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
  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:


Further study details as provided by Sanofi:

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 ]

Enrollment: 82
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRPC patients

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01076751     History of Changes
Other Study ID Numbers: DIREG_C_05073
Study First Received: February 25, 2010
Last Updated: February 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014