Early Endpoints in High-risk Localized Prostate Cancer: Exploratory Analysis of Three Radiation Therapy Oncology Group Phase 3 Studies

Perception of cure in prostate cancer: human-led and artificial intelligence-assisted landscape review and linguistic analysis of literature, social media and policy documents

“…defined as patients living with recovered testosterone and without PSA relapse, local or regional recurrence and distant metastases. 44 Additionally, NED is an emerging early endpoint in PC treatment that may measure clinically undetectable disease in LPC/LAPC as demonstrated by an ad hoc analysis of patients with high-risk LPC/LAPC following primary definitive radiotherapy and long-term androgen deprivation therapy. 44 The finding of an association between NED and biochemical recurrence in this study highlights the relevance of NED for communications about cure.…”

A US real-world study of treatment patterns and outcomes in localized or locally advanced prostate cancer patients

“…However, earlier measurable endpoints can be beneficial and may accelerate progress to identify beneficial treatments earlier, especially for disease states like LPC/LAPC, for which it takes many years to reach endpoints like MFS and OS. Other progression-related surrogate endpoints have been investigated for OS endpoints [ 8 , 23 ], with EFS with prostate-specific antigen (PSA) nadir + 2 ng/mL and rising, PSA > 5 ng/mL, or PSA doubling time < 6 months ± ADT initiation and no evidence of disease identified as promising early endpoints for high-risk LPC [ 8 ]. Based on the substantially higher rwOS among men without evidence of disease described here, and if validated for surrogacy in additional LPC datasets, no evidence of disease at defined time points could be a possible intermediate endpoint for earlier efficacy assessment in future clinical trials investigating treatment for LPC/LAPC.…”

“…Real-world data (RWD) can add to the available evidence and supplement clinical trial data by addressing questions relevant to ongoing trials and therapeutic controversies, and potentially informing on future trial designs [7]. RWD and clinical trials have demonstrated that the time to metastasisfree survival (MFS) for patients with localized disease is very long, and previous work evaluating the association of early endpoints for recurrence with longer-term outcomes using clinical trial data also supports the need for earlier efficacy assessment [8][9][10][11]. We therefore aimed to determine whether we could find earlier endpoints that also correlated with poor outcomes that could, if further validated in future studies, be used as endpoints to provide a timelier treatment efficacy assessment for the LPC/LAPC patient population.…”