Clinical trial NCT02853409: Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer
Official title: Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 628
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


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

Primary outcomes:
measure: Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
timeFrame: 12 months
Secondary outcomes:
measure: 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)
timeFrame: 12 months
measure: Anthropometric Characteristics - Body Mass Index
timeFrame: Baseline
measure: Prostate-specific Antigen (PSA)
timeFrame: Baseline, 12 months
measure: Testosterone level
timeFrame: Baseline, 12 months
measure: Digital rectal examination
timeFrame: Baseline, 12 months
measure: Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)
timeFrame: 12 months
measure: Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)
timeFrame: 12 months
measure: Change in general health status perception (from either patient or physician perspective)
timeFrame: 12 months
measure: Quality of life using EQ-5D questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Hospital Quirón Campo de Gibraltar
city: Córdoba
country: Spain
facility: H. San Juan de Dios
city: Erandio
country: Spain
facility: Hospital Quiron Vizcaya
city: Ibiza
country: Spain
facility: H. Can Misses
city: León
country: Spain
facility: Hospital San Juan de Dios
city: Madrid
country: Spain
facility: H. de Torrelodones
city: Madrid
country: Spain
facility: H. Montepríncipe
city: Madrid
country: Spain
facility: Hospital Quirón San Camilo
city: Madrid
country: Spain
facility: Hospital San Rafael
city: Marbella
country: Spain
facility: Hospital Quirón Marbella
city: Málaga
country: Spain
facility: Hospital Parque San Antonio
city: San Sebastián de los Reyes
country: Spain
facility: H. Infanta Sofía
city: Sevilla
country: Spain
facility: Hospital NISA
city: Sevilla
country: Spain
facility: Hospital Sagrado Corazón
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: