Clinical trial NCT02876237: Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer
Official title: Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 230
Sex: MALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
timeFrame: 2 months
measure: Complete geriatric assessment
timeFrame: 6 months
measure: General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: La Roche Sur Yon
country: France
facility: CHD
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: St Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: St Gregoire
country: France
facility: CHP
city: St Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: St Priest En Jarez
country: France
facility: Institut de Cancérologie de Loire
Study officials:
affiliation: Institut de Cancerologie de l'Ouest
name: Aurore GOINEAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Cancérologie de l'Ouest
name: Stéphane SUPIOT, MD
role: PRINCIPAL_INVESTIGATOR
References: