Real-World Effectiveness of Apalutamide in metastatic Hormone-Sensitive Prostate Cancer

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Several systemic therapies for Metastatic hormone-sensitive PC (mHSPC) have been introduced in recent years, including second-generation androgen receptor pathway inhibitors (ARPIs) such as abiraterone acetate, apalutamide, enzalutamide, and darolutamide in combination with docetaxel. When added to ADT, these drugs have demonstrated survival benefit in clinical trials and real-world studies, resulting in updated treatment guidelines and the transition to a new standard of care for patients with mHSPC. However, direct head-to-head evidence relating to the real-world effectiveness and tolerability of these treatment options is lacking in Europe. This study aims to address this gap in research.

This study will compare real-world clinical effectiveness and tolerability outcomes for patients with mHSPC who received treatment with apalutamide or other alternative systemic treatments (i.e., abiraterone acetate, enzalutamide, docetaxel plus either abiraterone or darolutamide), all in combination with ADT, using data from various hospitals across Europe.

Descriptive summaries will be produced for all baseline demographic, clinical, and treatment-related variables, as well as post-index exposure- and outcome-related variables, using descriptive statistics, for patients in each treatment arm. Comparative analyses will be conducted to estimate the relative effect of apalutamide versus abiraterone acetate, enzalutamide, and abiraterone acetate or darolutamide plus docetaxel, according to study objectives. Effectiveness and tolerability outcomes will be summarized and compared as binary or as time-to-event outcomes, where appropriate.