Observational Study of Apalutamide Treatment Adherence in Men with Metastatic Hormone-Sensitive Prostate Cancer in France

What this Trial Is About

Researchers are studying adherence to apalutamide treatment in men diagnosed with metastatic hormone-sensitive prostate cancer mHSPC. The study aims to understand how well participants stick to their apalutamide therapy during the first year and to assess the risk of non-adherence based on individual profiles and behaviors. This observational study is conducted in routine clinical practice in France and sponsored by Janssen Cilag S.A.S. Participants with confirmed mHSPC start apalutamide treatment as prescribed by their doctors. No additional treatments or interventions are given as part of the study. They are enrolled at the start of apalutamide therapy and followed for 12 months after their treatment ends, with no experimental procedures involved. During the study, participants complete questionnaires about their medication adherence and quality of life at baseline and throughout the year. Researchers collect clinical data such as PSA levels, disease status, and other health factors regularly. The main outcomes measured include the percentage of participants adhering to apalutamide at 12 months and changes in adherence over time. Safety and clinical risk factors are also monitored to better understand adherence patterns and health outcomes over the study period.

A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France