A trial looking at different steroid drugs to reduce the side effects of abiraterone

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 2

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

See if different doses of prednisolone or dexamethasone are better, or just as good, at reducing the side effects of abiraterone
Learn more about how well this treatment works for prostate cancer and how it affects pain and quality of life for men with prostate cancer

Who can enter

You may be able to enter this trial if you

Have prostate cancer that has spread to another part of your body
Don’t have any symptoms, but blood tests or scans show that your cancer is getting worse despite having hormone therapy
Have very low levels of the male hormone testosterone (either as a result of hormone therapy or after having surgery to remove your testicles)
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are able to swallow tablets
Are at least 18 years old
Are willing to use condoms and another form of contraception during the trial and for a week after taking the last dose of the trial drug if you are sexually active and there is any chance your partner could become pregnant

You cannot enter this trial if you

Have a type of prostate cancer called small cell cancer
Have cancer that has spread to your brain
Have already had steroids as treatment for prostate cancer
Have had chemotherapy or biological therapy for prostate cancer
Have had radiotherapy to your prostate gland in the last 6 weeks
Have had a type of radiotherapy called radionuclide therapy for prostate cancer that has spread and stopped responding to hormone therapy
Have taken a drug called ketoconazole for longer than a week, or have taken similar drugs such as fluconazole or itraconazole in the last 4 weeks
Have taken flutamide in the last 4 weeks or bicalutamide in the last 6 weeks (there are some exceptions to this that the trial team can advise you about)
Have taken water tablets (diuretics) in the last 4 weeks
Have taken opioid painkillers such as codeine in the last 4 weeks
Have already had abiraterone
Take steroids for any other medical condition (it is important that you don’t stop taking any medication before speaking to your doctor)
Can’t take steroids for some reason
Have had another experimental treatment in the last month
Have had any other cancer (apart from non melanoma skin cancer) if your doctor thinks there is more than about a 30% risk that it will come back within 2 years
Have had problems affecting your adrenal glands or your pituitary gland
Have high blood pressure, unless it is controlled with medication that you started at least 3 months ago
Have an active infection or other medical condition that means you shouldn’t have steroids
Have had a heart attack in the last 6 months or have certain other heart problems (the trial team can advise you about this)
Have diabetes , hepatitis or long term liver disease
Have a build up of fluid in your body that causes swelling (oedema)
Are known to be very sensitive to abiraterone or to anything it contains
Have any other medical condition that the trial team think could affect you taking part

Trial design

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

A prednisolone tablet twice a day
A prednisolone tablet once a day
A lower dose prednisolone tablet twice a day
A dexamethasone tablet once a day

trial diagram

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.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
A scan looking at your bone density (DXA scan )
Heart trace (ECG )
Heart scan (echocardiogram ) or MUGA scan
CT scan or MRI scan
Bone scan

You go to hospital to see the trial team

Twice in the first 4 weeks of treatment
Once a month for the next 6 months
Then every 3 months for as long as you continue to have the trial treatment

You also need to have blood tests

Every 2 weeks for the first 3 months
Then every 4 weeks for as long as you continue having the trial treatment

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.

Side effects

The most common side effects of abiraterone include

Swollen legs due to a build up of fluid in your body
A low level of potassium in your blood
High blood pressure
Urine infections

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