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A study looking at bone changes in men having hormone therapy and bisphosphonates for prostate cancer that has spread to the bones
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at 2 blood tests which may help to measure changes in your bones during treatment for prostate cancer.
After having hormone therapy for some time, it may stop controlling prostate cancer (the cancer becomes
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
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 have prostate cancer that is
hormone dependentand has spread to your bones
- You are having hormone therapy that lowers your testosterone level, or are about to start this type of treatment
kidneysare working well enough
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
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 (
You have blood tests at the beginning of the study and then every 3 months for 3 years.
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.
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)
- Weight gain
- Low mood
- Bone thinning (osteoporosis)
You may have some discomfort or bruising when you have the extra blood tests.
How to join a clinical trial
Dr Donald Bissett
ARI Oncology Research Endowment Fund
University of Aberdeen