A trial looking at ZD4054 for prostate cancer that has spread to the bones

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 2

This trial compared different doses of a new drug called ZD4054 for prostate cancer that had spread to the bones.

Doctors usually treat prostate cancer with surgery, radiotherapy or hormone therapy. But sometimes the cancer continues to grow, and when this happens it can be more difficult to treat.

Endothelin 1 (ET1) is a growth factor made by the body. It attaches to receptors on prostate cancer cells called endothelin A receptors. When ET1 binds to the receptor, it encourages the cell to grow and divide.

ZD4054 is a new type of biological therapy. It is called an ‘endothelin A receptor antagonist’. This means it stops ET1 attaching to the endothelin A receptor. Doctors hoped that if the ET1 could not attach to the receptor, it would not be able to tell the cell to grow and divide. But they were not sure how well it would work.

The aim of this trial was to find out how well ZD4054 worked for prostate cancer that had spread to the bones. And to find out more about the side effects of ZD4054.

Summary of results

The trial team found that overall ZD4054 did help men to live longer with prostate cancer that had spread.

This trial recruited 312 men. It was a randomised trial. The men were put in to 1 of 3 treatment groups by a computer. Neither the men nor their doctor knew which group they were in. This is called a double blind trial.

In group 1, 107 men had ZD4054.

In group 2, 98 men had a higher dose of ZD4054.

In group 3, 107 men had a dummy drug (placebo).

The average time it took for the cancer to start growing again was

4 months for men in group 1
Just under 4 months for men in group 2
Just over 3½ months for men in group 3

Overall the average amount of time the men in each group lived for was

24½ months in group 1
23½ months in group 2
Just under 17½ months in group 3

The main side effects reported were

Swelling of the arms or legs
Headache
Blocked or stuffy nose
Back pain
Feeling of being sick
Joint pain

After doing another trial the researchers decided not to develop ZD4054 further.

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.