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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

 

 

Introduction

This privacy notice explains who we are, the personal data we collect, how we use it, who we share it with, and your legal rights. This notice is in addition to UCL’s privacy policy (https://www.ctu.mrc.ac.uk/privacy/) and applies specifically to personal information held for research purposes in the PATCH trial.  We keep this Privacy Notice under regular review.

About MRC CTU at UCL

The MRC CTU at UCL is one of the UK’s leading centres for clinical trials. Our research helps to improve health care in the UK and around the world, resolving internationally important questions in infections and cancer, and delivering swifter and more effective translation of scientific research into patient benefits. The MRC CTU at UCL obtains appropriate ethical and legal approvals for all trials and studies that it runs. You can find out more about the MRC CTU here: https://www.ctu.mrc.ac.uk/.

The MRC CTU is part of the School of Life and Medical Sciences at UCL and is running the PATCH trial. UCL is the study sponsor and is the data controller.

Collecting personal information

[This section is about what will be collected and why (categories of personal data obtained) – e.g. purpose of processing, legal basis in GDPR (research in the public interest) and common law duty of consent.]

Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data). Information about your health is a special category of personal data.

To safeguard your rights, we will collect the minimal personal information necessary for our PATCH trial. We collect personal information, which includes information about your health and treatment, from the following sources:

  1. Directly from you with your consent
  2. From third party sources which routinely collect your health data (such as NHS Digital, other UK NHS bodies, and disease registries) with your consent.

Personal information specifically collected for the PATCH trial include hospital admissions including diagnoses and treatment, and information on cancers and on deaths.

Using your personal information

[How we use it (linkage, analysis, retention – how long) and who we share it with (any transfers to outside EEA etc).]

All of the personal information we collect is only used for the purposes of carrying out our scientific research in the public interest.

UCL is the data controller for processing personal data in the PATCH trial. This means they are responsible for ensuring that the processing of your data complies with the General Data Protection Regulation (GDPR; https://www.gdpr.org) and related legislation. The lawful basis for processing personal information in the PATCH trial is GDPR Article 6(1)(e) – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller,” and Article 9(2)(j) for special category data – “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.” We demonstrate that our research serves the interests of society by following the UK Policy Framework for Health and Social Care Research (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/).

Data linkage

We will ask for your consent to collect your NHS number, date of birth and postcode so we can link to your health records in databases held by NHS Digital, other NHS national bodies, Public Health England, Healthcare Quality Improvement Partnership, cancer registries, and their successor(s). The data we receive will provide us with information on your long-term health outcomes, such if your cancer recurs, new cancer diagnoses, long term side effects and other treatments you may receive. Linkage to these databases will enable us to better understand the long-term health issues arising in people who have been treated for prostate cancer, and tailor future treatment accordingly. Collecting information in this way should make things easier for the staff at your hospital, allowing them to spend more time on clinical care.

There is more information about the trial in the Patient Information Sheet and Consent Form that you received when you joined the trial. You can also contact the research nurse or doctor at your hospital if you have any questions, or you can visit the trial/study website at http://patch.mrcctu.ucl.ac.uk/.

Retention and storage of your data

The MRC CTU at UCL stores all personal identifiable data securely, and only authorised trained staff are permitted access. Your NHS number, date of birth, and postcode will be stored in the UCL Data Safe Haven until they are transferred to the data providers (NHS Digital, other NHS national bodies, Public Health England, Healthcare Quality Improvement Partnership, and cancer registries) for linkage with your health records. The UCL Data Safe Haven is known as a Trusted Research Environment – a secure space where sensitive personal data is stored and accessed. 

Your NHS number, date of birth, and postcode will only be used by the data providers to link to your health records in their databases so that they can extract the appropriate data for our use. The NHS number and the other personal data used for linkage are removed before the data is sent to us for analysis.

We retain personal information for as long as is necessary to support the research study and its findings, and in line with research retention schedules and regulatory requirements specific for research. For PATCH, your data will be held for 25 years after the end of the study.

We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. We have established procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.

NHS Digital, other NHS national bodies, Public Health England, Healthcare Quality Improvement Partnership, and cancer registries and UCL (by MRC CTU) will access identifiable information on participants. There will be no access to data by other third parties not listed in this agreement. No individual patients will be directly identified through any published results from the study. 

Researchers (under the supervision of UCL) who wish to access the data from this study and/or contact participants about future research will have to apply to the CTU’s Data Access Committee.

Your legal rights

You have rights over your personal information by law. Your usual rights to access, change or move your information are limited because of exceptions applicable to some types of research, and also because we need to manage your information in specific lawful ways in order for the research to be reliable and accurate.

You have the right to request the restriction or suppression of your personal data, so you have the right to withdraw your consent to data linkage at any time.

If you decide to withdraw consent to data linkage, there are simple ways to let us know:

  • If you are still in contact with your study team (i.e. you are still attending trial follow-up visits):
    Please contact your study team using the details in your Participant Information Sheet (PIS). They will pass your decision on to the PATCH study team at the MRC Clinical Trials Unit (CTU).
  • If you are no longer in touch with your study team (i.e. you no longer attend follow-up visits):
    You (or someone you trust, like a family member or friend) can contact the MRC Clinical Trials Unit (CTU) directly by email, or request a call-back using the contact details listed on our website: https://www.mrcctu.ucl.ac.uk/contact/
  • If you decide to withdraw, we will no longer collect your data from national health registries:

This decision will not affect the care you receive in any way. If you choose to withdraw , we will use your data up to the point that you say you no longer wish to participate.

If you would like further information or have any concerns about the use of your personal information, please contact our Data Protection Officer by email data-protection@ucl.ac.uk or by writing to University College London, Gower Street, London WC1E 6BT.