[Translation] An open-label, single-arm, multicenter clinical study evaluating the safety, efficacy and pharmacokinetics of leuprolide injection emulsion in the treatment of advanced prostate cancer
主要目的:1)以血清睾酮为有效性评价的替代性指标,以50 ng/dL作为去势限,评价亮丙瑞林注射乳剂从第1次给药后28天结束时至第2次给药后168天结束时的去势维持率。2)评价亮丙瑞林注射乳剂在晚期前列腺癌患者中2次皮下注射给药的安全性和耐受性。次要目的:1)以20 ng/dL作为显著去势限,评价注射用亮丙瑞林注射乳剂从第1次给药28天结束时至至第2次给药后168天结束时的显著去势维持率。2)评价亮丙瑞林注射乳剂2次给药对血清前列腺特异性抗原(PSA)的影响。3)评价亮丙瑞林注射乳剂2次给药对促黄体生成素(LH)的影响。4)评价亮丙瑞林注射乳剂给药期间出现的去势逃逸现象,包括第2次给药导致的睾酮水平波动(慢加急现象)。5)评价亮丙瑞林注射乳剂2次给药的药代动力学(PK)特征。
[Translation] Main purpose: 1) Using serum testosterone as a surrogate index for efficacy evaluation and 50 ng/dL as the castration limit, to evaluate the leuprolide injection emulsion from the end of 28 days after the first dose to the second dose. Castration maintenance at the end of 168 days post-dose. 2) To evaluate the safety and tolerability of leuprolide injection emulsion in 2 subcutaneous injections in patients with advanced prostate cancer. Secondary objectives: 1) Using 20 ng/dL as the significant castration limit, to evaluate the significance of leuprolide injection emulsion for injection from the end of 28 days after the first dose to the end of 168 days after the second dose. Castration maintenance rate. 2) To evaluate the effect of two administrations of leuprolide injection emulsion on serum prostate-specific antigen (PSA). 3) To evaluate the effect of 2 administrations of leuprolide injection emulsion on luteinizing hormone (LH). 4) To evaluate the escape from castration during the administration of leuprolide injection emulsion, including the fluctuation of testosterone level caused by the second administration (slow acceleration phenomenon). 5) To evaluate the pharmacokinetic (PK) characteristics of leuprolide injection emulsion for two administrations.