A trial looking at docetaxel, zoledronic acid and strontium 89 for prostate cancer that has spread to the bones (Trapeze trial)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial looked at finding the best combination of treatment to give to men when their cancer had spread to their bones.

More about this trial

Doctors usually treat prostate cancer with one or more of the following treatments:

  • surgery
  • hormone therapy 
  • radiotherapy
  • chemotherapy

But sometimes these treatments don’t work and the cancer continues to grow or spread (metastasise) to another part of the body.

When cancer spreads to the bones it can be painful. Treatments to help slow the growth of the cancer and relieve the pain include chemotherapy (such as docetaxel), a group of drugs called bisphosphonates (such as zoledronic acid) or a type of radiotherapy called strontium 89.

In this trial they compared:

These treatments are not usually given together. The aims of the trial were to find more about how well the combinations work and what the side effects were.

Summary of results

The team found strontium 89 with docetaxel increased the amount of time that people lived free of symptoms of bone spread. Zoledronic acid and docetaxel increased the length of time before new bone problems occurred. 

This was a phase 3 trial. 757 men took part in this randomised trial. They were put into 1 of 4 groups by a computer. Neither they nor their doctor chose which group they were in. 

The groups were:

  • 191 men had docetaxel
  • 188 men had docetaxel and zoledronic acid
  • 190 men had docetaxel and strontium 89
  • 188 men had docetaxel, zoledronic acid and strontium 89

A trial looking at docetaxel, zoledronic acid and strontium 89 for prostate cancer that has spread to the bones (Trapeze trial)

The team found that strontium 89 had a moderate effect of increasing the amount of time the men lived without any clinical signs of the cancer in their bones getting worse. 

The average delay for new symptoms to appear was about a month. Strontium 89 had no effect on the total number of bone problems experienced by men in the trial.

Zoledronic acid significantly delayed the amount of time before men presented with a new bone problem due to their prostate cancer. The delay was around 2½ months. 

The total number of unpleasant bone complications were reduced by about a third in men who had zoledronic acid. These include:

  • the need for radiotherapy to relieve bone pain
  • bone fractures
  • surgery for bone problems 

Neither strontium 89 or zoledronic acid increased the length of time the men lived after treatment. 

The side effects were the same in each treatment group. The worst side effects reported were mainly due to the chemotherapy and were:

  • a drop in red blood cells and white blood cells
  • high temperature (fever) and a drop in a type of white blood cells called neutrophils (febrile neutropenia) 

In addition, many men in the trial reported bone pain and tiredness but these were due to the cancer itself and not the treatments.

The team also found that adding strontium 89 or zoledronic acid to chemotherapy increased the cost of treatment initially. But in the long term it was a cost saving measure because the men were healthier for longer. And in particular needed fewer treatments such as radiotherapy or surgery for bone complications of cancer.

The team concluded that giving strontium 89 with docetaxel increased the amount of time men lived free of their bone spread getting worse. But because similar treatments worked better the team felt these results couldn’t support the widespread use of strontium 89.  

In comparison as zoledronic acid reduces bone problems caused by advanced prostate cancer it should still have an important role in treatment. 

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journals. The figures we quote above were provided by the trial team who did the research. 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 Nick James

Supported by

Experimental Cancer Medicine Centre (ECMC)
GE Healthcare
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
Novartis
Sanofi Aventis
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

629

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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