A trial of ipilimumab after radiotherapy to the bones for men who have already had docetaxel chemotherapy for prostate cancer (CA184043)

Who can enter

You can enter this trial if you

• Are a man and have prostate cancer that has spread to your bones that is getting worse despite treatment
• Have had an orchidectomy or are having a hormone therapy drug called a pituitary down regulator such as Zoladex
• Have already had chemotherapy that included a drug called docetaxel and your cancer got worse during chemotherapy, or within 6 months of finishing the treatment
• Are well enough to take part
• Have satisfactory blood test results, including liver function tests
• Are at least 18 years old

You cannot enter this trial if you

• Have cancer that has spread to your brain
• Have already had more than 2 types of chemotherapy for prostate cancer that has spread
• Have already had internal radiotherapy
• Have had radiotherapy to your pelvis and it caused diarrhoea - unless it was very mild
• Have been taking steroids or other drugs that damp down your immune system for a long time (it is important that you don’t stop taking these without talking to your doctor first)
• Have had any sort of vaccine to prevent an infectious disease in the last 4 weeks
• Have an autoimmune disease such as rheumatoid arthritis or Crohn’s disease
• Have another serious medical condition that the trial team think would affect you taking part in this trial
• Have needed high doses of strong painkillers in the last few days, unless this was to control pain caused by cancer in your bones that your doctors hope will be eased by radiotherapy
• Have had any other cancer in the last 3 years, apart from non melanoma skin cancer or superficial bladder cancer that has been successfully treated
• Have had treatment as part of a trial looking at the drug dasatinib with docetaxel for prostate cancer
• Are known to be HIV, hepatitis B or hepatitis C positive

Trial design

This is an international trial that will recruit about 800 men in different countries. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.

The men in one group have radiotherapy to the bones, followed by ipilimumab. The men in the other group have radiotherapy followed by a dummy drug (placebo).

You start having ipilimumab or the dummy drug 2 days after your radiotherapy. You have it through a drip into a vein in your arm. This takes about an hour and a half each time. You have 4 doses, 3 weeks apart, followed by 14 weeks without any treatment. This part of the trial is called the ‘induction’ phase and lasts for 24 weeks in total.

If you have not had bad side effects, your cancer has not got worse, and your blood and urine test results are satisfactory, you then move into the ‘maintenance’ phase of the trial. You have ipilimumab or the dummy drug every 12 weeks. Treatment can last up to a year all together. But if you have bad side effects, or the trial doctors can see that your cancer is getting worse, you will stop treatment earlier.

You will be asked to complete questionnaires on several occasions during the trial. The questionnaires will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.

Before some hospital visits, you fill in a diary at home for 5 days. In this, you record whether you have pain, and details of any painkillers you take.

Hospital visits

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

• Physical examination
• Blood tests
• Urine test
• CT scan or MRI scan
• Bone scan

You go to hospital at least 9 times during the induction phase, and every 6 weeks during the maintenance phase. You will need to have blood tests before each drug treatment, which may mean extra hospital visits. You have scans every 12 weeks throughout the treatment.

You see the trial doctors again a few weeks after you finish treatment. Then you have follow up appointments, blood tests and scans every 3 months.

If you start having other treatment for prostate cancer, you will stop the follow up appointments with the trial doctors, but a member of the trial team will continue to contact you or your doctor every 3 months to see how you are.

Side effects

As ipilimumab is a new drug, there may be some side effects we don’t know about yet. From earlier trials, doctors know that the possible side effects include

• Tiredness (fatigue)
• Abdominal pain or bowel problems such as diarrhoea
• Feeling or being sick
• Rash or itching
• High temperature (fever)
• Loss of appetite
• Headache

The side effects of radiotherapy to the bone include

• Changes to the skin in the area being treated
• Feeling or being sick (if you have radiotherapy to your head, or near your tummy)
• Tiredness
• Temporary worsening of symptoms
• A drop in the number of blood cells causing an increased risk of infection and tiredness

There is more information about side effects of radiotherapy on CancerHelp UK.