is Cancer Research UK trial number CRUK/07/008.
There is more information about the trial on the RADICALS trial website.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
