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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. This trial is supported by Cancer Research UK.
Prostate cancer needs the hormone testosterone to grow. One of the treatments for prostate cancer is hormone therapy which 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. Unfortunately these can have long term side effects, such as bone thinning which can cause bone fractures, and possibly an increased risk of heart problems or diabetes.
Having oestrogen tablets instead of injections may reduce testosterone levels without causing bone thinning. But in some men, these tablets can increase their risk of having heart problems, a blood clot or a stroke.One way to avoid this might be is to have oestrogen through a patch on the skin. This is because the body processes oestrogen in a different way if it is absorbed by the skin rather than taken as a tablet.
The PATCH trial is looking at oestrogen patches that stick on the skin (transcutaneous patches). 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 to live longer
- Learn more about the side effects, particularly how the patches may affect the heart
Who can enter
You may be able to enter this trial if either
- You have recently been diagnosed with prostate cancer that has grown outside the prostate gland, OR
- You have had surgery or radiotherapy (or both) for prostate cancer in the past, but the cancer has started to grow again
To be able to join this trial, all of the following must also apply. You
- Are due to have hormone therapy
- Are up and about for at least half of the day (performance status 0, 1 or 2)
You cannot join this trial if any of these apply. You
- Have had treatment that reaches the whole body (systemic treatment, such as hormone therapy or chemotherapy), since your cancer has spread. You may still be able to take part if you started taking bicalutamide (Casoxex) or flutamide (Drogenil) recently.
- Have certain heart problems (the trial team can advise you about this)
- Have, or have had, any other cancer or medical condition that the doctors think may affect the treatment or trial results
This trial started as a phase 2 trial. The research team stopped recruiting men for a time while they looked at the results of the first 250 men who had treatment. These early results showed that oestrogen patches appear to reduce testosterone levels as well as hormone injections and didn’t cause as many heart problems. So they have now started recruiting again as a larger phase 3 trial. They aim to recruit over 2,000 men altogether.
Your doctor may plan to give you docetaxel chemotherapy or radiotherapy along with your hormone therapy. If this applies to you, you may still be able to take part as long as your doctor documents this before you join.
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.
Group 1 have hormone injections. This will be one of a group of drugs called LHRH agonists, or pituitary down regulators such as leuprorelin (Prostap), goserelin (Zoladex) or triptorelin (Decapeptyl). You have injections once every 1 to 3 months, depending on which drug you have. These are currently standard treatments in the UK.
Group 2 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.
You will see the doctors and have some tests before you take part in this trial. The tests include
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
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
Looking at the results so far, doctors think that oestrogen patches are less likely than oestrogen tablets to cause heart problems. And early results also suggest they are less likely than LHRH injections to cause bone thinning.
We have more information about the side effects of hormone therapy for prostate cancer.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Paul Abel
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Imperial College London
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUK/06/001.