The State of Intermediate Clinical Endpoints as Surrogates for Overall Survival in Prostate Cancer in 2024 - Beyond the Abstract
The role of ICEs in clinical research is crucial, as they can streamline trials by reducing both time and costs, thereby expediting the identification of effective treatments. At the same time, ICEs carry a significant risk of leading to misguided treatment approvals. For years, ICEs have been largely based on qualitative assessment, but high-quality evidence-based medicine (EBM) necessitates formal verification. In our article, we provide readers with a concise summary of recent pivotal findings, shaping the future of PCa research and challenging the findings of many older ICE-based trials.
In total, seven meta-analyses encompassing over a hundred thousand PCa patients were identified. No ICEs for overall survival, except for metastasis-free survival (MFS), were identified in the setting of localized PCa; however, MFS proved to be a consistently well-performing ICE across several analyses. Importantly, endpoints based on local and biochemical control were found to be suboptimal, which could prompt us to question many previous findings.
No valid ICEs were identified in the setting of castration-resistant PCa (CRPC). Conversely, one of the studies suggested that clinical or radiologic progression-free survival (PFS) could be valid ICEs in the setting of metastatic hormone-sensitive prostate cancer (mHSPC). However, considering conflicting evidence from another study and the questionable generalizability of the data on which the surrogacy was established, we advise caution in using PFS as an ICE in the context of modern mHSPC treatment methods.
Written by: Marcin Miszczyk, Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria, Collegium Medicum, Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland
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