A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with ContinuedVersus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response inParticipants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

The purpose of this study is to help researchers understand more about the possible effectiveness and safety of apalutamide when given to patients with or without intermittent Androgen Deprivation Therapy (ADT) to treat metastatic Castration-Sensitive Prostate Cancer (mCSPC). Apalutamide is a type of drug that blocks the action of testosterone. By blocking the action of testosterone, it may slow down or stop the growth of prostate cancer cells. ADT works by stopping the body’s production of testosterone. The reason for using ADT is that prostate cancer needs androgen to grow and survive so by ‘starving’ the cancer of androgen it is hoped that the cancer will stop growing. Apalutamide is not being used in accordance to its labeling.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years or older - Able to swallow medications - Must agree to use a condom during the study and through 3 months after the last dose of study drug - Must have metastatic Castration-Sensitive Prostate Cancer (mCSPC)