Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)

Ipsen14 sites in 1 country628 target enrollmentJanuary 2014

ConditionsProstate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Ipsen
Enrollment: 628
Locations: 14
Primary Endpoint: Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate possible changes in quality of life related to health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of follow-up.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

December 2015

Last Updated

7 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men ≥ 18 years old
•Symptomatic prostate cancer patients who present symptoms due to prostate cancer disease
•Capacity to comply with the protocol
•Patient with an expected survival \> 12 months

Exclusion Criteria

•Patients who are also participating in any other clinical study
•Patient with other malignant diseases, apart from prostate cancer

Outcomes

Primary Outcomes

Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)

Time Frame: 12 months

Secondary Outcomes

Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)(12 months)
Quality of life using EQ-5D questionnaire(12 months)
Socio-demographic characteristics (percentage of patients (a) living married or living with a partner, (b) had completed primary studies, (c) retired or pensioners, (d) patients had a family history of PrCa)(12 months)
Anthropometric Characteristics - Body Mass Index(Baseline)
Prostate-specific Antigen (PSA)(Baseline, 12 months)
Testosterone level(Baseline, 12 months)
Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)(12 months)
Change in general health status perception (from either patient or physician perspective)(12 months)
Digital rectal examination(Baseline, 12 months)