Trial Information
Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen
Inclusion Criteria
Inclusion criteria:
- Patients with CRPC progressing during the course of first line docetaxel-based
chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line
docetaxel-based chemotherapy
- Patient who have given their written consent
Exclusion criteria:
- Current participation in a clinical trial for the second-line treatment of prostate
cancer
- Patients having received less than 3 cycles of first line docetaxel-based
chemotherapy and discontinued for a reason other than disease progression or toxicity
- Patients having already started a second line treatment
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Overall survival
Outcome Time Frame:
At Month 12 or death
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Institutional Review Board
Study ID:
DIREG_C_05073
NCT ID:
NCT01076751
Start Date:
February 2010
Completion Date:
October 2010
Related Keywords:
- Prostatic Neoplasms
- Neoplasms
- Prostatic Neoplasms
Name | Location |
Sanofi-Aventis Administrative Office |
Bridgewater, New Jersey 08807 |