This clinical trial is focused on studying the treatment of prostate cancer, a disease that affects the prostate gland in men. The study will explore the effectiveness of different treatments, including a medication called darolutamide (also known by its code name BAY 1841788), which is an androgen receptor inhibitor. Androgens are male hormones that can promote the growth of prostate cancer cells. The trial will also involve other treatments such as relugolix, leuprorelin acetate, goserelin acetate, degarelix, and docetaxel. These medications work in various ways to manage hormone levels or directly target cancer cells. A placebo will also be used in some parts of the study.
The purpose of the study is to determine if these treatments can improve outcomes for patients with high-risk prostate cancer. The study will be conducted in two parts. The first part will focus on intensifying treatment to see if it can prevent the spread of cancer as detected by a special imaging test called PSMA PET/CT. The second part will look at whether a less intense treatment approach can maintain or improve the quality of life for patients. Participants will receive treatment for up to 96 weeks, which is about 24 months, and their progress will be monitored over time.
Throughout the study, participants will undergo various assessments to track their health and the effectiveness of the treatments. These assessments will include regular imaging tests and questionnaires to evaluate their quality of life. The study aims to provide valuable insights into the best ways to treat high-risk prostate cancer and improve the lives of those affected by this condition.



Belgium
Spain