The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only

Inclusion criteria

• ✓. Be a male, at least 18 years old, with metastatic adenocarcinoma of the prostate defined by histological / pathological confirmation of PC.
• ✓. Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months.
• ✓. Have metastatic disease (≥1 metastatic lesions present on baseline CT, MRI, or bone scan imaging).
• ✓. Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone \[LHRH\]) and must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
• ✓. In the mCRPC setting, must have received a minimum of 12 weeks of prior therapy with a NAAD, either enzalutamide or abiraterone plus prednisone.
• ✓. Should have received one line of prior taxane therapy or have refused or be ineligible for taxanes
• ✓. Have a disease that is progressing at study entry, despite a castrate testosterone level (\<50 ng/dL or \<1.7 nmol/L), by the demonstration of at least one of the following:
• ✓. Rising PSA values done in sequence at least 1 week apart and with a minimal starting value of 2.0 ng/mL.

Exclusion criteria