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

Prostate Cancer Clinical Trial

— PROGERAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876237
• Other study ID #: ICO-A-2014-04
• Secondary ID: 2014-A00300-47
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• geriatric assessment and quality of life
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.

Radiation:
• Radiotherapy
standard radiotherapy

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Angers
France	Hopital Henri Mondor	Creteil
France	Centre Georges François Leclerc	Dijon
France	CHD	La Roche Sur Yon
France	Centre Hospitalier Bretagne Sud	Lorient
France	Centre Catherine de Sienne	Nantes
France	Clinique Armoricaine de Radiologie	St Brieuc
France	CHP	St Gregoire
France	Clinique Mutualiste de l'Estuaire	St Nazaire
France	Institut de Cancérologie de Loire	St Priest En Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Complete geriatric assessment	This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .	6 months
Primary	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