This clinical trial is focused on studying treatments for metastatic hormone-sensitive prostate cancer, a type of cancer that has spread beyond the prostate gland but still responds to hormone therapy. The study involves comparing two different dosing schedules of a chemotherapy drug called docetaxel. One group of patients will receive docetaxel at a dose of 75 mg per square meter of body surface area every three weeks, while another group will receive 50 mg per square meter every two weeks. Both groups will also receive a medication called darolutamide and a type of hormone therapy known as androgen deprivation therapy (ADT), which reduces levels of male hormones that can promote cancer growth.
The purpose of the study is to compare the safety of these treatment regimens by looking at the occurrence of serious side effects. The study will also monitor for a specific side effect called neutropenia, which is a low level of white blood cells that can increase the risk of infection. Patients will undergo six cycles of treatment, and the study will track their health and any side effects they experience during this time. The trial will also assess other outcomes, such as overall survival, the time it takes for the cancer to become resistant to hormone therapy, and the quality of life of the participants.
Participants in the study will receive their treatments either as an intravenous infusion, which is a method of delivering medication directly into the bloodstream, or as oral tablets. The study aims to provide valuable information on the best way to use docetaxel in combination with darolutamide and ADT for treating this type of prostate cancer. The results could help improve treatment strategies and outcomes for patients with this condition.



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