This clinical trial is focused on studying a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study will explore the effects of adding a medication called darolutamide to the standard first-line treatment for this condition. Darolutamide is an androgenic inhibitor, which means it helps block male hormones that can promote cancer growth.
In addition to darolutamide, the study will involve other treatments that are commonly used for mCRPC. These include Cabazitaxel, a chemotherapy drug given as an infusion; Xofigo, a radioactive injection used to treat cancer that has spread to the bones; Docetaxel, another chemotherapy infusion; Lynparza, a tablet that targets cancer cells with specific genetic changes; and Lutathera, a radioactive infusion used for certain types of tumors. The purpose of the study is to assess how well darolutamide, when added to these treatments, can help delay the progression of the cancer as seen on imaging tests.
Participants in the study will receive either the standard treatment alone or the standard treatment plus darolutamide. The study will monitor how long it takes for the cancer to progress, as well as overall survival and other health outcomes. The trial is designed to provide valuable information on whether adding darolutamide can improve outcomes for patients with mCRPC. The study is expected to continue until 2030, with recruitment starting in 2025.
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