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Completed

NCT Number: NCT02876237

Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer

The investigators propose to carry out a prospective analysis of physical impact, psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of localized prostate cancer with an indication of curative radiotherapy. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . The quality of life of patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate in this elderly population and will allow an answer within 2 years to the problem raised in clinical practice.

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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

75 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'Ouest, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Man with a histologically proven prostate cancer
  • Indication of a curative intent radiotherapy
  • Age ≥ 75 years
  • Patient who signed an informed consent

Exclusion criteria

  • Patient with metastatic prostate cancer
  • Patient unable to submit to monitoring of the protocol for social, geographical or family reasons
  • A person who is not affiliated to a social security scheme or of such a scheme
  • Patient under trusteeship

Treatment and study plan

geriatric assessment and quality of life

Other

Included patient must have a geriatric assessment before radiotherapy and 6 months later. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .

Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later.

Radiotherapy

Radiation

standard radiotherapy

Primary outcomes

  1. General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire

    Time frame: 2 months

    Tolerance will be called bad for the loss of 20 or more points (out of 100) between the initial assessment and evaluations at 2 and 6 months. Tolerance will be called correct in other cases. This threshold of 20 points was selected according to the work of Osoba.

  2. Complete geriatric assessment

    Time frame: 6 months

    This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .

  3. General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire

    Time frame: 6 months

    Tolerance will be called bad for the loss of 20 or more points (out of 100) between the initial assessment and evaluations at 2 and 6 months. Tolerance will be called correct in other cases. This threshold of 20 points was selected according to the work of Osoba.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent

Acronym: PROGERAD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
May 31, 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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