A trial looking at Zibotentan (ZD4054) for prostate cancer that has come back after hormone treatment (D4320C00015)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial was looking at a drug called zibotentan (ZD4054) for prostate cancer that had come back after hormone treatment. It was for men who had a rising PSA level but no signs that their cancer had spread to another area of the body.

Most men with early stage prostate cancer are treated successfully. But for some men the cancer comes back. Doctors often pick this up because the PSA level starts to rise. If this happens, many men will have hormone treatment. This can work very well but unfortunately the cancer often starts to grow again in time, causing the PSA level to rise again. This is called hormone refractory prostate cancer. It is not clear what the best treatment is in this situation.

Zibotentan is a type of biological therapy. It works by blocking growth receptors on cancer cells called endothelin receptors. It can be called an endothelin blocker or endothelin receptor antagonist. We knew from earlier trials that endothelin blockers may be able to slow down the growth of prostate cancer.

In this trial, doctors wanted to see if zibotentan helped men with hormone refractory prostate cancer to live longer. As all treatments have side effects, it is important that people do not have treatments that don’t work. The doctors were comparing zibotentan to a dummy drug (placebo).

The aims of this trial were to

Find out if zibotentan helps to slow down the growth of hormone refractory prostate cancer that hasn’t spread to other areas of the body
Learn more about the side effects

Summary of results

In this trial zibotentan did not help men with prostate cancer. The trial recruited 1,421 men. It was a randomised trial. Some of the men had zibotentan, others had a dummy drug.

Results of the trial were published in 2013 explaining that the trial was stopped early after a review by the committee that monitors the safety and design of the trial (the data monitoring committee). This was because early results suggested that it was very unlikely this trial would be able to show that zibotentan helps men with hormone refractory prostate cancer to live longer.

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.