• Martin Bögemann, Gaetano Facchini, Thomas Bauernhofer, Richard Cathomas, Evanguelos Xylinas, and Bertrand Tombal.
• Department of Urology, Münster University Medical Centre, Münster, Germany. Martin.Boegemann@ukmuenster.de.
• Ir J Med Sci. 2023 Dec 1; 192 (6): 264326512643-2651.

BackgroundPatients with advanced prostate cancer have a poor prognosis, and well-tolerated new treatment strategies are required to improve survival outcomes. Apalutamide is a novel androgen signalling inhibitor developed to be used in combination with continuous androgen deprivation therapy (ADT) for the treatment of patients with advanced prostate cancer. Based on evidence from two phase 3 pivotal clinical trials in non-metastatic castration-resistant (nmCRPC; SPARTAN) and metastatic hormone-sensitive prostate cancer (mHSPC; TITAN), ADT plus apalutamide significantly extends overall survival compared with the standard of care.AimsTo provide practical recommendations to guide optimal use in the real-world setting as the use of apalutamide in clinical practice increases.MethodsExpert opinion from a group of European physicians is presented here to educate on the use of apalutamide in combination with ADT in patients with mHSPC and patients with nmCRPC who are at risk of developing metastatic disease, focusing on practical considerations such as patient selection, monitoring, and management of side effects.ResultsIn clinical practice, apalutamide in combination with ADT can be used in a broad patient population including patients with high and low volume/risk mHSPC, patients with de novo metastatic disease or metastases following treatment for localised disease, as well as older patients. Apalutamide in combination with ADT is well tolerated, with manageable side effects which do not impact health-related quality of life compared to ADT alone.ConclusionsReal-world experience with apalutamide supports the efficacy and safety findings reported by the SPARTAN and TITAN clinical trials.© 2023. The Author(s).

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