<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/NCT02225925</url>
  </required_header>
  <id_info>
    <org_study_id>J13164</org_study_id>
    <secondary_id>NA_00091766</secondary_id>
    <nct_id>NCT02225925</nct_id>
  </id_info>
  <brief_title>Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound</brief_title>
  <official_title>Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the performance of a system of intraoperative dynamic&#xD;
      dosimetry during prostate seed implantation (brachytherapy) including its new elements, to&#xD;
      evaluate and refine technical methods of using the system, as well as confirm its performance&#xD;
      and accuracy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of brachytherapy or implantation of radioactive sources into the prostate for&#xD;
      adenocarcinoma has advantages over external beam radiation in that a very high dose can be&#xD;
      delivered to the tumor while limiting the doses to the surrounding normal tissue (i.e., bowel&#xD;
      and bladder). It is established that outcomes after treatment with brachytherapy are related&#xD;
      to the technical quality of source placement within the gland. Accurate placement of the&#xD;
      radioactive sources with achievement of optimum dose distributions within the prostate is key&#xD;
      to the success of brachytherapy with regard to both killing tumor as well as minimizing&#xD;
      toxicity.&#xD;
&#xD;
      Due to factors such as deformations of the prostate during needle insertion, needle deviation&#xD;
      from intended path during insertion, prostatic edema from needle trauma, and relaxation of&#xD;
      tissues as well as source migration after needle removal, the actual source positions upon&#xD;
      completion of the procedure may fail to accurately match their intended placement, resulting&#xD;
      in variations from the idealized dosimetric plan.&#xD;
&#xD;
      One way to overcome this complex problem is to have the capability of visualizing the sources&#xD;
      once they are in the prostate and then continuously updating the dosimetric plan in real&#xD;
      time. To this end, we have developed a mechanism whereby ultrasound and fluoroscopy are&#xD;
      quantitatively integrated to allow for real-time visualization of source positions&#xD;
      intraoperatively. A prior Phase I study performed by this group evaluated a prototype version&#xD;
      of this mechanism, resulting in the successful treatment of 6 patients with true&#xD;
      intraoperative dynamic dosimetry. Dosimetric outcomes within this cohort of patients was&#xD;
      excellent, and the intraoperative doses predicted by the system more accurate than that&#xD;
      predicted by the current standard method (ultrasound-based dosimetry).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Procedure Time</measure>
    <time_frame>at time of implantation procedure</time_frame>
    <description>Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seed Reconstruction From Intra-operative Fluoroscopy</measure>
    <time_frame>up to 30 days post-treatment</time_frame>
    <description>Number of patients with all seeds reconstructed from fluoroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry</measure>
    <time_frame>Treatment - 30 days</time_frame>
    <description>Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema</measure>
    <time_frame>Treatment - 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) Assessments</measure>
    <time_frame>baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5</time_frame>
    <description>Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Specific Antigen (PSA) Outcomes</measure>
    <time_frame>up to 5 years</time_frame>
    <description>PSA biochemical failure-free survival at last follow-up visit</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Adenocarcinoma of the Prostate</condition>
  <arm_group>
    <arm_group_label>Dynamic dosimetry brachytherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort treated with dynamic dosimetry brachytherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Brachytherapy</intervention_name>
    <arm_group_label>Dynamic dosimetry brachytherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed, localized adenocarcinoma of the prostate&#xD;
&#xD;
          -  Clinical stages T1b - T3a&#xD;
&#xD;
          -  The patient has decided to undergo brachytherapy (or brachytherapy plus external beam&#xD;
             radiation) as a treatment modality for his prostate cancer&#xD;
&#xD;
          -  Karnofsky Performance Status &gt; 60&#xD;
&#xD;
          -  Prostate volume by transrectal ultrasound (TRUS) &lt; 55 cc&#xD;
&#xD;
          -  International Prostate symptom score (IPSS) 20 or less&#xD;
&#xD;
          -  Ability to have Magnetic resonance imaging as part of post-implant assessment&#xD;
&#xD;
          -  Signed study-specific consent form prior to registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stage T3b or greater disease.&#xD;
&#xD;
          -  Prior history of pelvic radiation therapy&#xD;
&#xD;
          -  Significant obstructive symptoms (IPSS greater than 20)&#xD;
&#xD;
          -  Major medical or psychiatric illness which, in the investigator's opinion, would&#xD;
             prevent completion of treatment and would interfere with follow up.&#xD;
&#xD;
          -  Implanted device or apparatus which obstruct visibility of the implanted sources on&#xD;
             fluoroscopy&#xD;
&#xD;
          -  Metallic implants, claustrophobia not amenable to medication, or known&#xD;
             contraindications to undergoing MR scanning&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danny Song, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The SKCCC at Johns Hopkins</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The SKCCC at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>April 8, 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>
  <results_first_submitted>October 14, 2019</results_first_submitted>
  <results_first_submitted_qc>February 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2020</results_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>brachytherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dynamic Dosimetry Brachytherapy</title>
          <description>Cohort treated with dynamic dosimetry brachytherapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dynamic Dosimetry Brachytherapy</title>
          <description>Cohort treated with dynamic dosimetry brachytherapy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68" lower_limit="55" upper_limit="81"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Procedure Time</title>
        <description>Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure</description>
        <time_frame>at time of implantation procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Time</title>
          <description>Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="14" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seed Reconstruction From Intra-operative Fluoroscopy</title>
        <description>Number of patients with all seeds reconstructed from fluoroscopy</description>
        <time_frame>up to 30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Seed Reconstruction From Intra-operative Fluoroscopy</title>
          <description>Number of patients with all seeds reconstructed from fluoroscopy</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction</title>
        <description>Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)</description>
        <time_frame>30 days post-treatment</time_frame>
        <population>Data was not collected to assess this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction</title>
          <description>Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)</description>
          <population>Data was not collected to assess this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater</title>
        <description>Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater</title>
          <description>Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry</title>
        <description>Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry</description>
        <time_frame>Treatment - 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry</title>
          <description>Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry</description>
          <units>percentage of prescribed dose</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="6" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema</title>
        <time_frame>Treatment - 30 days</time_frame>
        <population>Data was not collected to assess this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema</title>
          <population>Data was not collected to assess this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QoL) Assessments</title>
        <description>Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)</description>
        <time_frame>baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5</time_frame>
        <population>Data was not collected to assess this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QoL) Assessments</title>
          <description>Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)</description>
          <population>Data was not collected to assess this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate Specific Antigen (PSA) Outcomes</title>
        <description>PSA biochemical failure-free survival at last follow-up visit</description>
        <time_frame>up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Dosimetry Brachytherapy</title>
            <description>Cohort treated with dynamic dosimetry brachytherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate Specific Antigen (PSA) Outcomes</title>
          <description>PSA biochemical failure-free survival at last follow-up visit</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were assessed for serious (Grade 3+) and/or unexpected events (those not expected/known risks of treatment); during treatment and up to 60 days after treatment.</time_frame>
      <desc>This is a research trial that is studying the feasibility and practicability of a new treatment planning system for patients who undergo brachytherapy. There are no expected adverse events associated with this trial, however, the research team will conduct post-follow-ups on all patients enrolled in this trial to report any adverse events (AEs) that are either unexpected or serious.&#xD;
No AEs or mortality were reported during this period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dynamic Dosimetry Brachytherapy</title>
          <description>Cohort treated with dynamic dosimetry brachytherapy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
              </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>Daniel Song</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410-502-5875</phone>
      <email>dsong2@jhmi.edu</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/NCT02225925
org study id: J13164
secondary id: NA_00091766
nct id: NCT02225925
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to assess the performance of a system of intraoperative dynamic
      dosimetry during prostate seed implantation (brachytherapy) including its new elements, to
      evaluate and refine technical methods of using the system, as well as confirm its performance
      and accuracy.
The use of brachytherapy or implantation of radioactive sources into the prostate for
      adenocarcinoma has advantages over external beam radiation in that a very high dose can be
      delivered to the tumor while limiting the doses to the surrounding normal tissue (i.e., bowel
      and bladder). It is established that outcomes after treatment with brachytherapy are related
      to the technical quality of source placement within the gland. Accurate placement of the
      radioactive sources with achievement of optimum dose distributions within the prostate is key
      to the success of brachytherapy with regard to both killing tumor as well as minimizing
      toxicity.

      Due to factors such as deformations of the prostate during needle insertion, needle deviation
      from intended path during insertion, prostatic edema from needle trauma, and relaxation of
      tissues as well as source migration after needle removal, the actual source positions upon
      completion of the procedure may fail to accurately match their intended placement, resulting
      in variations from the idealized dosimetric plan.

      One way to overcome this complex problem is to have the capability of visualizing the sources
      once they are in the prostate and then continuously updating the dosimetric plan in real
      time. To this end, we have developed a mechanism whereby ultrasound and fluoroscopy are
      quantitatively integrated to allow for real-time visualization of source positions
      intraoperatively. A prior Phase I study performed by this group evaluated a prototype version
      of this mechanism, resulting in the successful treatment of 6 patients with true
      intraoperative dynamic dosimetry. Dosimetric outcomes within this cohort of patients was
      excellent, and the intraoperative doses predicted by the system more accurate than that
      predicted by the current standard method (ultrasound-based dosimetry).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedure Time
time frame: at time of implantation procedure
description: Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure
measure: Seed Reconstruction From Intra-operative Fluoroscopy
time frame: up to 30 days post-treatment
description: Number of patients with all seeds reconstructed from fluoroscopy
measure: Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction
time frame: 30 days post-treatment
description: Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)
measure: Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater
time frame: 30 days post-treatment
description: Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater
measure: Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry
time frame: Treatment - 30 days
description: Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry
measure: Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema
time frame: Treatment - 30 days
measure: Quality of Life (QoL) Assessments
time frame: baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5
description: Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)
measure: Prostate Specific Antigen (PSA) Outcomes
time frame: up to 5 years
description: PSA biochemical failure-free survival at last follow-up visit
arm group label: Dynamic dosimetry brachytherapy
arm group type: Experimental
description: Cohort treated with dynamic dosimetry brachytherapy
intervention type: Radiation
intervention name: Brachytherapy
arm group label: Dynamic dosimetry brachytherapy
criteria: 
gender: Male
gender based: Yes
gender description: male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danny Song, M.D.
role: Principal Investigator
affiliation: The SKCCC at Johns Hopkins
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 