Sponsor: Novartis Corp.
Sponsor Study ID: CAAA617C12301
Study Title: PSMAddition: An International Prospective Open label, Randomized, Phase III Study comparing 177Lu PSMA 617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
CTO #: 103415
NCT Number: NCT04720157
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Prostate
Study Objectives: The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study.