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OpenTrials
Completed

NCT Number: NCT02853409

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hospital Quirón Campo de Gibraltar, Cadiz, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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)

Acronym: PROS-PROSQoLI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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