In a new study from Massachusetts General Hospital, researchers found that adding the androgen-receptor inhibitor darolutamide to androgen-deprivation therapy and chemotherapy prolongs the survival of men with metastatic, hormone-sensitive prostate cancer.
Standard treatment for patients with metastatic, hormone-sensitive prostate cancer includes the addition of either the chemotherapy drug docetaxel or an androgen-receptor pathway inhibitor to androgen-deprivation therapy.
The latter two treatments act to lower the effects of androgen hormones, such as testosterone.
In the study, the team combined all three treatments. They assigned 1,306 patients with metastatic, hormone-sensitive prostate cancer to receive the oral androgen-receptor inhibitor darolutamide or placebo, both in combination with androgen-deprivation therapy and docetaxel.
Survival rates in the two groups were compared after 533 patients had died.
Patients were followed for a median of approximately 3.5 years, and those who received darolutamide had a 32.5% lower risk of dying during that time than patients not taking darolutamide.
Patients taking darolutamide also experienced greater delays in developing castration-resistant prostate cancer (which no longer responds to treatments that lower testosterone), pain, and the need for other anti-cancer therapies.
The combination of three medications did not result in more toxic effects compared with the combination of androgen-deprivation therapy and docetaxel alone.
The team says the triplet therapy with darolutamide should become a new standard of care for the treatment of patients with metastatic hormone-sensitive prostate cancer
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The study is published in New England Journal of Medicine and was conducted by Matthew R. Smith et al.
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