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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01076751

Acronym

PORTREAT

Enrollment

Registered

2010-02-26

Start date

2010-02-28

Completion date

2010-10-31

Last updated

2011-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall survival	At Month 12 or death

Secondary

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

Countries

France, Germany, Spain, United Kingdom, United States

Outcome results