Real-world effectiveness of rezvilutamide plus androgen deprivation therapy in patients with low-volume, metastatic hormone-sensitive prostate cancer: a retrospective multicenter study

The CHART study established the combination of rezvilutamide and androgen deprivation therapy (ADT) as a standard treatment for patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). However, the therapeutic outcomes of this regimen in patients with low-volume mHSPC remain insufficiently defined. This study thus aimed to assess the real-world effectiveness of rezvilutamide combined with ADT in the treatment of low-volume mHSPC. This multicenter, noninterventional, observational study was conducted in China and included adult patients diagnosed with low-volume mHSPC who were treated with rezvilutamide in combination with ADT as determined by the investigator. The study assessed prostate-specific antigen (PSA) responses at multiple time points (3, 6, 9, and 12 months), including a PSA decline ≥50% (PSA50), a PSA decline ≥90% (PSA90), and a PSA level <0.2 ng/mL (undetectable PSA). Subgroup analyses of PSA responses were conducted according to baseline characteristics, including age, Eastern Cooperative Oncology Group performance status (ECOG PS), and Gleason score. Between August 29, 2023 and December 31, 2024, a total of 257 patients were enrolled in the study. The median age was 73 years [interquartile range (IQR), 68-77 years], and the median baseline PSA level was 38 ng/mL (IQR, 7-100 ng/mL). PSA responses were observed as early as 3 months after initiating rezvilutamide treatment, with 88% [176/199; 95% exact confidence interval (CI): 83-93%] achieving PSA50, 75% (149/199; 95% exact CI: 68-81%) achieving PSA90, and 54% (108/199; 95% exact CI: 47-61%) achieving undetectable PSA levels. These responses further improved at subsequent time points (6, 9, and 12 months). By 12 months, 100% (12/12; 95% exact CI: 74-100%) achieved PSA50, 92% (11/12; 95% exact CI: 62-100%) achieved PSA90, and 83% (10/12; 95% exact CI: 52-98%) had undetectable PSA levels. This study is the first to evaluate the effectiveness of rezvilutamide in patients with low-volume mHSPC. In a real-world clinical setting, the combination of rezvilutamide and ADT demonstrated favorable PSA response in this patient population. These findings provide additional treatment options for patients with low-volume mHSPC and support the need for further large-scale research on rezvilutamide in this subgroup.