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Androgen Receptor Inhibitor (ARi) — Non-Metastatic CRPC

Apalutamide

Brand names: Erleada

Apalutamide is an oral androgen receptor inhibitor used with androgen deprivation therapy in the treatment of non-metastatic castration-resistant and metastatic hormone-sensitive prostate cancer.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It binds the androgen receptor ligand-binding domain and inhibits receptor nuclear translocation, DNA binding and transcription, suppressing androgen-driven prostate cancer growth.

Prescribing in practice

  • Severe cutaneous reactions including Stevens-Johnson syndrome and DRESS have been reported, so warn the patient and stop treatment for serious skin reactions; falls, fractures, seizures and ischaemic cardiovascular events are also recognised risks.
  • It is a potent enzyme inducer affecting CYP3A4, CYP2C9 and other pathways, causing numerous interactions, so review all co-medications including anticoagulants.
  • It must be continued together with androgen deprivation therapy, and the SPC advises effective contraception measures for partners of childbearing potential.

Monitoring

Monitor for skin reactions, falls and fractures, seizure activity and cardiovascular events, alongside disease response and relevant blood tests.

Counselling the patient

  • Report any rash, blistering, or mouth ulcers promptly, and continue your hormone injections alongside these tablets.
  • Take care to reduce your risk of falls, and report any blackouts, fits, or chest pain.
  • Do not stop the medicine without advice.

Evidence & guidelines

Apalutamide's benefit in castration-resistant and hormone-sensitive prostate cancer is established by the SPARTAN and TITAN trials, the SPC and NICE guidance.

Reference: SPARTAN trial (Smith et al. NEJM 2018); NICE TA578; MHRA SPC Erleada; EAU Prostate Cancer Guidelines 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.