The prostate-specific membrane antigen (PSMA) inhibitor [177Lu]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. Methods: Forty chemotherapy-naïve, PSMA-positive metastatic castration-resistant prostate cancer patients were randomly assigned to [177Lu]Lu-PSMA-617 (n = 20) or docetaxel (n = 20). Thirty-five patients received treatment per the protocol. Survival analysis was done using Kaplan-Meier curves and the Cox regression model. Results: The mean follow-up duration was 33.4 mo. In intention-to-treat analysis, the median OS for the [177Lu]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 (P = 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 (P = 0.712). No significant difference in OS was observed between the 2 arms across the analyzed subgroups. Conclusion: Long-term outcomes with [177Lu]Lu-PSMA-617 administered earlier in the prechemotherapy setting are comparable to those with docetaxel.
Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2023 Sep 14 [Epub ahead of print]
Swayamjeet Satapathy, Bhagwant Rai Mittal, Ashwani Sood, Chandan Krushna Das, Ravimohan Suryanarayan Mavuduru, Shikha Goyal, Jaya Shukla, Shrawan Kumar Singh
Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India., Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India; ., Department of Clinical Hematology and Medical Oncology, Post Graduate Institute of Medical Education and Research, Chandigarh, India., Department of Urology, Post Graduate Institute of Medical Education and Research, Chandigarh, India; and., Department of Radiotherapy, Post Graduate Institute of Medical Education and Research, Chandigarh, India.