Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial

作者：Chengyuan Gu, Zengjun Wang, Tianxin Lin, Zhiyu Liu, Weiqing Han, Xuhui Zhang, Chao Liang, Hao Liu, Yang Yu, Zhenzhou Xu, Shuang Liu, Jingen Wang, Linghua Jia, Xin Yao, Wenfeng Liao, Cheng Fu, Zhaohui Tan, Guohua He, Guoxi Zhu, Rui Fan, Wenzeng Yang, Xin Chen, Zhizhong Liu, Liqiang Zhong, Benkang Shi, De‐Gang Ding, Shubo Chen, Junli Wei, Xudong Yao, Ming Chen, Zhan-peng Lu, Qun Xie, Zhiquan Hu, Yinhuai Wang, Hongqian Guo, Tiwu Fan, Zhaozhao Liang, Peng Chen, Wei Wang, Tao Xu, Chunsheng Li, Jinchun Xing, Hong Liao, Dalin He, Zhibin Wu, Jiandi Yu, Zhongwen Feng, Mengxiang Yang, Qifeng Dou, Quan Zeng, Yuanwei Li, Xin Gou, Guangchen Zhou, Xiaofeng Wang, Rujian Zhu, Zhonghua Zhang, Bo Zhang, Wanlong Tan, Xueling Qu, Sun Hongliang, Tianyi Gan, Dingwei Ye · 发表于：Chinese Medical Journal · 年份：2023 · DOI：10.1097/cm9.0000000000002638 · 被引用次数：9 · 研究领域：Prostate Cancer Diagnosis and Treatment、Prostate Cancer Treatment and Research、Hypothalamic control of reproductive hormones

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for ...