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

February 11, 2011 updated by: Sanofi

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Frankfurt, Germany
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • United Kingdom
      • Guildford Surrey, United Kingdom
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic castrate-resistant prostate cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CRPC patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: At Month 12 or death
At Month 12 or death

Secondary Outcome Measures

Outcome Measure
Time Frame
Sequence of treatment in second-line, third-line
Time Frame: At Month 6 (+/- 2 months), Month 12 or death
At Month 6 (+/- 2 months), Month 12 or death
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
At baseline, Month 6 (+/- 2 months), Month 12 or death
Indicators of health care resource utilization
Time Frame: At baseline, Month 6 (+/- 2 months), Month 12 or death
At baseline, Month 6 (+/- 2 months), Month 12 or death
Quality of life
Time Frame: At baseline, Month 6 (+/- 2 months) or Month 12
At baseline, Month 6 (+/- 2 months) or Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 14, 2011

Last Update Submitted That Met QC Criteria

February 11, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIREG_C_05073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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