A trial of intensity modulated radiotherapy to treat prostate cancer (PEARLS)
Cancer type:
Status:
Phase:
This trial is looking at radiotherapy to nearby lymph nodes in addition to radiotherapy to the prostate. It is open to men having radiotherapy for the first time. You have it alongside 
.
The that doctors treat with radiotherapy include:
- those in the area between the hip bones (pelvic lymph nodes)
- those that lie in front of the spine in the lower back near a main blood vessel in the body (para-aortic lymph nodes)
Cancer Research UK supports this trial.
More about this trial
Hormone therapy is a usual treatment for prostate cancer. You might also have radiotherapy to the prostate and the lymph nodes in the pelvis.
It might be useful to treat the para-aortic lymph nodes with radiotherapy if your prostate cancer has spread to the lymph nodes:
- in the pelvis and, or
- the nodes the para-aortic area
The para-aortic lymph nodes lie in front of the spine in the lower back near a blood vessel called the aorta. Doctors think that treating them with radiotherapy might help stop the cancer coming back. They aren’t sure so they are running this trial to find out more.
In this trial you have a type of radiotherapy called intensity modulated radiation therapy (IMRT). It is a way of targeting the area of cancer more accurately. This means that doctors are able to give a larger dose of radiotherapy to the cancer and a lower dose to surrounding healthy tissue.
The main aims of the trial are to see if:
- radiotherapy to the pelvis and para-aortic area is safe
- radiotherapy to the pelvis and para-aortic area reduces the risk of the cancer coming back
- having an extra dose of radiotherapy to the lymph nodes where the cancer cells are is useful
- radiotherapy to the para-aortic area increases the risk of side effects
Who can enter
The following bullet points are a summary of 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 all of the following apply. You:
- have
adenocarcinoma of the prostate - have prostate cancer that has spread to the lymph nodes in the pelvis and or the lymph nodes in the front of the spine in the lower back near the aorta
- are having or you are due to start a type of hormone therapy for prostate cancer called a luteinising hormone-releasing hormone agonists (LHRH agonists).
LH blockers or LHRH antagonists. For example, these include the drugs leuprorelin, buserelin, goserelin acetate, triptorelin or degarelix. - have satisfactory blood test results
- are well enough to be up and about for at least half the day but you might not be able to work (performance status 0, 1 or 2)
- are willing to use reliable contraception during the trial if there is any chance your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have already had radiotherapy to the prostate or pelvis, surgery to remove both testicles or surgery to remove the prostate gland
- have
digestive system side effects that are moderate to bad if you had docetaxel chemotherapy in the past or from hormone therapy. These side effects might include feeling or being sick. - have had both hips replaced or you have any metal implants that would affect the accuracy of having a
CT scan and make radiotherapy planning difficult. Your doctor will know about this and if it applies to you. - can’t have radiotherapy due to a medical condition. This may include inflammatory bowel disease, bladder problems that are hard to control or you have had bowel (colorectal) surgery in the past.
- have had another cancer within the last 2 years. This is apart from
basal cell skin cancer , squamous cell skin cancer or small kidney tumours that are being monitored. You can’t take part if you have had another cancer in the last 5 years that might get much worse. - can’t have radiotherapy to the para‐aortic and, or pelvic areas for any reason
- have any other medical condition or mental health problem that the trial team think will affect you taking part in this trial
Trial design
This phase 2/3 trial is taking place in the UK. The team need to find 893 people to take part. To begin with they need 150 people to join.
Then a committee that monitors the safety of trials will check to make sure it is safe for more people to take part. This is the . Once this is confirmed a further 743 people join the trial. This is routine in some trials so it isn’t anything to worry about.
Your doctor puts you into 1 of 2 groups. The group you are in depends on where the involved lymph nodes are.
- Group 1 is for people whose cancer has spread from the prostate to the pelvic lymph nodes
- Group 2 is for people whose cancer has spread to the para-aortic lymph nodes. It may also have spread to nearby lymph nodes in the pelvis.
The rest of the trial is randomised. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in.
Radiotherapy to the prostate and pelvis (Group 1)
This part of the trial is for people whose cancer has spread only to their pelvic lymph nodes. There are 2 treatment groups. You have 1 of the following:
- radiotherapy to the prostate and lymph nodes in the pelvis, with a boost to the involved lymph nodes. This is an extra dose.
- radiotherapy to prostate and lymph nodes in the pelvis. You also have radiotherapy to the para-aortic lymph nodes and a boost to involved lymph nodes.
Radiotherapy to the prostate, pelvis and para-aortic area (Group 2)
This part of the trial is for people who have cancer in their para-aortic lymph nodes. They may or may not have cancer in the pelvic lymph nodes. You have 1 of the following:
- radiotherapy to the prostate (usual treatment)
- radiotherapy to the prostate, pelvis and para-aortic lymph nodes. You also have a boost of radiotherapy to all involved lymph nodes. This is an extra dose.
Hormone therapy
Everyone has hormone therapy for at least 2 to 3 years as part of their . You start it before you begin radiotherapy and continue after radiotherapy finishes. Your doctor can tell you more about having hormone therapy and how long you have this for. They will explain what type you are having.
Having radiotherapy (IMRT)
Before you start radiotherapy you have a session to plan your radiotherapy. The dose you have depends on the group you join. Your doctor can tell you more about this. You start radiotherapy within 2 to 3 weeks of the planning session.
You have radiotherapy every day (Monday to Friday) for 4 weeks. You have 20 sessions in total. Each session takes about 10 to 15 minutes.
Samples for research
The researchers ask you to give some extra samples. These might include blood samples or poo samples. They also ask for a sample of tissue () from when you were diagnosed.
They plan is to use the samples to see:
- how your
immune system responds to radiotherapy. This is an immune response - if radiotherapy affects the bacteria in the gut
They might also ask you to have some extra scans. You don’t have to agree to give the samples or have the extra scans if you don’t want to. You can still take part in the main trial.
Quality of life
The trial team ask you to fill out questionnaires:
- before you start treatment
- at set times during treatment
The questionnaires ask about side effects and how you’ve been feeling. This is a quality of life study.
Hospital visits
You see the doctor and have tests before you can take part. These may include:
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 regular blood tests.
Follow up
When you finish radiotherapy you have a hospital appointment for a check up. You might see the doctor or they may call you. The appointments take place at the following times from the start of your radiotherapy:
- 6 weeks
- 2 months
- 3 months
- 18 weeks and then
- every 6 months for 5 years and then
- once a year after that
The team record any side effects you may have. You also have routine blood tests.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of radiotherapy are:
- tiredness (fatigue)
- frequent bowel movements, loose poo or diarrhoea
- tummy (abdominal) pain
- feeling you need to pass urine more often or pain when passing urine
- difficulty getting an erection
- bleeding from your back passage (rectum)
- losing your
fertility
The trial doctor will talk to you about all the possible side effects of treatment.
We have information about the side effects of:
Location
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 Julia Murray
Supported by
Cancer Research UK
Institute of Cancer Research (ICR)
Other information
This is Cancer Research UK trial number CRUK/19/016.
The trial team have made a short video about the trial. Go to the PEARLS trial website to watch it.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
