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STAMPEDE TRIAL

We are inviting you to take part in a study called STAMPEDE

·  Your doctor has explained to you that you have prostate cancer and has invited you to participate in this study.

·  Before you decide, it is important for you to understand why the research is being done and what it will involve.

·  Please take time to read the following information carefully. Discuss it with friends and relatives if you wish.

·  Take time to decide whether or not you would like to take part in this study. Participation is entirely voluntary. This decision is up to you. If you decide not to take part, this will not affect the care you get from your doctors in any way.

·  You can decide to stop taking part in the study at any time, without giving a reason.

·  Please just ask if there is anything that is not clear or if you would like more information.

·  Thank you for reading this information. If you decide to take part you will be given a copy of this information sheet for you to keep. You will also be asked to sign a consent form; you’ll get a copy of that to keep as well.

·  This sheet should be read with the General Patient Information Sheet- Part 1 and Treatment Specific Information Sheets.

·  In this information sheet, the term “study” and “clinical trial” will be used interchangeably and they are intended to mean the same thing.

Contents

1  What will happen to the results?

2  Will my taking part be kept confidential

3  Will I be paid for taking part?

4  Will my doctor be paid if I take part?

5  What if I change my mind?

6  Who is organising this study?

7  Who has reviewed this study?

8  What if things go wrong?

9  What if new information becomes available?

10 Further information

11 Some things to read

How to contact us

If you have any questions about this study, please talk to your doctor or nurse:

Name of doctor or nurse

Hospital Department

Hospital

Address

Address

Tel: XXXX XXX XXX

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1 /

What will happen to the results?

The results of this clinical trial will be of interest to all sorts of people that work in healthcare, including medical consultants and nurses, as well as, of course, to patients and their families.

Our findings will be communicated through conference presentations and journal articles, and through links we already have between the Medical Research Council (MRC), Cancer Research UK, prostate cancer support networks and the many hospitals taking part in the study.

Your doctor will be informed of the results and sent a summary of the findings so they can discuss the results with you. A copy of the results will be freely available to you on request.

No individual patients will be identified when the results are presented. For the Treatment Groups which are currently open for men to join, their results are not expected to be available until around 2022.

The results from some of those Treatment Groups which are no longer an option for you (Treatment Groups B, C and E) were presented at an international cancer conference in June 2015. A summary of what we found is available on the study website for anyone who would like to read them (www.stampedetrial.org)

2 / Will my taking part be kept confidential?

Yes. We follow guidelines developed by the NHS and legal requirements to make sure that all the information we have about you is treated in confidence. The Medical Research Council Clinical Unit at UCL (MRC CTU at UCL) is co-ordinating this clinical trial and will be collecting information about you, if you decide to take part in this study. As far as is possible, information kept about you is identified only by a unique study number rather than by your name.

The MRC CTU at UCL and the Medicines and Healthcare products Regulatory Agency (MHRA), the organisation that monitors medical research in the UK, may need to check that the information held is correct by reviewing your hospital notes; your confidentiality will be protected at all times.

If you do choose to take part we would like to tell your GP, but we will only do this with your permission.

With your permission we would like to access information held by others such as the NHS, HSCIC (via the Personal Demographics Service) or Office of National Statistics. This may be used to provide information about your health status after you have completed study treatment and remain on follow-up. The MRC CTU at UCL is registered under the UK Data Protection Act (DPA) to store this information. There is a question about this on the consent form that we will ask you to sign before you begin the study. We would keep this information separate from the other information we collect about you.

3 / Will I be paid for taking part?

There will be no payments to patients who decide they want to take part in STAMPEDE and additional travel expenses cannot be reimbursed.

4 / Will my doctor be paid if I take part?

There will be no payment to your doctor if you choose to participate in the STAMPEDE. However, the study is part of the National Cancer Research Network (NRCN) portfolio of studies. This means your doctor will be entitled to research support for the study (for example, help from a research nurse).

5 / What if I change my mind?

If you change your mind about taking part in the study, you can stop your treatment at any time. This will not affect your relationship with the doctors and nurses, or your subsequent care, in any way. Even then, we would still like to see how you are getting on and, if you agree, we would want to continue to collect some information so that the long-term effects of your treatment can be assessed.

6 / Who is organising this study?

The Medical Research Council (MRC) has overall responsibility for STAMPEDE which is funded by Cancer Research UK.

The MRC also supports the study through its core funding. Some further financial support and drug supplies have been obtained from the pharmaceutical companies: Novartis, SanofiAventis, Pfizer, Janssen and Astellas.

The study has received the favourable opinion of an independent Research Ethics Committee. The study is run from the MRC Clinical Trials Unit at UCL (MRC CTU at UCL), London.

7 / Who has reviewed this study?

To protect your safety, rights, well-being and dignity, this clinical trial has been reviewed by the West Midlands Research Ethics Committee. This committee has given this research the go-ahead. The research has also been reviewed by the MHRA. The science has been reviewed by many organisations, including Cancer Research UK’s funding body for clinical trials. The study has been developed by, and is overseen by, a committee which involves patient representatives.

8 / What if things go wrong?

The MRC is the sponsor of this study and University College London is responsible, as managing organisation, for holding insurance for the course of this clinical trial.

Every care will be taken in the course of this clinical trial. However, in the unlikely event that you are injured by taking part, compensation may be available. If you suspect that the injury is the result of the managing organisation (University College London) then you may be able to claim compensation. After discussing with your doctor, please make the claim in writing to the “STAMPEDE team at the MRC CTU at UCL”. You may have to bear the costs of the legal action initially, and you should consult a lawyer about this.

Participants may also be able to claim compensation for injury caused by participation in this clinical trial without the need to prove negligence on the part of the University College London or another party. You should discuss this possibility with your doctor in the same way as above.

The hospital(s) you are treated in continue to have a duty of care to you, whether or not you agree to participate in this study. Therefore, UCL does not accept liability for negligence on the part of employees of hospital. This applies whether the hospital is an NHS Trust or not, and UCL cannot be held liable for any breach in the hospital’s duty of care. If you wish to complain about any aspect of the way you have been approached or treated during the course of the study, the normal National Health Service complaint mechanisms will be available to you.

9 / What if new information becomes available?

Sometimes during the course of a clinical trial, new information becomes available about the treatments that are being looked at. The study may also be updated to test newer treatments that have since become available.

Throughout the study, medical information from within this study and also from any other ongoing studies will be looked at by an independent committee.

If any new information becomes available that may affect your participation, or would affect your future care, your doctor will tell you about it and discuss with you whether you want to continue to take part in this study. If you decide you no longer want to take part, your doctor will make arrangements for your care to continue.

If the clinical trial changes in any way you will be asked to sign a new consent form to confirm that this has been explained to you and that you still want to take part.

10 / Further information

Whichever treatments you receive, the aim is to control your cancer and help you feel well for as long as possible. If your cancer starts to grow or your doctor believes that you would be better helped by an alternative treatment, all options will be discussed with you.

Your care will not be affected if you decide you do not want to take part in this clinical trial.

If you have decided to take part but then in the future you no longer want to take part in the study this will not affect the care you receive in any way.

More information about clinical trials can be found on the Cancer Research UK's patient website, CancerHelp UK (www.cancerhelp.org.uk).

If you have private medical insurance, you should check with your company before agreeing to take part. This will usually not cover you for study procedures outside of standard practice, which will usually need to be delivered via the NHS. Standard treatments (e.g. radiotherapy) should still be covered by your policy as these are no different to the treatment received if you were not part of the study. Participation should not affect your ability to use your health insurance policy in future.

Please ask any questions you may have; take time to discuss the study with your family, friends and GP. If you decide you would like to take part in the study, you will be asked to sign a consent form.

11 / Some things to read

This information Sheet should be read together with the General Patient Information Sheet - Part 1 and and Treatment Specific Information Sheets for detailed information.

Table 1 below provides an overview on all information leaflets available for you to read.

Please make a note of any questions you might have and talk to your doctor or research nurse

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Table 1

STAMPEDE: Patient Information Sheets
What Patient Information Sheet (PIS)? / Content / Who should read it? / When?
General PIS Part 1 / Overview of why the study is being done and what it involves / Everyone / When being approached about the study
General PIS Part 2 / Details of study conduct and oversight / Everyone interested in taking part / When being approached about the study
Arm A and K PIS / Details of treatment associated with each arm of the study / Everyone interested in taking part / Before randomisation and informed consent
Additional Research PIS / Details of quality of life study and other optional studies / Everyone interested in taking part / Before randomisation and informed consent

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