1 1 A guide to prostate cancer clinical trials In this fact sheet: What is a clinical trial? Why are trials done? What are trials looking into at the moment? How are clinical trials done? Should I take part in a trial? What does taking part in a trial involve? Why can trials take so long? How do I find out about prostate cancer trials? Questions to ask your doctor or nurse More information About us Where can I get support? This fact sheet is for anyone affected by prostate cancer who wants to find out more about taking part in a clinical trial a type of medical research. What is a clinical trial? A clinical trial is a type of medical research. It aims to find new and improved ways of preventing, diagnosing, treating and controlling illnesses. People are involved in the trial in a controlled and carefully planned way. Often clinical trials test medicines, medical procedures or medical equipment. Sometimes they want to find out more about the psychological and social effects of illness and treatment. Why are trials done? Clinical trials are designed to answer questions about a treatment or a procedure. The main questions are usually: Does it work? Is it safe? Does it cause side effects? How does it affect quality of life? Does it work better than existing treatments? What is the best dose to use? They are done for all types of illnesses but in this fact sheet we re looking at clinical trials for prostate cancer.
2 2 What are trials looking into at the moment? Clinical trials for prostate cancer are looking at many different areas, including: Prevention whether medicines, vitamins, diet or exercise can reduce men s risk of prostate cancer. Screening the benefits and risks of a national screening programme, where lots of men are tested for prostate cancer. You can read more about screening in our booklet, Understanding the PSA test: A guide for men concerned about prostate cancer. Diagnosis trying out new tests or scans to make the diagnosis of prostate cancer more accurate. For example, developing better tests for prostate cancer and tests to work out how aggressive the cancer is, whether it may spread, or whether it already has spread outside the prostate gland. Quality of life looking at how prostate cancer or its treatment could affect you in your daily life. For example, a trial might look at the side effects of treatment and ways to deal with them. Counselling and complementary therapies looking at ways to deal with the effects of illness, such as counselling or complementary therapies. Treatments investigating new treatments or new ways of using existing treatments. Treatments for prostate cancer are a major focus of research at the moment. For example, current trials are: investigating different doses of radiotherapy and ways of giving it looking at drugs which could make radiotherapy more effective developing new techniques for surgery (radical prostatectomy) such as robotic surgery improving newer treatments like cryotherapy, which involves freezing and thawing the prostate combining treatments such as hormone therapy and radiotherapy developing new drugs to treat advanced prostate cancer that is no longer responding to other treatments looking at whether the order that treatments are given makes a difference. Researchers are also trying to find out why men respond differently to treatments, so that in the future they can be more tailored to the individual. How are clinical trials done? Types of trials There are different ways of gathering evidence in cancer research. Broadly speaking, trials can be split into two types observational studies and intervention studies. In an observational study, researchers collect information about you which they think will tell them more about the risk of getting cancer, or the effects of cancer or its treatment. For example, they might select a large group of people and take blood samples, or ask them to fill out questionnaires about lifestyle and diet, and a number of years later, record whether they develop cancer or not. They can then see if there were any differences between those who developed cancer and those who didn t. In an intervention study, researchers give a group of people a treatment or test to see how well it works. One particular kind of intervention study is a randomised controlled trial this is the kind of trial usually used to test new drugs. In a randomised controlled trial, one group of people is given the new treatment, and the other group (the control group) is given the current standard treatment or a dummy pill (also known as a placebo). Then the results are compared. Phase 1, 2, 3 and 4 trials, described on the next page, are intervention studies.
3 3 Phase 1, 2, 3 and 4 trials Trials that look at treatments usually take place in four stages, called phases. You might see these written with Roman numerals phase I, II, III and IV. If a phase is successful, the trial moves onto the next phase. Phase 1 Finds out about safety and side effects, and if the treatments could work well in humans. If it s a drug trial, the research team will begin to work out the best dose to use. Phase 2 Looks at how well a treatment works, and collects more information about safety and side effects, and the best dose to use. There are usually two groups in a randomised trial. Only one group has the new treatment. The other, called the control group, has the standard treatment or a placebo (see below). The research team can then compare results from the two groups. Because the groups are decided at random, you don t get to choose whether you get the new treatment or the standard treatment. One reason that trials are randomised is so that the research team can t choose who goes into which group based on what they know about their patients. For example, they might put people who they thought were healthier or more unwell into a particular group, which could make the results of the trial unreliable. All phase 3 trials and some phase 2 trials are randomised. Phase 3 Tests a new treatment against the best existing treatment (standard treatment), if there is one available. Researchers continue to look at safety and side effects. Phase 4 Happens after a new treatment is in use. Researchers collect information about longterm risks and benefits. Phase 1 and 2 trials include small numbers of people, anywhere between about 10 and a few hundred. They usually take place at specialist centres. Phase 3 and 4 trials usually involve many more people, sometimes thousands, and usually take place at your local hospital. Randomisation Everyone taking part in a randomised trial is put into different groups at random. Nobody has a say about who goes in which group and it s usually decided by computer. Making the decision about going on a randomised trial, where I may not have got the treatment I was hoping for, was hard. So I talked it through with my wife, and a lovely nurse at the hospital steered us through the decision. In the end I decided that I wanted to take the chance. A personal experience Placebo A placebo is a dummy treatment. For example, a pill that looks the same as the drug being tested but just contains sugar. People can sometimes feel better when they have a placebo because they think they are having a real treatment. This is known as the placebo effect.
4 4 Comparing a group of people taking a new treatment with a group taking a placebo can show if the new treatment is really having an effect. A truly effective drug will show better results than the placebo. Blinded trials In a blinded trial, you won t know whether you are getting the trial treatment, or the standard treatment or placebo. They will both look the same. Trials need to be blind because just knowing that you are getting a new treatment can affect how you respond to it and make the results unreliable. Often the health professionals on the trial who give you your treatment are also blinded, meaning they don t know which treatment you are getting either so they can t be influenced by what they know. If you decide to take part in a clinical trial, the research team must tell you whether it is randomised, if they are using a placebo, and if it s a blinded trial. Safety Before any trial begins, there is a long and thorough process to make sure it s as safe as possible. There are many stages of research before a drug is tested in humans. And when it s ready for that stage, experts study the design of the trial in great detail to make sure it s safe. Checks and tests before the trial (see page 6) can make sure you re suitable for it and it s safe for you to take part. Once the trial begins you ll be monitored closely so that any problems are spotted early and can be dealt with. You can find out more about how trials are run from CancerHelp UK. Should I take part in a trial? Without clinical trials and research studies we wouldn t have the treatments we have now. Thousands of people volunteer every year to take part in these trials. But you have to decide if it s right for you. For each trial, researchers need to find people who fit very specific criteria. For example, they might need people with a certain PSA level, or people with cancer at a particular stage. They might also take other things into account, such as how fit you are. If you find a trial that could be suitable for you, find out as much as you can about it. Each trial is different, but these are some of the potential advantages and disadvantages. Advantages You might have access to newer and perhaps more effective treatments which are not available outside the trial. You may have more regular check-ups, tests and support from doctors and nurses than usual some people find this very reassuring. You are helping to improve future cancer treatment for others. You feel you re doing something positive about your health and taking an active role in your treatment and recovery. Disadvantages You may have more frequent testing as well as treatment, which might be inconvenient. This can go on for a long time. Some people also find this makes them more anxious about their cancer. There could be check-ups for many months or years afterwards, with questionnaires, tests or scans. You might not know in advance about all the possible side effects the researchers themselves might not know them all yet. If the trial is randomised you won t get a choice about which treatment you have. If the trial is blinded, you won t know which treatment you are getting.
5 5 The new treatment may turn out to be no better than the existing treatment. There is the risk that the new treatment may not help you, even if it helps others. Before I decided to consent to the trial I felt it was important to educate myself about it. I was aware that the research team wanted me to know the virtues of the trial, but I wanted to know about the drawbacks as well. A personal experience Whether you decide to take part in a trial or not, you should receive the highest standard of care and support available. Remember that wherever there is a standard treatment available, new treatments are tested against this. So even if you don t get the new treatment, you will still have the best treatment currently available. On page 8 we ve suggested some questions to ask your health team. The answers may help you decide if taking part in a trial is right for you. For me, the benefits of being on the trial were that the oncologist had more time to talk me through what was happening, all the people in the trial unit were wonderful, and I was able to have scans every three months to check my progress. A personal experience What does taking part in a trial involve? There are differences between trials depending on what the trial is investigating and what type of trial it is. If you decide to take part in a trial, the research team should give you full details of what it involves. Before the trial, you ll probably need to go through checks and tests to see if you are suitable for it (see page 6). This includes filling in forms or questionnaires, a physical examination, and having some tests. During the trial you ll usually visit hospital to have the treatment that s being studied, as well as tests or scans. You ll have regular check-ups as part of the study, which may be in addition to your usual hospital checks. You won t be paid for taking part in a trial, but it s sometimes possible to claim back what you spend on expenses, such as on travel. The trial team will be able to tell you what they can cover. Other than the regular trips to the hospital for radiotherapy there was no problem with the treatment, and staff were kind and friendly. A personal experience Getting information and giving your consent The research team has to get your consent. This means signing a form to say that you understand what the trial involves and that you agree to take part. Before you decide to give your consent, the team should explain the trial to you in detail. They should give you written information and go though it with you face to face. They should answer your questions and give you time to think it over before you agree to sign the consent form.
6 6 Make sure you ve found out everything you can about the trial so you have all the information you need to make a decision you re happy with. And don t feel pressurised into making a quick decision. You might want to discuss the trial with someone else before you decide maybe your partner, family, GP, hospital doctor or nurse. Or you can call our Specialist Nurses on our confidential helpline they ll be happy to discuss the trial with you. Before you sign the form, ask yourself these things. Am I comfortable with the tests that need to be done during the trial and with how often they happen? Can I get to the hospital easily for the tests and treatment? (Some people having cancer treatment find travelling long distances very tiring.) Do I clearly understand the possible side effects and risks of having the treatment? If you decide to go ahead, the research team should also tell you who to contact if you ve got questions during the trial. The research team explained all the risks in great detail. At first this felt a bit like unnecessary information, but I was glad that they were thorough and told me everything. A personal experience The trial I was involved in meant I had to travel a long way for treatment. So I made sure I planned a route where I could get a seat on the train, in case I felt tired. A personal experience Checks and tests before the trial These are to make sure that you re suitable for the trial. Once you ve given your consent, the research team will ask about your medical and treatment history, and any symptoms you have. You will also have a physical examination and you might have blood tests, scans and other tests. This is to check the stage and grade of your prostate cancer and any other health conditions you have. In some trials, men with certain other health conditions can t take part. Can I leave the trial? You can leave the trial at any stage without giving a reason, but if you can give a reason this could help the research team design better trials in the future. If you leave a trial, you will still have treatment for your cancer. You ll be offered the standard treatments for your stage of cancer. Health professionals won t treat you differently because you have left a trial. What will happen to my personal information? Your personal information should be stored securely and kept confidential. The research team might use a code so you can t be identified by name. They will let you know how any information gathered during the trial will be used. Normally your GP will be told that you re taking part in a clinical trial. The research team will tell you what information they will give to your GP.
7 7 If other health professionals who are not working on the trial including your GP give you any treatment or medicines, ask them to contact the research team to discuss whether these will affect the outcome of the trial. When the trial finishes The research team should tell you what will happen with the results of the research. For example, whether they will be published in a medical journal and if you can see them. You won t be identified in any report or publication without your permission. If the trial is successful, you might want to continue with the treatment after it ends. This is sometimes but not always possible. You should ask about this before the trial starts. If a new treatment is very effective, the trial might be stopped early so that everyone on the trial can be offered it, not just those in the treatment group. The trial could also be stopped early if the new treatment doesn t work well or causes too many side effects. Where can I get support? Deciding whether to take part in a clinical trial can be difficult. You might want to ask questions or raise concerns before, during and after a trial. When a trial ends you might also feel you need some support. If you or those close to you are worried about anything, speak to your GP or other health professional. You can also speak to our Specialist Nurses on our confidential helpline. If you have access to the internet, sign up to the Prostate Cancer UK online community, where members share their experiences of prostate cancer. Registration is free and only takes a few minutes. Visit our website at prostatecanceruk.org to sign up. There are also prostate cancer support groups across the country, where you and your family can meet other people affected by prostate cancer. You can find details on our website or ask your nurse. Why can trials take so long? Sometimes you ll hear about research for a new treatment years before it actually becomes widely available. Developing a new procedure or treatment can take a long time. How long depends on lots of things, such as the type of treatment, how many patients are needed on the trial and the aim of the trial. How do I find out about prostate cancer trials? To find out about current clinical trials for men with prostate cancer you can: ask your doctor or nurse if there are any local or national trials that may be suitable for you call our Specialist Nurses on our confidential helpline search online lists of trials, such as the NHS Choices clinical trials page. If you find a trial you re interested in, show the details to your doctor or nurse. They can help you decide if it s likely to be suitable for you. You and your family might find that talking to someone with similar experiences helps. Our support volunteers include men and women with experience of prostate cancer. They are trained to listen and offer support over the telephone. Call our Specialist Nurses on our confidential helpline to arrange to speak to a volunteer.
8 8 Questions to ask your doctor or nurse You may find it helpful to keep a note of any questions you have to take to your next appointment. Do you know of any clinical trials for prostate cancer that I could go on? What does the trial aim to find out? Can you tell me the possible benefits and risks of taking part in the trial? Will I definitely get the new treatment or procedure? What extra tests will I have if I go on the trial?
9 9 How long will the trial last? Will I need to travel to another hospital? Will my travel or other expenses be paid? What happens if something goes wrong when I m on the trial? Am I covered by insurance? What support can I get during and after the trial? Who should I contact if I have questions while I m on the trial? If the trial is successful, will I be able to continue with the treatment after it ends?
10 10 Notes
11 11 More information CancerHelp UK Nurse helpline: Cancer Research UK s patient information resource. It includes a database of clinical trials and advice on finding a trial. Healthtalkonline Watch, listen to and read personal experiences of men with prostate cancer and other medical conditions. Macmillan Cancer Support Helpline: Practical, financial and emotional support for people with cancer, their family and friends. Includes information about clinical trials and lists websites where you can search for them. NHS Choices Information about treatments, conditions and lifestyle. Support for carers and a directory of health services in England. Includes a database of clinical trials. UK Clinical Trials Gateway Information about clinical trials in the UK. Allows you to search for trials which are currently recruiting and provides contact details for the trial team. About us Prostate Cancer UK fights to help more men survive prostate cancer and enjoy a better life. This fact sheet is part of the Tool Kit. You can order more Tool Kit fact sheets, including an A-Z of medical words, which explains some of the words and phrases used in this fact sheet. Download and order our fact sheets and booklets from our website at prostatecanceruk.org/publications or call us on At Prostate Cancer UK, we take great care to provide up-to-date, unbiased and accurate facts about prostate cancer. We hope these will add to the medical advice you have had and help you to make decisions. Our services are not intended to replace advice from your doctor. References to sources of information used in the production of this fact sheet are available at prostatecanceruk.org This publication was written and edited by: Prostate Cancer UK s Information Team It was reviewed by: Hashim Ahmed, MRC Clinician Scientist in Uro-Oncology, Division of Surgery and Interventional Science, University College London Susan Asterling, Urology Research Nurse, Sunderland Royal Hospital Christopher Scrase, Macmillan Consultant Clinical Oncologist and Honorary Senior Lecturer, Ipswich Hospital NHS Trust Linda Welsh, Prostate Specialist and Research Radiographer, Torbay Hospital Prostate Cancer UK Volunteers Prostate Cancer UK Specialist Nurses Tell us what you think If you have any comments about our publications, you can
12 Speak to our Specialist Nurses * prostatecanceruk.org Donate today help others like you Did you find this information useful? Would you like to help others in your situation access the facts they need? Every year, 40,000 men face a prostate cancer diagnosis. Thanks to our generous supporters, we offer information free to all who need it. If you would like to help us continue this service, please consider making a donation. Your gift could fund the following services: 10 could buy a Tool Kit a set of fact sheets, tailored to the needs of each man with vital information on diagnosis, treatment and lifestyle. 25 could give a man diagnosed with a prostate problem unlimited time to talk over treatment options with one of our Specialist Nurses. To make a donation of any amount, please call us on , visit prostatecanceruk.org/donations or text PROSTATE to 70004*. There are many other ways to support us. For more details please visit prostatecanceruk.org/get-involved **You can donate up to 10 via SMS and we will receive 100% of your donation. Texts are charged at your standard rate. For full terms and conditions and more information, please visit prostatecanceruk.org/terms Prostate Cancer UK May 2013 To be reviewed May 2015 Call our Specialist Nurses from Mon to Fri 9am - 6pm, Wed 10am - 8pm * Calls are recorded for training purposes only. Confidentiality is maintained between callers and Prostate Cancer UK. Prostate Cancer UK is a registered charity in England and Wales ( ) and in Scotland (SC039332). Registered company number CLT/MAR14
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