Translational andrology and urology · 2026
Real-world effectiveness of rezvilutamide plus androgen deprivation therapy in patients with high-volume metastatic hormone-sensitive prostate cancer: a retrospective multicenter cohort study.
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Wang Baojun, Xia Dan, Pan Yu, Hu Jia, Liu Huaijun, Zhang Xiangxiang, Chen Dong, Huang Hong, Chen Guoqiang, Fan Jiquan, Zhang Hongtuan, Wu Hongyi, Li Zixiang, Zhao Gang, Wang Qi, Li Li, Ye Mingji, Yang Guanglin, Liu Yuanlin, Lin Jianqun, Gu Yanqin, Liu Feng, Chen Zhi, Luo Jin, Wang Liping, Ying Zhou, He Ting, Lin Chaoyu, Zhang Xu, Niu Shaoxi
Аннотация
BACKGROUND: Rezvilutamide has demonstrated significant clinical benefits in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in the phase III CHART study. However, patients enrolled in clinical trials may not fully represent those encountered in routine clinical practice, and real-world evidence in this population remains limited. This study aimed to evaluate the real-world effectiveness of rezvilutamide in combination with androgen deprivation therapy (ADT) in patients with high-volume mHSPC.
METHODS: This multicenter retrospective cohort study included patients with high-volume mHSPC who received rezvilutamide plus ADT between August 29, 2023, and April 1, 2026 across 21 offline centers and one online center in China. Outcomes included prostate-specific antigen (PSA) 50 (defined as a ≥50% decline from baseline), PSA90 (defined as a ≥90% decline from baseline), and undetectable PSA (PSA <0.2 ng/mL) rates at 3, 6, 9, and 12 months, as well as the 12-month PSA progression-free rate. Prespecified subgroup analyses were performed according to age, Eastern Cooperative Oncology Group performance status, and Gleason score.
RESULTS: A total of 1,888 patients were included, with a median age of 73 years [interquartile range (IQR), 68-79 years]. The median baseline PSA was 70.9 ng/mL (IQR, 5.9-146.0 ng/mL). At 3 months, the PSA50, PSA90, and undetectable PSA rates were 83.3% [1,572/1,888, 95% exact confidence interval (CI): 81.5-84.9%], 71.7% (1,353/1,888, 95% exact CI: 69.6-73.7%), and 44.8% (845/1,888, 95% exact CI: 42.5-47.1%), respectively. Overall, the PSA response rates showed a gradual increasing trend over time. By month 12, the PSA50, PSA90, and undetectable PSA rates had reached 86.0% (282/328, 95% exact CI: 81.7-89.6%), 78.7% (258/328, 95% exact CI: 73.8-83.0%), and 72.0% (236/328, 95% exact CI: 66.8-76.8%), respectively. The PSA progression-free rate at 12 months was 93.4%.
CONCLUSIONS: These real-world findings support the clinical utility of rezvilutamide combined with ADT in achieving durable PSA suppression in patients with high-volume mHSPC. However, the absence of comprehensive safety data and the retrospective nature of the study warrant cautious interpretation, and further prospective validation is needed.
METHODS: This multicenter retrospective cohort study included patients with high-volume mHSPC who received rezvilutamide plus ADT between August 29, 2023, and April 1, 2026 across 21 offline centers and one online center in China. Outcomes included prostate-specific antigen (PSA) 50 (defined as a ≥50% decline from baseline), PSA90 (defined as a ≥90% decline from baseline), and undetectable PSA (PSA <0.2 ng/mL) rates at 3, 6, 9, and 12 months, as well as the 12-month PSA progression-free rate. Prespecified subgroup analyses were performed according to age, Eastern Cooperative Oncology Group performance status, and Gleason score.
RESULTS: A total of 1,888 patients were included, with a median age of 73 years [interquartile range (IQR), 68-79 years]. The median baseline PSA was 70.9 ng/mL (IQR, 5.9-146.0 ng/mL). At 3 months, the PSA50, PSA90, and undetectable PSA rates were 83.3% [1,572/1,888, 95% exact confidence interval (CI): 81.5-84.9%], 71.7% (1,353/1,888, 95% exact CI: 69.6-73.7%), and 44.8% (845/1,888, 95% exact CI: 42.5-47.1%), respectively. Overall, the PSA response rates showed a gradual increasing trend over time. By month 12, the PSA50, PSA90, and undetectable PSA rates had reached 86.0% (282/328, 95% exact CI: 81.7-89.6%), 78.7% (258/328, 95% exact CI: 73.8-83.0%), and 72.0% (236/328, 95% exact CI: 66.8-76.8%), respectively. The PSA progression-free rate at 12 months was 93.4%.
CONCLUSIONS: These real-world findings support the clinical utility of rezvilutamide combined with ADT in achieving durable PSA suppression in patients with high-volume mHSPC. However, the absence of comprehensive safety data and the retrospective nature of the study warrant cautious interpretation, and further prospective validation is needed.