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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


N/A
N/A
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

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 OfficeBridgewater, New Jersey  08807