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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 6, 2020

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Evaluation of sarcopenia severity
    • Time Frame: 36 months
    • The severity of the sarcopenia will be measured by the evaluation of the physical performances
  • 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)
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique Hopitaux De Marseille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emilie Garrido-Pradalié, Study Director, Assistance Publique Hôpitaux de Marseille
  • Overall Contact(s)
    • Anne Laure COUDERC, 04-91-74-45-30, anne-laure.couderc@ap-hm.fr

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