Prostate cancer is typically a disease of older men. As patients age, they develop comorbidities and require more medications, which may adversely affect or be affected by prostate cancer treatments.
We investigated whether the survival benefits and favorable safety profile of darolutamide in the phase 3 ARASENS trial could be seen regardless of age.
Patients received darolutamide 600 mg or placebo orally twice daily plus androgen-deprivation therapy and docetaxel. Outcomes were assessed in subgroups of patients aged <75 yr (n = 1086) and ≥75 yr (n = 219).
Most patients in both age groups had comorbidities (<75 yr: 94%; ≥75 yr: 97%) and concomitant medications (median 8-9). In both age subgroups, compared with placebo, darolutamide increased overall survival (<75 yr: hazard ratio 0.70 [95% confidence interval 0.58-0.84]; ≥75 yr: 0.61 [0.41-0.91]), delayed time to metastatic castration-resistant prostate cancer (<75 yr: 0.35 [0.30-0.43]; ≥75 yr: 0.42 [0.28-0.64]), and delayed time to initiation of subsequent therapy (<75 yr: 0.40 [0.34-0.48]; ≥75 yr: 0.35 [0.22-0.54]). Treatment-emergent adverse events were similar in the darolutamide/placebo groups, with slightly higher incidences in older patients. This analysis is limited by its post hoc nature.
In the 219 patients aged ≥75 yr in ARASENS, darolutamide demonstrated improved efficacy versus placebo and favorable safety, consistent with the findings in patients aged <75 yr. Thus, darolutamide and androgen-deprivation therapy with docetaxel can be considered a standard of care triplet therapy for metastatic hormone-sensitive prostate cancer regardless of patients' age.
European urology oncology. 2025 Nov 04 [Epub ahead of print]
Joan Carles, Bertrand Tombal, Maha Hussain, Fred Saad, Karim Fizazi, Álvaro Montesa Pino, Maria José Méndez-Vidal, Alejo Rodriguez-Vida, Daniel Castellano, Pablo Borrega, Patrick Adorjan, Cristina Moretones, Manjari Dissanayake, Matthew R Smith
Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Electronic address: ., Division of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium., Northwestern University, Feinberg School of Medicine, Chicago, IL, USA., University of Montreal Hospital Center, Montreal, Quebec, Canada., Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France; Centre Oscar Lambret, Lille, France., Hospital Regional Universitariode Málaga, IBIMA, Málaga, Spain., Reina Sofía University Hospital, Córdoba, Spain., Hospital del Mar Research Institute, Barcelona, Spain., Hospital 12 de Octubre, Madrid, Spain., Hospital San Pedro de Alcántara, Cáceres, Spain., Bayer Consumer Care AG, Basel, Switzerland., Bayer Hispania, S.L., Sant Joan Despí, Spain., Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA., Massachusetts General Hospital Cancer Center, Boston, MA, USA.