A trial to see if Decapeptyl can shrink your prostate gland before radiotherapy (EDVART)

This trial is looking at Decapeptyl (also known as triptorelin) to see how well it can shrink your prostate gland before you have radiotherapy for prostate cancer.

Doctors can treat prostate cancer with surgery, radiotherapy, or hormone therapy. The men taking part in this trial are going to have radiotherapy to try to cure their prostate cancer.

We know from research that having 3 months of hormone therapy before radiotherapy can shrink your prostate gland, and help the radiotherapy to work better. Goserelin (also known as Zoladex) is a hormone therapy drug that doctors often use. In this trial, the researchers are looking at another type of hormone therapy called Decapeptyl. They will compare it with Zoladex.

The aims of the study are to

See if Decapeptyl works as well as Zoladex at reducing the size of your prostate gland before radiotherapy
Learn more about the side effects and how the injections affect men’s quality of life

Recruitment

Start 14/02/2011

End 31/05/2013

Phase

Phase 2/3

You may be able to enter this trial if you

Have been diagnosed with prostate cancer and are going to have radiotherapy to try to cure your cancer - this can be external radiotherapy or internal radiotherapy (brachytherapy)
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Are at least 18 years old

You cannot enter this trial if you

Have prostate cancer that has spread to another part of your body (your tumour is stage T4)
Have had hormone therapy in the last year
Have had another experimental drug in the last month
Are going to have chemotherapy or any other type of anti cancer drug in the next few months
Have had an operation called a TURP to remove part of your prostate gland
Have a tube in your bladder to drain urine (an indwelling catheter)
Have a very large prostate gland (the trial doctors can advise you about this)
Have been taking drugs called finasteride or dutasteride for less than 6 months (if you have been taking them for longer than 6 months or have taken them in the past but stopped at least 6 months ago, you can take part)

The trial will recruit 72 men who are going to have radiotherapy to try to cure their prostate cancer. It is a randomised trial. 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.

Men in one group have Decapeptyl injections once a month for 3 months before their radiotherapy. Men in the other group have Zoladex injections once a month for 3 months before their radiotherapy.

You have Decapeptyl injections into the muscle in your bottom. You have Zoladex injections under the skin of your tummy (abdomen). Everybody taking part also has bicalutamide tablets for 4 weeks. This is because the first hormone injection can cause your body to make more testosterone. This is called tumour flare. The bicalutamide tablets help to prevent tumour flare. After a few weeks you stop making testosterone so don’t need to carry on taking the tablets.

The trial team will ask you to fill out some questionnaires before you start treatment, each time you have an injection and after your last injection. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Transrectal ultrasound scan
Blood tests to measure the levels of PSA and testosterone in your blood

You go to hospital once a month for 3 months to see the trial team and have your injection. After the 3rd injection, you go back to see the trial team and have a transrectal ultrasound scan.

You will then have radiotherapy to try to cure your prostate cancer.

The most common side effects of hormone therapy for prostate cancer include

Hot flushes
Decreased interest in having sex (loss of libido)
Difficulty getting an erection (impotence)

There is more information about the side effects of hormone therapy for prostate cancer on CancerHelp UK.

Location of trial

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
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