- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04484246
Sarcopenia in Older Patient With Prostate Cancer, Prevalence and Incidence After Androgen Deprivation Therapy (HoSAGE)
Evaluation of the Incidence and Prevalence of Sarcopenia in Patients 70 Year and Older With Localized and Locally Advanced Porstate Cancer, Treated by Radiotherapy and Androgen Deprivation Therapy. a Monocentric Cohort Trial
Prostate cancer is the most common cancer among men 50 years and older and mainly affets patients 75 years old.
Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after surgery. Current therapies induce inhibition of sexual hormones as androgens among which testosterone. These therapies present side effects which have to be acknowledeged during the elaboration therapeutic startegies in older patients: hypogonadism induced by androgen deprivation therapy (ADT) causes loss of bone mineral density, diminution of lean body mass and increase of fat body mass.
Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. In addition to aging, many factors may contribute to sarcopenia as cancer and/or ADT. This cohort study aims to evaluate risk factors associated to sarcopenia prevalence and the relationship between ADT and sarcopenia incidence, in patients 70 years or older with localized or locally advanced prostate cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 70 years and older
- Proven localized or locally advanced prostate cancer
- Treated by radiotherapy associated to ADT
- CGA needed (screened by G8 Score ≤14)
Exclusion Criteria:
- Protected pateint under guardiaship
- Metastatic prostate cancer
- Patient refusal
- Patient cripled with severe dementia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of sarcopenia in older patient with prostate cancer
Time Frame: 36 months
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All patients are screened for sarcopenia with the SAR-F questionnaire test
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of sarcopenia severity
Time Frame: 36 months
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The severity of the sarcopenia will be measured by the evaluation of the physical performances
|
36 months
|
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Skeletal Muscular Index
Time Frame: 36 months
|
Sarcopenia prevalence measuring Skeletal Muscular Index (SMI= Appendicular skeletal muscle mass/height²) using dual-energy X-ray absorptiometry (DXA)
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36 months
|
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Evaluation of sarcopenia severity
Time Frame: 36 months
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The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test
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36 months
|
Collaborators and Investigators
Investigators
- Study Director: Emilie Garrido-Pradalié, Assistance Publique Hopitaux de Marseille
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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