A trial looking at denosumab for prostate cancer (20050147)

Please note this trial is no longer recruiting patients.

This trial is looking at a monoclonal antibody called denosumab (AMG 162) for prostate cancer that has continued to grow despite treatment, but has not spread.

Doctors often treat prostate cancer with hormone therapy. But sometimes it starts to grow again and may spread to the bones (metastasise). If this happens it is usually harder to treat.

Denosumab is a new drug. It is a type of biological therapy called a monoclonal antibody. Doctors think that it may be useful for treating prostate cancer that has continued to grow but has not yet spread to the bones. They hope it can stop or slow growth, and help prevent spread. But it is a new treatment, and they are not sure yet how well it will work.

The aims of this trial are to find out

If denosumab can delay prostate cancer spreading to the bones or increase life expectancy
What effect denosumab has on the turnover of bone (this is done measuring ‘markers’ in the blood)
More about the side effects

Recruitment

Start 01/06/2006

End 30/05/2008

Phase

Phase 3

Who can enter

You can enter this trial if you

Have prostate cancer that has continued to grow despite hormone treatment but has not spread to another part of the body
Have a PSA level that has increased for 3 tests in a row and is more than 1 ng/ml (nanograms per millilitre), and either has been 8 ng/ml or more in the last 3 months, or has doubled in the last 10 months
Either had an operation to remove both testicles (a bilateral orchidectomy) at least 6 months ago, or have been on continuous anti androgen therapy and a pituitary down regulator for the last 6 months
Have a testosterone level of less than 50 ng/dL (nanograms per decilitre)
Have satisfactory blood test results
Are well enough for treatment (performance status 0 or 1)
Are at least 18 years old

You cannot enter this trial if you have

Prostate cancer that has spread to the bones or to any other part of the body (apart from lymph nodes)
Had intravenous bisphosphonate treatment
Taken bisphosphonate tablets for more than 3 years (if you had bisphosphonates for between 3 months and 3 years and finished treatment more than a year ago, you can still take part)
Had denosumab before
Had an experimental treatment as part of a trial in the last month
Had an infection in a bone (osteomyelitis) or osteonecrosis of the jaw in the past
Had any other cancer in the last 5 years, apart from basal cell skin cancer
Had a major operation or injury in the last 4 weeks
Hepatitis B, hepatitis C or HIV

Trial design

This is a randomised trial. It will recruit about 1,400 men from several different countries into two groups. The people 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. Neither will you know which group you are in. This is common in clinical trials and is called a ‘double blind’ trial.

If you are in group 1, you will have two denosumab injections into the skin (subcutaneous injections) once every 4 weeks. You will have the injections for about 2 ½ years or more, although exactly how long will depend on how well you are and how the trial goes.

If you are in group 2 you will have two dummy (placebo) injections into the skin once every 4 weeks. You will have the injections for about 2 ½ years or more, although exactly how long will depend on how well you are and how the trial goes.

Everyone taking part will also be asked to take daily calcium and vitamin D supplements. Although the trial doctors recommend you take the supplements, you can decide not to and still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

Physical examination
Oral examination (looking at your mouth, teeth and gums)
Bone scan
X-rays
Blood tests (including a PSA test)
Urine test

You may also have CT scan or an MRI scan.

During the trial you will have

Blood tests and either denosumab or placebo injections every 4 weeks
Physical examination every 3 months (12 weeks)
Bone scan every 4 months (16 weeks)
Oral examination about every 6 months (24 weeks)
Urine test about every 6 months for a year and then once a year after that
X-rays about once a year (every 49 weeks)

The research team will also take an extra blood sample to measure the amount of denosumab in your blood 8 times during the trial.

You will see the doctors 4 weeks after your last treatment, and you will have more tests at this appointment. After that you will either see the research team or they will contact you by phone every 6 months for 3 years. You will continue to see your own doctor as usual.

Side effects

As with all drugs, denosumab has some side effects. But as it is quite a new drug, there may be side effects that the doctors don’t know about yet.

The most common side effect is a drop in calcium. This can cause tingling and muscle cramps, but you will take calcium supplements to help stop this happening.

Other side effects may include

Feeling sick
Diarrhoea or constipation
Aching joints, bones or back
Tiredness or weakness
Itching or redness
Infection or inflammation in your respiratory system such as a sore throat or sinusitius

You may get several or very few side effects - everybody is different. The research team will keep an eye on you and ask you about any side effects you are having, so they can give you something to help relieve them.