Evaluating long-term outcomes of darolutamide in patients with hormone-resistant prostate cancer

This study evaluated the survival rate of patients with prostate cancer (PC) that no longer responded do hormonal therapy (castration resistant) being treated with darolutamide (Nubeqa). 

The study found that darolutamide may improve survival rates and delay the start of heavy chemotherapy in these patients.

The growth of prostate cancer (PC) can be stimulated by male sex hormones (androgens) like testosterone. The common treatment for advanced PC is androgen deprivation therapy (ADT). This usually involves hormonal therapy to suppress androgens. The goal is to reduce their production and block their effect on cancer cells. Some forms of PC become resistant to ADT and the PC continues to grow despite ADT. This is called castration-resistant (CR) PC.

 Darolutamide is another type of androgen blocker. Intermediate data from the same study has shown that darolutamide can improve survival time without metastasis (spread of cancer to other organs). However, longer-term safety and effectiveness of darolutamide in patients with non-metastatic CRPC remain under investigation.

This study included 1509 men with non-metastatic CRPC. They were randomly assigned to receive a placebo (554 men) or 600 mg darolutamide twice daily (955 men). Both groups continued ADT. Patients were followed up for an average of 29 months. After a period, patients on placebos were offered the option to go to the darolutamide group.

At 3 years, 83% of patients in the darolutamide and 77% in the placebo group were alive. The chance of survival with darolutamide was higher by 31% compared to the placebo.

At 3 years, 83% of the darolutamide group and 75% in the placebo group did not need heavy chemotherapy. Darolutamide was associated with a 42% lower risk of needing heavy chemotherapy compared to placebo after 3 years. Darolutamide was also associated with a 52% longer time to the first skeletal event such as bone fractures, spinal compression or a need for tumor-related orthopedic surgery or radiotherapy.

 Side effects were reported in 85.7% of the darolutamide group and 79.2% in the placebo group. A similar number of patients stopped treatment due to side effects (8.9% in the darolutamide group and 8.7% in the placebo group). The most common side effects included tiredness, bone fracture, falls, and weight loss.

The authors concluded that darolutamide provides an overall survival benefit andt can extend the time until chemotherapy in patients with non-metastatic CRPC.

This trial was funded by Bayer, the manufacturer of darolutamide. This trial served as basis for the FDA approval of darolutamide.