<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/NCT01664130</url>
  </required_header>
  <id_info>
    <org_study_id>CASE1812</org_study_id>
    <secondary_id>NCI-2012-01252</secondary_id>
    <nct_id>NCT01664130</nct_id>
  </id_info>
  <brief_title>High-Dose Stereotactic Radiation for Prostate Cancer</brief_title>
  <official_title>High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating&#xD;
      patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able&#xD;
      to send x-rays directly to the tumor and cause less damage to normal tissue&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for&#xD;
      patients who undergo SBRT for localized prostate cancer.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC)&#xD;
      and American Urological Association (AUA) scores.&#xD;
&#xD;
      II. Assess biochemical control after high-dose SBRT.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days&#xD;
      with at least 40 hours between each fraction in the absence of disease progression or&#xD;
      unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months,&#xD;
      every 6 months for 4 years, and then annually thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">January 12, 2017</completion_date>
  <primary_completion_date type="Actual">January 12, 2017</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>Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</measure>
    <time_frame>1.5 months</time_frame>
    <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</measure>
    <time_frame>4 months</time_frame>
    <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</measure>
    <time_frame>8 months</time_frame>
    <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by EPIC Scores</measure>
    <time_frame>Baseline and 1.5 months</time_frame>
    <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by EPIC Scores</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by EPIC Scores</measure>
    <time_frame>Baseline and 8 months</time_frame>
    <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by EPIC Scores</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by Change in AUA Scores</measure>
    <time_frame>Baseline and 1.5 months</time_frame>
    <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by Change in AUA Scores</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by Change in AUA Scores</measure>
    <time_frame>Baseline and 8 months</time_frame>
    <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by Change in AUA Scores</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</measure>
    <time_frame>Baseline and 1.5 months</time_frame>
    <description>Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</measure>
    <time_frame>Baseline and 8 months</time_frame>
    <description>Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Adenocarcinoma of the Prostate</condition>
  <condition>Recurrent Prostate Cancer</condition>
  <condition>Stage I Prostate Cancer</condition>
  <condition>Stage IIA Prostate Cancer</condition>
  <condition>Stage IIB Prostate Cancer</condition>
  <condition>Stage III Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (SBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>stereotactic body radiation therapy</intervention_name>
    <description>Undergo SBRT</description>
    <arm_group_label>Treatment (SBRT)</arm_group_label>
    <other_name>SBRT</other_name>
    <other_name>stereotactic radiation therapy</other_name>
    <other_name>stereotactic radiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>quality-of-life assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (SBRT)</arm_group_label>
    <other_name>quality of life assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (SBRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have prostate adenocarcinoma proven by histologic diagnosis&#xD;
&#xD;
          -  The patient must have clinical stage T1a-T3b with localized prostate cancer considered&#xD;
             low, intermediate, or high risk as defined by the National Comprehensive Cancer&#xD;
             Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo&#xD;
             screening with computed tomography (CT) or magnetic resonance imaging (MRI) of the&#xD;
             abdomen and pelvis as well as bone scan prior to enrollment for staging purposes; low&#xD;
             and intermediate risk patients do not require imaging for staging unless they have a&#xD;
             focal symptom warranting investigation&#xD;
&#xD;
          -  Performance status - Karnofsky performance status (PS) &gt;= 70&#xD;
&#xD;
          -  Life expectancy of &gt; 5 years, in the opinion of and as documented by the investigator&#xD;
&#xD;
          -  Patients must either already have fiducials already placed within the prostate, or&#xD;
             otherwise be candidates for prostate fiducial placement (no bleeding disorders which&#xD;
             may cause excessive bleeding with fiducial placement, INR &lt; 2.0).&#xD;
&#xD;
          -  Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Men must agree to use adequate contraception (double barrier method of birth control&#xD;
             or abstinence) for the duration of study participation and for 12 months after&#xD;
             completing treatment&#xD;
&#xD;
          -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment toxicities must be resolved to =&lt; grade 1 according to National Cancer&#xD;
             Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents&#xD;
&#xD;
          -  Evidence of metastatic disease prior to radiation&#xD;
&#xD;
          -  Patients with uncontrolled intercurrent illness including, but not limited to ongoing&#xD;
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,&#xD;
             cardiac arrhythmia, or psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements&#xD;
&#xD;
          -  Prior pelvic radiation therapy&#xD;
&#xD;
          -  Patients whom are planned to receive pelvic nodal radiation are excluded&#xD;
&#xD;
          -  Weight &gt; 350 lbs&#xD;
&#xD;
          -  Contraindications to placement of fiducials required for high-precision image guidance&#xD;
             (e.g. bleeding disorders which may cause excessive bleeding with placement,&#xD;
             requirement for coumadin, international normalized ratio [INR] &gt; 2.0)&#xD;
&#xD;
          -  Patients unable to maintain a full bladder during treatment&#xD;
&#xD;
          -  Previous prostatectomy&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  AUA score &gt; 15 in spite of optimal therapy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Stephans</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>June 12, 2019</results_first_submitted>
  <results_first_submitted_qc>August 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 18, 2019</results_first_posted>
  <last_update_submitted>May 8, 2020</last_update_submitted>
  <last_update_submitted_qc>May 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from regional hospitals from July 2012 thru Jan 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment (SBRT)</title>
          <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>competing secondary disease</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (SBRT)</title>
          <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>50-59 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80-89 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
        <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
        <time_frame>1.5 months</time_frame>
        <population>All patients that received treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
          <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
          <population>All patients that received treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
        <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
        <time_frame>4 months</time_frame>
        <population>Per protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
          <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
          <population>Per protocol</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
        <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
        <time_frame>8 months</time_frame>
        <population>Per protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
          <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
          <population>Per protocol</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
        <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
        <time_frame>12 months</time_frame>
        <population>All patients that received treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0</title>
          <description>Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0</description>
          <population>All patients that received treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by EPIC Scores</title>
        <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
        <time_frame>Baseline and 1.5 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>Before treatment</description>
          </group>
          <group group_id="O2">
            <title>After Treatment (SBRT)</title>
            <description>After treatment (SBRT)&#xD;
Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by EPIC Scores</title>
          <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urinary Incontenence Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" spread="16.5"/>
                    <measurement group_id="O2" value="84.0" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bowel Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" spread="12.4"/>
                    <measurement group_id="O2" value="83.7" spread="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Function Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" spread="30.4"/>
                    <measurement group_id="O2" value="36.8" spread="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hormonal Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" spread="19.4"/>
                    <measurement group_id="O2" value="76.6" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by EPIC Scores</title>
        <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
        <time_frame>Baseline and 4 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>Before treatment</description>
          </group>
          <group group_id="O2">
            <title>After Treatment (SBRT)</title>
            <description>After treatment (SBRT)&#xD;
Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by EPIC Scores</title>
          <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urinary Incontenence Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" spread="16.5"/>
                    <measurement group_id="O2" value="85.0" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bowel Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" spread="12.4"/>
                    <measurement group_id="O2" value="85.6" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Function Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" spread="30.4"/>
                    <measurement group_id="O2" value="33.6" spread="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hormonal Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" spread="19.4"/>
                    <measurement group_id="O2" value="79.4" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by EPIC Scores</title>
        <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
        <time_frame>Baseline and 8 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>Before treatment.</description>
          </group>
          <group group_id="O2">
            <title>After Treatment (SBRT)</title>
            <description>After treatment (SBRT)&#xD;
Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by EPIC Scores</title>
          <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urinary Incontenence Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" spread="16.5"/>
                    <measurement group_id="O2" value="85.7" spread="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bowel Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" spread="12.4"/>
                    <measurement group_id="O2" value="86.6" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Function Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" spread="30.4"/>
                    <measurement group_id="O2" value="37.5" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hormonal Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" spread="19.4"/>
                    <measurement group_id="O2" value="82.4" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by EPIC Scores</title>
        <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>Before treatment.</description>
          </group>
          <group group_id="O2">
            <title>After Treatment (SBRT)</title>
            <description>After treatment (SBRT)&#xD;
Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by EPIC Scores</title>
          <description>Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urinary Incontenence Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" spread="16.5"/>
                    <measurement group_id="O2" value="83.4" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bowel Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" spread="12.4"/>
                    <measurement group_id="O2" value="86.3" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Function Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" spread="30.4"/>
                    <measurement group_id="O2" value="37.1" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hormonal Domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" spread="19.4"/>
                    <measurement group_id="O2" value="87.3" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by Change in AUA Scores</title>
        <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
        <time_frame>Baseline and 1.5 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by Change in AUA Scores</title>
          <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="1" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by Change in AUA Scores</title>
        <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
        <time_frame>Baseline and 4 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by Change in AUA Scores</title>
          <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="0" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by Change in AUA Scores</title>
        <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
        <time_frame>Baseline and 8 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by Change in AUA Scores</title>
          <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="0" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by Change in AUA Scores</title>
        <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>Participants that were able to complete the questionnaire at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by Change in AUA Scores</title>
          <description>Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.</description>
          <population>Participants that were able to complete the questionnaire at specific time point.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="0" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
        <description>Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
        <time_frame>Baseline and 1.5 months</time_frame>
        <population>participants who had a PSA values up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
          <description>Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
          <population>participants who had a PSA values up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
        <description>Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
        <time_frame>Baseline and 4 months</time_frame>
        <population>participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
          <description>Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
          <population>participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
        <description>Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
        <time_frame>Baseline and 8 months</time_frame>
        <population>participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
          <description>Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
          <population>participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="89.7" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
        <description>Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (SBRT)</title>
            <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA</title>
          <description>Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.</description>
          <population>participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="89.7" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collect from participants up to 1 year in follow-up.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (SBRT)</title>
          <description>Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.&#xD;
stereotactic body radiation therapy: Undergo SBRT&#xD;
quality-of-life assessment: Ancillary studies&#xD;
laboratory biomarker analysis: Correlative studies</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Prostate infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dermatitis radiation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kevin Stephans MD</name_or_title>
      <organization>Case Comprehensive Cancer Center</organization>
      <phone>216-445-8285</phone>
      <email>stephak@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01664130
org study id: CASE1812
secondary id: NCI-2012-01252
nct id: NCT01664130
lead sponsor: 
collaborator: 
has dmc: Yes
This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating
      patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able
      to send x-rays directly to the tumor and cause less damage to normal tissue
PRIMARY OBJECTIVES:

      I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for
      patients who undergo SBRT for localized prostate cancer.

      SECONDARY OBJECTIVES:

      I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC)
      and American Urological Association (AUA) scores.

      II. Assess biochemical control after high-dose SBRT.

      OUTLINE:

      Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days
      with at least 40 hours between each fraction in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months,
      every 6 months for 4 years, and then annually thereafter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
time frame: 1.5 months
description: Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
measure: Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
time frame: 4 months
description: Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
measure: Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
time frame: 8 months
description: Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
measure: Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
time frame: 12 months
description: Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
measure: Quality of Life as Assessed by EPIC Scores
time frame: Baseline and 1.5 months
description: Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
measure: Quality of Life as Assessed by EPIC Scores
time frame: Baseline and 4 months
description: Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
measure: Quality of Life as Assessed by EPIC Scores
time frame: Baseline and 8 months
description: Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
measure: Quality of Life as Assessed by EPIC Scores
time frame: Baseline and 12 months
description: Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
measure: Quality of Life as Assessed by Change in AUA Scores
time frame: Baseline and 1.5 months
description: Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
measure: Quality of Life as Assessed by Change in AUA Scores
time frame: Baseline and 4 months
description: Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
measure: Quality of Life as Assessed by Change in AUA Scores
time frame: Baseline and 8 months
description: Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
measure: Quality of Life as Assessed by Change in AUA Scores
time frame: Baseline and 12 months
description: Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
time frame: Baseline and 1.5 months
description: Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
time frame: Baseline and 4 months
description: Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
time frame: Baseline and 8 months
description: Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
time frame: Baseline and 12 months
description: Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
arm group label: Treatment (SBRT)
arm group type: Experimental
description: Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.
intervention type: Radiation
intervention name: stereotactic body radiation therapy
description: Undergo SBRT
arm group label: Treatment (SBRT)
other name: SBRT
other name: stereotactic radiation therapy
other name: stereotactic radiotherapy
intervention type: Procedure
intervention name: quality-of-life assessment
description: Ancillary studies
arm group label: Treatment (SBRT)
other name: quality of life assessment
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (SBRT)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin Stephans
role: Principal Investigator
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 