Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02876237
Acronym
PROGERAD
Enrollment
230
Registered
2016-08-23
Start date
2015-02-28
Completion date
2017-08-31
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

OTHERgeriatric 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.

RADIATIONRadiotherapy

standard radiotherapy

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire2 monthsTolerance 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 assessment6 monthsThis standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026