Evaluating Long-Term ARPI Clinical Trial Data in mCSPC

This segment reviewed long-term efficacy and safety data from pivotal trials evaluating androgen receptor pathway inhibitors (ARPIs) in metastatic castration-sensitive prostate cancer (mCSPC). Panelists summarized key findings from LATITUDE and STAMPEDE (abiraterone), TITAN (apalutamide), ARCHES and ENZAMET (enzalutamide), and ARASENS/ARANOTE (darolutamide). Across these studies, combination therapy with ARPIs and androgen deprivation therapy (ADT) consistently demonstrated significant survival benefits without new long-term safety concerns. While abiraterone required ongoing monitoring for metabolic and hepatic effects, lutamides generally showed strong tolerability with low discontinuation rates. Enzalutamide offered the longest follow-up data—up to eight years—showing a durable reduction in mortality risk and stable safety profile over time. Darolutamide also proved highly tolerable and effective, particularly in triplet therapy. Panelists concluded that extended follow-up reinforces ARPIs as essential components of mCSPC treatment, achieving unprecedented survival durations and raising new questions about optimizing therapy duration and patient selection.

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.