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 Apr 2024. 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.