Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

February 25, 2010

Last Updated Date

February 11, 2011

Start Date ^ICMJE

February 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival [ Time Frame: At Month 12 or death ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01076751 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sequence of treatment in second-line, third-line [ Time Frame: At Month 6 (+/- 2 months), Month 12 or death ] [ Designated as safety issue: No ]
Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others [ Time Frame: At baseline, Month 6 (+/- 2 months), Month 12 or death ] [ Designated as safety issue: No ]
Indicators of health care resource utilization [ Time Frame: At baseline, Month 6 (+/- 2 months), Month 12 or death ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: At baseline, Month 6 (+/- 2 months) or Month 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients

Official Title ^ICMJE

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

Brief Summary

Primary Objective:

Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression

Secondary Objective:

Describe treatment patterns
Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
Describe economic and patient-reported outcomes

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Biospecimen

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic castrate-resistant prostate cancer

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Comparison Groups

CRPC patients

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France, Germany, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01076751

Other Study ID Numbers ^ICMJE

DIREG_C_05073

Has Data Monitoring Committee

Responsible Party

Trial Transparency Team, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP