Discussion on PROSPER: Safety and Efficacy Study of Enzalutamide in Patients with nmCRPC - Thomas Keane
February 15, 2018
Dr. Thomas Keane reviews the first presentation on the PROSPER study which was a much awaited presentation presented by Dr. Maha Hussain at the recent 2018 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium.
Dr. Hussain started her presentation on PROSPER, a phase III randomized double-blind controlled trial, Safety and Efficacy Study of Enzalutamide (ENZA) in Patients With Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) by focusing on the adverse event profiles. Serious Grade 3+ adverse events were higher in the ENZA group (31% vs. 23%), and the most common ones were hypertension, fatigue and hematuria. Patients on enzalutamide discontinued treatment due to adverse events as a slightly higher rate (9% vs. 6%) and had a slightly higher mortality rate (3% vs. 1%).
Dr. Thomas Keane highlights several important factors presented by Dr. Hussain including addressing progression when looking at clinical outcomes. She first addressed progression in the ENZA arm was 50% that of the placebo arm – 219 events in 933 patients (23%) vs. 228 events in 468 patients (49%). However, she also point out briefly that there was a 15% mortality rate (death without documented progression) in the ENZA arm, compared to 2% in the placebo arm.
Dr. Thomas Keane reviews the PROSPER primary and secondary endpoints and lastly notes the impressiveness of the study findings which certainly seem to favor the use of enzalutamide. He points out there were some questions particularly on the number patients who died in this study which Dr. Philip Kantoff discusses in his presentation review of both SPARTAN and PROSPER studies at the 2018 ASCO GU meeting. Dr. Thomas Keane provides a commentary on Dr. Kantoff’s review in the latter part of his SPARTAN commentary.
Thomas E. Keane, MBBCh, FRCSI, FACS
Maha Hussain, MD, FACP, FASCO, is the Genevieve Teuton Professor of Medicine in the Division of Hematology Oncology, Department of Medicine, and the Deputy Director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine.
She is a practicing oncologist, internationally renowned expert and clinical researcher in genitourinary oncology particularly prostate and bladder cancer. Her clinical research has contributed to impacting the standards ... Maha Hussain, MD, FACP, FASCO, is the Genevieve Teuton Professor of Medicine in the Division of Hematology Oncology, Department of Medicine, and the Deputy Director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine.
Watch: Changing the Standard of Care in the M0 CRPC Patient: PROSPER - A Conversation with Cora Sternberg
Cora Sternberg's EAU 2018 Presentation:Prostate-Specific Antigen Response in Men with Nonmetastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide: Results from PROSPER
First Presentation - SPARTAN: A Study of Apalutamide (ARN-509) in Men with Non-Metastatic Castration-resistant Prostate Cancer
First Presentation - PROSPER: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC)
Philip Kantoff Review of First Presentation: SPARTAN and PROSPERof First Presentation: SPARTAN and PROSPER
Watch: Discussion on SPARTAN: A Study of Apalutamide in Men with Non-Metastatic Castration-resistant Prostate Cancer - Thomas Keane