
"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 the combination of pembrolizumab and olaparib with:
Abiraterone is a hormone treatment doctors use to treat prostate cancer. You have the steroid prednisolone with abiraterone to help reduce some of its side effects.
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.
Olaparib is a called a PARP inhibitor. It stops a protein called PARP from working. Some cancer cells use PARP to repair damaged
. When olaparib stops PARP from repairing the DNA the cancer cells die.
Doctors use pembrolizumab and olaparib on their own to treat other types of cancer.
Researchers think the combination of pembrolizumab and olaparib might help men with prostate cancer that has spread.
In this trial some men have pembrolizumab and olaparib. And some have either abiraterone and prednisolone or enzalutamide on its own.
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
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 team need up to 780 people to join worldwide with around 40 joining in the UK.
It is a randomised trial. There are 2 groups. Neither you nor your doctor choses which group you are in. You and your doctor will both know which group you are in. The groups are:
Out of every 3 people who join, 2 go into the pembrolizumab and olaparib group.
You have pembrolizumab as a drip into a vein. You have it once a week every 3 weeks. You continue to have pembrolizumab for up to 2 years as long as it is working and the side effects aren’t too bad.
Olaparib is a tablet or a capsule. You take it twice a day.
Abiraterone is a tablet. You take it once a day.
Prednisolone is a tablet. You take it twice a day.
Enzalutamide is a capsule. You take it once a day.
You continue taking which ever treatment you are on as long as they are still working and the side effects aren’t too bad.
Men having pembrolizumab and olaparib should not eat or drink the following while on treatment:
This is because they can affect how pembrolizumab and olaparib work. Your doctor will talk to you about this.
Research samples
When you join the trial you give a fresh tissue sample (biopsy). If this isn’t possible the team will ask for a piece of tissue from when you had an earlier biopsy.
You give blood samples and urine samples regularly 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:
The questions ask about:
This is a quality of life questionnaire.
Some of these questionnaires are completed at home in between treatment visits on an electronic device similar to a mobile phone. 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.
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 then again a month after you finish treatment. After this you see the doctor every 9 weeks for a year and then every 12 weeks.
During the trial if your cancer gets worse, or you have started another cancer treatment, the study team will see you every 12 weeks. For some of them they might phone you.
You have a scan every 9 weeks and then every 12 weeks. If your disease has gotten worse, you may not need to have any more scans as part of the study.
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:
The most common side effects of olaparib are:
We have information about:
Your doctor or a member of the trial team will talk about the possible side effects from treatment before you agree to join 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.”