LAUSR

Expert's summary: The Intermediate Clinical Endpoints in Cancer of the Prostate working group analyzed data from 28 randomized controlled trials comparing treatments in localized prostate cancer (PCa). Disease-free survival (DFS) was determined for 21 140 patients from 24 trials and metastasis-free survival (MFS) for 12 712 patients from 19 trials [1]. The surrogacy of DFS and MFS for overall survival (OS) was evaluated using a meta-analytical two-stage validation model in which two conditions must hold to claim DFS and MFS as a surrogate for OS. After median follow-up of 10 yr, 45% of the study populations experienced a DFS or MFS event, and 63% and 66% of these patients, respectively, had high-risk disease. MFS is a strong surrogate for OS (at a patient level, Kendall's g for correlation with OS was 0.91; at a trial level, R was 0.83, with 95% confidence interval 0.71–0.88) in a patient population with clinically localized PCa with an approximate 15% risk of dying from PCa over 10 yr despite potentially curative local therapy.