Sarcopenia in Older Patient With Prostate Cancer, Prevalence and Incidence After Androgen Deprivation Therapy

• Conditions: Prostate Cancer

• Registration Number: NCT04484246
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-11
• Status Verified: 2020-07
• Primary Completion: 2020-07-06
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of sarcopenia in older patient with prostate cancer	36 months	All patients are screened for sarcopenia with the SAR-F questionnaire test

Secondary Outcome Measures

Name	Time	Method
Evaluation of sarcopenia severity	36 months	The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test
Skeletal Muscular Index	36 months	Sarcopenia prevalence measuring Skeletal Muscular Index (SMI= Appendicular skeletal muscle mass/height²) using dual-energy X-ray absorptiometry (DXA)

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France