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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: geriatric assessment and quality of life
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: geriatric assessment and quality of life<br>Included patient must have a geriatric assessment before radiotherapy and 6 months later. Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later. | Other: geriatric assessment and quality of life<br>* 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.<br>Radiation: Radiotherapy<br>* standard radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire | 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 months | 
| Complete geriatric assessment | This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . | 6 months | 
| General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire | 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. | 6 months |