A trial comparing denosumab and zoledronic acid for prostate cancer that has spread to the bones (20050103)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial compared denosumab with zoledronic acid to see which is better for prostate cancer that has spread to the bones.

When cancer spreads to the bone (bone metastases) it can make the bone weaker and cause pain. Drugs called bisphosphonates can slow down the damage and reduce pain. Zoledronic acid (Zometa or zoledronate) is a bisphosphonate which doctors sometimes use for cancer that has spread to the bones.

In this trial, researchers tested another drug called denosumab. They hoped it would help slow down the bone damage and reduce pain. Denosumab is a type of biological therapy called a monoclonal antibody.

The aims of this trial were to find out

  • How well denosumab works for prostate cancer that has spread to the bones
  • More about the side effects

Summary of results

The research team found that denosumab did help people with prostate cancer that had spread to the bones.

This trial recruited 1,901 men with prostate cancer. They had all had treatment before but their cancer had continued to grow and had spread to the bones.

  • 955 men had denosumab as an injection into the skin and a dummy (placebo) injection into a vein every 4 weeks
  • 946 men had a dummy injection into the skin and a zoledronic acid (zoledronate) injection into a vein every 4 weeks

Neither the men nor their doctors knew which treatment they were having. This is called a double blind trial.

The research team looked at a number of factors including how many men had fractures or bone pain, and how many needed treatment such as radiotherapy. They call these ‘skeletal related events’.

They found the most common time until the first skeletal related event was

  • Nearly 21 months for the men who had denosumab
  • Just over 17 months for the men who had zoledronic acid

They also looked at when the cancer started to grow again and how many men were living. They found there was no difference between the 2 groups.

Most of the men in both groups had some side effects and the rates were similar in the 2 groups.

The researchers concluded that denosumab was better than zoledronic acid at delaying the time to the first skeletal related event caused by prostate cancer that has spread to the bone.

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed) or published in a medical journal yet. 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

Professor Peter Hoskin

Supported by

Amgen

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 882

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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