Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer (PROGERAD)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
geriatric assessment and quality of life
Radiotherapy
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Institut de Cancérologie de l'Ouest
- Hopital Henri Mondor
- Centre Georges François Leclerc
- CHD
- Centre Hospitalier Bretagne Sud
- Centre Catherine de Sienne
- Clinique Armoricaine de Radiologie
- CHP
- Clinique Mutualiste de l'Estuaire
- Institut de Cancérologie de Loire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
geriatric assessment and quality of life
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Complete geriatric assessment
This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02876237
First Posted
July 22, 2016
Last Updated
May 29, 2018
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT02876237
Brief Title
Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer
Acronym
PROGERAD
Official Title
Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
geriatric assessment and quality of life
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
geriatric assessment and quality of life
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
standard radiotherapy
Primary Outcome Measure Information:
Title
General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
Description
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.
Time Frame
2 months
Title
Complete geriatric assessment
Description
This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .
Time Frame
6 months
Title
General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurore GOINEAU, MD
Organizational Affiliation
Institut de Cancerologie de l'Ouest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphane SUPIOT, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHD
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hospitalier Bretagne Sud
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Clinique Armoricaine de Radiologie
City
St Brieuc
ZIP/Postal Code
22015
Country
France
Facility Name
CHP
City
St Gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
Clinique Mutualiste de l'Estuaire
City
St Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
Institut de Cancérologie de Loire
City
St Priest En Jarez
ZIP/Postal Code
42270
Country
France
12. IPD Sharing Statement
Learn more about this trial
Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer
We'll reach out to this number within 24 hrs