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

Prostatic Neoplasms Clinical Trial

— PORTREAT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01076751
• Other study ID #: DIREG_C_05073
• Status: Terminated
• Phase: N/A
• First received: February 25, 2010
• Last updated: February 11, 2011
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Frankfurt
Spain	Sanofi-Aventis Administrative Office	Barcelona
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		At Month 12 or death	No
Secondary	Sequence of treatment in second-line, third-line		At Month 6 (+/- 2 months), Month 12 or death	No
Secondary	Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others		At baseline, Month 6 (+/- 2 months), Month 12 or death	No
Secondary	Indicators of health care resource utilization		At baseline, Month 6 (+/- 2 months), Month 12 or death	No
Secondary	Quality of life		At baseline, Month 6 (+/- 2 months) or Month 12	No