<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/NCT04489745</url>
  </required_header>
  <id_info>
    <org_study_id>VALosAngeles</org_study_id>
    <nct_id>NCT04489745</nct_id>
  </id_info>
  <brief_title>Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Greater Los Angeles Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Greater Los Angeles Healthcare System</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>
      This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients&#xD;
      with localized high-risk or unfavorable intermediate risk prostate cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>Phase 2</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>progression free survival</measure>
    <time_frame>5 years</time_frame>
    <description>progression is defined by biochemical (phoenix definition), clinical, or radiographic</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>SBRT and ADT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SBRT</intervention_name>
    <arm_group_label>SBRT and ADT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgen deprivation therapy (ADT)</intervention_name>
    <arm_group_label>SBRT and ADT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed primary non-metastatic adenocarcinoma of the prostate&#xD;
&#xD;
          -  High-risk or unfavorable intermediate-risk as defined below:&#xD;
&#xD;
        High-risk localized prostate cancer, as defined by any one of the following factors:&#xD;
&#xD;
        Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy&#xD;
        core, or cT3a or higher.&#xD;
&#xD;
        Unfavorable intermediate risk localized prostate cancer, as defined as any of the following&#xD;
        factors:&#xD;
&#xD;
        Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and &gt;50% biopsy&#xD;
        cores positive, or The presence of any two of the following: PSA&gt;10, cT2b-c, Gleason score&#xD;
        3+4 in any core&#xD;
&#xD;
          -  No pelvic nodal metastases (based on CT or MRI findings)&#xD;
&#xD;
          -  No distant metastases, based upon:&#xD;
&#xD;
        CT scan or MRI of the pelvis within 120 days prior to registration, Bone scan within 120&#xD;
        days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must&#xD;
        be obtained to rule out metastasis&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  KPS ≥ 70 (or ECOG 0-2)&#xD;
&#xD;
          -  Ability to understand, and willingness to sign, the written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with low-risk or favorable intermediate-risk prostate cancer do not meet&#xD;
             inclusion criteria (these patients would be eligible for SBRT off-trial as a standard&#xD;
             of care option)&#xD;
&#xD;
          -  Patients with any evidence of distant metastases&#xD;
&#xD;
          -  Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to&#xD;
             registration&#xD;
&#xD;
          -  Prior cryosurgery, HIFU or brachytherapy of the prostate&#xD;
&#xD;
          -  Prior pelvic radiotherapy&#xD;
&#xD;
          -  History of Crohn's Disease or Ulcerative Colitis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Androgens</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04489745
org study id: VALosAngeles
nct id: NCT04489745
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients
      with localized high-risk or unfavorable intermediate risk prostate cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: 5 years
description: progression is defined by biochemical (phoenix definition), clinical, or radiographic
arm group label: SBRT and ADT
arm group type: Experimental
description: Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy
intervention type: Radiation
intervention name: SBRT
arm group label: SBRT and ADT
intervention type: Drug
intervention name: Androgen deprivation therapy (ADT)
arm group label: SBRT and ADT
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Androgens
sharing ipd: Undecided