A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer
机构：[1]Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai, China.[2]Hunan Cancer Hospital and The Afliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.[3]Shengjing Hospital of China Medical University, Shenyang, China.中国医科大学附属盛京医院中国医科大学盛京医院[4]Harbin Medical University Cancer Hospital, Harbin, China.[5]Yantai Yuhuangding Hospital, Yantai, China.[6]The Second Hospital of Anhui Medical University, Hefei, China.[7]The Afliated Hospital of Guizhou Medical University, Guiyang, China.[8]The First Afliated Hospital of Bengbu Medical University, Bengbu, China.[9]The First Afliated Hospital of Wannan Medical College, Wuhu, China.[10]Heping Hospital Afliated to Changzhi Medical College, Changzhi, China.[11]Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.华中科技大学同济医学院附属协和医院[12]The First Afliated Hospital of Zhengzhou University, Zhengzhou, China.[13]Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.[14]Xingtai People’s Hospital, Xingtai, China.[15]Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou, China.[16]The Afliated Hospital of Hebei University, Baoding, China.[17]The Afliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.河南省肿瘤医院[18]The Tenth Afliated Hospital of Southern Medical University (Dongguan People’s Hospital), Dongguan, China.[19]The First Afliated Hospital of Nanchang University, Nanchang, China.[20]Yunnan Cancer Hospital, Kunming, China.[21]The First People’s Hospital of Chenzhou, Chenzhou, China.[22]Shandong University Qilu Hospital, Jinan, China.[23]Foshan Fosun Chancheng Hospital, Foshan, China.[24]Jilin Province People’s Hospital, Changchun, China.[25]Chongqing University Cancer Hospital, Chongqing, China.[26]Sanya Central Hospital (Hainan Third People’s Hospital), Sanya, China.[27]Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Background Abiraterone is a 17 alpha-hydroxylase/C17-20 lyase inhibitor used for the treatment of metastatic castration-resistant prostate cancer (CRPC). This multi-center, randomized, open-label, active-controlled phase II study compared the pharmacodynamics (PD), pharmacokinetics (PK), and safety of abiraterone acetate tablets (II) (AAT[II]), a new formulation of abiraterone acetate, and ZYTIGA (R), the originator abiraterone acetate (OAA), in patients with metastatic CRPC. Methods Patients were randomized 1:1 to receive 300 mg AAT(II) daily plus 5 mg prednisone twice daily or 1000 mg OAA daily plus 5 mg prednisone twice daily for 84 days. The primary endpoint was the serum testosterone level (rounded-up) on Day 9 and/or Day 10. Absolute testosterone concentration, prostate-specific antigen (PSA) concentration, steady-state PK of abiraterone, and safety were also evaluated. Results Sixty-nine patients were enrolled in the study, with 35 assigned to AAT(II) and 34 to OAA. The least squares (LS) mean (standard error) of serum testosterone concentration (rounded-up) on Day 9 and/or Day 10 were 1.075 (0.034) and 1.000 (0.034) in the AAT(II) and OAA groups, respectively. The geometric mean ratio (AAT[II] vs. OAA) was 1.053 (90% confidence interval [CI], 0.998 to 1.110) and the LS mean difference was 0.075 (95% CI, -0.021 to 0.171). The 90% CI fell within the 80.0% to 125.0% equivalence limits, suggesting equivalent PD effect of the two formulations. AAT(II) also exhibited high testosterone inhibition rate (> 90% at all visits) and PSA-50 rate (> 65% on Days 56 and 84), which were comparable to that of OAA. AAT(II) also demonstrated an improved safety profile with lower incidence of adverse events compared to OAA. Conclusions AAT(II) at 300 mg plus prednisone demonstrated equivalent PD as OAA at 1000 mg plus prednisone in reducing serum testosterone on Day 9 and/or Day 10, and the effect was maintained up to the end of the study. Compared to OAA, AAT(II) was given at a much lower dosage and was not affected by food consumption. AAT(II) was well tolerated, and no new safety issues were found.
第一作者机构：[1]Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai, China.
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推荐引用方式(GB/T 7714)：
Lu Xiaolin,Dai Tao,Chen Xue,et al.A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer[J].BMC MEDICINE.2025,23(1):doi:10.1186/s12916-025-04053-7.
APA：
Lu, Xiaolin,Dai, Tao,Chen, Xue,Wu, Bin,Chen, Hui...&Ye, Dingwei.(2025).A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer.BMC MEDICINE,23,(1)
MLA：
Lu, Xiaolin,et al."A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer".BMC MEDICINE 23..1(2025)
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