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.

At the study visits, the following procedures should happen: • Your study eligibility will be determined • There will be a review of your current medications and medical history • You will undergo a physical examination that includes measuring your height, weight, taking your vital signs, checking your heart with an electrocardiogram, and determining your ECOG performance status (a measure of your daily functional activity) • You may undergo tumor biopsy if clinically feasible according to your doctor or may be asked for a previously collected sample. You will be asked for a previously collected tumor biopsy if clinically feasible by your doctor • Blood and urine will be taken to determine the function of your liver, kidneys, and bone marrow function. • Blood samples will also be collected to assess potential changes in biological molecules in the blood such as certain proteins and pieces of DNA shed from tumor cells • You will receive a variety of imaging procedures to determine the status of your cancer throughout the study. These will include CT and PET scans, bone scans and may include other scans like X-rays and MRI scans. • On repeat visits, your doctor will ask you about any changes in the way you feel