A trial looking at different ways of giving radiotherapy for cancer of the prostate (PIVOTALboost)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Phase 3

This trial is to find out if having radiotherapy to the lymph nodes in the pelvis as well as the prostate, improves treatment for prostate cancer. And to see if extra boosts of radiotherapy to the prostate is a useful treatment.

It is for men with a medium to high risk of their cancer coming back.

Cancer Research UK supports this trial.

More about this trial

Radiotherapy to the prostate is one of the usual treatments for prostate cancer. You might have a type of external radiotherapy called intensity modulated radiotherapy (IMRT). Or you might have a type of internal radiotherapy called high dose brachytherapy (HDR). Some men have both. Most men also have hormone therapy to lower the amount of testosterone in the body. 
 
For men with prostate cancer that is medium to high risk, there is a chance it might have spread to the nearby pelvic lymph nodes. Although there might not be any signs of this on a scan. 
 
Researchers want to improve treatment for medium to high risk prostate cancer. They think that adding radiotherapy to the pelvic lymph nodes could keep the cancer under control for longer. But they aren’t sure. All treatments have side effects, so they don’t want to give people treatments they don’t need. 
 
The researchers also want to find out if extra boosts of radiotherapy to the tumour area or the whole prostate gland stops the cancer coming back in the longer term. They think this might work, but they want to find out more. 
 
The main aims of the trial are to compare treatments to find out:
  • which treatment works best and causes the fewest side effects
  • if having radiotherapy to the pelvic nodes stops or delays the cancer growing again
  • more about quality of life 

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. 
 
Who can take part
 
You may be able to join this trial if the following apply.
You:
  • have prostate cancer that hasn’t spread elsewhere in the body 
  • haven’t had treatment yet
  • have a PSA that is less than 50 before starting hormone therapy
  • are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • are willing use 2 forms of reliable contraception during the trial and for up to a year afterwards if there is any chance your partner could become pregnant 
  • are expected to live for more than 5 years
  • are at least 18 years old
For men with locally advanced prostate cancer or who have a high risk of their cancer coming back, the following must also apply:
You:
  • have prostate cancer that has gown outside of the prostate gland into nearby tissues and organs in the pelvis (the area between the hip bones), stage T3a, T3b or stage T4
  • have a Gleason score of 4 or 5
  • have a PSA that is more than 20
For men with a medium risk of their cancer coming back, 1 or more of the following must also apply.
You:
  • have cancer in more than half of 1 side of the prostate gland or in both sides but it is still inside the prostate gland
  • have a Gleason score of 7 (4+3) or above
  • have a PSA level between 10 and 20
  • have a tumour that is bigger than 6mm or other unfavourable factors that show up in your scans or tissue samples (biopsies) – the trial team will check this
Who can’t take part
You cannot join this trial if any of these apply. 
 
Cancer related
You:
  • have cancer that has spread to the lymph nodes, it looks like it might have on a scan or it has spread to other parts of the body
  • have already had radiotherapy to the prostate or pelvis
  • have had an operation to remove the prostate gland, surrounding tissues, lymph nodes and the tubes that carry semen (seminal vesicles) - a radical prostatectomy.
  • have had hormone therapy for more than 6 months when you join the trial
  • have had a chemotherapy drug called docetaxel
  • have had both hips replaced or any other implants or metal inside that would make it hard to interpret CT scans or plan radiotherapy 
  • can’t have an MRI scan for any reason if you are joining certain groups in this trial
  • can’t have external radiotherapy to the pelvis for any reason
  • are going to have high dose rate brachytherapy (HDR) and you take blood thinning medication that you can’t stop for a short time, you have had your prostate removed and the wound hasn’t healed, you have had a recent blood clot in your leg or lung, you have heart problems or you aren’t suitable to have a general anaesthetic
  • have had any other cancer in the last 2 years apart from basal cell skin cancer or squamous cell skin cancer or any other cancer in the past that might need treatment 
 
Medical conditions
You:
  • aren’t suitable to have radiotherapy because you have inflammatory bowel disease, any other long term bowel problem or problems passing urine

Trial design

This phase 3 trial is based in the UK. The trial team hope 1,952 men will take part. 
 
The trial involves:
  • hormone treatment – everyone has this
  • MRI scan – to work out which group you go into
  • planning of your radiotherapy
  • radiotherapy 
Hormone therapy
Everyone will have hormone therapy for 6 months to 2 years as part of their standard treatment. You start hormone therapy between 2 to 4 months before starting radiotherapy and continue with this afterwards. In some cases, you might have started this treatment already.
 
MRI scan
Before you start treatment, the trial doctors look at your MRI scans. They work out who is suitable to have boosts of radiotherapy to the tumour and who isn’t. 
 
Radiotherapy
Radiotherapy is the use of high energy waves similar to X-rays to kill cancer cells.
 
Everyone has IMRT to the prostate. And some men have this to the prostate and lymph nodes in the pelvis. In addition, some men have:
  • high dose brachytherapy (a type of internal radiotherapy) 
  • boosts of radiotherapy to the tumour area
  • boosts of radiotherapy to the whole prostate gland
This is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. 
 
You will be put into 1 of the following groups:
  • group A have radiotherapy to the prostate
  • group B have radiotherapy to the prostate and pelvic lymph nodes
  • group C have radiotherapy to the prostate and some men have a boost of radiotherapy to the tumour or whole prostate gland 
  • group D have radiotherapy to the prostate and pelvic lymph nodes and some men have a boost of radiotherapy to the tumour or prostate gland

Having intensity modulated radiotherapy (IMRT)

Everyone has IMRT. You have it to the prostate alone or to the prostate and pelvic lymph nodes. 
 
Your doctor will need to plan your treatment before having IMRT. This is to plan where to give the treatment and how much to give. You have a planning CT scan which shows where the cancer is. This takes about 2 hours.
 
Each IMRT session takes about 10 to 15 minutes. 
 
Depending on which group you are in, you have IMRT:
  • every weekday, Monday to Friday for 4 weeks
or 
  • every weekday, Monday to Friday for 3 weeks
 
Having high dose rate brachytherapy (HDR) 
Some men will also have HDR. You have a single treatment. You have this 14 to 21 days before starting external radiotherapy. Your doctor will plan your treatment for high dose rate brachytherapy. This is done immediately before having treatment.
 
You have HDR under anaesthetic. You have either a general anaesthetic or an anaesthetic into the spine (epidural). The doctor puts thin tubes through the skin behind your testicles and your back passage (rectum). These tubes will be attached to a high dose rate brachytherapy machine. 
 
The radioactive substance goes from the machine through the thin tube to your prostate. When treatment is finished the doctor removes the radioactive substance and tubes. So, there is no radioactive material left in your body. 
 
Once you have recovered from your anaesthetic and passed urine normally without any problem you can go home. In some cases, you might need to stay overnight. You then have IMRT 2 to 3 weeks later. 
 
Samples for research
The researchers will ask for samples of your prostate cancer that the doctors took when you had a biopsy. They plan to use these samples for future research. This might include genetic tests. You don’t have to agree to this if you don’t want to. You can still take part in the trial and it won’t affect your care in any way. 
 
Quality of life
The trial team will ask you to fill in a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
 

Hospital visits

You will see a doctor and have some tests before you can take part in this trial. The tests include
  • blood tests (including a PSA test)
  • physical examination
  • MRI scan
You have your radiotherapy at the hospital. During treatment you see a doctor, nurse or radiographer every week. They will ask how you are and if you are having any side effects. You also have a blood test.
 
How often you go to the hospital for treatment will depend on which group you are in. The trial team can tell you more about this.
 
When you finish radiotherapy, you see the trial doctor for a check up: 
  • every 6 weeks for the first 6 months
  • every 3 months up to 2 years
  • every 6 months up to 5 years
  • once a year after that

Side effects

The trial doctor will talk to you about all possible side effects. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.
 
The most common side effects of radiotherapy include:
  • tiredness (fatigue)
  • frequent bowel movements, loose poo or diarrhoea
  • feeling you need to pass urine more often or pain when passing urine
  • difficulty getting an erection
  • bleeding from your back passage (rectum)
  • blood in your urine 
Most symptoms usually resolve after 4 to 12 weeks. Although some can persist in the longer term. 
 
Having extra boosts of radiotherapy might mean you have worse bladder and bowel side effects. You might also have some bruising and discomfort after high dose rate brachytherapy.
 
The most common side effects of hormone therapy include:
  • tiredness
  • muscle weakness
  • hot flushes
  • swelling of the breast tissue
  • loss of sex drive (loss of libido)
We have more information about the side effects of:

Location

Brighton
Bristol
Bury St Edmunds
Cambridge
Canterbury
Cardiff
Cheltenham
Glasgow
Kings Lynn
Lincoln
London
Maidstone
Northwood
Norwich
Oxford
Southampton
Sutton
Torquay
Wirral

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Isabel Syndikus

Supported by

Cancer Research UK
Institute of Cancer Research (ICR)

 

Other information

This is Cancer Research UK trial number CRUK/16/018.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15120

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

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