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
Phase 3
- Conditions
- Prostatic NeoplasmsNeoplasm MetastasisC61Malignant neoplasm of prostate
- Registration Number
- DRKS00003881
- Lead Sponsor
- Sanofi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 1224
Inclusion Criteria
Histologically- or cytologically-confirmed prostate adenocarcinoma;
- Metastatic disease;
- Progressive disease while receiving hormonal therapy or after surgical castration;
- Effective castration.
Exclusion Criteria
- Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except
adjuvant/neoadjuvant treatment completed >3 years ago;
- Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF
receptor inhibitors;
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Overall Survival Time; time frame: From randomization up to the cut-off date (median follow-up of 35.4 months); Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.<br>The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier.<br>
- Secondary Outcome Measures
Name Time Method