DARolutamide ObservationaL (DAROL) study in patients with nonmetastatic castration-resistant prostate cancer: prespecified third interim analysis

Evan Y Yu; Hiroyoshi Suzuki; Christopher M Pieczonka; Geoffrey Gotto; Alberto Briganti; Murilo Luz; Declan Murphy; Ryan Malone; Joelle Hamilton; Jonathan E Chan; Paul Sieber; Robert W Given; Eva Hellmis; Thomas Kretz; Philipp Spiegelhalder; Antonio Gómez-Caamaño; Yaovi Messan Amela; Xavier Artignan; Hiroji Uemura; Naoki Fujita; Patrick Adorjan; Mercedeh Ghadessi; Frank Verholen; Andrew J Armstrong

doi:10.1038/s41391-025-01047-7

DARolutamide ObservationaL (DAROL) study in patients with nonmetastatic castration-resistant prostate cancer: prespecified third interim analysis

Prostate Cancer Prostatic Dis. 2025 Nov 1. doi: 10.1038/s41391-025-01047-7. Online ahead of print.

Authors

Evan Y Yu¹, Hiroyoshi Suzuki², Christopher M Pieczonka³, Geoffrey Gotto⁴, Alberto Briganti⁵, Murilo Luz^{6

7}, Declan Murphy⁸, Ryan Malone⁹, Joelle Hamilton^{10

11}, Jonathan E Chan¹², Paul Sieber¹³, Robert W Given¹⁴, Eva Hellmis¹⁵, Thomas Kretz¹⁶, Philipp Spiegelhalder¹⁷, Antonio Gómez-Caamaño¹⁸, Yaovi Messan Amela¹⁹, Xavier Artignan²⁰, Hiroji Uemura²¹, Naoki Fujita²², Patrick Adorjan²³, Mercedeh Ghadessi²⁴, Frank Verholen²³, Andrew J Armstrong²⁵

Affiliations

¹ Fred Hutchinson Cancer Center and University of Washington, Seattle, WA, USA. evanyu@uw.edu.
² Toho University Sakura Medical Center, Chiba, Japan.
³ Associated Medical Professionals of NY, Syracuse, NY, USA.
⁴ University of Calgary, Southern Alberta Institute of Urology, Calgary, AB, Canada.
⁵ Urological Research Institute, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.
⁶ Hospital Erasto Gaertner, Curitiba, Brazil.
⁷ Icahn School of Medicine at Mount Sinai, New York, USA.
⁸ University of Melbourne and Peter MacCallum Cancer Centre, Melbourne, Australia.
⁹ First Urology, Jeffersonville, IN, USA.
¹⁰ Urology Centers of Alabama, Homewood, AL, USA.
¹¹ Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, AL, USA.
¹² Department of Surgery, University of Toronto, Toronto, ON, Canada.
¹³ Keystone Urology Specialists, Lancaster, PA, USA.
¹⁴ Urology of Virginia, Virginia Beach, VA, USA.
¹⁵ Urologicum Duisburg, Duisburg, Germany.
¹⁶ Urologie-Heinsberg, Heinsberg, Germany.
¹⁷ Urologie Neandertal, Mettmann, Germany.
¹⁸ Hospital Clínico Universitario, Santiago de Compostela, Spain.
¹⁹ Centre Bourgogne, Hôpital Privé le Bois, Lille, France.
²⁰ Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire, France.
²¹ Yokohama City University Medical Center, Yokohama, Japan.
²² Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
²³ Bayer Consumer Care AG, Basel, Switzerland.
²⁴ Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA.
²⁵ Duke University School of Medicine, Durham, NC, USA.

PMID: 41176520
DOI: 10.1038/s41391-025-01047-7

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.