A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Aflibercept
- drug : Prednisone or Prednisolone
- drug : Docetaxel
- drug : Placebo (for aflibercept)
Phase: Phase 3
Ages Eligible For Study:
- Histologically- or cytologically-confirmed prostate adenocarcinoma; - Metastatic disease; - Progressive disease while receiving hormonal therapy or after surgical castration; - Effective castration.