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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01076751

Purpose

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

Condition
Prostatic Neoplasms

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	700
Study Start Date:	February 2010
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
CRPC patients

Eligibility

Study Population

Patients with metastatic castrate-resistant prostate cancer

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076751

Contacts

Contact: Public Registry GMA

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office	Recruiting
Bridgewater, New Jersey, United States
France
Sanofi-Aventis Administrative Office	Not yet recruiting
Paris, France
Germany
Sanofi-Aventis Administrative Office	Not yet recruiting
Frankfurt, Germany
Spain
Sanofi-Aventis Administrative Office	Not yet recruiting
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office	Not yet recruiting
Guildford Surrey, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Portfolio Value Development

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Portfolio Value Development Study Director )
ClinicalTrials.gov Identifier:	NCT01076751 History of Changes
Other Study ID Numbers:	DIREG_C_05073
Study First Received:	February 25, 2010
Last Updated:	April 20, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 01, 2010