
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new vaccine called PROSTVAC for prostate cancer that has spread.
If prostate cancer has spread outside the prostate gland, doctors often treat it with hormone therapy. This can work very well, but at some stage the cancer may start to grow again. This may not cause symptoms, but your doctor might see changes on a scan or there may be an increase in the level of PSA in your blood.
The immune system can recognise and kill cancer cells. But it is not always very good at doing this. In this trial, researchers are looking at a vaccine called PROSTVAC that can help the immune system to recognise and attack prostate cancer cells.
GM-CSF is a type of growth factor. Growth factors are proteins made in the body and some of them make the produce blood cells. GM-CSF makes the body produce white blood cells. The researchers want to find out if giving GM-CSF alongside the vaccine can help it to work better.
The men taking part in this trial have prostate cancer that scans or blood tests show is getting worse. But their cancer is not causing symptoms or only causing very mild symptoms. The researchers will compare men in 3 groups
The aims of the trial are to
You may be able to join this trial if all of the following apply
You cannot join this trial if any of these apply
This is an international phase 3 trial. The researchers need 1,200 men to join.
It is a randomised trial. The men taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
You have all of these as an injection under the skin. You have an injection of PROSTVAC or the dummy vaccine every 2 weeks for 3 visits. Then you have it every 4 weeks for 4 visits. You have the injections for a total of about 5 months.
At each visit, after the vaccine injection, you have an injection of GM-CSF or dummy growth factor. You then have it for the next 3 days. The 1st injection you have at the hospital. You can do the next 3 injections at home. The researchers will show you how to give yourself these injections. If you prefer, you may be able to return to the hospital to have these injections. You can talk to your doctor about this.
You will also take hormone therapy to reduce the level of in your body. If you have had surgery to remove your testicles you won’t need to take the hormone therapy.
For 3 weeks after having your 1st PROSTVAC or dummy vaccine you must not have close contact with
If you aren’t able to do this you cannot take part in the trial.
The trial team will ask you to fill out a 3 questionnaires when you start treatment, at the end of treatment and then 6 months after you have finished treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor regularly for a physical examination and blood tests. You have another bone scan after 13 weeks and CT scan or MRI scan, if needed.
Six months after the end of treatment you see the doctor for the same tests you had before starting treatment and then every 6 months for a check up.
PROSTVAC is an experimental drug and there may be side effects we don’t know about yet. The most common side effects reported include
The most common side effects of GM-CSF are
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
We have information about GM-CSF.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Chris Parker
Bavarian Nordic Inc
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”