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To be presented on local headed paper paper 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 2 and Treatment Specific Information Sheets. V15.0PIS General Part 1 Jul-2016 To be presented on local headed Contents 1 Why are we doing this study? 2 How is the research done? 3 What do I need to know about the treatments used in this study? 4 Can I receive radiotherapy as my standard treatment? 5 Can I also receive chemotherapy (docetaxel)? 6 Do I have to take part in the study? 7 What are the possible advantages of taking part? 8 What are the possible disadvantages of taking part? 9 Will I need extra tests? 10 What follow up care should I expect? 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: XXXXXXXX XXX Page 1 of 7 1 Why are we doing this study? This study is called STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) and looks at the effect of adding new or different treatments to the standard way in which prostate cancer is currently managed. The standard treatment for prostate cancer involves hormone treatment and may also include chemotherapy and/or radiotherapy. Prostate cancer needs the male hormone testosterone to grow. Hormone treatments work by stopping testosterone from reaching prostate cancer cells. There are different types of hormone treatments but the most common are injections or implants that work by stopping the testicles making testosterone. Some men will have an operation to remove a part or all of the testicles instead. Your doctor may also discuss chemotherapy or radiotherapy as part of your standard treatment (see Sections 4 and 5 for more details). This study aims to see if, by adding new or different treatments to the standard approach, we can improve the way in which prostate cancer is currently managed and enable men to live longer and enjoy a better quality of life. We would like your consent to carry out a small number of additional tests to help us do this. One of these blood tests will check if you have diabetes. The clinical research team at your local hospital will let you know the results of this test and confirm whether you have diabetes or not. If you do, your GP will be informed and treatment to manage your V15.0PIS General Part 1 Jul-2016 diabetes will be prescribed as per standard clinical care. This study will also aim to find out more about how prostate cancer grows and becomes resistant to treatment. For more information on this please read the information sheet entitled Additional Research Patient Information Sheet. 2 How is the research done? The best way of knowing whether one treatment is better than another is by carrying out a “randomised controlled trial”. These types of studies aim to make a fair comparison between new treatments and the existing treatment to see which one works best. A randomised controlled trial compares two or more groups of people: a research group who receive the new ‘research’ treatment and a control group who receive the existing ‘standard’ treatment. This allows researchers to see whether the new treatment is better than the existing treatment. In this information sheet, the term “study” and “clinical trial” will be used interchangeably and they are intended to mean the same thing. If you take part in the study, a computer will randomly decide which treatment group you will join. This ensures the groups are as similar as possible, except for the treatment they receive. This is important to enable a fair comparison. As neither you nor your doctor can decide which group you join, if you choose to take part, you must be willing to accept whichever treatment group you are allocated to. Page 2 of 7 This study has been running since 2005 and has compared 8 different treatment approaches so far. We expect to include over 9,000 men like you in the study. They will be treated at hospitals all across the UK and internationally. We expect to take between 6 and 10 years to complete recruitment to the study and for results to become available. 3 What do I need to know about the treatments in this study? All men taking part in the study will receive standard treatment. This will include hormone treatment and may also include radiotherapy and chemotherapy (see Sections 4 and 5). Your doctor will talk to you about what your standard treatment will involve. This will remain unchanged whether or not you choose to join the study. We have called the men who receive standard treatment alone Treatment Group A (the control group). All research treatments are given in addition to standard treatment. There is currently 1 research group open that men may join, this is named Treatment Group K. All men allocated to Treatment Group K will receive metformin in addition to standard treatment. Metformin is a diabetic treatment that may also have an effect on prostate cancer growth and help prevent some of the side effects of hormone treatment. Only men with no diabetes can join Treatment Group K, therefore all men wishing to take part must have a blood test to check for diabetes first. You could be randomised to either treatment group. For every 2 men joining the study, on average, 1 will be allocated to Treatment Group V15.0PIS General Part 1 Jul-2016 A (the control group), and 1 to Treatment Group K. This is shown in Figure 1 on page 8. Your doctor or nurse will discuss which Treatment Groups you may join. Further details about these treatments are given in the treatment specific patient information sheets. For your information, this study previously looked at other treatments (Groups B, C, D, E, F, G,J and H). It is no longer possible to join these groups as we already have enough men to test these treatments. Results for Treatment Groups B, C and E were presented at an international cancer conference in June 2015 and a summary can be found on the study website, if you would like to read about what we found. 4 Can I receive radiotherapy as my standard treatment? Recent research has shown us that there are some groups of men who benefit from radiotherapy. Because of this it is now recommended as part of standard treatment if: (i) You have disease that remains within the prostate or (ii) Your disease is within the prostate and lymph glands nearby in the pelvis. Your clinical oncologist (radiotherapy doctor) will discuss whether this is suitable for you. If you have radiotherapy it should start around 4-6 months after you have started hormone treatment. Radiotherapy treatment is typically given over a 4-7 week period and this will be discussed in more detail by the radiotherapy team. Page 3 of 7 5 Can I also receive chemotherapy (docetaxel)? Recent results from STAMPEDE and another study (CHAARTED) have shown that, in men starting long-term hormonal therapy for the first time, adding chemotherapy controls prostate cancer for longer and in both studies, men who received chemotherapy lived longer. You and your doctor should discuss if docetaxel chemotherapy is recommended for you. If you and your doctor decide to use chemotherapy it should start no more than 12 weeks after you start hormone treatment. Your doctor or nurse will give you more detailed information about docetaxel if this is to be part of your standard treatment. You can participate in the study regardless of whether you and your doctor decide to use chemotherapy in your treatment but you must make this decision before joining the study. 6 Do I have to take part in the study? Your participation in the STAMPEDE trial is entirely voluntary. If you decide not to take part, your decision will be accepted without question and your standard treatment will not be affected in any way. If you decide you would like to take part in the study you are free to stop the research treatment at any time without giving your reasons and without affecting your future care. 7 What are the possible advantages of taking part? We hope that the additional treatments that you may receive will help control your prostate cancer better than the current standard approach; however, this is not certain which is why it has to be tested in a clinical trial. Also, although by taking part in the study, you may not directly benefit, this research will help improve our understanding of prostate cancer and hopefully led to better treatments for men like you in the future. 8 Where are the possible disadvantages of taking part? In this clinical trial you may receive extra treatments which will mean you are very likely to have extra side-effects. The most common unwanted side effects are described in the Treatment Specific Information Sheets (Arm A, and Arm K). Being part of a clinical trial will also mean you will need some extra hospital visits and blood tests. If you want to know more, please read the next section. 9 Will I need extra tests? If you are considering joining STAMPEDE and you do not have known diabetes then you will need to have a blood test to check this first. If your blood tests are abnormal you will be referred to your GP to discuss this further. Not all people with diabetes have symptoms and V15.0PIS General Part 1 Jul-2016 Page 4 of 7 therefore it is possible that this will be picked up early. This will enable you to receive appropriate advice and treatment. Should you have diabetes, depending on your stage of prostate cancer you may not be able to join the study (see Section 3). stroke, peripheral vascular disease (blood supply to other parts of the body) and diabetes. If you have already been diagnosed with diabetes then you do not need extra tests. All other tests required by the study are part of standard practice. Heart problems e.g heart attack or angina (chest pain) 10 What follow up care should I expect? In order to assess the long-term effects of treatment the study needs to collect follow-up information. Your research team will need to assess you regularly in order to update the study team as to your progress. Whichever Treatment Group you join, this will likely mean a hospital visit at least every 3 months for the next 2 years and then every 6 months. Once we reach 5 years after you joined the study, the research team will only need to review your progress once a year. However, if you are receiving metformin you will need to attend more regularly in order to pick up your tablets. Please make sure you let the study team know if you are admitted into hospital for any reason and if you develop any of the following medical conditions: Stroke or transient ischaemic attack (TIA or “mini-stroke”) Peripheral vascular disease (“claudication”) Diabetes 11 Some things to read Please read the Patient Information Sheet Part 2 for detailed information. Please read the patient information sheet specific to each treatment group. 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 When reviewed by your research doctor or nurse you should expect to be asked about any new symptoms you may be experiencing and any new medications you may have started. We will also record your weight and waist circumference and perform some blood tests. As well as testing whether the research treatments help control your prostate cancer, we are interested in the effects of treatment on other medical problems such as heart disease, V15.0PIS General Part 1 Jul-2016 Page 5 of 7 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 V15.0PIS General Part 1 Jul-2016 Page 6 of 7 Figure 1. STAMPEDE treatment groups V15.0PIS General Part 1 Jul-2016 Page 7 of 7