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BACKGROUND: DAROL is an ongoing study of real-world safety and effectiveness of darolutamide in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). SUBJECTS/METHODS: This prespecified interim analysis included 550 patients with nmCRPC who completed ≥6 months of treatment with darolutamide 600 mg twice daily. RESULTS: Darolutamide showed consistent safety and effectiveness in DAROL vs ARAMIS. Most treatment-emergent adverse events were grade 1/2. Two-year overall survival and metastasis-free survival rates and prostate-specific antigen responses were similar to ARAMIS. CONCLUSIONS: These findings indicate that darolutamide offers effectiveness and a favorable safety profile in the broad range of patients seen in clinical practice.
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Yu et al. (2025) studied this question.
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