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 in the testicles is one way to keep 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 there are severe side effects, 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 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of apalutamide compared with the standard treatments for 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 sham treatment (placebo). All men continued using hormone blockers.

What are the advantages of apalutamide?

  • Symptoms: As prostate cancer progresses, various problems may develop or become worse, such as bone fractures or pain. Further treatment like surgery or radiation therapy may also become necessary. The study suggests that apalutamide can decrease the symptoms and the number of treatments due to the progression of the cancer. In the men who took apalutamide, progressing cancer caused symptoms or made further treatment necessary in about 8 out of 100 men, compared to about 16 out of 100 men in the placebo group.
  • Kidney and urinary problems: Early results suggest that apalutamide has an advantage here. About 5 out of 100 men who took apalutamide developed kidney and urinary problems, compared to about 10 out of 100 men who didn't use apalutamide.

What are the disadvantages of apalutamide?

  • Diseases of the skin and subcutaneous tissue: The study suggests that apalutamide has a disadvantage in terms of these severe side effects. About 6 out of 100 men who took apalutamide had skin rashes or itching, compared to less than 1 out of 100 men in the placebo group.
  • General symptoms: Early results suggest that apalutamide has a disadvantage here. Fatigue occurred in about 2 out of 100 men who took apalutamide, compared to less than 1 out of 100 men who were given a placebo.

No difference

  • Life expectancy: No difference was found in terms of life expectancy.
  • Overall health and quality of life: There were no differences between the treatment groups here, either.
  • Severe side effects and stopping treatment: In terms of side effects or the discontinuation of treatment due to side effects, overall the study did not show any differences between the treatment groups.

More information

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