This clinical trial is focused on studying treatments for metastatic hormone-naïve prostate cancer, a type of prostate cancer that has spread to other parts of the body but has not yet been treated with hormone therapy. The study will explore the effects of different medications, including darolutamide (also known as ODM-201 or BAY 1841788), goserelin acetate, leuprorelin acetate (also known as leuprolide acetate), apalutamide (also known as ARN-509), relugolix (also known as TAK-385), degarelix, enzalutamide (also known as MDV3100), abiraterone, and triptorelin acetate. These medications are used in hormone therapy to manage prostate cancer by blocking or reducing the effects of male hormones that can promote cancer growth.
The purpose of the study is to compare two approaches to hormone therapy: intermittent maximum androgen blockade (iMAB) and continuous maximum androgen blockade (cMAB). The study aims to determine the benefits and risks of these approaches in patients who have shown a significant response to initial hormone therapy. Participants will be randomly assigned to either continue their hormone therapy without interruption or to have breaks in their treatment. The study will monitor how long patients can go without restarting hormone therapy and compare the overall survival rates between the two groups.
Throughout the study, participants will be observed for changes in their quality of life, including physical functioning, sexual activity, and pain levels. The study will also track the time it takes for patients to need additional prostate cancer treatments and monitor their testosterone and PSA (prostate-specific antigen) levels. The trial will help determine if taking breaks in hormone therapy can maintain the same level of cancer control as continuous treatment while potentially improving the quality of life for patients.



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