Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC). The secondary objectives were: * To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL); * To assess the overall safety in both treatment arms; * To determine the pharmacokinetics of intravenous (IV) aflibercept in this population; * to determine immunogenicity of IV aflibercept.
The study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. After disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first. The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.
25 mg/ml solution 6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle
Sterile aqueous buffered solution identical to aflibercept 1-hour IV on Day 1 of each 3-Week cycle
Marketed formulation 75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)
Marketed formulation 5 mg twice daily PO from day 1 continuously
Buenos Aires, Argentina