Comparing darolutamide with apalutamide and enzalutamide for treating non-metastatic castration-resistant prostate cancer.

The study compared the effectiveness and safety outcomes of darolutamide (Nubeqa) with apalutamide (Erleada) and enzalutamide (Xtandi) in treating non-metastatic castration-resistant prostate cancer (CRPC). The data showed that darolutamide was safer and had similar effectiveness compared to apalutamide and enzalutamide.

Non-metastatic CRPC is an aggressive form of prostate cancer that has not spread beyond the prostate gland but is no longer responsive to hormonal therapy such as androgen-deprivation therapy (ADT). ADT reduces the production of androgens (male sex hormones such as testosterone). Reducing these androgens prevents cancer cell growth.

Darolutamide, apalutamide, and enzalutamide are all anti-androgen medications. They block testosterone from reaching PC cells. They are recommended for the treatment of non-metastatic CRPC. They have been shown to improve outcomes such as overall survival and to lower the risk of disease progression and spread in men with CRPC. However, there are few studies comparing the effectiveness and safety outcomes of darolutamide with apalutamide and enzalutamide for the treatment of patients with non-metastatic CRPC.

The authors analyzed data from 3 studies reporting the effects of darolutamide, apalutamide, and enzalutamide on a total 4104 patients with non-metastatic CRPC. Patients had received either darolutamide, apalutamide, enzalutamide, or a placebo.

No differences in the survival without metastasis (cancer spread) were found between either darolutamide versus apalutamide or darolutamide versus enzalutamide. 

Darolutamide was associated with significantly lower risks for fall, fracture, and rash rates than apalutamide. Darolutamide was also associated with significantly lower risks for fall, fracture, mental impairment disorder, diarrhea, nausea, fatigue, and severe fatigue than enzalutamide.

This study concluded that darolutamide was safer and had similar survival without metastasis compared to apalutamide and enzalutamide for the treatment of men with non-metastatic CRPC.

This study did not directly compare the 3 drugs. A randomized study is needed to confirm the results of this study. The study was funded by Bayer, the manufacturer of darolutamide.