This clinical trial is focused on studying a type of prostate cancer known as low-volume metastatic castration-sensitive prostate cancer. This condition refers to prostate cancer that has spread to other parts of the body but is still responsive to treatments that lower testosterone levels. The study will explore the effects of two medications, apalutamide and enzalutamide, which are known as androgen receptor signaling inhibitors (ARSIs). These medications work by blocking the effects of male hormones that can promote the growth of prostate cancer cells.
The purpose of the study is to determine if stopping the use of ARSIs after 12 months, with the option to restart if necessary, is as effective as continuing the treatment without interruption. This approach aims to reduce the side effects and costs associated with prolonged medication use. Participants in the study will receive either apalutamide or enzalutamide, along with standard hormone therapy, for a total period of 12 months. Some participants will continue the treatment beyond this period, while others will stop and be monitored for any changes in their condition.
Throughout the study, participants will undergo regular check-ups to monitor their health and the progression of their cancer. The study will assess various outcomes, including the time it takes for the cancer to progress, overall survival rates, and the impact of treatment on quality of life. The study will also explore the relationship between certain genetic markers and treatment outcomes, using advanced imaging techniques like PSMA-PET scans to gather detailed information about the cancer’s behavior. The trial is expected to run until 2029, providing valuable insights into the management of this type of prostate cancer.
The Netherlands 
