Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man’s body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Drug: Androgen Therapy, Drug: Apalutamide, Drug: Docetaxel, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Bone Scan, Procedure: PSMA PET Scan, Procedure: Biospecimen Collection, Other: Questionnaire Administration