A study of sipuleucel-T for prostate cancer that has spread and is no longer responding to hormone therapy

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 2

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 abdomen and pelvis
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 steroids in 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 GM-CSF
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

Trial design

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.

Hospital visits

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.