Real-world treatment patterns and survival outcomes in patients with metastatic castration-resistant prostate cancer in France: lessons from the prospective OPALE study

In metastatic castration-resistant prostate cancer (mCRPC), several treatments are available, including androgen-receptor pathway inhibitors (ARPis) and chemotherapy (CT). There is a lack of real-world prospective data on treatment sequences and survival. The aim of the study was to evaluate overall survival (OS) in real-world conditions for patients treated for mCRPC. The OPALE study is a French prospective observational multicentre study. We included between 2018 and 2023, 212 patients undergoing first or second-line treatment for mCRPC. The primary outcome was the median OS, defined as the time between mCRPC diagnosis and death from any cause. The key secondary endpoints included OS according to therapeutic sequences, progression-free survival, response, and toxicities. Survival analysis was estimated using the Kaplan-Meier method and compared using the log-rank test. Associations between treatments and survival were assessed using Cox models. The 212 patients received first-line treatment (L1), 130 second-line (L2), 85 third-line (L3), and 51 fourth-line (L4). Most patients received ARPis in L1 (85.8%) and then chemotherapy in L2 (56.2%) and L3 (55.3%). The mean duration of follow-up was 31.8 months. Median OS was 46.4 months [95% confidence interval (CI): 35.9-53.8]. Our data did not significantly demonstrate the superiority of one therapeutic sequence over the others. Limitations are the observational design and the lack of statistical power. The OPALE study provided valuable data on the real-life management of mCRPC, contributing to a better understanding of current practice. We did not identify any optimal regimen, reflecting the evolution of knowledge and recent recommendations.