Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials

Junlong Zhuang; Yuwen Wang; Shun Zhang; Yao Fu; Haifeng Huang; Xiaoyu Lyu; Shiwei Zhang; Giancarlo Marra; Linfeng Xu; Xuefeng Qiu; Hongqian Guo

doi:10.3389/fphar.2023.1217303

Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials

Front Pharmacol. 2023 Jun 26:14:1217303. doi: 10.3389/fphar.2023.1217303. eCollection 2023.

Authors

Junlong Zhuang^{1

2}, Yuwen Wang^{1

3}, Shun Zhang^{1

2}, Yao Fu⁴, Haifeng Huang^{1

2}, Xiaoyu Lyu^{1

2}, Shiwei Zhang^{1

2}, Giancarlo Marra⁵, Linfeng Xu^{1

2}, Xuefeng Qiu^{1

2}, Hongqian Guo^{1

2

3}

Affiliations

¹ Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
² Institute of Urology, Nanjing University, Nanjing, China.
³ Medical School of Southeast University Nanjing Drum Tower Hospital, Nanjing, China.
⁴ Department of Pathology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
⁵ Department of Surgical Sciences, Division of Urology, Molinette Hospital, Città della Salute e della Scienza and University of Turin, Turin, Italy.

Abstract

Objective: The study aimed to compare the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone or docetaxel versus ADT alone as neoadjuvant therapy in patients with very-high-risk localized prostate cancer. Methods: This was a pooled analysis of two single-center, randomized, controlled, phase II clinical trials (ClinicalTrials.gov: NCT04356430 and NCT04869371) conducted from December 2018 to March 2021. Eligible participants were randomly assigned to the intervention (ADT plus abiraterone or docetaxel) and control (ADT alone) groups at a 2:1 ratio. Efficacy was evaluated by pathological complete response (pCR), minimal residual disease (MRD), and 3-year biochemical progression-free survival (bPFS). Safety was also analyzed. Results: The study included 42 participants in the ADT group, 47 in the ADT plus docetaxel group, and 48 in the ADT plus abiraterone group. A total of 132 (96.4%) participants had very-high-risk prostate cancer, and 108 (78.8%) had locally advanced disease. The ADT plus docetaxel group (28%) and ADT plus abiraterone group (31%) had higher rates of pCR or MRD (p = 0.001 and p < 0.001) compared with the ADT group (2%). The 3-year bPFS was 41.9% (95% CI: 26.6-57.2), 51.1% (95% CI: 36.8-65.4), and 61.2% (95% CI: 45.5-76.9), respectively. Significant difference was found among groups in terms of bPFS (p = 0.037). Conclusion: Compared with ADT alone, neoadjuvant therapy with ADT plus docetaxel or abiraterone could achieve better pathological outcomes (pCR or MRD) for very-high-risk localized prostate cancer. The ADT plus abiraterone group showed longer bPFS than ADT alone. The combination regimens were tolerable.

Keywords: abiraterone; docetaxel; neoadjuvant therapy; prostate cancer; radical prostatectomy.

Associated data

ClinicalTrials.gov/NCT04356430
ClinicalTrials.gov/NCT04869371

Grants and funding

This work was funded by the National Natural Science Foundation of China (grant nos 81974394 to JZ, 82172639 to XQ, and 81972388 to HG), the Natural Science Foundation of Jiangsu Province for Excellent Young Scholars (BK20200051 to JZ), and the Project of Invigorating Healthcare through Science, Technology, and Education, Jiangsu Provincial Key Medical Discipline (Laboratory) (ZDXKB2016014 to HG).