1 Recommendations

1.1 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. It is recommended only if the company provides apalutamide according to the commercial arrangement.

Why the committee made these recommendations

Hormone-relapsed non-metastatic prostate cancer is usually treated with ADT alone or with darolutamide plus ADT.

Clinical trial evidence suggests that, compared with placebo plus ADT, apalutamide plus ADT increases the time until the disease spreads and how long people live. The cost‑effectiveness estimates are within what NICE considers to be an acceptable use of NHS resources. So, apalutamide plus ADT is recommended.

  • National Institute for Health and Care Excellence (NICE)