A study looking at using a vaccine for prostate cancer (VANCE01)

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 1

This study is looking at a vaccine for men with prostate cancer who are due to have their prostate gland removed or who are having active surveillance. Active surveillance means monitoring the cancer closely and treating it if it starts to grow.

This study is for men with localised prostate cancer that is low or intermediate risk.

More about this trial

Vaccines are a newer way of treating cancer.

Doctors think that one of the ways cancers can spread in the body is because the immune system does not recognise the cancer cells as foreign and so does not attack them.

A vaccine could encourage the body to attack the cancer cells (an immune response Open a glossary item).

This study is looking at 2 vaccines used in combination

  • Chimpanzee adenovirusOX1 (ChAdOx1.5T4)
  • Modified vaccine virus Ankara (MVA.5T4)

Both of these vaccines have been designed to produce a protein called 5T4. 5T4 is found on prostate cancer cells.

Doctors think that by injecting these vaccines the body’s immune system will target the protein and destroy the cancer cells.

The doctors also want to see if giving a low dose of a chemotherapy tablet called cyclophosphamide with the vaccines will help them to work better by increasing the immune response.

The study aims to find out if

  • The vaccines are safe to give to men with low or intermediate risk localised prostate cancer
  • The vaccines works on the immune system and recognise the 5T4 protein

Who can enter

The following bullet points list the entry conditions for this study. If you are unsure about any of these speak with your doctor or the study team. They will be able to advise you.

You may be able to join this study if all of the following apply.

You are due to have your prostate gland removed (radical prostatectomy) and

  • You have been diagnosed with prostate cancer in the last 6 months which is low or intermediate risk
  • You are able to wait for up to 12 weeks before you have your surgery

Or you are having active surveillance and

  • You have been diagnosed with prostate cancer which is low or intermediate risk
  • You have had a type of MRI scan called an mpMRI scan
  • Your prostate cancer has been stable for at least 12 months
  • Your doctor thinks you are suitable to remain on active surveillance

And everyone wanting to take part must

  • Have satisfactory blood test results
  • Be willing, and have a partner who is willing, to use reliable contraception during the time they are on the study
  • Be at least 18 years old

You cannot join this study if any of these apply. You have

  • Prostate cancer that the doctors think may have spread to another part of your body (metastatic cancer)
  • A Gleason grade Open a glossary item of 5 from any prostate biopsies Open a glossary item
  • Had invasive treatment (for example surgery) for any condition of the prostate such as benign prostate disease (BPH) in the last 2 years
  • Had any other type of cancer in the last five years apart from basal cell carcinoma
  • An autoimmune disease Open a glossary item and need to have medication to control this or the disease is currently active
  • Any other condition that could lower your immune system Open a glossary item such as a chronic infection
  • Taken part or are planning to take part in research for any experimental product in the month before joining this study or during the study
  • Had immunoglobulins or any other blood product in the last 3 months
  • A history of allergic reactions (including hypersensitivity, anaphylaxis or haemorrhagic cystitis)
  • An  allergy to the antibiotic neomycin, certain vaccines and any component of the study vaccines such as egg products
  • HIV, hepatitis B or hepatitis C
  • Problems with alcohol or drugs that concerns your doctor
  • Any other serious medical condition or mental health problem that the study team think could affect you taking part

Trial design

This is a phase 1 study. The study team need 48 men to take part.

The study is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

You have the vaccine either two or three times, this depends on the treatment group you are in. The time between each vaccination depends on the treatment group you are in. You have it as an injection into your thigh.

Half the men taking part will also take a low dose cyclophosphamide tablet twice a day for 1 week before each vaccination.

For men having surgery to remove their prostate gland there are 6 treatment groups. There will be twice as many men in groups 5 to 6 than in groups 1 to 4.

Men having surgery have the operation 2 to 4 weeks after the final vaccination.

Treatment groups for men having surgery

  • Group 1 have ChAdOx1.5T4 then 4 weeks after that they have a MVA.5T4 vaccination and another 4 weeks after that
  • Group 2 have cyclophosphamide tablets for 1 week before each vaccination. Their first vaccination is ChAdOx1.5T4 then 4 weeks after that they have a MVA.5T4 vaccination and another one 4 weeks after that
  • Group 3 have MVA.5T4 3 times 4 weeks apart
  • Group 4 have cyclophosphamide tablets for 1 week before each vaccination and then MVA.5T4 3 times 4 weeks apart
  • Group 5 have 1 vaccination with ChAdOx1.5T4 and 1 week later a MVA.5T4 vaccination
  • Group 6 have cyclophosphamide tablets for 1 week before each vaccination. They have 1 vaccination with ChAdOx1.5T4 and 1 week later 1 with MVA.5T4

Group 1 to 6 diagram

Treatment groups for men having active surveillance

  • Group 7 have 1 vaccination with ChAdOx1.5T4 and 1 week later a  MVA.5T4 vaccination
  • Group 8 have cyclophosphamide tablets for 1 week before each vaccination. They have 1 vaccination with ChAdOx1.5T4 and 1 week later a MVA.5T4 vaccination

Group 7 and 8 diagram

You will be given a diary card either when you start your cyclophosphamide tablets or on the first day of your vaccination. This is for you to record your

  • Temperature
  • Measurements around the vaccination site (the study team will explain this in more detail)
  • How you are feeling.
  • If you are taking cyclophosphamide you also need to record when you have the tablets.

You complete the diary for up to 14 days after your 1st vaccination and 7 days after your 2nd and if you are having one, your 3rd injections.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

  • Blood tests
  • A urine test
  • A physical examination

You may also have an mpMRI scan.

If you are in one of the groups having cyclophosphamide you need to pick the tablets up from the hospital a week before you start your vaccinations.

You go to hospital for your injections and have to stay for about an hour after having them.

Before each injection you have your blood pressure, temperature and heart rate checked. This will be done again around 30 minutes after the vaccination. The doctors may also take a photo of the injection site if you have agreed to this. You also have blood tests and urine tests done at these visits.  You have these to

  • Check your general health
  • Monitor your prostate cancer
  • See how the vaccines are working in your body

A nurse will call you the day after your injection to see how you are and to remind you to complete your diary card.

If you are having cyclophosphamide tablets the week before your injection they will also call you to remind you to take these.

If you are having surgery

2 to 4 weeks after your final vaccination you have your operation to remove your prostate gland.  If you had an MRI scan done before you started the study you may have another one done a few days before your operation. At this appointment you will see the doctor and they will ask you for some blood samples and a urine sample.

The study team see you about 3 months after your operation. You then see your own doctor for follow up appointments.

If you are on active surveillance

8 weeks after your last vaccination you have an mpMRI scan.

Depending on the results of the MRI scan you have a sample of the prostate gland taken (a biopsy) by either

  • A standard needle biopsy (a TRUS biopsy) or
  • A targeted prostate biopsy

These are done within about 2 weeks of the MRI scan.

The study team then see you every 3 months until a year after you started the study treatment. They will ask you for blood and urine samples at these visits.

Side effects

The side effects of the vaccines include

  • Pain and discomfort at the injection site
  • The injection site may become warm, red or swollen
  • Tiredness
  • Headache
  • High temperature (fever)
  • Muscle and joint pain

There is also a risk of an allergic reaction to the vaccines. So, a specialist doctor will be there when you have the injections in case you have a severe allergic reaction (anaphylaxis).

As the vaccines are new there may be some side effects that are not known. The team will give you a telephone number to contact them if you are worried about anything.

The most common side effect of low dose cyclophosphamide is

  • Low white blood cells increasing the risk of infection

Find out more about cyclophosphamide

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Freddie Hamdy

Supported by

Experimental Cancer Medicine Centre (ECMC)
European Commission
NIHR Clinical Research Network: Cancer
University of Oxford

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13025

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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