<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/NCT02225262</url>
  </required_header>
  <id_info>
    <org_study_id>CK Prostate-01</org_study_id>
    <nct_id>NCT02225262</nct_id>
  </id_info>
  <brief_title>A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors</brief_title>
  <official_title>Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Community Cancer Center, Normal, Illinois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Community Cancer Center, Normal, Illinois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients&#xD;
      with early stage prostate cancer.&#xD;
&#xD;
      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the&#xD;
      CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and&#xD;
      effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile&#xD;
      bulb, and bowel) from receiving damaging doses of radiation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CyberKnife system is a type of radiation machine that uses a special system to precisely&#xD;
      focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate&#xD;
      large doses of radiation onto the tumor so that injury from radiation to the nearby normal&#xD;
      tissue will be minimal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2008</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Local control rate</measure>
    <time_frame>5-10 years</time_frame>
    <description>To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival [bDFS], Phoenix and ASTRO definitions, at 5 and 10 years).&#xD;
To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5-10 years</time_frame>
    <description>To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival; quality of life (QOL) in generic and organ-specific domains.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Cancer of the Prostate</condition>
  <condition>Prostate Neoplasm</condition>
  <arm_group>
    <arm_group_label>CyberKnife Radiosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>CyberKnife Radiosurgery</intervention_name>
    <description>36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction</description>
    <arm_group_label>CyberKnife Radiosurgery</arm_group_label>
    <other_name>CyberKnife</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male Age ≥ 21&#xD;
&#xD;
          -  Histologically proven prostate adenocarcinoma&#xD;
&#xD;
          -  Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)&#xD;
&#xD;
          -  PSA ≤ 20 ng/ml&#xD;
&#xD;
          -  Prostate volume ≤ 100 cc&#xD;
&#xD;
        Patients belonging in one of the following risk groups:&#xD;
&#xD;
          -  Low:&#xD;
&#xD;
               -  CS T1b-T2a and Gleason 2-6 and PSA ≤ 10&#xD;
&#xD;
          -  Intermediate:&#xD;
&#xD;
               -  CS T2b and Gleason 2-6 and PSA ≤ 10, OR&#xD;
&#xD;
               -  CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any histology other than adenocarcinoma&#xD;
&#xD;
          -  Age &lt; 21&#xD;
&#xD;
          -  KPS &lt;= 40 &lt;70&#xD;
&#xD;
          -  ECOG Performance Status ≥ 2&#xD;
&#xD;
          -  Patient weight &gt;350 lbs. (table limitation)&#xD;
&#xD;
          -  Prior XRT to prostate or lower pelvis&#xD;
&#xD;
          -  Prior surgery or cryotherapy to prostate&#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;
&#xD;
          -  Hormone ablation for 2 months prior to enrollment, or during treatment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shermian Woodhouse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Community Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community Cancer Center</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>CyberKnife</keyword>
  <keyword>Stereotactic</keyword>
  <keyword>Radiation</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/NCT02225262
org study id: CK Prostate-01
nct id: NCT02225262
lead sponsor: 
has dmc: No
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients
      with early stage prostate cancer.

      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the
      CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and
      effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile
      bulb, and bowel) from receiving damaging doses of radiation.
The CyberKnife system is a type of radiation machine that uses a special system to precisely
      focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate
      large doses of radiation onto the tumor so that injury from radiation to the nearby normal
      tissue will be minimal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local control rate
time frame: 5-10 years
description: To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival [bDFS], Phoenix and ASTRO definitions, at 5 and 10 years).
To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.
measure: Overall survival
time frame: 5-10 years
description: To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival; quality of life (QOL) in generic and organ-specific domains.
arm group label: CyberKnife Radiosurgery
arm group type: Experimental
intervention type: Radiation
intervention name: CyberKnife Radiosurgery
description: 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
arm group label: CyberKnife Radiosurgery
other name: CyberKnife
criteria: 
gender: Male
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Shermian Woodhouse, MD
role: Principal Investigator
affiliation: Community Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms