<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/NCT02206724</url>
  </required_header>
  <id_info>
    <org_study_id>140794</org_study_id>
    <nct_id>NCT02206724</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer</brief_title>
  <official_title>PROSPECTIVE EVALUATION OF STEREOTACTIC BODY RADIOTHERAPY FOR METASTATIC PROSTATE CANCER</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sharp HealthCare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sharp HealthCare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to test the safety and feasibility of prostate gland stereotactic body&#xD;
      radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators and other investigators have previously documented the safety and efficacy&#xD;
      of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized&#xD;
      prostate cancer.&#xD;
&#xD;
      In the metastatic setting for multiple malignancies, improved survival rates and disease&#xD;
      outcomes have been shown with definitive treatment of the primary disease site. This concept&#xD;
      of &quot;cytoreductive&quot; surgery or decreasing the primary tumor burden is now considered the&#xD;
      standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus&#xD;
      post-surgery irradiation).&#xD;
&#xD;
      With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed&#xD;
      metastatic prostate cancer is expected to increase. A recent population-based study has&#xD;
      concluded significant improvements in the definitive treatment of the local prostate cancer&#xD;
      in the stage IV setting with either radical prostatectomy or conventional prostate radiation&#xD;
      treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently&#xD;
      accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive&#xD;
      treatment with either radical prostatectomy or conventionally fractionated radiation therapy&#xD;
&#xD;
      The investigators hypothesize that the addition of primary disease SBRT to best systemic&#xD;
      therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable&#xD;
      safety profile, quality of life, disease progression, and overall survival. The addition of&#xD;
      SBRT to best systemic therapy is also expected to be better-received for stage IV patients&#xD;
      (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy,&#xD;
      or radical prostatectomy. The above endpoints would initially be tested in a prospective&#xD;
      phase II multi-institutional trial and in comparison with historical controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to enroll patients&#xD;
  </why_stopped>
  <start_date type="Actual">July 16, 2014</start_date>
  <completion_date type="Actual">April 17, 2018</completion_date>
  <primary_completion_date type="Actual">April 17, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation related toxicity</measure>
    <time_frame>5 years</time_frame>
    <description>Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires:&#xD;
SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility</measure>
    <time_frame>3-4 years</time_frame>
    <description>Feasibility in terms of accrual and practical treatment delivery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Metastatic Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>STEREOTACTIC BODY RADIOTHERAPY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STEREOTACTIC BODY RADIOTHERAPY to the prostate gland</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>STEREOTACTIC BODY RADIOTHERAPY to the prostate gland</intervention_name>
    <arm_group_label>STEREOTACTIC BODY RADIOTHERAPY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically-confirmed, adenocarcinoma of the prostate&#xD;
&#xD;
          -  Clinical Stage T1b - T4, NX-0-1, M1&#xD;
&#xD;
          -  Any Gleason score&#xD;
&#xD;
          -  PSA&lt;1000&#xD;
&#xD;
          -  ECOG Performance Status 0-2&#xD;
&#xD;
          -  No prior prostate radiation or other definitive therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior prostatectomy or cryotherapy of the prostate&#xD;
&#xD;
          -  Prior radiotherapy to the prostate or lower pelvis&#xD;
&#xD;
          -  Implanted hardware or other material that would prohibit appropriate treatment&#xD;
             planning or treatment delivery, in the investigator's opinion&#xD;
&#xD;
          -  Chemotherapy for a malignancy in the last 5 years&#xD;
&#xD;
          -  History of an invasive malignancy (other than this prostate cancer, or basal or&#xD;
             squamous skin cancers) in the last 5 years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sharp Healthcare</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic prostate cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT02206724
org study id: 140794
nct id: NCT02206724
lead sponsor: 
has dmc: No
The investigators aim to test the safety and feasibility of prostate gland stereotactic body
      radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.
The investigators and other investigators have previously documented the safety and efficacy
      of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized
      prostate cancer.

      In the metastatic setting for multiple malignancies, improved survival rates and disease
      outcomes have been shown with definitive treatment of the primary disease site. This concept
      of "cytoreductive" surgery or decreasing the primary tumor burden is now considered the
      standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus
      post-surgery irradiation).

      With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed
      metastatic prostate cancer is expected to increase. A recent population-based study has
      concluded significant improvements in the definitive treatment of the local prostate cancer
      in the stage IV setting with either radical prostatectomy or conventional prostate radiation
      treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently
      accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive
      treatment with either radical prostatectomy or conventionally fractionated radiation therapy

      The investigators hypothesize that the addition of primary disease SBRT to best systemic
      therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable
      safety profile, quality of life, disease progression, and overall survival. The addition of
      SBRT to best systemic therapy is also expected to be better-received for stage IV patients
      (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy,
      or radical prostatectomy. The above endpoints would initially be tested in a prospective
      phase II multi-institutional trial and in comparison with historical controls.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radiation related toxicity
time frame: 5 years
description: Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires:
SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire
measure: Feasibility
time frame: 3-4 years
description: Feasibility in terms of accrual and practical treatment delivery
arm group label: STEREOTACTIC BODY RADIOTHERAPY
arm group type: Experimental
description: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
intervention type: Radiation
intervention name: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
arm group label: STEREOTACTIC BODY RADIOTHERAPY
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms