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TITAN - A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus
Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-
sensitive Prostate Cancer (mHSPC)
• STRATIFICATION: Volume of Disease (high vs. low); Use of Bone Targeted Agents, Co-Morbidities (0-1
vs. 2-3), Docetaxel Use
• SPONSOR: Janssen
• PRIMARY COMPLETION DATE: November 2020
Phase 3, Double-blind, Placebo-Controlled Randomized Study
Positive
bone/CT/MRI
scan, ECOG 0-1,
prior doce use if
stable disease,
1 prior rad tx, ≤6
months ADT,
localized tx if ≥
1 year
randomization
N=1052
ADT
+
Apalutamide
ADT
+
Placebo
R
Primary Objective
- rPFS and OS
Secondary Objectives
- Time to Pain
progression
- Time to SRE
- Time to Chronic Opioid
Use
- Time to Initiation of
Cytotoxic
Chemotherapy
TITAN
(NCT02489318).