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Completed

NCT Number: NCT04484246

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevalence of sarcopenia in older patient with prostate cancer

Other

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.

Primary outcomes

  1. Prevalence of sarcopenia in older patient with prostate cancer

    Time frame: 36 months

    All patients are screened for sarcopenia with the SAR-F questionnaire test

Secondary outcomes

  1. Evaluation of sarcopenia severity

    Time frame: 36 months

    The severity of the sarcopenia will be measured by the evaluation of the physical performances

  2. 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)

  3. Evaluation of sarcopenia severity

    Time frame: 36 months

    The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Acronym: HoSAGE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2020
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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