Types of Drugs Used in the VISION study:

Investigational Agent, 177Lu-PSMA-617

The study drug in the Phase 3 VISION trial is a compound called 177Lu-PSMA-617. It is a radioligand therapy. It delivers lutetium-177 (a radioactive isotope) to cancers of the prostate which have PSMA proteins on the cell surface. After being injected in a patient’s body, 177Lu-PSMA-617 is designed to target cells that express PSMA. It is designed to target these cells expressing PSMA, and neighboring cancer cells which includes prostate cancer that has spread to soft tissues, (such as lymph nodes and visceral organs – organs in the chest or abdomen), as well as to bone Once it has bound to a cancer cell through the PSMA receptor, the lutetium-177 atom releases a kind of energy called a beta particle, that travels to the surrounding tumor area. 177Lu-PSMA-617 is an experimental radioligand therapy, meaning that it has not been approved yet for treatment use or sale in the United States by the Food and Drug Administration (U.S. FDA) or any other global regulatory authority for any use beyond this clinical trial. It is too early to know whether treatment with 177Lu-PSMA-617 will provide benefit to patients with prostate cancer, and the results of this study will help answer that question.

Best Supportive/Standard of Care

For patients enrolled in the clinical trial, the treating physician will determine what the best supportive/best standard of care is for each patient. These decisions will be made according to the physician’s orders and institutional practice. This may be influenced by any of the patient’s prior prostate cancer treatments. Novel androgen-axis drugs like enzalutamide or abiraterone are allowed, as will be palliative care.