A trial to find out if levels of interleukin 8 (IL8) in the blood can predict who will benefit from steroid treatment for prostate cancer that has spread

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 trial is looking at the link between levels of interleukin 8 in the blood and the benefit from dexamethasone for prostate cancer that has spread and is not responding to hormone therapy.

Doctors often use hormone therapy to treat prostate cancer that has spread outside the prostate gland. But eventually the cancer can stop responding to the hormone treatment and starts to grow again. This is called hormone refractory prostate cancer.

If you have hormone refractory prostate cancer, your doctor may suggest that you have chemotherapy. The chemotherapy drug they most often use is docetaxel. You may have chemotherapy in combination with steroids, such as prednisolone and dexamethasone. Some men with hormone refractory prostate cancer have dexamethasone without chemotherapy.

Doctors don’t really know why steroids help men with prostate cancer, but they think that a substance called interleukin 8 (IL8) is involved. This is a substance that occurs naturally in the body. But people with certain types of cancer, including prostate cancer, seem to have high levels of it in their blood. Dexamethasone may reduce the amount of IL8 in the blood, and doctors want to find out more about how this affects prostate cancer.

The aims of this trial are

To find out if measuring the amount of IL8 in the blood can help doctors to predict which men will get the most benefit from dexamethasone
To learn more about how dexamethasone (either alone or in combination with chemotherapy) helps men with hormone refractory prostate cancer

Please note you won’t get any direct benefit from taking part in this study, nor will it affect any treatment you have. It is possible that the results may help to improve treatment for prostate cancer in the future.

Who can enter

You can enter this trial if you

Have prostate cancer that has spread outside the prostate gland and is not responding to hormone therapy
Are well enough to take part in the trial
Are at least 18 years of age

You cannot enter this trial if you

Have had other chemotherapy or hormone therapy (apart from LHRH agonists such as Zoladex) in the last 4 weeks
Have had radioisotope therapy, such as Strontium, in the last 6 weeks
Have had steroids in the last 8 weeks (please note, it is important that you do not stop taking steroids unless your doctor tells you to)
Have had any other cancer in the last 5 years, apart from basal cell skin cancer, that has been successfully treated
Have had an experimental treatment in the last 4 weeks as part of another clinical trial
Have an infection that cannot be controlled with medicine
Have any other serious medical condition

Trial design

The trial will recruit 38 men who are going to have dexamethasone, either alone, or in combination with docetaxel chemotherapy and prednisolone.

If you take part in this trial, the doctors will take one extra sample of blood when you have blood tests before and during your treatment. This is to measure the levels of IL8 in your blood.