A study looking at bone changes in men having hormone therapy and bisphosphonates for prostate cancer that has spread to the bones

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer





This study is looking at 2 blood tests which may help to measure changes in your bones during treatment for prostate cancer.

If prostate cancer spreads to the bones, doctors often treat it with hormone therapy. This treatment helps treat the cancer but can cause thinning of the bones. You may hear this called osteoporosis.

After having hormone therapy for some time, it may stop controlling prostate cancer (the cancer becomes resistant Open a glossary item to the drugs). When this happens, you may get pain in the bones where the cancer has spread.

Drugs called bisphosphonates can help to stop bone thinning. And they can help with bone pain caused by cancer that has become resistant to hormone therapy. Zoledronic acid is a bisphosphonate drug that doctors often use.

Researchers think it may be best to start taking zoledronic acid at the same time as hormone therapy, but they are not sure of the best dose to give, how often you should have it, or how long for.

In this study, everybody has hormone therapy and zoledronic acid, as well as having extra blood tests. The blood tests measure substances that may show bone changes. These biomarkers Open a glossary item are called CTx and P1NP. The aim of the study is to see if the tests are reliable and if they can show what is happening to prostate cancer in the bones.

Please note – you will not get any direct benefit from taking part in this trial and results of the blood tests will not alter your treatment. If the researchers find the blood tests are useful, they may plan another study that would use them to help doctors decide the dose of zoledronic acid for individual men.

Who can enter

You may be asked to join this study if you are being treated in Aberdeen and

You cannot enter this trial if you

  • Have already had a bisphosphonate drug
  • Are not able to take a calcium and vitamin D supplement by mouth
  • Have problems with your teeth (dental problems) that cannot be treated before you start the study treatment

Trial design

Everybody taking part has hormone therapy and zoledronic acid. Your doctors will decide which hormone therapy drug you will have.

You have zoledronic acid through a drip into a vein. You have it once every 3 months for 2 years. It takes about 15 minutes each time.

As bisphosphonates can reduce the amount of calcium in your body (hypocalcaemia Open a glossary item), you also take a supplement of calcium and vitamin D throughout the study. This is a tablet that you take once a day.

You have blood tests at the beginning of the study and then every 3 months for 3 years.

Hospital visits

You see the study team at the beginning of the study and then once every 3 months for 3 years.

You have a scan to measure the thickness of your bones (bone density) at the beginning of the study and then once a year for 3 years.

You will also have bone scans and PSA tests during the study. This is part of standard care to monitor how well hormone therapy is working.

Side effects

The side effects of zoledronic acid include

  • High temperature (fever)
  • Flu like symptoms
  • Low levels of calcium in your blood
  • Muscle cramps

Rarely, zoledronic acid can cause damage to your jaw bone (osteonecrosis) or a fast, irregular heart beat.

The side effects of hormone therapy for prostate cancer include

  • Hot flushes and sweating
  • Erection problems (impotence)
  • Tiredness
  • Weight gain
  • Low mood
  • Bone thinning (osteoporosis)

There is more information about the side effects of hormone therapy and zoledronic acid on CancerHelp UK.

You may have some discomfort or bruising when you have the extra blood tests.

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 Donald Bissett

Supported by

ARI Oncology Research Endowment Fund
NHS Grampian
University of Aberdeen

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 7782

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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