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
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:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 20, 2014