Darolutamide

What is darolutamide?

Darolutamide (Nubeqa^®) is a type of hormone therapy used to treat some men with prostate cancer. Prostate cancer cells usually need the hormone testosterone to grow. Darolutamide works by blocking the effect of testosterone on prostate cancer cells.

Darolutamide won’t cure your prostate cancer, but it can help keep it under control. It has been shown to give some men longer before their cancer spreads to other parts of the body (advanced prostate cancer). This means it can help to delay the symptoms of advanced prostate cancer in these men, and can delay the need for further treatment.

Who can have darolutamide?

If your cancer hasn’t spread to other parts of the body

Darolutamide may be a treatment option if your prostate cancer has stopped responding to other types of hormone therapy but has not yet spread to other parts of the body. Darolutamide will only be an option if tests suggest your prostate cancer has started to grow and is likely to spread to other parts of the body.

You may have scans to make sure your prostate cancer hasn’t spread to other parts of your body. These may include a bone scan and a computerised tomography (CT) scan.

If your cancer has spread to other parts of the body

If your cancer has spread to other parts of your body, darolutamide may be an option for you in combination with docetaxel chemotherapy. This is a new treatment known as triplet therapy. Read more about triplet therapy.

Other treatment options

Darolutamide may not be suitable for you if you have other medical conditions, such as heart disease. If darolutamide isn’t suitable for you, or if you choose not to have it, you will usually continue with your first type of hormone therapy – even though it’s no longer working so well. This is because it will still help to keep the amount of testosterone in your body low.

Although your prostate cancer is no longer responding so well to your first type of hormone therapy, it may respond well to other types of hormone therapy or a combination of treatments. For example, your doctor may suggest adding an anti-androgen or steroid to your usual hormone therapy.

Speak to your doctor about your treatment options. They can also tell you about any clinical trials that might be suitable for you.

Problems getting darolutamide?

If you think darolutamide may be a suitable treatment for you, speak to your hospital doctor. If they agree that it is suitable, but you’re still unable to get it, please let us know.

What does treatment involve?

Darolutamide is usually taken as two 300mg tablets, twice a day. This means a total dose of 1,200mg per day. Swallow the tablets whole with food and a glass of water.

You will keep having your original hormone therapy alongside darolutamide. This will help to keep the amount of testosterone in your body low and may help the darolutamide to work.

Other health problems and medicines

Tell your doctor about any other health problems you have. You should also tell them about any other medicines you’re taking or have taken recently, including any vitamins or herbal supplements. This is because darolutamide might affect how some other medicines work. And some other medicines might affect how well darolutamide works. Your doctor will talk to you about whether darolutamide is suitable for you.

If you have moderate or severe liver problems, or severe kidney problems, you may be given a lower dose of darolutamide (one 300mg tablet, twice a day).

What are the side effects of darolutamide?

Like all treatments, darolutamide can cause side effects. These may affect each person differently, and you’re unlikely to get all the possible side effects. Before you start treatment, your doctor or nurse will explain the possible side effects. Knowing what to expect and how to manage them can help you to feel more prepared and in control.

The most common side effects include:

Fatigue (extreme tiredness)

Fatigue can have a big impact on your daily life, both physically and emotionally. But there are ways to manage fatigue. 

A low number of white blood cells

This drop means you are at higher risk of infection. Symptoms may include a high temperature, feeling cold, shivering or generally unwell. You may want to use an at home thermometer to check your temperature if you begin to feel unwell. Contact your doctor or hospital straight away if your temperature goes over 37.5°C, or you think you may have an infection.   

Affecting how your liver works

These changes are usually mild. You will have regular blood tests to check how well your liver is working.

Other side effects may include:

• skin rash
• pain in your arms or legs
• pain in your muscles or bones
• increased risk of broken bones (fractures)
• changes to how your heart works – but this isn’t very common.

If you are worried about any of the side effects listed above, speak to your doctor or nurse. They can help answer your questions or concerns.  You can also speak to one of our Specialist Nurses.

Dealing with side effects

Living with side effects can be difficult to deal with, both physically and emotionally. But there are things that can help. Speak to your doctor or specialist nurse if you have any side effects from taking darolutamide, even if they’re not listed here. They may offer you other treatments to help manage any side effects. They may also suggest taking a lower dose of darolutamide for a short time, to see if your side effects improve. Only a small number of men choose to stop taking darolutamide because of side effects.

If you are having darolutamide to treat prostate cancer that hasn’t spread, but has stopped responding to other types of hormone therapy, you’ll still have your original hormone therapy alongside darolutamide. So if your original hormone therapy has caused any side effects, you’ll probably continue to get these. Many men who start taking darolutamide don’t notice any increase in side effects.

You may also find our Wellbeing hub helpful. The hub has information and support to help men and their loved ones look after their emotional, mental, and physical wellbeing.

Keeping your bones healthy

Being on hormone therapy, including darolutamide, may cause your bones to get thinner and weaker over time. You can help keep your bones strong and reduce your risk of severe bone thinning (osteoporosis) by making changes to your lifestyle.

If you already have osteoporosis, your doctor may suggest taking medicines, such as bisphosphonates, to help reduce the risk of broken bones.

Contraception

If you’re sexually active and there is a chance your partner could become pregnant, use a condom together with another form of contraception while you are taking darolutamide and for one week after.

If your partner is pregnant, you should use a condom if you have sex. This is because we don’t yet know if darolutamide can harm an unborn baby.

Changes to how you think and feel

Living with prostate cancer and managing side effects can impact not only your physical but emotional health. Men on hormone therapy may experience changes in their mood, energy levels, self-esteem and body image.  This is normal, give yourself time to deal with your feelings.  It’s important to look after your emotional and mental wellbeing. Remember that you are not alone, and there is support available.

Getting support from loved ones or joining support groups can help you deal with the emotional side of living with prostate cancer.  

Visit our wellbeing hub for information to help support you in looking after your emotional, mental, and physical wellbeing.

If you are close to someone with prostate cancer, find out more about how you can support someone with prostate cancer and where to get more information.

What happens next?

You will have regular prostate specific antigen (PSA) blood tests and blood pressure checks while you’re taking darolutamide – at first monthly, then usually every three months. You may also have bone density scans during your treatment to check for signs of bone thinning.

Your doctor will use your PSA level and any other test results, along with information about how you’re feeling, to check how well the treatment is working. Tell your doctor or nurse about any side effects you’re having, as there may be ways to manage these.

If your PSA level falls, this usually suggests your treatment is working. How quickly the PSA level falls, and how low, will vary from person to person.

In some men, the PSA level doesn’t fall or it continues to rise. This might mean the darolutamide isn’t working. You may have scans, such as an MRI or CT scan to see if the cancer has spread.

If the scans show your cancer hasn’t spread, your doctor may suggest you keep taking darolutamide. If your cancer has spread to other parts of your body, your doctor will talk to you about treatments for advanced prostate cancer.

For more information about darolutamide, speak to your hospital doctor or specialist nurse, or to our Specialist Nurses.

What is triplet therapy?

Triplet therapy is a new treatment. It combines darolutamide with both hormone therapy and a type of chemotherapy called docetaxel.

Triplet therapy has been shown to help some men live longer. It won’t cure your prostate cancer, but it may help to keep it under control, and has also been shown to delay:

• the need for other prostate cancer treatments
• your pain from getting worse
• bone thinning and broken bones (fractures), and
• your cancer becoming castration-resistant – the cancer is growing, even though your testosterone levels are being kept low by standard hormone therapy or surgery to remove the testicles (orchidectomy).

Who can have triplet therapy?

Triplet therapy is a treatment for men with newly diagnosed hormone-sensitive advanced prostate cancer. This means your prostate cancer has spread to other parts of the body but can be treated with hormone therapy. You need to be quite fit to have triplet therapy. This is because the side effects of chemotherapy can be harder to deal with if you have other health problems.

Triplet therapy usually will not be suitable for you if:

• you have been on hormone therapy for more than 12 weeks
• you have already started chemotherapy treatment
• you have already been given darolutamide, or another new (second-generation) hormone therapy such as, enzalutamide, apalutamide, or

Speak to you doctor for more information about who can have triplet therapy and whether it’s suitable for you.

What does triplet therapy involve?

If suitable for triplet therapy, you will be given hormone therapy and darolutamide first.

You will start your chemotherapy treatment within six weeks of starting darolutamide. You will have up to six sessions (also called cycles) of treatment. You’ll usually have treatment every three weeks. To begin with, your doctor will monitor you after each session to check that your treatment is working and you don’t have too many side effects. Read more about what chemotherapy treatment involves.

You will continue taking darolutamide and hormone therapy after chemotherapy.  Your doctor will use your PSA level and any other test results, along with information about how you’re feeling, to check how well the treatment is working.

If your prostate cancer stops responding to hormone therapy your doctor will talk to you about other treatment for advanced prostate cancer.

What are the side effects of triplet therapy?

Like all treatments, darolutamide, hormone therapy, and chemotherapy (docetaxel) can all cause side effects. The most common side effect of having all three treatments at the same time are:

• high or raised blood pressure (hypertension)
• and a skin rash.

Each treatment can cause different side effects and may affect each personal differently. And it’s unlikely you will get all of the possible side effects.

You can read about the main side effects of darolutamide above. Most common side of darolutamide are similar to side effects of standard hormone therapy.

Side effects of chemotherapy are often temporary and will gradually go away after you finish treatment. Read more about chemotherapy side effects.

Speak to your doctor about any side effects. They can answer any questions and talk to you about ways to help manage side effects.

Questions to ask your doctor or nurse

• Is darolutamide a suitable treatment for me, and why?
• What are the most common side effects? Are there ways to manage them?
• If I go on darolutamide, what tests will I have to monitor my prostate cancer, and how often will I have them?
• What will happen if my PSA level continues to rise while I’m on darolutamide?
• What treatments might be suitable if my cancer becomes advanced?
• What treatments might be suitable if my advanced prostate cancer stops responding to hormone therapy?

References

Reviewed March 2024 | To be reviewed March 2027