A trial of triamcinolone with hormone therapy for prostate cancer (TRICREST)

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 study is looking at a steroid drug called triamcinolone (pronounced try-am-sin-o-lone) for prostate cancer that has stopped responding to hormone therapy.

More about this trial

Doctors can treat prostate cancer with hormone therapy. But after some time, the cancer may stop responding to hormone treatment and start to grow again. Doctors call this hormone refractory prostate cancer or castration resistant prostate cancer.

In this situation, you may have steroids. In this trial, researchers are looking at a steroid drug called triamcinolone. The men taking part have triamcinolone alongside hormone therapy.

The aim of the trial is to see if triamcinolone helps men who have prostate cancer that is no longer responding to hormone therapy.

Who can enter

You may be able to enter this trial if you

Have prostate cancer that is getting worse despite having hormone therapy
Have a PSA level of 5 ng/ml or higher
Are at least 18 years old

You cannot enter this trial if you

Are in bed or a chair all the time and need complete care (performance status of 4)
Can’t take steroids or have injections into a muscle
Have already had steroids or chemotherapy as treatment for prostate cancer
Are taking part in any other trial of an experimental drug
Have had any other type of cancer, apart non melanoma skin cancer or another cancer if it was successfully treated at least 5 years ago

If you have diabetes Open a glossary item , triamcinolone may upset your blood sugar balance. To be able to take part in this study, it must be possible to control this by adjusting your diabetes medication.

Trial design

This is a phase 2 trial. Everybody taking part has triamcinolone.

The first time you have triamcinolone, you have 2 injections. After that you have 1 injection each time. A member of the trial team will give the injections into the muscle in your bottom. Within a week of having the first injections, they will phone you to see how you are and ask if you’ve had any side effects.

You then have an injection once every 4 weeks. You also have a hormone therapy injections such as Zoladex or Prostap once a month, or once every 3 months.

The trial team will check the level of PSA in your blood after 12 weeks of treatment. If the level is falling, you carry on having triamcinolone.

As long as you don’t have bad side effects, you can carry on having the trial treatment until your prostate cancer starts to grow again.

The trial team will ask you to fill out a questionnaire when you join the trial, and then every month. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

The trial team will ask your permission to take an extra blood sample to study your genes and other substances in your blood. You don’t have to give this sample for research if you don’t want to. You can still take part in the main trial.

Hospital visits

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

Physical examination
Blood tests
Bone scan

You go to hospital once a month to have the triamcinolone injections. You can have your hormone therapy injections at your GP surgery

During the trial, you have regular blood tests and a bone scan every 12 weeks. At different times during your treatment, the trial team will ask you to keep all the urine you pass in a 24 hour period.

Side effects

The side effects of triamcinolone include

Mood changes
Stomach problems, indigestion or bloating
Increased appetite and weight gain
Feeling weak or tired
Increased risk of infection and wounds being slow to heal
Water retention
Diabetes
Skin problems such as thinning of the skin, bruising, rash, redness, itching or itchy raised lumps (hives)
Increased hair growth and sweating or flushing
Eye problems such as cataracts
Anxiety and problems sleeping
Thinning of your bones and muscle wasting

Rarely, people can have severe reaction to steroids. If you take steroids for a few months, you may notice weakness of your arms and legs and develop a rounder face.