In the past, selection of intermediate clinical endpoints (ICEs) in prostate cancer
(PCa) trials largely depended on qualitative assessments; however, the advancing quality
of research necessitates a robust correlation with overall survival (OS). This review
summarises the results from several high-quality meta-analyses that explored the validity
of ICEs as surrogates for OS. We found strong evidence that metastasis-free survival
can serve as an ICE in localized PCa. In advanced disease, valid ICEs were identified
only within the context of metastatic hormone-sensitive PCa, including radiological
and clinical progression-free survival; however, concerns remain regarding their use
owing to the limited generalisability of the data used to validate their surrogacy.
Patient summary: Intermediate clinical endpoints can reduce the costs of trials and
allow earlier introduction of new treatment methods. This article summarises results
from studies verifying the validity of these endpoints as surrogates for overall survival.
(c) 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association
of Urology. This is an open access article under the CC BY license (http://creativecommons.
org/licenses/by/4.0/).
