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:

Prostate cancer

Status:

Closed

Phase:

Phase 3

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 bone marrow Open a glossary item 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

Trial diagram

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 testosterone Open a glossary item 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

A physical examination
Blood tests
Urine test
Heart trace (ECG )
Bone scan
CT scan or MRI scan

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.