TITANApalutamide and ADT for Metastatic Hormone-sensitive Prostate Cancer

This clinical study is investigating the effects of a drug called apalutamide combined with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to determine if adding apalutamide to the standard ADT treatment can improve outcomes for these patients. Prostate cancer that has spread to other parts of the body and still responds to hormone therapy is considered hormone-sensitive. The study is important as it seeks to find better treatment options that could potentially extend the life and improve the quality of life for men suffering from this advanced form of prostate cancer. Participants in this study are randomly assigned to receive either the combination of apalutamide and ADT or a placebo with ADT, without knowing which group they are in to ensure unbiased results. The treatment is given in 28-day cycles and continues until the disease progresses or side effects become unacceptable. The study monitors the overall survival of participants, which is the time from starting the treatment until death from any cause. It also measures how long the participants live without the cancer showing further progression on scans, known as radiographic progression-free survival. Regular safety checks are performed throughout the study to ensure participant safety. If the study shows positive results, participants may have the chance to continue receiving apalutamide in an open-label extension phase, where all participants receive the active drug.