DARolutamide ObservationaL (DAROL) study in patients with nonmetastatic castration-resistant prostate cancer: prespecified third interim analysis
- Author(s)
- Yu, EY; Gómez-Caamaño, A; Suzuki, H; Pieczonka, CM; Gotto, G; Briganti, A; Luz, M; Murphy, D; Malone, R; Hamilton, J; Chan, JE; Sieber, P; Given, RW; Hellmis, E; Kretz, T; Spiegelhalder, P; Amela, YM; Artignan, X; Uemura, H; Fujita, N; Adorjan, P; Ghadessi, M; Verholen, F; Armstrong, AJ;
- Details
- Publication Year 2026-09,Volume 29,Issue #3,Page 642-645
- Journal Title
- Prostate Cancer and Prostatic Diseases
- Publication Type
- Research article
- Abstract
- 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.
- Publisher
- Springer Nature
- Keywords
- Humans; Male; *Prostatic Neoplasms, Castration-Resistant/drug therapy/pathology/mortality/blood; Aged; Middle Aged; *Pyrazoles/therapeutic use/adverse effects/administration & dosage; Prostate-Specific Antigen/blood; Aged, 80 and over; Treatment Outcome
- Department(s)
- Surgical Oncology
- Publisher's Version
- https://doi.org/10.1038/s41391-025-01047-7
- Open Access at Publisher's Site
https://doi.org/10.1038/s41391-025-01047-7- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2026-01-09 02:59:45
Last Modified: 2026-09-16 04:38:39