Apalutamide (Erleada) for the treatment of metastatic prostate cancer

Introduction

Apalutamide (trade name: Erleada) has been approved in Germany since January 2019 for the treatment of non-metastatic prostate cancer if the standard treatment with hormone blockers is no longer effective. In January 2020 it was also approved for the treatment of metastatic hormone-sensitive prostate cancer.

In metastatic prostate cancer, the tumor has already spread to other parts of the body and complete recovery is no longer possible. The cancer cells need male sex (androgens) to grow. The main androgen is testosterone. If the body’s production of androgens is inhibited ("blocked") by medication, the tumor growth can be slowed down. If the cancer cells react sensitively to such hormone blockers, the prostate cancer is said to be “hormone-sensitive.”

The hormone blocker apalutamide is used to try to slow the growth of the cancer cells and kill the tumor tissue.

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. It is combined with hormone therapy (androgen deprivation therapy, or ADT).

Other treatments

In men who have hormone-sensitive prostate cancer with metastases (tumors that have developed in other parts of the body) and are otherwise in good overall health, the treatment options are conventional ADT in combination with docetaxel and prednisone or ADT in combination with prednisolone. The standard treatment for newly diagnosed metastatic hormone-sensitive high-risk prostate cancer is conventional ADT in combination with abiraterone acetate and prednisone or prednisolone.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether apalutamide has any advantages or disadvantages compared to the standard treatments for metastatic prostate cancer.

The manufacturer provided data based on an indirect comparison. The results of this kind of comparison are generally less conclusive than the results of a direct comparison. In this case, one study compared apalutamide with a placebo (fake treatment), and another study compared apalutamide with a combination of docetaxel and prednisolone. All of the patients were also given ADT. The following was found:

What are the advantages of apalutamide?

Severe side effects: Early analyses suggest that severe side effects are less common in people who receive treatment with apalutamide and ADT than they are in people who have treatment with docetaxel, prednisolone and ADT.

What are the disadvantages of apalutamide?

Apalutamide didn’t have any disadvantages compared to docetaxel and prednisolone.

No difference

Life expectancy: There was no difference between the two treatment groups here.

What remains unanswered?

The manufacturer didn’t provide any usable data about the following aspects:

  • Bone damage
  • Health-related quality of life
  • Treatment stopped due to severe side effects

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).

Institute for Quality and Effciency in Health Care (IQWiG, Germany). Apalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-20. May 28, 2020. (IQWiG reports; Volume 919).

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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Created on July 2, 2020
Next planned update: 2023

Authors/Publishers:

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

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