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
Abstract Background Abiraterone is a 17α-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 saf...
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2025-05-01
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| Online Access: | https://doi.org/10.1186/s12916-025-04053-7 |
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| author | Xiaolin Lu Tao Dai Xue Chen Bin Wu Hui Chen Jitao Wu Dexin Yu Huixin Ge Jian Li Houbao Huang Tiwu Fan Linzhong Cheng Xiaoping Zhang Xuepei Zhang Xin Yao Junli Wei Zhenqiang Xu Wenzeng Yang Chaohong He Jiexin Luo Ling Guan Bin Fu Qilin Wang Xiaofeng Chen Yongdong Zhang Benkang Shi Bin Zheng Yong Wang Hong Luo Guoqiang Chen Huan Wang Quanren Wang Dingwei Ye |
| author_facet | Xiaolin Lu Tao Dai Xue Chen Bin Wu Hui Chen Jitao Wu Dexin Yu Huixin Ge Jian Li Houbao Huang Tiwu Fan Linzhong Cheng Xiaoping Zhang Xuepei Zhang Xin Yao Junli Wei Zhenqiang Xu Wenzeng Yang Chaohong He Jiexin Luo Ling Guan Bin Fu Qilin Wang Xiaofeng Chen Yongdong Zhang Benkang Shi Bin Zheng Yong Wang Hong Luo Guoqiang Chen Huan Wang Quanren Wang Dingwei Ye |
| author_sort | Xiaolin Lu |
| collection | DOAJ |
| description | Abstract Background Abiraterone is a 17α-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®, 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. Trial registration ClinicalTrials.gov, NCT04862091. |
| format | Article |
| id | doaj-art-fb9b44fb5f4845948262b1e57f9b8fad |
| institution | Kabale University |
| issn | 1741-7015 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj-art-fb9b44fb5f4845948262b1e57f9b8fad2025-08-20T03:53:12ZengBMCBMC Medicine1741-70152025-05-012311910.1186/s12916-025-04053-7A 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 cancerXiaolin Lu0Tao Dai1Xue Chen2Bin Wu3Hui Chen4Jitao Wu5Dexin Yu6Huixin Ge7Jian Li8Houbao Huang9Tiwu Fan10Linzhong Cheng11Xiaoping Zhang12Xuepei Zhang13Xin Yao14Junli Wei15Zhenqiang Xu16Wenzeng Yang17Chaohong He18Jiexin Luo19Ling Guan20Bin Fu21Qilin Wang22Xiaofeng Chen23Yongdong Zhang24Benkang Shi25Bin Zheng26Yong Wang27Hong Luo28Guoqiang Chen29Huan Wang30Quanren Wang31Dingwei Ye32Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan UniversityHunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South UniversityHunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South UniversityShengjing Hospital of China Medical UniversityHarbin Medical University Cancer HospitalYantai Yuhuangding HospitalThe Second Hospital of Anhui Medical UniversityThe Affiliated Hospital of Guizhou Medical UniversityThe First Affiliated Hospital of Bengbu Medical UniversityThe First Affiliated Hospital of Wannan Medical CollegeHeping Hospital Affiliated to Changzhi Medical CollegeHeping Hospital Affiliated to Changzhi Medical CollegeUnion Hospital Tongji Medical College Huazhong University of Science and TechnologyThe First Affiliated Hospital of Zhengzhou UniversityTianjin Medical University Cancer Institute and HospitalXingtai People’s HospitalZhangzhou Municipal Hospital of Fujian ProvinceThe Affiliated Hospital of Hebei UniversityThe Affiliated Cancer Hospital of Zhengzhou UniversityThe Tenth Affiliated Hospital of Southern Medical University (Dongguan People’s Hospital)The Tenth Affiliated Hospital of Southern Medical University (Dongguan People’s Hospital)The First Affiliated Hospital of Nanchang UniversityYunnan Cancer HospitalThe First People’s Hospital of ChenzhouThe First People’s Hospital of ChenzhouShandong University Qilu HospitalFoshan Fosun Chancheng HospitalJilin Province People’s HospitalChongqing University Cancer HospitalSanya Central Hospital (Hainan Third People’s Hospital)Jiangsu Hengrui Pharmaceuticals Co., LtdJiangsu Hengrui Pharmaceuticals Co., LtdFudan University Shanghai Cancer Center, Shanghai Medical College, Fudan UniversityAbstract Background Abiraterone is a 17α-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®, 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. Trial registration ClinicalTrials.gov, NCT04862091.https://doi.org/10.1186/s12916-025-04053-7Castration-resistant prostate cancerAbiraterone acetateCYP17 inhibitorTestosteroneProstate-specific antigen |
| spellingShingle | Xiaolin Lu Tao Dai Xue Chen Bin Wu Hui Chen Jitao Wu Dexin Yu Huixin Ge Jian Li Houbao Huang Tiwu Fan Linzhong Cheng Xiaoping Zhang Xuepei Zhang Xin Yao Junli Wei Zhenqiang Xu Wenzeng Yang Chaohong He Jiexin Luo Ling Guan Bin Fu Qilin Wang Xiaofeng Chen Yongdong Zhang Benkang Shi Bin Zheng Yong Wang Hong Luo Guoqiang Chen Huan Wang Quanren Wang Dingwei Ye 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 Castration-resistant prostate cancer Abiraterone acetate CYP17 inhibitor Testosterone Prostate-specific antigen |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Castration-resistant prostate cancer Abiraterone acetate CYP17 inhibitor Testosterone Prostate-specific antigen |
| url | https://doi.org/10.1186/s12916-025-04053-7 |
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