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A study of sipuleucel-T for prostate cancer that has spread and is no longer responding to hormone therapy
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This is a study looking at a new treatment called sipuleucel-T for men who have prostate cancer that has spread and is not responding to hormone therapy.
If prostate cancer spreads to other parts of the body, doctors often treat it with hormone therapy. But after a while, this can stop working. Researchers are looking for treatments to help men in this situation. In this study, they are looking at a new treatment called sipuleucel-T.
Sipuleucel-T uses some of your own white blood cells that are part of your immune system. The white blood cells are mixed with a protein that activates them to attack prostate cancer cells.
Sipuleucel-T is already licensed in the United States. The aim of this study is to look at the practicalities of producing sipuleucel-T, ensuring its quality and giving it safely to men in Europe.
Who can enter
You may be able to enter this study if you
- Have prostate cancer that has spread to another part of your body
- Have prostate cancer that, can be seen on a bone scan or a CT scan of your
- Have prostate cancer that is not responding to hormone therapy
- Have very low levels of the hormone testosterone – either because you have had your testicles removed or you have been taking hormone therapy for at least 3 months to reduce your testosterone level
- Have a PSA level of 5 ng/ml or more
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are at least 18 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain
- Have had broken bones caused by cancer spread to your bones, or have spinal cord compression
- Have had the drugs bicalutamide, flutamide, or nilutamide in the last 4 weeks
- Have ever had drugs called denosumab or ipilimumab
- Have had
steroidsin the last 4 weeks or taken any other medication that damps down your immune system (steroid creams and inhalers are allowed)
- Have had major surgery, radiotherapy, any other drug treatment for prostate cancer that reaches your whole body (apart from hormone therapy to reduce your testosterone level), or any other experimental drug in the last 4 weeks
- Have already had sipuleucel-T or have had any sort of experimental vaccine in the last 2 years
- Have ever had an allergic reaction to anything similar to sipuleucel-T or to a growth factor called
- Have had chemotherapy, GM-CSF or another growth factor called G-CSF in the last 3 months
- Have already had more than 2 courses of chemotherapy
- Have any other type of cancer that is likely to need treatment in the next 6 months
- Have HIV, hepatitis B, hepatitis C or a virus called HTLV
- Have any other medical condition that the trial team think could affect you taking part
This phase 2 study will recruit up to 60 men in up to 4 hospitals in Europe.
First, you have a procedure called leucopheresis to remove some of your white blood cells. You have a small tube put into a vein in one or both of your arms. Blood is removed and passes it into a machine that removes some white blood cells. The rest of your blood then goes back into your body through the tube in your arm.
The trial team send the white blood cells to a laboratory in Holland where they are mixed with proteins to stimulate them to attack prostate cancer cells. This mixture is called sipuleucel-T.
A small amount of your cells are kept by the researchers to check that the quality of sipuleucel-T made in Europe is the same as in the United States.
Your sipuleucel-T is then sent back to London and about 3 days after the leucopheresis, you have it through a drip into a vein. This takes about an hour.
You have the treatment again about 2 weeks and about 4 weeks later. Each time, you have leucopheresis and then have your sipuleucel-T back through a drip into a vein about 3 days later.
The trial team will ask you to fill out a questionnaire before you start treatment and a month after you finish 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 trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
You go to a clinic in central London 3 times for leucopheresis. You go to hospital 3 times to see the trial doctors and have the sipuleucel-T treatment. You also have a physical examination within a week before the 2nd and 3rd treatment.
You see the trial team again about 1 month and 6 months after your last sipuleucel-T treatment. At each of these visits you have a physical examination and blood tests. The trial team may want to see you before 6 months if your cancer gets worse or you start another type of treatment.
The possible side effects of sipuleucel-T include
- Chills or shivering
- Tiredness (fatigue) and loss of strength
- Numbness or tingling in your lips, fingers or toes
- Feeling lightheaded
- Feeling or being sick
- A drop in the number of red blood cells (
- Constipation or diarrhoea
The trial team will discuss these and other possible side effects with you before you agree to take part in the trial.
How to join a clinical trial
Prof Thomas Powles
Assign Clinical Research GmbH
Experimental Cancer Medicine Centre (ECMC)