Background: The VISION trial demonstrated a survival benefit of PSMA-RLT treatment (tx) for pts with PSMA-positive mCRPC. However, outcomes in a real-world setting are unknown. PSMA-RLT has been used at Essen University Hospital (UKE) in Germany since 2017. This retrospective cohort study describes characteristics and real-world overall survival (rwOS) of pts with mCRPC treated with PSMA-RLT. We contextualize these findings with results from a US-based mCRPC cohort that did not receive this novel tx. Methods: The UKE cohort included mCRPC pts treated with ≥ 1 cycle of PSMA-RLT from 11/2017 to 10/2022. Data comprised structured and unstructured data from UKE’s electronic health record (EHR). The US cohort was selected from the nationwide EHR-derived Flatiron Health database. It included pts with mCRPC diagnosis (dx) from 01/2014 to 09/2021 who received tx (=index tx) following ≥ 1 taxane and ≥ 1 androgen receptor pathway inhibitor (ARPI). Results: In the UKE cohort (N = 219, median (med) age: 73, interquartile range (IQR): 67, 78) med time from initial dx and mCRPC dx to the initiation of PSMA-RLT was 69 mos (IQR: 42, 128) and 23 mos (IQR: 13, 40), respectively. Pts were heavily pre-treated (1 taxane: 55.5%, ≥ 2 taxanes: 27.8%; 1 ARPI: 37.3 %, ≥ 2 ARPIs: 58.9%). Disease burden at the time of tx start was extensive, as indicated by sites of metastases (for tumor patterns see table). Median OS (mOS) from the start of PSMA-RLT was 9.8 mos (95% CI: 8.6, 11.3). In the US cohort (N = 857, med age = 71, IQR: 65, 78) med time from initial dx and mCRPC dx to index tx was 49 mos (IQR: 27, 99) and 16 mos (IQR: 10, 25), respectively. 88.9% of pts received prior tx with 1 taxane and 11.1% with ≥2 taxanes, 65% with 1 ARPI and 35% with ≥ 2 ARPIs. Med OS for US patients was 8.5 mos (95% CI:7.6, 9.1). Conclusions: This study provided the unique opportunity to describe real-world outcomes for late stage mCRPC patients treated with PSMA-RLT. The study design did not allow for a direct comparison between the two cohorts. Qualitatively, UKE patients were heavily pre-treated with extensive disease burden at the start of PSMA-RLT. Nevertheless, the study demonstrated promising rw outcomes for patients with mCRPC under PSMA-RLT. Future work, including the direct comparison of PSMA-RLT versus other tx in a similar disease setting, will help further characterize the benefit of this novel tx in practice.

*Index UKE: Date of 1st PSMA-RLT cycle; index US: Start of tx following ≥ 1 taxane and ≥ 1 ARPI.