NICE guidance - Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer

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NICE state (1):

  • Apalutamide plus androgen deprivation therapy (ADT) is recommended as an option for treating hormone-sensitive metastatic prostate cancer in adults, only if:

    • docetaxel is not suitable

    • the company provides apalutamide according to the commercial arrangement

NICE state (2):

  • Apalutamide plus androgen deprivation therapy (ADT) is recommended, within its marketing authorisation, as an option for treating hormone-relapsed non-metastatic prostate cancer that is at high risk of metastasising in adults. High risk is defined as a blood prostate-specific antigen (PSA) level that has doubled in 10 months or less on continuous ADT


  • Apalutamide is a AR (androgen receptor) inhibitor that was discovered using a structure-activity relationship-guided medicinal chemistry approach designed to find more potent antiandrogens that retain full antagonist activity with no significant agonistic activity in the setting of increased AR expression
  • Apalutamide binds directly to the ligand-binding domain of the AR, and thereby prevents AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription.
  • Apalutamide selectively blocks androgen signaling to decrease tumor cell proliferation and increase cell death, leading to potent antitumor activity in preclinical prostate cancer models


Last edited 11/2021 and last reviewed 11/2021