[<sup>177</sup>Lu]Lu-PSMA-617 Versus Docetaxel in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: Final Survival Analysis of a Phase 2 Randomized, Controlled Trial
Swayamjeet Satapathy, Bhagwant Rai Mittal, Ashwani Sood, Chandan Krushna Das, Ravimohan Suryanarayan Mavuduru, Shikha Goyal, Jaya Shukla, Shrawan Kumar Singh
Abstract
The prostate-specific membrane antigen (PSMA) inhibitor [<sup>177</sup>Lu]Lu-PSMA-617 has been previously demonstrated to be noninferior to docetaxel in achieving a biochemical response in chemotherapy-naïve metastatic castration-resistant prostate cancer patients. Here, we report the final analysis of overall survival (OS) for a phase 2 randomized, controlled trial. <b>Methods:</b> Forty chemotherapy-naïve, PSMA-positive metastatic castration-resistant prostate cancer patients were randomly assigned to [<sup>177</sup>Lu]Lu-PSMA-617 (<i>n</i> = 20) or docetaxel (<i>n</i> = 20). Thirty-five patients received treatment per the protocol. Survival analysis was done using Kaplan–Meier curves and the Cox regression model. <b>Results:</b> The mean follow-up duration was 33.4 mo. In intention-to-treat analysis, the median OS for the [<sup>177</sup>Lu]Lu-PSMA-617 and docetaxel arms was 15.0 mo (95% CI, 9.5–20.5 mo) and 15.0 mo (95% CI, 8.1–21.9 mo), respectively (<i>P</i> = 0.905). In per-protocol analysis, the median OS was 19.0 mo (95% CI, 12.3–25.7 mo) versus 15.0 mo (95% CI, 8.1–21.9 mo), respectively (<i>P</i> = 0.712). No significant difference in OS was observed between the 2 arms across the analyzed subgroups. <b>Conclusion:</b> Long-term outcomes with [<sup>177</sup>Lu]Lu-PSMA-617 administered earlier in the prechemotherapy setting are comparable to those with docetaxel.