About the Patch Trial
About the study
Prostate cancer needs the male hormone testosterone to grow. Hormone therapy is usually used to lower the level of testosterone, which helps to control the growth of the cancer. LHRH agonists (luteinizing hormone-releasing hormone agonists) are the most common type of injection or implant. The pituitary gland in the brain makes a hormone called luteinising hormone (LH), and LHRH agonists work by interfering with this action and stop the testicles making testosterone. There are several available that all work in the same way, including:
- goserelin (Zoladex®)
- leuprorelin acetate (Prostap®)
- triptorelin (Decapeptyl®)
Unfortunately, standard hormone treatment with injections or implants can cause a range of long-term side effects. They may cause bones to thin which might lead to them becoming fragile (osteoporosis) and more likely to break. They might also increase the chance of developing diabetes or heart disease.
An alternative way of giving hormone therapy is through the use of hormone patches. These patches, referred to as transdermal oestradiol, allow oestradiol (a type of hormone) to pass through the skin. Giving hormone therapy this way might be able to treat the cancer in a similar way as standard hormone therapy without causing some of these side effects.
The PATCH trial has already shown transdermal oestradiol can suppress testosterone as effectively as standard hormone therapy, while having a number of other potential benefits:
• It does not cause the bone to thin.
• Men treated with transdermal oestradiol generally reported better quality-of-life than those on hormone injections.
• Cholesterol and glucose levels increased in men on hormone injections but decreased in those on transdermal oestradiol.
The PATCH trial has been extended in order to look at whether transdermal oestradiol patches can control prostate cancer as well as standard hormone injections.
How we use your data
The co-ordination of the study has not changed since it began however there have been new data protection regulations introduced across the UK and Europe and we need to update all of our PATCH participants on how we collect and protect the information provided for the study.
The MRC CTU at UCL will continue to use information from you and / or your medical records in order to undertake this study and will act as the joint data controller for this study with the Sponsor. This means that we are responsible for looking after your information and using it properly.
Your rights to access, change or move your information are limited as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information at www.mrcctu.ucl.ac.uk/general/privacy-policy.
How your data will be stored and collected
Your hospital will collect information from you and from your medical records for this research study in accordance with our instructions. They will use this information as needed for your care.
The MRC CTU at UCL will collect information about you for this research study from your hospital. This information will include health information, which is regarded as a special category of information. We will use this information to conduct our research. This information is supplied via paper forms designed to collect the study information.
Certain individuals from the MRC CTU at UCL, the Sponsor and regulatory organisations may look at your medical and research records to check the accuracy of the research study. UCL will only receive information without any identifying information. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.
The MRC CTU at UCL will keep information about you for a minimum of 25 years after the study has finished.
Trial Participant Information Linkage
The information we receive from study staff at your hospital provides the PATCH researchers with information about your progress. However we need accurate long term information to know if the treatments being tested are improving life expectancy.
Through our research we would like to improve reliability of the collection of long term data of a study’s result by investigating linkage of the information we collect about you with electronic health records held by a variety of national registries and bodies such as the Office of National Statistics, NHS Digital, Public Health England and National Clinical Audit programs.
We will securely transfer the directly identifiable data such as your name, NHS number or postcode for this purpose only. This is information that you provided when you first joined the study to enable us to do this. We will continue to store this personal data separately from the clinical data. All information is stored securely at the MRC CTU at UCL and the data controller is UCL. Only the mentioned parties will access the identifiable information on the participants (ONS, NHS Digital, national Clinical Audit programs and UCL). Any published results from the trial will not lead to participants being directly identified.
If at any point you do not want us to collect information about your health from national sources of health information then please talk to your study doctor or nurse who will then inform the PACTH study team of your decision. Contact details for members of your study team will be listed within your Patient Information Sheet (PIS). This decision will not affect the care you receive in any way.
How your data will be used in future & other research
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the relevant legislation, ethics and research policy requirements.
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
If you have any questions or concerns about the Study please contact your PATCH site team.
