
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for men with prostate cancer that has spread and is getting worse despite having hormone therapy or having their testicles removed. This is called metastatic castration resistant prostate cancer.
The trial is comparing pembrolizumab and enzalutamide with a dummy drug (placebo) and enzalutamide.
Enzalutamide is a hormone treatment doctors use to treat prostate cancer that has spread to another part of the body.
Pembrolizumab is an immunotherapy. It works by stimulating the to fight cancer. Pembrolizumab is used to treat other types of cancer.
Researchers think the combination of enzalutamide and pembrolizumab might work well for men with prostate cancer that has spread and is getting worse.
To find this out in this trial:
The aims of this trial are to find out:
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 all of the following apply. You:
Who can’t take part
You cannot join this trial if any of these apply. You:
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The trial team need about 1,200 men to join worldwide with around 70 men in the UK.
This is a randomised trial. You go into 1 of 2 groups. Neither you nor your doctor chooses which group. The 2 groups are:
Enzalutamide is a capsule or tablet. You take it once a day. You continue taking it as long as the side effects aren’t too bad and it is still working.
Research samples
When you join the trial you give a fresh tissue sample (). If this isn’t possible the team may ask for a piece of tissue from when you had an earlier biopsy.
You give blood samples and urine samples during the trial. The team use these samples to see what happens to the drugs in your body and how they affect your body. They also use them to look for substances () that might show how well the drugs are working.
Quality of life
You fill in a questionnaire at the hospital:
The questions ask about:
This is a quality of life questionnaire.
You will also have an electronic device similar to a mobile phone to take home with you to complete other quality of life questionnaires. The device alerts you when to fill in the questionnaire.
Pain questionnaire
The trial team want to know if you have any pain and what medication you take if you do. You have a diary to write down what pain medication you use at home.
You bring both the device and the diary to all your clinic visits in the hospital.
You see the doctor to have some tests before taking part. These tests include:
During the treatment you see the doctor every 3 weeks for blood tests and to see how you are.
You see the doctor when you stop treatment and again a month later.
If your cancer has not yet got worse and you haven’t started another treatment, you then see the doctor every 9 weeks for a year and then every 12 weeks. You have a scan every 9 weeks for the first year and then every 12 weeks.
If your cancer has got worse or you have started another treatment, your doctor or study team will contact you at least every 12 weeks to see how you are.
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.
Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.
If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy.
The most common side effects of pembrolizumab are:
We have information on enzalutamide.
Your doctor or a member of the trial team will talk to you about the possible side effects before you agree to join the trial, and regularly throughout the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Johann de Bono
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”