Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI)

December 20, 2018 updated by: Ipsen

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cádiz, Spain
        • Hospital Quirón Campo de Gibraltar
      • Córdoba, Spain
        • H. San Juan de Dios
      • Erandio, Spain
        • Hospital Quiron Vizcaya
      • Ibiza, Spain
        • H. Can Misses
      • León, Spain
        • Hospital San Juan de Dios
      • Madrid, Spain
        • H. de Torrelodones
      • Madrid, Spain
        • H. Monteprincipe
      • Madrid, Spain
        • Hospital Quirón San Camilo
      • Madrid, Spain
        • Hospital San Rafael
      • Marbella, Spain
        • Hospital Quirón Marbella
      • Málaga, Spain
        • Hospital Parque San Antonio
      • San Sebastián de los Reyes, Spain
        • H. Infanta Sofia
      • Sevilla, Spain
        • Hospital NISA
      • Sevilla, Spain
        • Hospital Sagrado Corazón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Anthropometric Characteristics - Body Mass Index
Time Frame: Baseline
Baseline
Prostate-specific Antigen (PSA)
Time Frame: Baseline, 12 months
Baseline, 12 months
Testosterone level
Time Frame: Baseline, 12 months
Baseline, 12 months
Digital rectal examination
Time Frame: Baseline, 12 months
Baseline, 12 months
Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)
Time Frame: 12 months
12 months
Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)
Time Frame: 12 months
12 months
Change in general health status perception (from either patient or physician perspective)
Time Frame: 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.
12 months
Quality of life using EQ-5D questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-92-52014-215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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