A trial of ipilimumab after radiotherapy for prostate cancer spread to the bones (CA184043)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial looked at a drug called ipilimumab after radiotherapy for prostate cancer that has spread to the bones.

Doctors usually treat prostate cancer that has spread with a chemotherapy drug called docetaxel. But sometimes the cancer stops responding or continues to grow despite having this treatment. So researchers are looking for ways to improve treatment. In this trial, they looked at radiotherapy to the bones followed by a drug called ipilimumab.

Ipilimumab is a type of biological therapy called a monoclonal antibody. It may help the body’s immune system Open a glossary item to attack cancer cells.

The aims of this trial were to find out

  • How well the combination of radiotherapy and ipilimumab works for prostate cancer that is not responding to other treatments
  • More about the side effects

Summary of results

The trial team found that the combination of radiotherapy and ipilimumab was not any better than radiotherapy alone for this group of men.

The trial recruited men who had already had docetaxel chemotherapy for prostate cancer that had spread to their bones.

799 men took part and

  • Half had radiotherapy to the areas of cancer spread to the bone (up to 5 areas could be treated) and 4 doses of  ipilimumab
  • Half had radiotherapy to the areas of cancer spread to the bone and 4 doses of dummy drug (placebo)

Following the initial treatment, the men continued to have ipilimumab or the dummy drug once every 3 months to try and keep the cancer under control for longer. Doctors call this ‘maintenance treatment’.

The trial team looked at the average length of time the men lived. They found there was no difference between the 2 different groups.

The most common side effects of ipilimumab were diarrhoea, tiredness, pain and irritation to the bowel and a drop in red blood cells causing tiredness.

The trial concluded that the combination of radiotherapy and ipilimumab was no better than radiotherapy alone for this group of men.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Santhanam Sundar

Supported by

Bristol-Myers Squibb
NIHR Clinical Research Network: Cancer

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 4789

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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