HTA91 Correlation of intermediate clinical endpoints (ICES) for overall survival (OS) in localized or locally advanced prostate cancer (LPC/LAPC): Analysis of individual real-world data (RWD)

RWD from the UK (Clinical Practice Research Datalink [CPRD] electronic health records [EHR]) and US (ConcertAI RWD360® claims and EHR; Optum claims; Optum EHR) were analyzed separately. Patients with LPC/LAPC who underwent radical prostatectomy before progression to metastatic or castration-resistant PC were included. Correlation analyses between ICEs and rwOS were estimated with parametric statistical models developed by Fleischer (Fleischer, Stat Med. 2009); bootstrapping to validate sample statistics was performed. Hazard ratios with 95% confidence intervals were calculated for landmark analyses of rwOS according to ICEs landmark-event status at 3, 4, and 5 years post prostatectomy.

A total of 6,894 (CPRD), 5,457 (ConcertAI), 28,530 (Optum claims), and 34,653 (Optum EHR) patients were included. Across databases, correlation coefficients were strong between rwMFS and rwOS (Fleischer’s r range: 0.99-1.00) and moderate between rwEFS and rwOS and rwNED and rwOS (r range: 0.52-0.57, 0.43-0.57), respectively. Patients without landmark rwEFS or rwNED events (non-progressors) had significantly better rwOS than those with such event (progressors). Hazard ratios for rwEFS/rwNED ranged between: 3-year, 1.8-3.4/1.8-2.9; 4-year, 1.7-3.2/1.7-2.7; 5-year, 1.6-2.9/1.6-2.4, across the 4 databases.

Strength of correlation evidence from individual RWD reinforces MFS as a clinically meaningful ICE, concordant with existing evidence (Xie, Ann Oncol. 2024). Moreover, this study suggests that EFS and NED could potentially be clinically meaningful ICEs for OS in patients with LPC/LAPC. These results are consistent with a correlation analysis of ICEs for OS using data from randomized and nonrandomized studies (Siebert, IJTAHC. 2025).Strength of correlation evidence from individual RWD reinforces MFS as a clinically meaningful ICE, concordant with existing evidence (Xie, Ann Oncol. 2024). Moreover, this study suggests that EFS and NED could potentially be clinically meaningful ICEs for OS in patients with LPC/LAPC. These results are consistent with a correlation analysis of ICEs for OS using data from randomized and nonrandomized studies (Siebert, IJTAHC. 2025).