A trial looking at denosumab for prostate cancer (20050147)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial looked at a monoclonal antibody called denosumab (AMG 162) to prevent the spread of prostate cancer to the bones.

More about this trial

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

Denosumab is a type of biological therapy called a monoclonal antibody. Doctors thought that it may have been useful for treating prostate cancer that had continued to grow but had not yet spread to the bones. They hoped it could stop or slow the cancer spread to the bones.

The aims of this trial were to find out

If denosumab could delay prostate cancer spreading to the bones
More about the side effects

Summary of results

The trial team found that denosumab can delay prostate cancer spreading to the bones.

This was a randomised trial. The men taking part were put into 1 of 2 groups. Neither they nor their doctor could choose which group they were in. It was a double blind trial. Neither their doctor nor the men knew which group they were in. This trial recruited 1,432 men. Half had denosumab and the other half had a dummy drug (placebo).

The average amount of time the men had denosumab was just over 19 months. And the men who had the dummy drug had it for 18 months.

The trial team looked at how long it was before either the cancer in the men taking part had spread to the bone, or how long they lived for.The average amount of time it took for men having denosumab was about 29½ months. And for men having the dummy drug it was just over 25 months.

The side effects between the 2 groups were similar and included

Back and joint pain
Constipation
Diarrhoea
Urine infection

Two serious, but rare, side effects occurred in the 716 men who had denosumab

33 had osteonecrosis of the jaw
12 had low levels of calcium (2 men in the dummy drug group also had low levels of calcium)

When the trial team looked at a similar large trial using denosumab in prostate cancer, the number of men who had osteonecrosis of the jaw was about the same.

The trial team concluded that denosumab could delay prostate cancer spreading to the bones.

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.