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

Prostate Cancer Clinical Trial

— HoSAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484246
• Other study ID #: 2019-35
• Status: Recruiting
• Start date: December 11, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Anne Laure COUDERC
• Phone: 04-91-74-45-30
• Email: anne-laure.couderc[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Sarcopenia

Intervention

Other:
• Prevalence of sarcopenia in older patient with prostate cancer
All patients are screened for sarcopenia with the SAR-F questionnaire test score =4/10 suspected of sarcopenia will undergo a dual-X-ray exam to dertemine their skeletal muscle mass and the prevalence of sarcopenia before oncological treatment.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of sarcopenia in older patient with prostate cancer	All patients are screened for sarcopenia with the SAR-F questionnaire test	36 months
Secondary	Evaluation of sarcopenia severity	The severity of the sarcopenia will be measured by the evaluation of the physical performances	36 months
Secondary	Skeletal Muscular Index	Sarcopenia prevalence measuring Skeletal Muscular Index (SMI= Appendicular skeletal muscle mass/height²) using dual-energy X-ray absorptiometry (DXA)	36 months
Secondary	Evaluation of sarcopenia severity	The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test	36 months