A study looking at giving triptorelin every 6 months (GREAT)

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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 4

This study is looking at giving triptorelin (Decapeptyl) every 6 months instead of every 3 months to treat prostate cancer.

Doctors can treat prostate cancer with surgery, radiotherapy or hormone therapy. This study is looking at men who are having hormone therapy.

Doctors can use the hormone therapy drugs goserelin (Zoladex), leuprorelin (Prostap) and triptorelin (Decapeptyl SR). You usually have these every 3 months. The researchers have developed a new type of triptorelin that you have every 6 months. They want to compare having triptorelin every 6 months with having other hormone therapy drugs every 3 months.

The aims of this trial are to find out

How well 6 monthly triptorelin works for prostate cancer
How safe it is to give
If the men prefer having their hormone therapy every 6 months or every 3 months

Who can enter

You may be able to enter this study if you

Have prostate cancer that has spread out of the prostate into surrounding tissue or lymph nodes (locally advanced) or has spread to another part of the body
Have had a least 2 injections of 3 monthly hormone therapy
Are at least 18 years old

You cannot enter this study if you

Have had your testicles removed
Are taking more than 1 type of hormone therapy for your prostate cancer
Are having hormone therapy before radiotherapy or with radiotherapy to treat your prostate cancer
Have had surgery to remove your prostate
Are having surgery to remove your prostate in the near future
Are having radiotherapy to relieve symptoms in the near future
Have had another cancer apart from non melanoma basal cell carcinoma or any other cancer that has been successfully treated and it has not continued to get worse or there has been no sign of it in the last 5 years
Have had another experimental drug or treatment as part of a clinical trial in the last month or may do so in the near future
Are allergic to any of the hormone therapy drugs, or their ingredients, that are used in this study
Have any other medical condition that could affect you taking part in this study

Trial design

This is a phase 4 study. It will recruit 168 men in the UK. This is a randomised study. The men 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.

The men in group 1 will continue to have their hormone therapy injections every 3 months. The men in group 2 will have their triptorelin hormone injection every 6 months.

GREAT study diagram (randomisation)

The trial team will ask you to fill out 2 questionnaires before you start treatment and at 6 and 12 months during your treatment. The questionnaire will ask about side effects, how you’ve been feeling and how satisfied you are with your current prostate cancer medication. This is called a quality of life study.

Hospital visits

All study visits take place at your general practitioners (GP). How many visits you have will depend on which group are in.

Before taking part in this study everyone will see the doctor for a physical examination and blood tests.

During treatment you see the doctor every 3 months if you are in group 1 and every 6 months if you are in group 2. At 6 and 12 months you have a physical examination and blood tests.

After treatment your doctor will talk to you about which treatment is best for you.