Real-World Prostate-Specific Antigen (PSA) reduction and survival outcomes of metastatic hormone-sensitive prostate cancer patients treated with Apalutamide: an observational, retrospective and multicentre study Optimizing Treatment Strategies for Metastatic Hormone-Sensitive Prostate Cancer Patients: Insights from a Real-world Study

MHSPC treatment has changed drastically during the last years with the emergence of Androgen Receptor Targeted Agents (ARTA).ARTA combined with ADT has demonstrated better oncological and survival outcomes in these patients. However, the optimal choice among different ARTAs remains uncertain due to their analogous efficacy. To describe PSA response and oncological outcomes of patients with mHSPC treated with Apalutamide. Medical records from three different hospitals in Spain were used to conduct this study. Patients diagnosed with mHSPC and under Apalutamide treatment were included between March 2021 and January 2023. PSA response, overall survival (OS), and radiographic-free progression survival (rFPS) were collected and stratified by metastasis volume, timing and stating. 193 patients were included. 34.2% of patients were de novo mHSPC and the majority were classified as m1b. The 18-month OS and rPFS were 92.5% and 88.9% respectively. Patients with PSA levels ≤ 0.2ng/ml showcased an 18-month OS rate of 98.7%, contrasting with 65.3% for those with PSA >0.2 ng/ml. Similar trends emerged for rPFS(97.4% and 53.7% respectively). When differentiating between low-volume and high-volume metastasis, the OS rate stood at 98.4% and 80.7% respectively, while rPFS rates were 93% and 81.6% respectively. No significant differences were found between groups stratified by metastasis timing. This real-world study on patients with mHSPC treated with Apalutamide plus ADT revealed robust oncological outcomes, aligning with the emerging evidence.The study’s hallmark finding highlights the significance of rapid and deep PSA response as a predictor of improved oncological and survival outcomes.