The addition of the androgen-receptor inhibitor darolutamide to androgen deprivation therapy and chemotherapy increases the survival of men with metastatic, hormone-sensitive prostate cancer, a disease that is usually fatal. These findings come from an international, randomized, double-blind, placebo-controlled, phase 3 clinical trial.
The study, which was conducted by a team led by investigators at Massachusetts General Hospital (MGH), is published in the New England Journal of Medicine.
The docetaxel chemotherapy medication or an androgen-receptor pathway inhibitor, both of which operate to reduce the effects of androgen hormones like testosterone, are usually added to androgen-deprivation therapy in patients with metastatic, hormone-sensitive prostate cancer. Conflicting findings have been found in clinical trials that included all three therapies.
Despite progress in recent years, survival is short for patients with metastatic prostate cancer. Results from ARASENS are an important step forward, and triplet therapy with darolutamide should become a new standard of care for the treatment of patients with metastatic hormone-sensitive prostate cancer.Matthew R. Smith
To provide clarity, investigators designed the large, international ARASENS Trial and randomly assigned 1,306 patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio 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. Participants were monitored for a median of 3.5 years, and those who took darolutamide had a 32.5% lower mortality risk than those who did not receive the medication.
Moreover, castration-resistant prostate cancer, which does not respond to therapy that suppress testosterone, discomfort, and the requirement for additional anti-cancer therapies were all more likely to occur in patients using darolutamide.
Comparatively to the combination of androgen-deprivation therapy and docetaxel alone, the three drugs did not produce additional harmful consequences.
“Despite progress in recent years, survival is short for patients with metastatic prostate cancer. Results from ARASENS are an important step forward, and triplet therapy with darolutamide should become a new standard of care for the treatment of patients with metastatic hormone-sensitive prostate cancer,” says lead author Matthew R. Smith, MD, PhD, director of the Genitourinary Oncology Program at the Mass General Cancer Center and an associate professor of medicine at Harvard Medical School.
The study was supported by Bayer and Orion Pharma.