Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Chin Med J (Engl). 2023 May 20;136(10):1207-1215. doi: 10.1097/CM9.0000000000002638. Epub 2023 Apr 3.
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.
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.
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 non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
ClinicalTrials.gov, NCT04563936.
LY01005（醋酸亮丙瑞林缓释微球注射剂）是一种每月注射一次的改良促性腺激素释放激素（GnRH）激动剂。这项 III 期临床试验旨在评估 LY01005 在中国前列腺癌患者中的疗效和安全性。
我们在中国 49 个地点进行了一项随机、对照、开放标签、非劣效性试验。这项研究纳入了 290 例前列腺癌患者，他们分别接受 LY01005 或戈舍瑞林植入物治疗，每 28 天注射一次，共注射三次。主要疗效终点为第 29 天睾酮抑制率≤50ng/dL 的患者比例和第 29 天至 85 天睾酮≤50ng/dL 的累积概率。非劣效性的预设界值为-10%。次要终点包括显著去势（≤20ng/dL）、重复给药后 72 小时内的睾酮激增，以及黄体生成素、卵泡刺激素和前列腺特异抗原水平的变化。
第 29 天，LY01005 组和戈舍瑞林植入物组中，分别有 99.3%（142/143）和 100%（140/140）的患者的睾酮浓度降至医学去势水平以下，两组间差异为-0.7%（95%置信区间[CI]，-3.9%至 2.0%）。从第 29 天到第 85 天维持去势的累积概率分别为 99.3%和 97.8%，组间差异为 1.5%（95%CI，-1.3%至 4.4%）。这两个结果均符合非劣效性标准。两组的次要终点结果相似。两种治疗方法均具有良好的耐受性。LY01005 与戈舍瑞林植入物相比，注射部位反应发生率更低（0%比 1.4%[2/145]）。
LY01005 在降低睾酮至去势水平方面与戈舍瑞林植入物同样有效，且安全性特征相似。
ClinicalTrials.gov，NCT04563936。
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