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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: geriatric assessment and quality of life; Radiation: Radiotherapy

• Registration Number: NCT02876237
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-23
• Primary Completion: 2017-02
• Study Completion: 2017-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 230

Inclusion Criteria

1. Man with a histologically proven prostate cancer
2. Indication of a curative intent radiotherapy
3. Age ≥ 75 years
4. Patient who signed an informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
geriatric assessment and quality of life	Radiotherapy	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.
geriatric assessment and quality of life	geriatric assessment and quality of life	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.

Primary Outcome Measures

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

Trial Locations

Locations (10)

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre Hospitalier Bretagne Sud; 🇫🇷 Lorient, France

Clinique Armoricaine de Radiologie; 🇫🇷 St Brieuc, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Angers, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

Centre Catherine de Sienne; 🇫🇷 Nantes, France

CHP; 🇫🇷 St Gregoire, France

Clinique Mutualiste de l'Estuaire; 🇫🇷 St Nazaire, France

CHD; 🇫🇷 La Roche Sur Yon, France

Institut de Cancérologie de Loire; 🇫🇷 St Priest En Jarez, France