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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853409
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Prostate Cancer

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Study Type : Observational
Actual Enrollment : 628 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Anthropometric Characteristics - Body Mass Index [ Time Frame: Baseline ]
  3. Prostate-specific Antigen (PSA) [ Time Frame: Baseline, 12 months ]
  4. Testosterone level [ Time Frame: Baseline, 12 months ]
  5. Digital rectal examination [ Time Frame: Baseline, 12 months ]
  6. Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy) [ Time Frame: 12 months ]
  7. Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD) [ Time Frame: 12 months ]
  8. 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.

  9. Quality of life using EQ-5D questionnaire [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853409


Locations
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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 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
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02853409    
Other Study ID Numbers: A-92-52014-215
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases