Neeraj Agarwal, MD, presented “TITAN Phase 3 Trial with Apalutamide in Metastatic Castration Sensitive Prostate Cancer” for the Grand Rounds in Urology audience in October 2021.
How to cite: Agarwal, Neeraj. “TITAN Phase 3 Trial with Apalutamide in Metastatic Castration Sensitive Prostate Cancer.” October 2021. Accessed Nov 2025. https://grandroundsinurology.com/titan-phase-3-trial-with-apalutamide-in-metastatic-castration-sensitive-prostate-cancer/
TITAN Phase 3 Trial with Apalutamide in Metastatic Castration Sensitive Prostate Cancer
Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute at the University of Utah in Salt Lake City, summarizes results from the phase 3 TITAN trial of apalutamide in metastatic castration-sensitive prostate cancer (mCSPC), focusing on patient-reported quality of life outcomes. He briefly discusses the design of the study, explaining that it featured a 1:1 randomization of over 1000 patients to apalutamide plus ADT or placebo plus ADT and had dual endpoints of overall survival (OS) and radiographic progression-free survival (rPFS). Dr. Agarwal notes that both primary and final analysis found significant improvements in both OS and rPFS. Surprisingly, adjusting for the approximately 40% crossover from the placebo arm to the apalutamide arm actually led to an even greater reduction in risk of death (48% compared to 35%). Dr. Agarwal notes that this is an unprecedented improvement in survival with mCSPC, and also that rapid and deep PSA decline with apalutamide and ADT was associated with improved OS. He also considers quality of life (QoL) measurements, describing the assessment tools for evaluating pain, fatigue, and health-related QoL, and then highlighting that neither primary nor final analysis saw declines in any of these with apalutamide as compared to placebo. In fact, patients on apalutamide reported experiencing less pain. Dr. Agarwal concludes that in men with mCSPC treatment with apalutamide significantly improved survival outcomes without adversely affecting quality of life and fatigue.
For more on cutting-edge treatments for advanced prostate cancer, check out the collection page for the 31st International Prostate Cancer Update, held in Snowbird, Utah, in July 2021.
ABOUT THE AUTHOR
Neeraj Agarwal, MD, FASCO, is a Professor of Medicine and Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute (HCI) at the University of Utah in Salt Lake City. He also directs the Genitourinary Oncology Program and the Center for Investigational Therapeutics at HCI. Dr. Agarwal also serves as the Senior Director (Associate Director) of Clinical Research, overseeing clinical and late translation research at the HCI, an NCI-designated comprehensive cancer center.
Dr. Agarwal earned his medical degree from the All India Institute of Medical Sciences in New Delhi, India. He completed a residency in Internal Medicine and a fellowship in Geriatric Medicine at the University of Iowa in Iowa City, followed by a fellowship in Hematology/Oncology at the Huntsman Cancer Institute.
Dr. Agarwal has authored or co-authored more than 550 scientific publications and numerous book chapters and abstracts. He has served as a panel member for the NCCN, ESMO, and ASCO guidelines committees for genitourinary cancers and the leader of early therapeutics for the SWOG GU Cancers Committee for more than a decade. Dr. Agarwal has served on the editorial boards of several journals, including theJournal of Clinical OncologyandEuropean Urology, and currently serves as an ASCO Genitourinary Cancers Advisory Panel member, as well as the Chief Editor of theASCO Daily News. He has received the SWOG Young Investigator Award, the William D. Odell Young Investigator Award, and a National Cancer Institute (NCI) Cancer Clinical Investigator Team Leadership Award, and recognition as a Fellow of the American Society of Clinical Oncology (FASCO).
