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A trial looking at Radium 223 for men with prostate cancer that has spread to the bones (ALSYMPCA)
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This trial looked at combining radium 223 (Xofigo) with best standard care to treat men whose prostate cancer had spread to their bones. This trial recruited men whose cancer was no longer responding to hormone therapy.
Doctors often treat prostate cancer with hormone therapy. Sometimes the hormones can stop working and the cancer can spread to the bones. Cancer that has spread to the bones can cause pain. To control the pain, doctors often start with painkillers. If these do not control the pain, they may use also use steroids, hormone therapy, estramustine or radiotherapy as well.
You can have the radiotherapy to treat the cancer cells causing pain in the bone as an injection. This is called a radioactive isotope (radioisotope). This radioactive substance targets cancer in the bones and gives off high energy. Doctors think radioisotopes stop cancer growing in the bones. This may help control bone pain.
Radium 223 is a new type of radioactive injection that gives off high energy that is more localised than radioisotopes that are currently used. We know from research that radium 223 targets cancer cells in the bones better than radioisotopes. And so reduces the amount of radiation that goes to the surrounding tissue .
The aims of this trial were to
- Find out if men having radium 223 with
best standard carelived longer than men having best standard care only
- Learn about the safety of radium 223 in men with prostate cancer that were no longer responding to hormone therapy
Summary of results
The trial found that men who had radium 223 and best standard care lived longer than those who had best standard care only.
This was a randomised trial. The men who took part were put into 1 of 2 groups. Neither they nor their doctor could choose which group they were in. Of the 921 men who took part, 614 had radium 223 and the other 317 had a dummy drug (placebo).
When the trial had recruited for about 2½ years, the
- 14 months for those who had radium 223
- Just over 11 months for those who had the dummy drug
They also looked at how long it was before the men taking part had bone problems or needed treatment for the cancer that had spread to their bones. This could be a fracture, pressure on the spine from cancer (spinal cord compression), radiotherapy for control of bone pain or surgery, for example. Doctors call these ‘skeletal related events’ or SREs. They found that the average amount of time it took was
- 13½ months for men who had radium 223
- Just under 8½ months for men who had the dummy drug
The data monitoring committee recommended stopping the trial early because they concluded that radium 223 was safe and worked well for men whose prostate cancer no longer responded to hormone therapy.
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
Dr Christopher Parker