A trial looking at Radium 223 for men with prostate cancer that has spread to the bones (ALSYMPCA)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

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 care lived 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 data monitoring committee Open a glossary item looked at the data already collected. At that time they were able to look at 809 men, 541 had radium 223 and 268 had the dummy drug. They found that the average overall time the men lived was

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 (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.