A trial looking at hormone patches for prostate cancer (PATCH)

This trial is comparing oestrogen patches that stick on the skin with hormone injections for prostate cancer.

Prostate cancer needs the hormone testosterone to grow. So one of the treatments for prostate cancer is hormone therapy that reduces the level of testosterone. To begin with, hormone therapy was mainly used for prostate cancer that had grown outside the prostate and couldn’t be removed with surgery. But it is now sometimes used for patients who have earlier stage prostate cancer.

This means that men can end up having treatment with injections of hormones called pituitary down regulators (also called LHRH agonists) for many years. Long term use increases the risk of some side effects, including bone thinning (osteoporosis) and bone fractures. Oestrogen tablets, another form of hormone therapy, can reduce testosterone levels without causing osteoporosis. But in some men, these tablets can increase their risk of having heart problems, a blood clot or a stroke.

This trial is looking at oestrogen patches that stick on the skin (trans cutaneous patches). Researchers think that oestrogen patches will work as well as hormone injections, but will cause fewer side effects than oestrogen tablets. This is because the body processes oestrogen in a different way if it is absorbed by the skin rather than taken as a tablet.

In this trial, some men will have hormone injections and some will have oestrogen patches. The aims of the trial are to

See if the patches help men with prostate cancer
Learn more about the side effects, particularly how the patches may affect your heart

Recruitment

Start 07/04/2006

End 30/09/2013

Phase

Phase 2

Who can enter

You can enter this trial if either

You have recently been diagnosed with stage 3 or 4 prostate cancer, OR
You have had surgery or radiotherapy (or both) for early stage prostate cancer in the past, but the cancer has started to grow again

As well as that, you must

Be due to have hormone therapy
Be well enough to take part in the trial (performance status 0, 1 or 2)
Have a normal testosterone level

You cannot enter this trial if you have

Had hormone treatment for localised prostate cancer in the last 12 months, or had treatment for longer than 12 months
Had treatment for locally advanced or metastatic prostate cancer already
Heart failure or high blood pressure
Angina, or have had a heart attack in the last 6 months
Had a blood clot (such as deep vein thrombosis, or DVT) in the past or a stroke in the last 2 years
Had any other cancer or serious medical condition that could affect how you cope with treatment in this trial

Trial design

This is a randomised trial. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. One group will have oestrogen patches and the other will have hormone injections.

If you are in group 1 you will have hormone injections. This will be one of a group of drugs called LHRH agonists, or pituitary down regulators such as leuprorelin (Prostap) or goserelin (Zoladex). You have injections once every 1 to 3 months, depending on which drug you have. These are currently ‘standard treatments’ in the UK.

If you are in group 2 you will have oestrogen patches. The patches are changed twice a week. You have 4 patches at a time for the first 4 weeks. After that you have 3 or 4 patches at a time depending on your blood test results.

The patches will go on an area of your body that is dry and doesn’t have any hair or wrinkles. This could be your shoulder, tummy, chest, arm, hip or bottom for example. Different areas will be used each time.

You will fill out a questionnaire before you start treatment, every month for 3 months, then every 3 months until 2 years. It will ask you how you have been feeling and about any side effects you have had. This is called a quality of life questionnaire.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. Tests include

Physical examination
Blood tests (including a PSA test)
Chest X-ray
Bone scan
Heart trace (ECG)

You may also have a CT scan or MRI scan, and possibly a heart ultrasound (echo) or muga scan.

If you are in group 1 you will go to the hospital or your family doctor (GP) every 1 to 3 months to have your hormone injections.

If you are in group 2 the doctors will give you some patches to take home so you can change them yourself. They may give you enough for a month or so, and then you will need to go to the hospital to collect more patches.

Everyone taking part will see the trial doctors and have blood tests and a physical examination

Every month for 3 months, then
Every 3 months until 3 years, and
Every 6 months after that

Side effects

The most common side effects of LHRH agonist injections include

Problems getting an erection (impotence)
Hot flushes
Breast tenderness
Weight gain, osteoporosis and memory problems with long term use

The most common side effects of oestrogen patches include

Problems getting an erection (impotence)
Breast tenderness or growth of breast tissue (gynaecomastia)
Skin irritation

Doctors think oestrogen patches are less likely than oestrogen tablets to cause heart problems. And less likely than LHRH injections to cause osteoporosis. But we cannot be sure about this yet.

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