Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer

Ipsen628 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

628

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Hospital Quirón Campo de Gibraltar

Cadiz, Spain

H. San Juan de Dios

Córdoba, Spain

Hospital Quiron Vizcaya

Erandio, Spain

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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)

Time frame: 12 months

Anthropometric Characteristics - Body Mass Index

Time frame: Baseline

Prostate-specific Antigen (PSA)

Time frame: Baseline, 12 months

Testosterone level

Time frame: Baseline, 12 months

Digital rectal examination

Time frame: Baseline, 12 months

Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)

Time frame: 12 months

Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)

Time frame: 12 months

Change in general health status perception (from either patient or physician perspective)

Assessment of health in relation to Prostate Cancer, the options are: very good, quite good, slightly good, neither good nor bad, slightly bad, quite bad or very bad.

Time frame: 12 months

Quality of life using EQ-5D questionnaire

Data from ClinicalTrials.gov

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