Conditions: Prostatic Neoplasms Neoplasm Metastasis
Keywords: metastatic prostate cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1224
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone arm 2: Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Interventions: intervention 1: Aflibercept intervention 2: Placebo (for aflibercept) intervention 3: Docetaxel intervention 4: Prednisone or Prednisolone
Intervention descriptions: intervention 1: 25 mg/ml solution

6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle intervention 2: Sterile aqueous buffered solution identical to aflibercept

1-hour IV on Day 1 of each 3-Week cycle intervention 3: Marketed formulation

75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo) intervention 4: Marketed formulation

5 mg twice daily PO from day 1 continuously

Protocol document: