Daniel J. George, MD, presented “Phase 3 VISION Study of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer” during the 31st International Prostate Cancer Update in July 2021 in Snowbird, Utah.

How to cite: George, Daniel J. “Phase 3 VISION Study of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer.” July 2021. Accessed Jul 2024. https://grandroundsinurology.com/phase-3-vision-study-of-177lu-psma-617-in-patients-with-metastatic-castration-resistant-prostate-cancer/

Phase 3 VISION Study of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer

Daniel J. George, MD, Professor of Oncologic and Urologic Medicine and Surgery at Duke University, reviews the results of the VISION phase 3 study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. He begins by describing 177Lu-PSMA-617, explaining how it binds to PSMA and causes DNA damage and cell death in cancer. Dr. George then introduces the VISION study, discussing its two arms (standard-of-care, or SOC, and 177Lu-PSMA-617 based treatment vs. SOC alone), as well as its primary endpoints (radiographic progression-free survival, or rPFS, and overall survival). He also highlights the impact of an early dropout rate of 56% in the SOC arm which required enhanced study site education and communication to overcome and resulted in 2 study populations. Dr. George then summarizes the baseline characteristics of the patient populations before detailing the results. He states that 177Lu-PSMA-617 improved rPFS in OS, as shown by the SOC plus 177Lu-PSMA-617-based treatment arm having a higher median survival of 3-5 months. Dr. George then notes that 177Lu-PSMA-617 plus SOC had a 42% partial response rate, a 9.2% complete response rate, and an overall response rate of 50%, whereas SOC alone had a 3% partial response rate and no complete response rate. He states that 177Lu-PSMA-617 with SOC also created a 50% or greater decline in PSA in 46% of patients compared to SOC alone doing the same in only 7.1%. Dr. George discloses that fatigue, bone marrow suppression, dry mouth, nausea and vomiting, renal effects, second primary malignancies, and intracranial hemorrhage are all side effects of this treatment. He concludes that in a heavily pretreated and PSMA-enriched population 177Lu-PSMA-617 demonstrated clinically and statistically significant improvement in OS, rPFS, PSA, and objective responses.

About The 31st Annual International Prostate Cancer Update:

The International Prostate Cancer Update (IPCU), founded in 1990, is a multi-day CME conference focused on prostate cancer treatment updates with expert, international faculty. It is led by expert physicians and is designed for urologists, medical oncologists, radiation oncologists, and other healthcare professionals involved in the diagnosis and treatment of prostate cancer. Dr. George delivered this educational activity during the 31st iteration of the meeting in July 2021 in Snowbird, Utah.

ABOUT THE AUTHOR

Dr. Daniel J. George is a Professor of Medicine and Surgery, Divisions of Medical Oncology and Urology in the Duke University School of Medicine. He also has appointments in the Duke Clinical Research Institute and the Duke Cancer Institute where he is Co-leader for the DCI Center for Prostate and Urologic Cancers. He an internationally recognized clinical researcher and thought leader in GU malignancies, with over 150 peer-reviewed publications. His areas of research include new drug development and biomarkers of GU cancers with an emphasis on health disparities. Dr. George is principal investigator of the Duke site for the Department of Defense (DOD) Prostate Cancer Clinical Trials Consortium since 2006, specializing in Phase I and II studies in prostate cancer. He is also the PI of the MaRCC registry in advanced renal cell carcinoma and Co-PI of the PCF 5000, an international, multi-sponsor supported registry in advanced prostate cancer. Nationally, Dr. George has served on the ASCO scientific committee and the Conquer Cancer Foundation grants review committee, and is chair for 2019-20. He alsoserves on two grant committees for AACR. He is the scientific leader for kidney cancer in the Alliance Cooperative Group since 2011 and serves on the Alliance GU scientific committee, NCI GU Steering Committee and the NCI Renal Task Force. He serves as a senior editor for Clinical Cancer Research and Co-editor in Chief of Clinical Advances in Hematology and Oncology.