Apalutamide

What is apalutamide?

Apalutamide (Erleada®) is a type of hormone therapy used to treat prostate cancer.

Prostate cancer cells usually need the hormone testosterone to grow. Apalutamide works by blocking the effect of testosterone on prostate cancer cells.

Apalutamide won’t cure your prostate cancer, but it can help keep it under control. It has been shown, in some men, to delay the spread of prostate cancer 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 it can delay the need for further treatments, such as chemotherapy.

Who can have apalutamide?

If you have localised or locally advanced prostate cancer

Apalutamide is a treatment for localised prostate cancer or locally advanced 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 castration-resistant (or hormone-relapsed) prostate cancer (nmCRPC).

  • Non-metastatic – the cancer hasn’t spread to other parts of the body.
  • 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).

Apalutamide will only be an option if your prostate specific antigen (PSA) level has doubled in the last 10 months. You may hear this described as a PSA doubling time of 10 months or less.

If you have advanced prostate cancer

Some men with advanced prostate cancer may be able to have apalutamide if they’ve never had hormone therapy. You may hear this called metastatic hormone-sensitive prostate cancer (mHSPC). This means your cancer may grow more slowly or stop growing for a while if you’re treated with hormone therapy.

If you do have advanced prostate cancer, apalutamide will only be suitable if you can’t have a type of chemotherapy called docetaxel.

Other health problems and medicines

Apalutamide may not be suitable for you if you have:

  • kidney or liver problems
  • a history of fits (seizures)
  • brain injuries or cancer in your brain.
  • had a stroke in the past year
  • a medicine to thin your blood, called warfarin.

Talk to your hospital healthcare team about any other health problems you have, and any other medicines you’re taking or have taken recently. This is because apalutamide may affect how other medicines work. And some medicines can affect how well apalutamide works. Your hospital healthcare team will talk to you about which prostate cancer treatment would be best for you.

Other treatment options

If you decide not to have apalutamide, there are other treatment options available. Read more about the treatment options for localised prostate cancer, locally advanced prostate cancer, or advanced prostate cancer.

Will having apalutamide affect my treatment options later on?

If you decide to have apalutamide to treat your prostate cancer and it stops working, you may not be able to have some other hormone therapies, called abiraterone, enzalutamide or darolutamide. This is because research suggests that men who have already had one of these drugs don’t respond so well to the other drugs.

Your hospital healthcare team will go through the advantages and disadvantages of each treatment so that you can decide which treatment is right for you. You can also talk through things with our Specialist Nurses.

What does apalutamide treatment involve?

Apalutamide is usually taken as four tablets, once a day. You can take these tablets with food or in between meals. Your hospital will provide you with enough tablets to last you until your next hospital appointment (see What happens next?).

If you were having another type of hormone therapy before starting apalutamide, you will continue having it at the same time as your apalutamide treatment.

If apalutamide is your first treatment, you will also be given another type of hormone therapy at the same time.

For most men, this extra hormone therapy taken with apalutamide will be an injection given at their GP surgery. Depending on your GP surgery, you may have an injection either once a month, once every three months or once every six months. This will keep your testosterone low and help apalutamide to work.

What are the side effects?

Like all treatments, apalutamide 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 hospital healthcare team 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.

The most common side effects of apalutamide are:

  • extreme tiredness (fatigue)
  • skin rash
  • high blood pressure (hypertension)
  • hot flushes
  • bone pain
  • diarrhoea
  • falls and fractures
  • loss of appetite and weight loss.

There is also a small increased risk of having a seizure (fit). Speak to your hospital healthcare team about whether you have an increased risk of having a seizure, if it’s safe for you to drive or operate machines or if you have had seizures before. Apalutamide may not be suitable for you if you have a history of seizures.

Speak to your hospital healthcare team if you have any side effects from taking apalutamide, even if they’re not listed above. They may be able to help you manage any side effects.

Contraception

If your partner is pregnant or there is a chance your they could become pregnant, use contraception when having sex. Use a condom together with another form of contraception while you are taking apalutamide, and for three months after. This is because apalutamide could harm the baby.

There is no evidence that having unprotected sex while you are taking apalutamide will harm your partner. But if you or your partner are worried about this, it’s best to use a condom until you stop your treatment.

What happens next?

You will continue taking apalutamide until it stops working or if you have serious side effects.

You’ll have regular hospital appointments while you’re taking apalutamide to check how well your treatment is working. How often you have these appointments will depend on your hospital. You will probably have one hospital appointment a month for the first three months. After that you’ll have a hospital appointment every two or three months.

At these appointments, you will have a number of tests. What tests you have, and how often you have them will depend on your hospital. Your healthcare team will discuss this with you. They will include:

  • a PSA blood test
  • blood tests to check for any problems with your kidney or liver
  • blood pressure tests.

Your doctor will use your PSA level, results from any other tests you may have, 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 of managing 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.

What happens if my PSA levels don’t fall?

In some men, the PSA level won’t fall. This alone doesn’t mean that apalutamide isn’t working. Your doctor will also ask you about any symptoms you’re having.

If your PSA level goes up you may have an MRI scan, a bone scan or a CT scan. This is to see if your cancer has spread.

Your hospital healthcare team may suggest you keep taking apalutamide or, if they’re concerned the cancer is growing, they may talk to you about other treatment options.

For more information about apalutamide, speak to your hospital healthcare team. You can also speak to our Specialist Nurses for information and support.

Dealing with prostate cancer

Being diagnosed with prostate cancer can change how you feel about life. If you or your loved one is dealing with prostate cancer you may feel scared, stressed or even angry. There is no ‘right’ way to feel and everyone reacts differently. There are things you can do to help yourself and people who can help.

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.

Questions you may want to ask your doctor or nurse

  • Is apalutamide a suitable treatment for me, and why?
  • What treatments can I have instead of apalutamide?
  • If I get any side effects, are there ways I can manage them?
  • If I have apalutamide, what tests will I have to monitor my prostate cancer, and how often will I have them?
  • Will I have other treatments alongside apalutamide?
  • What will happen if my PSA level continues to rise while I’m on apalutamide?
  • What other treatments might be suitable if my cancer becomes advanced?

List of references and reviewers

Created: October 2021 | To be reviewed: October 2023

  • Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13–24.
  • Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, et al. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294–303.
  • Erleada 60 mg film coated tablets - Summary of Product Characteristics (SmPC) - (emc) [Internet]. [cited 2021 Sep 6]. Available from: https://www.medicines.org.uk/emc/product/9832/smpc
  • National Institute for Health and Care Excellence. Apalutamide for treating prostate cancer [ID1534]  - Final appraisal document [Internet]. National Institute for Health and Care Excellence; 2021 [cited 2021 Oct 6]. Available from: https://www.nice.org.uk/guidance/gid-ta10423/documents/final-appraisal-determination-document
  • National Institute for Health and Care Excellence. Overview | Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer | Guidance | NICE [Internet]. NICE; 2021 [cited 2021 Nov 2]. Available from: https://www.nice.org.uk/guidance/ta740
  • National Institute for Health and Care Excellence. Overview | Apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer | Guidance | NICE [Internet]. NICE; 2021 [cited 2021 Nov 2]. Available from: https://www.nice.org.uk/guidance/ta741
  • Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide and Overall Survival in Prostate Cancer. Eur Urol. 2021 Jan 1;79(1):150–8.
  • Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408–18.
  • Johann de Bono, Head of Clinical Studies Division, Royal Marsden Hospital
  • Fabiola Morales-Azofra, Macmillan Prostate Cancer Specialist Nurse, University Hospital Southampton NHS Trust
  • Joe O’Sullivan, Consultant Clinical Oncologist, Belfast City Hospital
  • Sally-Anne Shelton, Macmillan Advanced Prostate Cancer Clinical Nurse Specialist, University Hospital Southampton NHS Trust
  • Deborah Victor, Uro-oncology Clinical Nurse Specialist, Royal Cornwall Hospital
  • Our volunteers.