A trial of capivasertib for prostate cancer that has spread (CAPItello-281)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at adding capivasertib to abiraterone for men with prostate cancer. It is for men whose:
- cancer has recently been diagnosed and has spread elsewhere in the body. This is called advanced or metastatic prostate cancer.
- cancer cells have low levels of a protein called PTEN
More about this trial
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:
- how well abiraterone and capivasertib work for people who have low levels of PTEN on their cancer cells
- more about the side effects
- how treatment affects
quality of life
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 to have treatment if all of the following apply. You:
- have
adenocarcinoma of the prostate - have recently been diagnosed with cancer and it is confirmed that the cancer has spread to another part of the body in the last 3 months
- have cancer that has low levels of PTEN on the prostate cancer cells
- are male
- have cancer that is sensitive to hormone treatment
- have had surgery to remove your testicles or you are taking drugs to lower the level of
testosterone in your body. For example you are having goserelin, leuprorelin, degarelix or bicalutamide. To take part you must have had surgery or started hormone treatment within 3 months of starting the treatment in this trial. - don’t have symptoms that prostate cancer can cause or have only mild symptoms. Your doctor will know this.
- have a sample of tissue (
biopsy ) of your cancer available for the trial team to do some tests on - have cancer that the doctor can see and measure on a scan
- are suitable to have abiraterone and steroid treatment
- can swallow medication
- are willing to complete questionnaires for a week before starting trial treatment. These ask how you are feeling and about any pain you may have.
- have satisfactory blood test results
- are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- are willing not to donate blood during the trial and for a period after
- are willing to use a condom and another type of reliable contraception during the trial and for a period after if there is any chance your partner could become pregnant
- are willing not to donate sperm during the trial and for a period after
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have had radiotherapy to a large area of your body within a month of starting trial treatment
- have cancer that has spread to the brain or spinal cord or you have
spinal cord compression unless it isn’t causing symptoms, has been treated and is stable - have another cancer that has got worse and needed treatment in the last 3 years. This doesn’t include
non melanoma skin cancer that has been successfully treated. - have had other chemotherapy, an
immunotherapy , certain drugs that damp down the immune system or any other cancer treatment within 3 weeks of starting trial treatment - have had a chemotherapy drug called mitomycin C or a drug called a
nitrosourea within 6 weeks of the first dose of trial treatment - have taken part in another trial of an experimental treatment within a month of starting the treatment in this trial
Medical conditions
You cannot join this trial if any of these apply. You:
- have scarring on the lungs or active inflammation of the lungs (
pneumonitis ) - have had a heart attack, stroke or blood clot in the last 6 months or a significant heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial.
- have diabetes and need to have insulin injections or you have high levels of sugar in the blood
- have had major surgery within a month of starting trial treatment
- have a problem with bleeding and have an active bleed
- have HIV, an active hepatitis B or hepatitis C infection, or any severe infection that needs treatment
- have ongoing problems with feeling or being sick caused by chemotherapy
- have a problem with your
digestive system , you have had surgery to remove part of your bowel or you can’t absorb medication - have had a bone marrow transplant with somebody else’s cells (an
allogeneic transplant ) or you have had an organ transplant in the past - take any drugs that affect an enzyme called CYP within 2 weeks of starting trial treatment
- are allergic to capivasertib, abiraterone or anything they contain
- have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Trial design
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 and then
- some people having trial treatment
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:
- abiraterone and capivasertib
- abiraterone and a dummy drug (
placebo )
Capivasertib and the dummy drug are tablets. Each week you take them:
- twice a day for 4 days and then
- you don’t take any tablets for the next 3 days
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:
- see how well the treatment is working
- look at
genes in cancer cells to understand more about prostate cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - look for cancer cells in the blood. These are known as circulating tumour cells or CTCs.
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:
- before you start treatment
- at set times during treatment
- after treatment for up to 1 year
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.
Hospital visits
Before you have the treatment in this trial, you see a doctor and have some tests.
These include:
- a
physical examination - heart scan (
echocardiogram ) or MUGA scan - blood tests
- urine tests
- heart trace (
ECG ) - CT scan or MRI scan
- bone scan
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:
- every 2 weeks for the first 3 months and then
- once a month for the first year and then
- every 2 months until you stop the trial treatment
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.
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 capivasertib are:
- high blood sugar
- diarrhoea
- skin rash or dry skin
- feeling or being sick
- redness and swelling of the mouth and lips
- loss of appetite
Possible side effects of having the combination of capivasertib and abiraterone are:
- diarrhoea
- skin rash
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:
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
Professor Choudhury
Supported by
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
