Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT02853409
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 628
- 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
- Patients who are also participating in any other clinical study
- Patient with other malignant diseases, apart from prostate cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) 12 months
- Secondary Outcome Measures
Name Time Method 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 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.
Digital rectal examination Baseline, 12 months
Trial Locations
- Locations (14)
Hospital Quirón Campo de Gibraltar
🇪🇸Cádiz, Spain
H. San Juan de Dios
🇪🇸Córdoba, Spain
H. Can Misses
🇪🇸Ibiza, Spain
Hospital San Juan de Dios
🇪🇸León, Spain
Hospital Quirón San Camilo
🇪🇸Madrid, Spain
Hospital San Rafael
🇪🇸Madrid, Spain
Hospital Quirón Marbella
🇪🇸Marbella, Spain
Hospital Parque San Antonio
🇪🇸Málaga, Spain
H. Infanta Sofía
🇪🇸San Sebastián de los Reyes, Spain
Hospital NISA
🇪🇸Sevilla, Spain
Hospital Sagrado Corazón
🇪🇸Sevilla, Spain
H. Montepríncipe
🇪🇸Madrid, Spain
Hospital Quiron Vizcaya
🇪🇸Erandio, Spain
H. de Torrelodones
🇪🇸Madrid, Spain