Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer
PROS-PROSQoLI
Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)
1 other identifier
observational
628
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedDecember 21, 2018
December 1, 2018
1.9 years
April 1, 2016
December 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
12 months
Secondary Outcomes (9)
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
Digital rectal examination
Baseline, 12 months
- +4 more secondary outcomes
Eligibility Criteria
Community sample
You may qualify if:
- 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
You may not qualify if:
- Patients who are also participating in any other clinical study
- Patient with other malignant diseases, apart from prostate cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (14)
Hospital Quirón Campo de Gibraltar
Cadiz, Spain
H. San Juan de Dios
Córdoba, Spain
Hospital Quiron Vizcaya
Erandio, Spain
H. Can Misses
Ibiza Town, Spain
Hospital San Juan de Dios
León, Spain
H. de Torrelodones
Madrid, Spain
H. Montepríncipe
Madrid, 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
Seville, Spain
Hospital Sagrado Corazón
Seville, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2016
First Posted
August 2, 2016
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 21, 2018
Record last verified: 2018-12