Prostatic Neoplasms Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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