xml: <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/NCT06040125</url>
    </required_header>
    <id_info>
      <org_study_id>23-109</org_study_id>
      <nct_id>NCT06040125</nct_id>
    </id_info>
    <brief_title>Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial</brief_title>
    <official_title>Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dana-Farber Cancer Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Prostate Cancer Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Dana-Farber Cancer Institute</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>
        The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit&#xD;
        training intervention utilizing resistance and functional exercises and self-directed aerobic&#xD;
        exercise will improve frailty and sarcopenic status and disease progression outcomes among&#xD;
        pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy&#xD;
        (ADT).&#xD;
  &#xD;
        The names of the study intervention involved in this study is:&#xD;
  &#xD;
        • Supervised circuit training (aerobic and resistance exercise regimen)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research study is a pilot, randomized control study, which is the first-time&#xD;
        investigators are examining this intervention in this setting.&#xD;
  &#xD;
        Participants will be randomized into one of two study groups: Exercise Group versus Attention&#xD;
        Control Group. Randomization means a participant is placed into a group by chance.&#xD;
  &#xD;
        The research study procedures include screening for eligibility, study treatment, including&#xD;
        extensive evaluations of fitness, physical health and strength, blood tests, muscle biopsy,&#xD;
        surveys, and follow-up visits.&#xD;
  &#xD;
        Participation in this research study is expected to last about 16 weeks.&#xD;
  &#xD;
        It is expected that about 80 people will take part in this research study.&#xD;
  &#xD;
        The Prostate Cancer Foundation is providing funding for this research study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">February 28, 2027</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Circulating Inflammation for Exercise Group</measure>
      <time_frame>Baseline (week 0) and Post-intervention (week 17)</time_frame>
      <description>Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frailty</measure>
      <time_frame>Baseline (week 0) and Post-intervention (week 17)</time_frame>
      <description>This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sarcopenia</measure>
      <time_frame>Baseline (week 0) and Post-intervention (week 17)</time_frame>
      <description>A sarcopenia score of ≤10.75 kg/m2, as assessed by computed tomography (CT), will be the cut point used for identifying muscle loss = 1 point.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skeletal Muscle Biomarkers - myokines</measure>
      <time_frame>Baseline (week 0) and Post-intervention (week 17)</time_frame>
      <description>Assessed from muscle biopsy specimens of the vastus lateralis (ul/ml).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>PROSTATE CANCER</condition>
    <condition>Metastatic Prostate Cancer</condition>
    <condition>Metastatic Prostate Carcinoma</condition>
    <arm_group>
      <arm_group_label>Exercise Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will partake in a 16-week supervised exercise program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Attention Control Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will continue with their normal daily activities.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Supervised Circuit Training</intervention_name>
      <description>16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.</description>
      <arm_group_label>Attention Control Group</arm_group_label>
      <arm_group_label>Exercise Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign informed consent prior to any&#xD;
               study-related procedures.&#xD;
  &#xD;
            -  Diagnosed with metastatic prostate cancer.&#xD;
  &#xD;
            -  Aged ≥18 years; due to the rarity of the disease in those &lt;18 years, this age bracket&#xD;
               will not be included.&#xD;
  &#xD;
            -  Have been receiving androgen deprivation (either with or without androgen receptor&#xD;
               targeted treatment) for at least one month and expect to remain on their treatment for&#xD;
               at least 4 months.&#xD;
  &#xD;
            -  Are pre-frail or frail as indicated by the FRAIL scale (a score of 1-2 = pre-frail;&#xD;
               3-5 = frail).&#xD;
  &#xD;
            -  Have physician's clearance to participate in exercise.&#xD;
  &#xD;
            -  Speak English.&#xD;
  &#xD;
            -  Participate in less than 2 structured resistance exercise sessions per week over the&#xD;
               last 4 months.&#xD;
  &#xD;
            -  Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic&#xD;
               exercise per week over the last month.&#xD;
  &#xD;
            -  Willing to travel to Dana-Farber Cancer Institute for necessary data collection and&#xD;
               exercise sessions.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Receiving chemotherapy. This study is exclusively targeting androgen deprivation&#xD;
               therapy-related effects.&#xD;
  &#xD;
            -  Have unstable bone lesions. In general patients with severely symptomatic/unstable&#xD;
               bone lesions due to bone metastases are at a higher risk of fractures.&#xD;
  &#xD;
            -  Complete 2 or more structured resistance exercise sessions per week over the last 4&#xD;
               months and participate in more than 60 minutes of moderate-to-vigorous aerobic&#xD;
               exercise per week over the last month. Excess additional exercise is a confounding&#xD;
               factor in assessing the effect of the current exercise program.&#xD;
  &#xD;
            -  Unstable comorbidities that prevent participation in moderate-to-vigorous intensity&#xD;
               exercise. Patients with unstable comorbidities likely require supervised exercise for&#xD;
               safety, and part of this study involves unsupervised exercise; therefore, for safety&#xD;
               reasons, these persons are excluded.&#xD;
  &#xD;
            -  Patients receiving treatment for other active malignancies (except basal cell&#xD;
               carcinoma). This study is exclusively targeting androgen deprivation therapy-related&#xD;
               effects.&#xD;
  &#xD;
            -  Subjects who in the opinion of the investigators may not be able to comply with the&#xD;
               safety monitoring requirements of the study.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christina Dieli-Conwright, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dana-Farber Cancer Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christina Dieli-Conwright, MD</last_name>
      <phone>617-582-8321</phone>
      <email>ChristinaM_Dieli-Conwright@dfci.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beth Israel Deaconess Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David Einstein, MD</last_name>
        <phone>617-667-1957</phone>
        <email>Deinstei@bidmc.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>David Einstein, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Brigham and Women's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Dana-Farber Cancer Institute</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Christina Dieli-Conwright, MD</last_name>
        <phone>617-582-8321</phone>
        <email>ChristinaM_Dieli-Conwright@dfci.harvard.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
      <investigator_full_name>Christina Dieli-Conwright, PhD</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <keyword>Prostate Cancer</keyword>
    <keyword>Metastatic Prostate Cancer</keyword>
    <keyword>Metastatic Prostate Carcinoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
      <mesh_term>Sarcopenia</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
      <ipd_access_criteria>Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040125
  org study id: 23-109
  nct id: NCT06040125
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit
        training intervention utilizing resistance and functional exercises and self-directed aerobic
        exercise will improve frailty and sarcopenic status and disease progression outcomes among
        pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy
        (ADT).
  
        The names of the study intervention involved in this study is:
  
        • Supervised circuit training (aerobic and resistance exercise regimen)
  This research study is a pilot, randomized control study, which is the first-time
        investigators are examining this intervention in this setting.
  
        Participants will be randomized into one of two study groups: Exercise Group versus Attention
        Control Group. Randomization means a participant is placed into a group by chance.
  
        The research study procedures include screening for eligibility, study treatment, including
        extensive evaluations of fitness, physical health and strength, blood tests, muscle biopsy,
        surveys, and follow-up visits.
  
        Participation in this research study is expected to last about 16 weeks.
  
        It is expected that about 80 people will take part in this research study.
  
        The Prostate Cancer Foundation is providing funding for this research study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Circulating Inflammation for Exercise Group
  time frame: Baseline (week 0) and Post-intervention (week 17)
  description: Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).
  measure: Frailty
  time frame: Baseline (week 0) and Post-intervention (week 17)
  description: This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.
  measure: Sarcopenia
  time frame: Baseline (week 0) and Post-intervention (week 17)
  description: A sarcopenia score of ≤10.75 kg/m2, as assessed by computed tomography (CT), will be the cut point used for identifying muscle loss = 1 point.
  measure: Skeletal Muscle Biomarkers - myokines
  time frame: Baseline (week 0) and Post-intervention (week 17)
  description: Assessed from muscle biopsy specimens of the vastus lateralis (ul/ml).
  arm group label: Exercise Group
  arm group type: Experimental
  description: Participants will partake in a 16-week supervised exercise program.
  arm group label: Attention Control Group
  arm group type: Experimental
  description: Participants will continue with their normal daily activities.
  intervention type: Behavioral
  intervention name: Supervised Circuit Training
  description: 16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.
  arm group label: Attention Control Group
  arm group label: Exercise Group
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christina Dieli-Conwright, MD
  role: Principal Investigator
  affiliation: Dana-Farber Cancer Institute
  last name: Christina Dieli-Conwright, MD
  phone: 617-582-8321
  email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
  facility: 
  contact: 
  investigator: 
  facility: 
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Dana-Farber Cancer Institute
  investigator full name: Christina Dieli-Conwright, PhD
  investigator title: Principle Investigator
  mesh term: Prostatic Neoplasms
  mesh term: Sarcopenia
  mesh term: Frailty
  sharing ipd: Yes
  ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication
  ipd access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu