To Be Presented on Local Headed Paper to Be Presented on Local Headed Paper

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Treatment Specific Information STAMPEDE TRIAL Sheets. We are inviting you to take part in a study  In this information sheet, the term called STAMPEDE “study” and “clinical trial” will be used interchangeably and they are  Your doctor has explained to you that you have intended to mean the same thing. prostate cancer and has invited you to participate in this study. Contents  Before you decide, it is important for you to 1 What will happen to the results? understand why the research is being done and 2 Will my taking part be kept what it will involve. confidential  Please take time to read the following 3 Will I be paid for taking part? information carefully. Discuss it with friends and 4 Will my doctor be paid if I take part? relatives if you wish. 5 What if I change my mind? 6 Who is organising this study?  Take time to decide whether or not you would 7 Who has reviewed this study? like to take part in this study. Participation is 8 What if things go wrong? entirely voluntary. This decision is up to you. If 9 What if new information becomes you decide not to take part, this will not affect available? the care you get from your doctors in any way. 10 Further information  You can decide to stop taking part in the study 11 Some things to read at any time, without giving a reason. How to contact us  Please just ask if there is anything that is not If you have any questions about this clear or if you would like more information. study, please talk to your doctor or  Thank you for reading this information. If you nurse: decide to take part you will be given a copy of Name of doctor or nurse this information sheet for you to keep. You will Hospital Department also be asked to sign a consent form; you’ll get a Hospital copy of that to keep as well. Address Address  This sheet should be read with the General Tel: XXXX XXX XXX Patient Information Sheet- Part 1 and

V15.0 Mar-2016 PIS General Part 2 Page 1 of 5 Council Clinical Unit at UCL (MRC CTU at UCL) is co-ordinating this clinical trial and will be 1 What will happen to the results? collecting information about you, if you decide to take part in this study. As far as is The results of this clinical trial will be of possible, information kept about you is interest to all sorts of people that work in identified only by a unique study number healthcare, including medical consultants and rather than by your name. nurses, as well as, of course, to patients and their families. The MRC CTU at UCL and the Medicines and Healthcare products Regulatory Agency Our findings will be communicated through (MHRA), the organisation that monitors conference presentations and journal articles, medical research in the UK, may need to and through links we already have between check that the information held is correct by the Medical Research Council (MRC), Cancer reviewing your hospital notes; your Research UK, prostate cancer support confidentiality will be protected at all times. networks and the many hospitals taking part in the study. If you do choose to take part we would like to tell your GP, but we will only do this with your Your doctor will be informed of the results permission. and sent a summary of the findings so they can discuss the results with you. A copy of the With your permission we would like to access results will be freely available to you on information held by others such as the NHS, request. HSCIC (via the Personal Demographics Service) or Office of National Statistics. This No individual patients will be identified when may be used to provide information about the results are presented. For the Treatment your health status after you have completed Groups which are currently open for men to study treatment and remain on follow-up. The join, their results are not expected to be MRC CTU at UCL is registered under the UK available until around 2022. Data Protection Act (DPA) to store this information. There is a question about this on The results from some of those Treatment the consent form that we will ask you to sign Groups which are no longer an option for you before you begin the study. We would keep (Treatment Groups B, C and E) were this information separate from the other presented at an international cancer information we collect about you. 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) 3 Will I be paid for taking part?

There will be no payments to patients who Will my taking part be kept decide they want to take part in STAMPEDE confidential? and additional travel expenses cannot be 2 reimbursed.

Yes. We follow guidelines developed by the NHS and legal requirements to make sure that Will my doctor be paid if I take all the information we have about you is part? treated in confidence. The Medical Research 4 V15.0 Mar-2016 PIS General Part 2 Page 2 of 5 There will be no payment to your doctor if Who has reviewed this study? you choose to participate in the STAMPEDE. 7 However, the study is part of the National Cancer Research Network (NRCN) portfolio of To protect your safety, rights, well-being and studies. This means your doctor will be dignity, this clinical trial has been reviewed by entitled to research support for the study (for the West Midlands Research Ethics example, help from a research nurse). 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, What if I change my mind? including Cancer Research UK’s funding body 5 for clinical trials. The study has been developed by, and is overseen by, a If you change your mind about taking part in committee which involves patient the study, you can stop your treatment at any representatives. 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 What if things go wrong? and, if you agree, we would want to continue 8 to collect some information so that the long- term effects of your treatment can be The MRC is the sponsor of this study and assessed. 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 6 Who is organising this study? clinical trial. However, in the unlikely event that you are injured by taking part, compensation may be available. If you suspect The Medical Research Council (MRC) has that the injury is the result of the managing overall responsibility for STAMPEDE which is organisation (University College London) then funded by Cancer Research UK. you may be able to claim compensation. After discussing with your doctor, please make the The MRC also supports the study through its claim in writing to the “STAMPEDE team at core funding. Some further financial support the MRC CTU at UCL”. You may have to bear and drug supplies have been obtained from the costs of the legal action initially, and you the pharmaceutical companies: Novartis, should consult a lawyer about this. SanofiAventis, Pfizer, Janssen and Astellas. Participants may also be able to claim The study has received the favourable opinion compensation for injury caused by of an independent Research Ethics participation in this clinical trial without the Committee. The study is run from the MRC need to prove negligence on the part of the Clinical Trials Unit at UCL (MRC CTU at UCL), University College London or another party. London. You should discuss this possibility with your doctor in the same way as above.

V15.0 Mar-2016 PIS General Part 2 Page 3 of 5 The hospital(s) you are treated in continue to have a duty of care to you, whether or not Whichever treatments you receive, the aim is you agree to participate in this study. to control your cancer and help you feel well Therefore, UCL does not accept liability for for as long as possible. If your cancer starts to negligence on the part of employees of grow or your doctor believes that you would hospital. This applies whether the hospital is be better helped by an alternative treatment, an NHS Trust or not, and UCL cannot be held all options will be discussed with you. liable for any breach in the hospital’s duty of care. If you wish to complain about any Your care will not be affected if you decide aspect of the way you have been approached you do not want to take part in this clinical or treated during the course of the study, the trial. normal National Health Service complaint mechanisms will be available to you. 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. What if new information 9 becomes available? More information about clinical trials can be found on the Cancer Research UK's patient Sometimes during the course of a clinical trial, website, CancerHelp UK new information becomes available about the (www.cancerhelp.org.uk). treatments that are being looked at. The study may also be updated to test newer If you have private medical insurance, you treatments that have since become available. should check with your company before agreeing to take part. This will usually not Throughout the study, medical information cover you for study procedures outside of from within this study and also from any other standard practice, which will usually need to ongoing studies will be looked at by an be delivered via the NHS. Standard independent committee. treatments (e.g. radiotherapy) should still be covered by your policy as these are no If any new information becomes available that different to the treatment received if you may affect your participation, or would affect were not part of the study. Participation your future care, your doctor will tell you should not affect your ability to use your about it and discuss with you whether you health insurance policy in future. want to continue to take part in this study. If you decide you no longer want to take part, Please ask any questions you may have; take your doctor will make arrangements for your time to discuss the study with your family, care to continue. friends and GP. If you decide you would like to take part in the study, you will be asked to If the clinical trial changes in any way you will sign a consent form. 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. 11Some things to read

Further information This information Sheet should be read 10 together with the General Patient

V15.0 Mar-2016 PIS General Part 2 Page 4 of 5 Information Sheet - Part 1 and and Please make a note of any questions you Treatment Specific Information Sheets for might have and talk to your doctor or detailed information. research nurse Table 1 below provides an overview on all information leaflets available for you to read.

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

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