
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for men who have prostate cancer that has spread elsewhere in the body despite hormone treatment.
Prostate cancer that has spread to other parts of the body is advanced or metastatic cancer.
You might have chemotherapy for advanced prostate cancer if hormone treatment stops working. The usual treatment is a chemotherapy drug called docetaxel. You have this with a steroid drug called prednisolone.
Doctors are looking for ways to improve treatment. In this trial they are looking at adding a drug called pembrolizumab.
Pembrolizumab is an immunotherapy. It stimulates the body's to fight cancer cells.
In this trial some people have docetaxel and pembrolizumab. And some people have docetaxel and a dummy drug ().
The main aims of the trial are to:
The following bullet points list the entry conditions for this trial. The trial doctor reviews the entry conditions to make sure you are suitable to join the 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.
Cancer related
You:
Medical conditions
You:
Other
This phase 3 trial is taking place worldwide. The researchers need 1,000 men to take part including about 48 men from the UK.
It is a randomised trial. There are 2 treatment groups. You are put into a treatment group by a computer. Neither you nor your doctor can decide which group you are in. And neither of you know which group you are in. This is a double blind study.
You have 1 of the following:
Prednisolone is a tablet. You take it by mouth during the same period you have docetaxel. The trial team tell you when to take it.
You have pembrolizumab or the dummy drug as a drip into a vein. You have it once every 3 weeks (on the same day as your docetaxel). You have it for up to 2 years as long as it is working and the side effects are manageable.
Samples for research
You give a new tissue sample of the cancer if there isn’t one available from a past surgery or . You also give some extra blood samples. Where possible, you give these at the same time as your routine blood tests.
The team plan to look at:
Pain questionnaire
The trial team want to find out if you have pain and if so, how bad it is. You fill in a pain questionnaire on a small electronic device. The device alerts you when you need to complete it. An alarm goes off at the same time every day to remind you to complete it. You complete this until you stop treatment.
You take the device with you to each hospital visit. The team also give you a paper diary to record any pain medication you take. You bring this with you to each visit.
You see a doctor and have some tests before you join the trial. These include:
You have treatment at the hospital in the outpatient department. So you shouldn’t need to stay overnight.
At each treatment visit you see the doctor for a check up and you have some blood tests.
When you stop treatment you see the trial team 1 month later. If your cancer has got worse the trial team phone you every 3 months to see how you are getting on. Your doctor will talk to you about other treatment options.
If you stop treatment but your cancer hasn’t got worse you see the trial team for a check up every:
You have regular CT scans, MRI scans or bone scans until your cancer gets worse. You have these every:
The trial team monitor you during treatment and afterwards. Having pembrolizumab with docetaxel is a new treatment so there might be some side effects we don’t know about yet. Contact your advice line or tell your doctor or nurse if you have any side effects.
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. You should tell them that you are on, or have been on, an immunotherapy.
The most common side effects of pembrolizumab are:
The trial doctor talks to you about all the possible side effects of each treatment before you join the trial and during the trial.
We have more information about:
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
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”