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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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.

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