What is darolutamide?

Darolutamide (Nubeqa®) is a new type of hormone therapy for men whose prostate cancer has stopped responding to other types of hormone therapy, but has not yet spread to other parts of the body.

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 treatments such as chemotherapy.

Who can have darolutamide?

Darolutamide is a treatment for prostate cancer that has stopped responding to other types of hormone therapy, but has not yet spread to other parts of the body. You may hear this called non-metastatic castrate-resistant (or hormone-relapsed) prostate cancer (nmCRPC).

  • Non-metastatic – the cancer hasn’t spread to other parts of the body.
  • Castrate-resistant – the cancer is growing, even though your testosterone levels are being kept low by standard hormone therapy (androgen deprivation therapy) or an operation called an orchidectomy.

Darolutamide will only be an option if tests show your prostate cancer has started to grow and is likely to spread to other parts of the body. This will usually be if your PSA level is 2 ng/ml or higher, and has doubled in the last 10 months. You may hear this described as a PSA doubling time of 10 months or less.

You’ll need to have scans to make sure your prostate cancer hasn’t spread to other parts of your body. These may include a bone scan, a computerised tomography (CT) scan, or sometimes a positron emission tomography (PET) scan.

If your cancer has spread to other parts of your body, darolutamide won’t be an option for you. Your doctor will talk to you about treatments for advanced prostate cancer instead.

If scans show the cancer has spread to lymph nodes near the prostate, you may be able to have darolutamide. But if the cancer has spread to lymph nodes in other parts of your body, darolutamide won’t be an option.

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. 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 (300mg, twice a day).

Other treatment options

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?

Darolutamide was approved for use on the NHS in England, Wales and Scotland in November 2020. The Northern Ireland Department of Health hasn’t yet decided whether darolutamide should be available through the Health and Social Care (HSC) service in Northern Ireland. This means your hospital may not have started offering darolutamide to patients yet.

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.

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.

What are the side effects of darolutamide?

Like all treatments, darolutamide can cause side effects. Because darolutamide is a new treatment, we don’t yet know about the risk of side effects in the long term (longer than three years). But studies suggest that most men only get mild side effects from darolutamide.

The main side effect of darolutamide is fatigue (extreme tiredness), with just over one in ten men (13 per cent) getting fatigue while taking darolutamide. Fatigue can have a big impact on your daily life. But there are ways to manage fatigue.

Other less common side effects of darolutamide are similar to the side effects of standard hormone therapy.

Remember that 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.

Side effects affect everyone differently, and you’re unlikely to get all the possible side effects of darolutamide. Before you start treatment, your doctor or nurse will explain the possible side effects. Knowing what to expect can help you deal with them. You can find more information in the leaflet that comes with your medicine or from the Electronic Medicines Compendium.

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.

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.

What happens next?

You will have regular prostate specific antigen (PSA) blood tests and blood pressure checks while you’re taking darolutamide – usually every three months. You may also have a bone density scan every few months 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 man to man.

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 a CT scan or PET 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.

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?

References

Updated: November 2020|To be reviewed: November 2022

  • List of references used to create this information  

    • Electronic Medicines Compendium. NUBEQA 300 mg film-coated tablets - Summary of Product Characteristics. [cited 2020 Nov 25]. Available from: https://www.medicines.org.uk/emc/product/11324
    • Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, et al. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040–9.
    • National Institute for Health and Care Excellence. Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer. Technology Appraisal 660. 2020.
    • Owen PJ, Daly RM, Livingston PM, Fraser SF. Lifestyle guidelines for managing adverse effects on bone health and body composition in men treated with androgen deprivation therapy for prostate cancer: an update. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):137–45.
    • Scottish Medicines Consortium. Darolutamide 300mg film-coated tablets (Nubeqa®). SMC 2297. 2020.
    • Serpa Neto A, Tobias-Machado M, Esteves MAP, Senra MD, Wroclawski ML, Fonseca FLA, et al. Bisphosphonate therapy in patients under androgen deprivation therapy for prostate cancer: a systematic review and meta-analysis. Prostate Cancer Prostatic Dis. 2012;15(1):36–44.
    • Shore N, Zurth C, Fricke R, Gieschen H, Graudenz K, Koskinen M, et al. Evaluation of Clinically Relevant Drug–Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct 1;14(5):527–39.