Apalutamide (Erleada) for the treatment of prostate cancer

Introduction

Apalutamide (trade name: Erleada) has been approved in Germany since January 2019 for the treatment of non-metastatic prostate cancer if conventional hormone blockers are no longer effective. This medication is an option if there is a high risk of the cancer spreading (metastasis).

In early stages, prostate cancer usually needs the hormone testosterone in order to grow. Testosterone is produced in the testicles. Blocking the production of testosterone is one way to stop prostate cancer from progressing. Cancer that continues to grow despite the use of these hormone blockers is also referred to as "hormone-refractory" or "castration-resistant" prostate cancer.

The drug apalutamide aims to inhibit the growth of new cancer cells and kill the existing cancer cells.

Application

Apalutamide is taken once a day in tablet form at a dose of 240 mg, which is equivalent to four 60 mg apalutamide tablets.

Patients also continue using hormone blockers.

If severe side effects occur, the treatment with apalutamide can be interrupted temporarily.

Other treatments

For men with non-metastatic, castration-resistant prostate cancer, watchful waiting is an option. Patients also continue using hormone blockers.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last looked into the advantages and disadvantages of apalutamide in men with non-metastatic castration-resistant prostate cancer.

To answer this question, the manufacturer provided early results of an ongoing study involving 1,207 men: 806 of them received apalutamide and 401 had a fake treatment (placebo). All of the men continued using hormone blockers.

What are the advantages of apalutamide?

  • Life expectancy: Early results suggest that apalutamide can increase life expectancy: Men who did not use apalutamide died after about 59 months on average (median value). Men who used apalutamide died after about 66 months on average (median value).
  • Disease-related symptoms: If the prostate cancer progresses, various problems may develop or become worse, such as bone fractures or pain. Additional treatments may also become necessary, such as surgery or radiation therapy. The study suggests that apalutamide can decrease the symptoms and the number of treatments needed due to the progression of the cancer. Progressing cancer caused symptoms or made further treatment necessary in about 19 out of 100 men who took apalutamide, compared to about 25 out of 100 men in the placebo group.
  • Severe kidney and urinary tract problems: Early results suggest that apalutamide has an advantage here. Kidney and urinary tract problems occurred in about 8 out of 10 men who took apalutamide, compared to about 12 out of 100 men who didn't use apalutamide.

What are the disadvantages of apalutamide?

Severe side effects: Early results suggest that apalutamide has a disadvantage in terms of various severe side effects:

  • Infections: Infections occurred in about 10 out of 100 men who took apalutamide, compared to about 2 out of 100 men in the placebo group.
  • Complications resulting from surgical procedures: About 8 out of 100 men who took apalutamide had complications such as a fall or pain after their procedure. This happened in about 2 out of 100 men in the placebo group.
  • Diseases of the skin and subcutaneous tissue: The study suggests that apalutamide has a disadvantage here: About 7 out of 100 men who took apalutamide developed severe diseases of the skin and subcutaneous tissue, such as severe rashes. This happened in less than 1 out of 100 men in the placebo group.

Side effects: Early study results also suggest that apalutamide has a disadvantage in terms of various non-severe side effects:

  • Joint pain (arthralgia)
  • Diseases of the nervous system
  • Underactive thyroid (hypothyroidism)

No difference

  • Severe side effects and stopping treatment due to side effects: The study did not find any differences between the treatment groups in terms of side effects and stopping treatment due to side effects.
  • Quality of life: No difference was found here between the treatment groups.

What remains unanswered?

Overall health: The manufacturer didn't provide any suitable data about overall health.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of apalutamide (Erleada).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Apalutamide (prostate cancer)  – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-09. April 29, 2019. (IQWiG reports; Volume 762).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Apalutamide (prostate cancer) – Addendum to commission A19-09; Commission A19-51. July 11, 2019. (IQWiG reports; Volume 793).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Apalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V (expired deadline). Dossier assessment; Commission A20-36. June 29, 2020. (IQWiG reports; Volume 941).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on July 16, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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