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

Prostate Cancer Clinical Trial

— PROS-PROSQoLI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853409
• Other study ID #: A-92-52014-215
• Status: Completed
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Spain	Hospital Quirón Campo de Gibraltar	Cádiz
Spain	H. San Juan de Dios	Córdoba
Spain	Hospital Quiron Vizcaya	Erandio
Spain	H. Can Misses	Ibiza
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 Parque San Antonio	Málaga
Spain	Hospital Quirón Marbella	Marbella
Spain	H. Infanta Sofía	San Sebastián de los Reyes
Spain	Hospital NISA	Sevilla
Spain	Hospital Sagrado Corazón	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)		12 months
Secondary	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
Secondary	Anthropometric Characteristics - Body Mass Index		Baseline
Secondary	Prostate-specific Antigen (PSA)		Baseline, 12 months
Secondary	Testosterone level		Baseline, 12 months
Secondary	Digital rectal examination		Baseline, 12 months
Secondary	Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)		12 months
Secondary	Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)		12 months
Secondary	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.	12 months
Secondary	Quality of life using EQ-5D questionnaire		12 months