6 UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE ® ERLEADA (Apalutamide) in Metastatic Hormone-Sensitive Prostate Cancer Androgen deprivation therapy (ADT) has long been the standard of care for metastatic 1 hormone-sensitive prostate cancer (mHSPC). However, despite initial responses, many patients eventually develop resistance to ADT, 1 leading to disease progression. The introduction of androgen receptor pathway inhibitors (ARPIs) (abiraterone, apalutamide and enzalutamide) has changed the treatment landscape of mHSPC, demonstrating improved survival benets with additional androgen 1 receptor suppression when added to ADT. ® ERLEADA (apalutamide) is an orally administered, selective Androgen Receptor (AR) inhibitor indicated for the treatment of 2 mHSPC in combination with ADT. It binds directly to the ligand-binding domain of the AR, preventing AR nuclear translocation, inhibiting DNA binding and impeding AR-mediated 2 transcription. This mechanism underpins its efcacy in extending survival in patients with mHSPC, as demonstrated in the pivotal phase 3 3, randomised, multinational TITAN study. TITAN study ndings TITAN (Targeted Investigational Treatment Analysis of Novel Anti-androgen) enrolled over 1000 mHSPC patients, including those with highvolume or low-volume disease, previous docetaxel use, previous treatment for localised disease, and previously or newly diagnosed 3 disease. Patients were randomised to ® treatment with ERLEADA or placebo added to 3 ® ADT. ERLEADA plus ADT signicantly prolonged median radiographic progression-free survival (rPFS), median overall survival (OS) and the median time to cytotoxic chemotherapy relative to placebo plus ADT, with benecial effects on median rPFS and median OS 3 consistent across various subgroups. The safety prole did not differ notably between the two groups, and health-related quality of life was ® 3 preserved during ERLEADA treatment. TITAN ® underscores ERLEADA 's broad applicability in mHSPC and extends treatment options available for standard of care in this patient 1,3 population. Real-world evidence While clinical trials provide controlled environments to assess the efcacy and safety of new therapies, real-world evidence (RWE) offers valuable insights into how these 4 treatments perform in routine clinical practice. Recent RWE studies, such as the OASIS and ROME studies, have further solidied the role of ® ERLEADA in treating mHSPC, particularly in 5,6 comparison to enzalutamide. OASIS study ndings The OASIS study, a retrospective observational cohort study, evaluated clinical outcomes among patients with mHSPC using the 5 ConcertAI RWD 360 prostate cancer dataset. This comprehensive analysis included over 2 700 patients with newly diagnosed mHSPC, providing a robust dataset to evaluate the real5 world impact of various treatment regimens. The study revealed that patients initiating ® treatment with ERLEADA + ADT had signicantly better outcomes than those treated with other androgen receptor pathway inhibitors (ARPIs), docetaxel + ADT, or ADT ADVERTORIAL ERLEADA® in mHSPC
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