Evaluating the effectiveness and safety of darolutamide in combination with androgen deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer.

This study evaluated the effectiveness and safety of darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) and docetaxel (Taxotere) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The data showed that darolutamide in combination with ADT and docetaxel significantly improved the overall survival of these patients.

Patients with mHSPC have prostate cancer that has spread beyond the prostate gland and responds 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 is an anti-androgen medication that blocks testosterone from reaching PC cells. Darolutamide in combination with ADT has been shown to improve clinical outcomes like overall survival and lower the risk of disease progression in men with non-metastatic castration-resistant (no longer responds to ADT) prostate cancer. However, whether a combination of darolutamide plus ADT and docetaxel would increase survival among patients with mHSPC is still unknown.

This study involved 1306 men with mHSPC. Patients were randomly assigned into 2 groups. Group 1 included 651 patients who received darolutamide in combination with ADT and docetaxel. Group 2 included 655 patients who received a placebo in combination with ADT and docetaxel. The average follow-up time was 43.7 months for group 1 and 42.4 months for group 2.

The average overall survival was not reached in group 1 (exceeded the average follow-up period) compared to 48.9 months in group 2. Patients in group 1 were 32.5% more likely to survive than those in group 2. After 4 years, 62.7% of the patients in group 1 were alive compared to 50.4% in group 2.

The rate of serious side effects was similar between the 2 groups. The most common side effect in both groups was low white blood cell counts.

This study showed that darolutamide in combination with ADT and docetaxel significantly improved the overall survival in patients with mHSPC.

This study was funded by Bayer and Orion Pharma, the manufacturers of darolutamide.