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A trial of ipilimumab for prostate cancer that has stopped responding to hormone therapy (CA184095)

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

This trial is looking at a new drug called ipilimumab for prostate cancer that is no longer responding to hormone therapy. It is for men who only have mild symptoms, or no symptoms at all, and who have not had chemotherapy.

If prostate cancer stops responding to hormone therapy, you may have chemotherapy. But if you don’t have any bad symptoms, your doctor may suggest you don’t start any other treatment. Instead, they can keep a close eye on you, and you have regular tests to monitor your cancer. If your cancer starts to grow, or you have more symptoms, your doctor will talk to you about starting treatment at that time. You may hear this called this watchful waiting.

The men taking part in this trial have prostate cancer that is no longer responding to hormone therapy. But they don’t have bad symptoms, and would not start any more treatment at this time if they were not taking part in the trial.

Researchers think that a new drug called ipilimumab may help men in this situation, but they want to find out more about how well it works, and how safe it is.

Ipilimumab is a type of biological therapy called a monoclonal antibody (MAB). Monoclonal antibodies target cancer cells by looking for particular proteins on the cells’ surface. Ipilimumab targets a protein called CTLA4. Ipilimumab stops CTLA4 from shutting down part of the immune system. So it may help the immune system to destroy cancer cells.

The aims of the trial are to

  • See if having ipilimumab helps men with prostate cancer to live longer
  • Learn more about the side effects

Recruitment

Start 01/10/2010
End 13/06/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

  • Have prostate cancer that has spread to other parts of your body (metastatic cancer)
  • Have cancer that got worse during hormone therapy
  • Have had an orchidectomy or are having a hormone therapy drug called a pituitary down regulator such as Zoladex, and now have a low level of testosterone (your doctor can advise you about this)
  • Have satisfactory blood test results
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Don’t have any bad symptoms such as pain that you need to take opioid drugs for, or that on a scale of 1 to 10, you would rate as 4 or above
  • Are willing to use a reliable form of contraception during the trial and for 12 weeks afterwards if there is any chance your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have cancer that has spread to your liver, lungs or brain
  • Have had chemotherapy for prostate cancer
  • Have had radiotherapy to the area between your hip bones (the pelvis) in the last 3 months
  • Have already had internal radiotherapy
  • Have had any sort of immunotherapy for prostate cancer
  • Had side effects from radiotherapy to the pelvis that have only got better in the last year (unless the side effects were mild)
  • Have had any sort of vaccine to prevent an infectious disease in the last 4 weeks
  • 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 any disease where your immune system attacks your body tissues (autoimmune disease), apart from a skin condition called vitiligo
  • Have any other medical condition that the trial doctors think could affect you taking part in the trial
  • Have had any other cancer in the last 3 years unless it was completely cured with treatment just to the local area
  • Are known to be HIV, hepatitis B or hepatitis C positive

Trial design

This trial will recruit about 600 men in a number of different countries. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

  • Men in group 1 have ipilimumab through a drip into a vein
  • Men in group 2 have a dummy drug (placebo) in the same way

More people will be randomised to have Ipilimumab than placebo.

The first part of treatment is called the induction phase. It lasts for 24 weeks in total. You have treatment 4 times, 3 weeks apart. Then about 3 months later you have more tests and scans.

If these show that your cancer is not getting worse, and you are not having any bad side effects, your doctor will ask you to carry on having treatment. This is the maintenance phase of the trial. If you don’t go into the maintenance phase, the trial doctors will continue to monitor your progress.

Men who do continue into the maintenance phase then have ipilimumab or the dummy drug every 12 weeks. As long as you don’t have any bad side effects, you can carry on having treatment for as long as it helps you.

During the trial, the doctors will take some extra blood samples. They will look at the amount of the drug in your blood. This is called pharmacokinetics. They will also check to see if your immune system is responding to the drug.

You will be asked to fill out questionnaires a number of times during the trial. The questionnaires ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Before each hospital visit 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 will see the doctors and have some tests before you start treatment. The tests include

During the induction phase, you go to hospital to have either ipilimumab or the dummy drug every 3 weeks, for a total of 4 treatments. It takes about an hour and a half each time. You have another hospital appointment 2 weeks later, then 6 weeks and 12 weeks after your last treatment, you go to hospital for a bone scan and CT or MRI. You see the doctors, and have blood and urine tests each time you go to hospital.

If you carry on into the maintenance phase, you go to hospital to have blood tests, treatment and scans every 12 weeks.

When you finish treatment, you may need to go back and have more tests between 4 and 6 weeks later. And you will see the doctors every 12 weeks until you start another type of treatment. Once you start another treatment, a member of the trial team will keep in contact with you either by phone or hospital visits every 3 months to see how you are.

Side effects

As ipilimumab is a new drug, there may be 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 and severe infections
  • Feeling or being sick
  • Skin rash or itching
  • High temperature (fever)
  • Loss of appetite
  • Headache

There is a risk of having a reaction while you are having ipilimumab, or within the next few hours. You may have a fever, chills, flushing, a drop in blood pressure, or sickness.

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr Rob Jones

Supported by

Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
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Updated: 15 June 2012