¿Qué trae el futuro de Enzalutamida?

24 / 46

24
ARASENS - A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201)
Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With
Metastatic Hormone Sensitive Prostate Cancer
• STRATIFICATION: Unknown
• SPONSOR: Bayer
• PRIMARY COMPLETION DATE: August 2022
Phase 3, Double-blind, Placebo-Controlled Randomized Study
Metastatic PC (could have rec'd ADT
± 1st gen anti-androgen within 12
weeks randomization), ECOG 0-1,
Adequate hematologic, hepatic &
renal function
N=1303
ADT +
Docetaxel
Darolutamide
(ODM-021)
Placebo
R
Primary Objective
- OS
Secondary Objectives
- Time to CRPC
- Time to Initiation of Subsequent
Antineoplastic Therapy
- Symptomatic Skeletal Event
Free Survival
- Time to First Symptomatic
Skeletal Event
- Time to Opioid Use
- Time Pain Progression
- Time to Worsening of Physical
Symptoms of Disease
- Safety
ARASENS
(NCT02799602).