Clinical trials

If you have prostate cancer, you might be able to take part in a clinical trial – a type of medical research. Trials are done for many types of illnesses, but on this page, we’ll just look at clinical trials for prostate cancer.  

We’ll describe what a clinical trial is, what it involves and what you can do to help you decide if a clinical trial is right for you.

Speak to your doctor or nurse if you’re thinking about taking part in a trial. You can also speak to our Specialist Nurses. Partners and family of people thinking about taking part in a clinical trial may also find this information helpful.

What is a clinical trial?

A clinical trial is a type of medical research. It helps researchers and healthcare professionals find new and improved ways of preventing, screening, diagnosing, treating and managing health problems such as prostate cancer. Clinical trials often test new medicines, medical procedures or medical equipment.

Why are clinical trials done?

Clinical trials aim to answer questions, usually about a treatment or a procedure. Questions may include the following:

• Is it safe?
• Does it cause side effects?
• What is the best dose to use?
• Does it work against your cancer?
• Does it work better than existing tests or treatments?
• How does it affect a person’s daily life?

What are prostate cancer clinical trials looking into?

Prostate cancer clinical trials can look at many different things, including the following.

Prevention – these types of clinical trials test whether medicines, vitamins, diet, physical activity or certain lifestyles can affect a person’s risk of prostate cancer.

Screening – these types of clinical trials involve looking at which tests could be used as part of a screening programme (where lots of men are tested).

Diagnosis – these types of clinical trials try out new tests, scans or other ways to help diagnose prostate cancer.

Treatment – these types of clinical trials test new treatments or new ways of using existing treatments.

Lifestyle – these types of clinical trials look at whether lifestyle habits such as diet, physical activity or not smoking could help someone with prostate cancer live longer.

Monitoring – these types of clinical trials look at new tests or scans to help doctors monitor whether a treatment is working or how well prostate cancer responds to treatment.

Quality of life – these types of clinical trials look at ways to improve the day-to-day life of people with prostate cancer.

Counselling and complementary therapies – these types of clinical trials look at other ways to help people affected by prostate cancer, including their partners or family, deal with the effects of prostate cancer and its treatment.

Genetics – these types of clinical trials look at whether certain genes (or changes to genes) can affect a person’s risk of getting prostate cancer, the growth of prostate cancer, or how well people respond to certain treatments.

For up-to-date information about some of the prostate cancer trials that are happening in the UK at the moment, visit the Cancer Research UK website or speak to our Specialist Nurses. Your medical team at the hospital will also be able to talk to you about clinical trials.

How do clinical trials work?

Types of clinical trials

There are two main types of trials – observational studies and intervention studies. 

• In an observational study, researchers collect information about the people taking part (participants) so that they can find out 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 answer questions about their lifestyle and diet at the start of the study. Then years later, the researchers will look at whether or not those people developed cancer. They will also be able to see if there are any differences between the people who develop cancer and those who do not.
• In an intervention study, researchers give a group of people a treatment or test and monitor them to see how well it works. One type of intervention study is called a randomised controlled trial – this is normally used to test new treatments.

The different phases in clinical trials

Clinical trials that look at new treatments usually go through a number of different stages, called phases. If a phase is successful, the trial moves on to the next phase. Each phase helps researchers answer different questions and collect more information about the new treatment.

Earlier phases include small numbers of people and usually take place at specialist centres. Later stage trials usually involve many more people, sometimes thousands, and usually take place at your local hospital. Read more about the different phases of a clinical trial on the NHS website.

Randomisation

There are usually two groups in a randomised trial. One group has the new treatment. The other, called the control group, has the standard treatment or a placebo (dummy treatment). The research team can then compare results from the two groups.

Placebo

A placebo is a dummy treatment. It can look or feel the same as the drug or procedure that’s being tested. For example, it can be a pill that contains an inactive ingredient that will not have any effect, like 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’.

Blinded trials

In a blinded trial, you will not know whether you are getting the trial treatment, the standard treatment or a placebo. They will all look the same. Trials need to be ‘blind’ because knowing what treatment you are getting can affect how you respond to it. This can make the results unreliable.

If you decide to take part in a clinical trial, the research team should always 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 allowed to be tested in people. When it’s ready to be tested in people, researchers and health professionals design the trial very carefully to make sure it’s safe. If you take part in a trial, you’ll be monitored closely so that any problems are spotted early and can be dealt with.

For more information about how trials are run, visit the Cancer Research UK website.

Should I take part in a clinical trial?

Without clinical trials and research studies we would not have the treatments we have now. Thousands of people volunteer every year to take part in trials. You may want to talk to your partner or family to help you decide. But only you can decide if it’s right for you.

You should never feel like you must take part in a trial. Your care will not be affected if you decide not to take part.

Advantages

• You might be able to have treatments that are not available outside of the trial.
• You may have more regular check-ups, tests and support from doctors and nurses than usual – some people find this reassuring.
• You will be helping to improve future cancer treatment for others.
• You may feel you’re doing something positive about your health and taking more control of your treatment and recovery.

Disadvantages

• There could be extra check-ups for many months or years afterwards, with questionnaires, tests or scans. Some people find that having lots of tests makes them worry more about their cancer.
• As with all medicines, clinical trial drugs may have side effects. Talk to the research team about the possible side effects, and how common they are.
• You might not know about all the possible side effects before the trial starts. The research team might not know about them all yet either.
• If the trial is randomised you will not be able to choose which treatment you have.  
• If the trial is blinded, you will not know which treatment you are getting.
• The new treatment may not be any better than the existing treatment.
• The new treatment might not help you, even if it helps others.
• Taking part may affect any insurance you already have and what insurance you can take out. For example, you may find it difficult getting travel insurance.
• You may not be able to take part in the trial, or have to leave the trial part way through. Some men say this can be disappointing.

We’ve suggested some questions below to ask your medical team. The answers may help you decide if taking part in a trial is right for you.

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 possible advantages and disadvantages.

What happens if I take part in a clinical trial?

If you decide to take part in a trial, the research team should give you information about what it involves.

During the trial you’ll usually go to a hospital to have your treatment, as well as tests or scans. You’ll have regular check-ups as part of the trial. You might have your usual hospital checks as well.

You will not be paid for taking part in a trial. However, some trials may offer to pay for things like travel to and from the hospital. Ask your research team about this.

Checks and tests before the trial

Once you’ve given your consent, you’ll have some tests and checks to make sure you’re suitable for the trial. The research team will ask about your medical and treatment history, and any symptoms you have. You’ll also have a physical examination, and you might have blood tests, scans and other tests. This is to find out more about your prostate cancer and any other health problems you might have.

If the tests show that you do not meet the criteria for the trial, you will not be able to take part. But you will still get the best care available.

Can I leave the trial?

You can leave the trial at any time without giving a reason. But if you’re happy to give a reason, it could help the research team to improve their trials in the future.

Leaving a trial will not affect any future care you receive. You’ll be offered the standard treatments for your stage of cancer. Health professionals will not 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 cannot be identified by your name. They should let you know how any information they collect during the trial will be used and ask for your permission to use your information.

Normally your GP will be told that you’re taking part in a clinical trial. The research team should tell you what information they will give to your GP. If your GP, or other health professionals who are not involved in the trial, prescribe you any treatment or medicines – not just for prostate cancer – ask them to contact the research team to make sure it will not affect the trial. You should also let the research team know about any vaccines you need, including for flu, covid or shingles. This is to make sure they’re safe to have while you’re on the trial.

What happens 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 will not be identified in any report or publication without your permission.

If the trial is successful, you might want to keep having the treatment after it ends. This is sometimes possible, but not always. Ask the research team about this before the trial starts.

The research team may also want to stay in touch for some time after the trial. This is so that they can collect long-term information about the effects of the treatment you received.

Why can trials take so long?

How long a clinical trial takes 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 can I be sure that a clinical trial is safe?

All clinical trials must follow strict rules and guidelines to make sure the research is well planned, safe and fair (ethical) to anyone taking part. Before researchers in the UK can involve people in their research, their study must be approved by two main groups. These are:

• Research Ethics Committee (REC)

Any research taking place in the NHS in England and Wales is approved by the Health Research Authority (HRA) and Health and Care Research Wales (HCRW).  

Health and Social Care Research and Development (HSC R&D) organises permission for research in Northern Ireland. In Scotland, permission for research is organised by NHS Research Scotland.

Once a trial is approved, it is monitored to make sure the researchers continue to follow all the rules and that the study remains safe.

How can I find out about prostate cancer clinical trials?

If you are thinking about joining a trial, speak to your doctor or nurse first. They can let you know about any local or national trials that may be suitable for you. You can also:

• search Cancer Research UK’s list of clinical trials in the UK – this only shows some of the current trials
• search the Be Part of Research database
• speak to our Specialist Nurses for up-to-date information on clinical trials
• see a map of clinical trials funded by us.

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 or after a trial. When a trial ends you might also feel you need some support. 

Questions to ask your medical team

As well as the questions listed here, you and your family may have some additional questions. Write down any other questions you have to take to your next appointment.

• Are there any clinical trials for prostate cancer that I could take part in? If so, what will the trial aim to find out?
• What are the possible benefits and risks of taking part in the trial, including any possible side effects?
• What extra tests and appointments will I need to have if I take part in the trial?
• Will I need to travel to another hospital? If so, will my travel or other expenses be paid?
• What support can I get during and after the trial?
• Who should I contact if I have questions while I’m on the trial?
• Is it safe?

References