Real-World Evidence in mCSPC Management

This segment explored how real-world evidence (RWE) contributes to understanding the effectiveness and tolerability of therapies for metastatic castration-sensitive prostate cancer (mCSPC). Panelists agreed that while RWE provides valuable insights into how treatments perform outside controlled clinical trial settings—particularly in more diverse, comorbid, or underrepresented populations—it must be interpreted with caution. They emphasized that study design and data quality are critical to determining the validity of findings, as RWE often relies on retrospective or administrative databases that lack randomization. Although RWE has largely confirmed the efficacy and safety of ARPIs observed in phase 3 trials, its role in influencing drug selection or sequencing remains limited. Panelists noted that while it may offer reassurance regarding generalizability—for example, including more African American patients or real-world practice settings—it cannot definitively determine superiority between agents. Ultimately, RWE complements but does not replace robust randomized clinical evidence in guiding mCSPC treatment decisions.

Panelists noted that abiraterone, apalutamide, and enzalutamide demonstrate overall survival benefits, while darolutamide primarily delays progression. They discussed side-effect profiles and monitoring needs—highlighting the need for liver function monitoring and steroid co-administration with abiraterone—and emphasized that treatment selection often depends on balancing efficacy, toxicity, and clinician comfort.