LATITUDE — Abiraterone Acetate Plus Prednisone Added to Androgen Deprivation Therapy in High-Risk Metastatic Hormone-Sensitive Prostate Cancer (LATITUDE)

Phase 3 · 2017 · Prostate Cancer

Design

Randomized double-blind trial of abiraterone acetate plus prednisone plus ADT versus placebo plus ADT.

Population

Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (≥2 of: Gleason ≥8, ≥3 bone lesions, visceral metastases).

Primary Endpoint

overall survival and radiographic progression-free survival

Key Result

Final OS analysis (median 51.8 mo): OS 53.3 vs 36.5 mo (HR 0.66); radiographic PFS co-primary endpoint also met.

Guideline Impact

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