
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at adding capivasertib to abiraterone for men with prostate cancer. It is for men whose:
Doctors are looking for ways to improve treatment for prostate cancer that has spread to another part of the body. In this trial they are looking at a drug called capivasertib in combination with abiraterone.
Capivasertib is a called a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Researchers think that capivasertib works best for people who have low levels of PTEN on their prostate cancer cells. This is also called PTEN deficient cancer.
Abiraterone is a . It is already a treatment for prostate cancer that has spread elsewhere in the body.
In this trial some people have abiraterone and capivasertib. And some have abiraterone and a dummy drug ().
The main aims of the trial are to find out:
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 to have treatment 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:
This phase 3 trial is taking place worldwide. The team need about 1,000 people to have the treatment in this trial. This includes 16 from the UK.
The trial involves:
Checking for the PTEN protein
To begin with, the trial team invite about 5,500 men to take part. They have all been recently diagnosed with prostate cancer that has spread. The team check the PTEN protein on the cancer cells. To do this they look at samples of cancer people gave when they were diagnosed. The researchers are looking for people whose cancer cells lack PTEN. The team think this will be about 1,000 men.
Please note, to have trial treatment you must have cancer that lacks PTEN.
Your doctor will talk to you about other treatment options if this doesn’t apply to you.
Trial treatment
This is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
Capivasertib and the dummy drug are tablets. Each week you take them:
Abiraterone is also a tablet. You take them once a day, every day. You take abiraterone with a steroid drug called prednisolone. This is to help reduce some of the side effects. The trial team give you an electronic device to record when you take your tablets. This helps to keep track and confirm that you have taken your medication. You can do this using a paper diary if you prefer.
You have treatment for as long as it is working and the side effects aren’t too bad.
You also have standard hormone therapy. This may include drugs such as degarelix or goserelin. You might have already started this treatment. Your doctor can tell you more about this.
Samples for research
The researchers ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests. The researchers also ask you to give some extra tissue samples.
They plan to use the blood and tissue samples to:
You need to agree to give most of the samples to take part in the trial. There are a few you can say no to. The team can let you know more about this.
Quality of life
The trial team ask you to fill out some questionnaires on an electronic device:
The trial team give you the device to take home with you.
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study. They also ask about any pain you may have and about painkillers you take.
Before you have the treatment in this trial, you see a doctor and have some tests.
These include:
The team also check for symptoms that might be due to cancer spread in the bones, such as an increase in pain. They also check if you have required any further intervention to help manage this.
You might also need to have another sample of tissue taken. The team will let you know if this applies.
You go to the hospital for a check up and blood tests:
Most of the treatment visits take about 3 hours. Some visits might take a bit longer. The trial team can tell you more about this.
You have a CT scan or MRI scan every 4 months. You stop having the scans if your cancer gets worse. You also have some blood tests at these timepoints.
You see the trial doctor a month after you stop treatment.
Follow up
You continue to have regular check ups and scans if you stopped treatment, but your cancer didn’t get worse.
If you stopped treatment because your cancer got worse, the team follow you up every 3 months. You might see them at a routine hospital appointment, or they may call you to see how you are getting on. The team ask you to continue completing the quality of life questionnaires. You do this for up to 1 year after you finish treatment.
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 capivasertib are:
Possible side effects of having the combination of capivasertib and abiraterone are:
The trial doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them any questions you may have.
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Choudhury
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.