Darolutamide in hormone-sensitive and castration-resistant prostate cancer

Introduction: Important changes in the treatment of prostate cancer have taken place in recent years. Non-metastatic castration-resistant prostate cancer (nmCRPC) has been clinically delineated. In this setting, three drugs have been approved in high-risk disease: apalutamide, enzalutamide and darolutamide. Areas covered:This manuscript aims to profile darolutamide, its clinical development, pharmacologic properties, efficacy and safety. We presented the results of published clinical studies, but we also investigated ongoing ones. Expert opinion: An indirect comparison with the other two aforementioned drugs emerged. While the clinical efficacy is comparable, the toxicity profile is different for darolutamide, resulting in greater tolerance. We must wait for the results of the trials that study darolutamide in hormone-sensitive disease, both in the metastatic phase and in the localized phase. Clinical experience will also be important to determine ever more personalized treatments for patients.

Automated summary

Important changes have occurred in prostate cancer treatment in recent years, particularly regarding non-metastatic castration-resistant prostate cancer (nmCRPC). Three drugs have been approved for high-risk disease - apalutamide, enzalutamide, and darolutamide. While clinical efficacy is comparable, darolutamide has a different toxicity profile and greater tolerance. Further trials and clinical experience are needed to determine personalized treatments for patients.