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A trial of enzalutamide for prostate cancer that has spread and is not responding to hormone therapy (PREVAIL)
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This trial looked at a drug called enzalutamide (pronounced en-za-loo-ta-mide) for prostate cancer. The trial was for men who had prostate cancer that had spread to other parts of the body and was getting worse despite hormone therapy. It was for men who had not already had chemotherapy for prostate cancer. Enzalutamide is also called MDV3100.
Prostate cancer depends on the male hormone
Hormone therapy usually works well, but after a while prostate cancer may stop responding. Doctors are looking for new treatments to help men in this situation. In this trial, they looked at a new hormone therapy drug called enzalutamide.
Prostate cancer cells have
The aims of this trial were to
- See if enzalutamide helped men with prostate cancer to live longer or if it slowed down the growth of the disease
- Learn more about the side effects and what happened to enzalutamide in the body
Summary of results
The trial team found that enzalutamide did help men with prostate cancer that had spread and was getting worse despite other hormone therapy.
This was a randomised trial. The 1,717 men who took part were put into 1 of 2 treatment groups. Neither they nor their doctor could choose which group they were in. The men and their doctor also didn’t know which group they were in. This is called a double blind trial.
- 872 men had enzalutamide
- 845 men had a dummy drug (
A year after treatment the researchers looked at how many men had no sign of their cancer getting worse. They found that
- 569 men (65%) who had enzalutamide had no sign of cancer
- 118 men (14%) who had the dummy drug had no sign of cancer
After an average follow up of just under 2 years, the team looked at how many men were still alive. They found that
- 626 who had enzalutamide were alive
- 532 who had the dummy drug were alive
The most common reported side effects of enzalutamide were
- Tiredness (fatigue)
- Back pain
- High blood pressure
- Joint pain
The trial also found that for the men who had enzalutamide, there was an average delay of 17 months before they needed to have chemotherapy.
The trial team concluded that enzalutamide
- Slowed down the growth of prostate cancer
- Helped men with prostate cancer live longer
- Had few side effects
- Significantly delayed the need for chemotherapy
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 (
How to join a clinical trial
Professor Johann de Bono
Experimental Cancer Medicine Centre (ECMC)