A trial of docetaxel with or without dasatinib for prostate cancer that is no longer responding to hormone therapy (READY)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial looked at dasatinib and chemotherapy for prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy.

Prostate cancer that is no longer responding to hormone therapy is known as hormone refractory prostate cancer. Doctors may use chemotherapy to treat it. The drug they most often use is called docetaxel (Taxotere). You have steroids with docetaxel to reduce the risk of side effects.

Dasatinib (Sprycel) is a type of biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Researchers hoped it would be useful for men who have hormone refractory prostate cancer.

In this trial, half the men had docetaxel and dasatinib, and half had docetaxel and a dummy drug (placebo).

The aims of the trial were to

  • Find out if dasatinib with docetaxel works better than docetaxel alone for hormone refractory prostate cancer
  • Learn more about the side effects

Summary of results

The research team found that dasatinib and docetaxel did not work better than docetaxel alone for prostate cancer that was no longer responding to hormone therapy.

This trial recruited 1,522 men from 25 countries. They all had prostate cancer that had continued to grow despite hormone therapy, but had not had chemotherapy before. The men taking part were put into 1 of 2 treatment groups at random, and

  • 762 men had docetaxel and dasatinib
  • 760 men had docetaxel and a dummy (placebo) drug

The research team looked at how long it took for the cancer to start growing again after the men started treatment. They found, on average, it was

  • 11.8 months for men who’d had docetaxel and dasatinib
  • 11.1 months for men who’d had docetaxel and placebo

They also looked at how many men in each group had died, and found it was

  • 452 men (59%) who’d had docetaxel and dasatinib
  • 462 men (61%) who’d had docetaxel and placebo

Most men taking part had at least one side effect. When they looked at how many men in each group had a more serious side effect, they found it was

  • 454 men (60%) who’d had docetaxel and dasatinib
  • 415 men (55%) who’d had docetaxel and placebo

The most common side effects in both groups were diarrhoea, tiredness (fatigue), hair loss and a drop in red blood cells. A few more people in the dasatinib group had diarrhoea, fatigue and weakness.

The trial team concluded that because there was so little difference between the groups, there was no benefit in giving dasatinib as well as docetaxel to men with hormone refractory prostate cancer.

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 Bruce Sizer

Supported by

Bristol-Myers Squibb

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 3589

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

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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