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

This study has been terminated.
(delay in recruitment)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01076751
First received: February 25, 2010
Last updated: February 11, 2011
Last verified: February 2011

February 25, 2010
February 11, 2011
February 2010
October 2010   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: At Month 12 or death ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01076751 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients
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

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with metastatic castrate-resistant prostate cancer

Prostatic Neoplasms
Not Provided
CRPC patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
82
October 2010
October 2010   (final data collection date for primary outcome measure)

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.

Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Spain,   United Kingdom
 
NCT01076751
DIREG_C_05073
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2011

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