TITAN — Apalutamide Plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer (TITAN)

Phase 3 · 2019 · Prostate Cancer

Design

Randomized double-blind trial of apalutamide plus ADT versus placebo plus ADT.

Population

Metastatic hormone-sensitive prostate cancer regardless of disease volume or prior docetaxel.

Primary Endpoint

radiographic progression-free survival and overall survival

Key Result

Final analysis (median 44 mo): OS not reached vs 52.2 mo (HR 0.65); crossover-adjusted HR 0.52; castration resistance significantly delayed despite 39.5% placebo crossover.

Guideline Impact

NCCN category 1 apalutamide plus ADT for metastatic castration-sensitive prostate cancer