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:
Status:
Phase:
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 
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 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 have prostate cancer that is
hormone dependent and has spread to your bones - You are having hormone therapy that lowers your testosterone level, or are about to start this type of treatment
- Your
kidneys are 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
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 (), 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.
Chief Investigator
Dr Donald Bissett
Supported by
ARI Oncology Research Endowment Fund
NHS Grampian
University of Aberdeen
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
