COU-AA-301: Diseño
Abiraterona 1000 mg día
Prednisona 10 mg
N=797
Objetivo principal
•OS
Objetivos secundarios
•
TTPP
•
rPFS
•
Respuesta PSA
Placebo
Prednisona 10 mg
n=398
ALEATORIZACIÓN
2:1
• N=1195
• 1 o 2 regímenes de QT
previa, uno de ellos
docetaxel
Pacientes
de Bono, J.S. et al. Abiraterone and increased survival in metastasic prostate cancer. NEJM: 2011;364(21):1995-2005.
•
Stratification by:
•
ECOG performance status (0-1
vs. 2)
•
Worst pain over previous 24
hours (BPI short form; 0-3
[absent] vs. 4-10 [present])
•
Prior chemotherapy (1 vs. 2)
•
Type of progression (PSA only
vs. radiographic progression
with or without PSA
progression)
