
"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 comparing different steroid drugs alongside abiraterone as treatment for prostate cancer that has spread to other parts of the body. It is for men whose prostate cancer is not causing symptoms, but is no longer responding to hormone therapy.
If prostate cancer has spread outside the prostate gland, doctors often treat it with hormone therapy. But after a while, prostate cancer may stop responding. If this happens, you may have a drug called abiraterone.
If you have abiraterone, you usually have a steroid drug with it. This is to reduce some of the side effects of abiraterone such as such as high blood pressure, low levels of potassium in your blood, and swollen legs due to a build up of fluid in the body.
In this trial, researchers are comparing 2 different steroid drugs called prednisolone and dexamethasone. They are looking at 3 different doses of prednisolone and 1 dose of dexamethasone.
The aims of the trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 2 trial will recruit 144 men in Europe. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. But you will both know which treatment you are having.
Everybody will take 4 abiraterone tablets once a day. Depending on which group you are in, you also have 1 of the following
The length of time you stay in the trial will depend on when you join and how much the treatment helps you. As long as you don’t have bad side effects, and your cancer doesn’t get worse, you can carry on having treatment for up to 5 years after the first man joins the trial.
If you stop having treatment because you have side effects, you may be able to start the treatment again when the side effects improve.
The trial team will ask you to fill out some questionnaires before you start treatment, a couple of times during treatment and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
You go to hospital to see the trial team
You also need to have blood tests
You have a scan every 3 months during treatment. This will be either a CT, MRI or bone scan. You also have a DXA scan after 3 months, 6 months and a year.
When you finish treatment, or after 3 years of treatment (whichever is sooner), you see the trial team again and have a physical examination, blood tests, a CT or MRI scan, a bone scan and a DXA scan. You see them again about 4 weeks later and have a physical examination and blood tests.
You may be able to carry on having abiraterone and steroids for longer than 3 years if your cancer responds well to the treatment. If you do, you carry on seeing the trial team every 3 months.
Whenever you finish taking the tablets, the trial team will continue to monitor how you are for up to 5 years.
The most common side effects of abiraterone include
Steroids may reduce some of the side effects of abiraterone, but may cause some side effects themselves. The most common side effects of steroids include
We have more information about the side effects of prednisolone and dexamethasone.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Gerhardt Attard
Experimental Cancer Medicine Centre (ECMC)
Janssen
NIHR Clinical Research Network: Cancer
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.”