A trial of a vaccine called PROSTVAC for prostate cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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
- PROSTVAC alongside GM-CSF
- PROSTVAC alongside a dummy drug (placebo)
- PROSTVAC dummy drug alongside GM-CSF dummy drug
The aims of the trial are to
- See if either PROSTVAC alone or PROSTVAC alongside GM-CSF is better than a dummy drug to help men with prostate cancer live longer
- Learn more about the side effects
Who can enter
You may be able to join this trial if all of the following apply
- You have prostate cancer that has got worse after having surgery to remove your testicles or during hormone therapy
- Your cancer has spread to your
lymph nodes or bones and is causing no, or very few, symptoms - You are taking hormone therapy called gonadotrophin releasing hormone (GnRH), unless you have had surgery to remove your testicles (your doctor can tell you which type of hormone therapy you are having)
- You have had the smallpox vaccination (the trial team will check for a mark from the vaccination or check your medical notes)
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Your blood test results are satisfactory
- You are willing to use reliable contraception if you are sexually active during treatment and there is any chance your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply
- You have already had chemotherapy for your prostate cancer spread. If you had chemotherapy when first diagnosed with prostate cancer, this must have been more than 3 years ago
- Your prostate cancer has spread to another part of your body other than your bones or lymph nodes
- You are taking regular
strong painkillers to control pain caused by your cancer, such as morphine, fentanyl or codeine - During the past 6 months, your PSA level doubled within a month
- You are having, or have had, Provenge (sipuleucel-T) immunotherapy for your prostate cancer (your doctor can tell you this)
- You have had an experimental drug in the past month
- You have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer
- You have certain heart problems (the trial team can advise you about this)
- You have had an
organ transplant or bone marrow transplant - You have a problem with your immune system
- You have had your
spleen removed - You are taking long term steroids apart from inhalers, sprays or creams to a small area of your body
- You have tested positive for HIV, hepatitis B or hepatitis C
- You have any other medical condition that could affect you taking part in this trial
- You are allergic to eggs, egg products, certain antibiotics or GM-CSF
Trial design
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.
- Men in group 1 have PROSTVAC and GM-CSF
- Men in group 2 have PROSTVAC and GM-CSF dummy drug (placebo)
- Men in group 3 have PROSTVAC dummy drug and GM-CSF dummy drug
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
- Children under 3 years old
- Pregnant or breastfeeding women
- People who have, or have had, problems such as eczema, a significant skin rash, itching , infection, burns, chicken pox or an injury to the skin
- People who have problems with their immune system
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.
Hospital visits
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.
Side effects
PROSTVAC is an experimental drug and there may be side effects we don’t know about yet. The most common side effects reported include
- High temperature (fever)
- Chills
- Tiredness
- Headache
- Swollen lymph nodes near the injection site
- Redness, soreness and swelling at the injection site
- Joint and muscle pain
- Feeling or being sick
The most common side effects of GM-CSF are
- Diarrhoea
- Tiredness
- High temperature
- Headache
- Change to the way your heart, kidneys and liver work
- Shortness of breath
- Skin rash
- Bone and muscle aches
- Swelling causing by an excess of fluid in your body
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.
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 Chris Parker
Supported by
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
