<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484246</url>
  </required_header>
  <id_info>
    <org_study_id>2019-35</org_study_id>
    <nct_id>NCT04484246</nct_id>
  </id_info>
  <brief_title>Sarcopenia in Older Patient With Prostate Cancer, Prevalence and Incidence After Androgen Deprivation Therapy</brief_title>
  <acronym>HoSAGE</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer is the most common cancer among men 50 years and older and mainly affets&#xD;
      patients 75 years old.&#xD;
&#xD;
      Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate&#xD;
      cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after&#xD;
      surgery. Current therapies induce inhibition of sexual hormones as androgens among which&#xD;
      testosterone. These therapies present side effects which have to be acknowledeged during the&#xD;
      elaboration therapeutic startegies in older patients: hypogonadism induced by androgen&#xD;
      deprivation therapy (ADT) causes loss of bone mineral density, diminution of lean body mass&#xD;
      and increase of fat body mass.&#xD;
&#xD;
      Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal&#xD;
      muscle mass. In addition to aging, many factors may contribute to sarcopenia as cancer and/or&#xD;
      ADT. This cohort study aims to evaluate risk factors associated to sarcopenia prevalence and&#xD;
      the relationship between ADT and sarcopenia incidence, in patients 70 years or older with&#xD;
      localized or locally advanced prostate cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 11, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of sarcopenia in older patient with prostate cancer</measure>
    <time_frame>36 months</time_frame>
    <description>All patients are screened for sarcopenia with the SAR-F questionnaire test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of sarcopenia severity</measure>
    <time_frame>36 months</time_frame>
    <description>The severity of the sarcopenia will be measured by the evaluation of the physical performances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal Muscular Index</measure>
    <time_frame>36 months</time_frame>
    <description>Sarcopenia prevalence measuring Skeletal Muscular Index (SMI= Appendicular skeletal muscle mass/height²) using dual-energy X-ray absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of sarcopenia severity</measure>
    <time_frame>36 months</time_frame>
    <description>The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prevalence of sarcopenia in older patient with prostate cancer</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients 70 years or older with localized or locally advanced prostate cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 70 years and older&#xD;
&#xD;
          -  Proven localized or locally advanced prostate cancer&#xD;
&#xD;
          -  Treated by radiotherapy associated to ADT&#xD;
&#xD;
          -  CGA needed (screened by G8 Score ≤14)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Protected pateint under guardiaship&#xD;
&#xD;
          -  Metastatic prostate cancer&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Patient cripled with severe dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emilie Garrido-Pradalié</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne Laure COUDERC</last_name>
    <phone>04-91-74-45-30</phone>
    <email>anne-laure.couderc@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Laure COUDERC</last_name>
      <phone>04-91-74-45-30</phone>
      <email>anne-laure.couderc@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484246
org study id: 2019-35
nct id: NCT04484246
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
observational model: Cohort
time perspective: Prospective
measure: Prevalence of sarcopenia in older patient with prostate cancer
time frame: 36 months
description: All patients are screened for sarcopenia with the SAR-F questionnaire test
measure: Evaluation of sarcopenia severity
time frame: 36 months
description: The severity of the sarcopenia will be measured by the evaluation of the physical performances
measure: Skeletal Muscular Index
time frame: 36 months
description: Sarcopenia prevalence measuring Skeletal Muscular Index (SMI= Appendicular skeletal muscle mass/height²) using dual-energy X-ray absorptiometry (DXA)
measure: Evaluation of sarcopenia severity
time frame: 36 months
description: The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test
intervention type: Other
intervention name: Prevalence of sarcopenia in older patient with prostate cancer
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Emilie Garrido-Pradalié
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Anne Laure COUDERC
phone: 04-91-74-45-30
email: anne-laure.couderc@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Sarcopenia