REZVILUTAMIDE plus androgen-deprivation therapy (ADT) was associated with longer radiographic progression-free survival (rPFS), delayed castration resistance and improved prostate-specific antigen (PSA) responses compared with bicalutamide plus ADT in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC).
The multicentre retrospective cohort study included patients treated between 2021 and 2024. Propensity-score matching produced 50 patients in each treatment group. Calendar year was incorporated as a covariate in prespecified sensitivity analyses to address potential treatment-era bias.
Median rPFS was 25.9 months with rezvilutamide compared with 16.1 months with bicalutamide (hazard ratio [HR]: 0.64; 95% confidence interval [CI]: 0.41–0.98; p=0.038).
Time to castration resistance was also longer with rezvilutamide at 18.6 versus 11.4 months (HR: 0.61; 95% CI: 0.39–0.94; p=0.026), while time to PSA progression was 20.1 versus 12.9 months (HR: 0.57; 95% CI: 0.36–0.91; p=0.018).
PSA responses also favoured rezvilutamide. A PSA reduction of at least 50% occurred in 84% of patients receiving rezvilutamide compared with 62% receiving bicalutamide (p=0.011), while PSA reductions of at least 90% occurred in 50% and 28%, respectively (p=0.022).
Overall survival did not differ significantly between groups (HR: 0.85; 95% CI: 0.50–1.43; p=0.54), and symptomatic skeletal events were also not significantly different (HR: 0.82; 95% CI: 0.44–1.54; p=0.53).
Grade 3 or higher adverse events occurred in 26% of patients receiving rezvilutamide and 24% receiving bicalutamide. Prespecified central nervous system related events were reported in 8% and 14%, respectively, with events defined using standardised criteria and independently reviewed by a neurologist.
An exploratory analysis included patients with prior docetaxel exposure, who represented 24% of each treatment group and had been excluded from the CHART trial. rPFS numerically favoured rezvilutamide in this subgroup (HR: 0.68; 95% CI: 0.30–1.55), although the analysis was underpowered.
The researchers concluded that rezvilutamide plus ADT provided superior disease control to bicalutamide plus ADT in high-volume mHSPC. The retrospective design and modest sample size limit definitive conclusions, particularly for subgroups, while longer follow-up is needed to assess potential survival differences.
Reference
Lou Y e tal. Rezvilutamide versus bicalutamide with androgen-deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer: a multicenter retrospective cohort study. Sci Rep. 2026;DOI:10.1038/s41598-026-69117-x.
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