Darolutamide: A New Hope in the Battle Against Prostate Cancer Plain Summary
Murat Sari1, Osman Kostek11Division of Medical Oncology, Department of Internal Medicine, Marmara University Hospital, İstanbul, Türkiye
Prostate cancer is the second most prevalent cancer among men globally and represents a significant global health concern. According to GLOBOCAN 2022 data, there were 1,467,854 new cases and 397,430 deaths from prostate cancer worldwide. In Türkiye, 17,274 new cases were diagnosed, with approximately 5,428 deaths reported in 2022. Prostate cancer is typically diagnosed in older age groups, with most patients presenting at localized or locally advanced stages, while a smaller proportion present with de novo metastatic disease. The five-year survival rate for localized prostate cancer is over 98%, whereas it drops to around 30% for metastatic disease. Darolutamide has emerged as a promising treatment option for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Approved by the FDA in 2019 for nmCRPC and in 2022 for use in combination with docetaxel for mHSPC, Darolutamide has demonstrated significant efficacy. The ARAMIS trial revealed that Darolutamide significantly extended metastasis-free survival (MFS) to 40.4 months compared to 18.4 months with placebo, representing a 59% reduction in the risk of metastasis or death. Similarly, the ARASENS trial showed that Darolutamide improved overall survival (OS) by 32.5% and delayed the progression to castrationresistant prostate cancer (CRPC) in mHSPC patients. Darolutamide is noted for its favorable safety profile, particularly regarding central nervous system (CNS) adverse events, due to its minimal CNS penetration. This distinguishes it from other anti-androgens, which may have higher risks of cognitive and neurological side effects. The recommended dosage is 600 mg twice daily, with potential adjustments for severe hepatic or renal impairment. Understanding Darolutamide’s administration and drug interactions is crucial for optimizing treatment outcomes in prostate cancer patients. Keywords: Castration-sensitive, Darolutamide, Metastasis, Overall survival, Prostate cancer
Cite This Article
Sari M, Kostek O. Darolutamide: A New Hope in the Battle Against Prostate Cancer Plain Summary. EJMI. 2025; 9(1): 1-11
Corresponding Author: Murat Sari