<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/NCT03030625</url>
  </required_header>
  <id_info>
    <org_study_id>CaP-VMAT-DIL</org_study_id>
    <nct_id>NCT03030625</nct_id>
  </id_info>
  <brief_title>VMAT for Dominant Intraprostatic Lesion</brief_title>
  <acronym>CaP-VMAT-DIL</acronym>
  <official_title>Dose Intensification With a Focal Boost to Dominant Intraprostatic Lesion Using Volumetric Modulated Arc Therapy /Image Guided Radiotherapy in Patients With Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to determine the efficacy and safety of the implementation of a&#xD;
      program of &quot; image-guided focal Intensification dose to intraprostatic dominant lesion &quot; in&#xD;
      men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN)&#xD;
      eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital&#xD;
      Universitario de La Princesa), within the established dose escalation protocol with intensity&#xD;
      modulated image-guided radiotherapy (IMRT / IGRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to determine the efficacy and safety of the implementation of a&#xD;
      program of &quot; image-guided focal Intensification dose to intraprostatic dominant lesion &quot; in&#xD;
      men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN)&#xD;
      eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital&#xD;
      Universitario de La Princesa), within the established dose escalation protocol with intensity&#xD;
      modulated image-guided radiotherapy (IMRT / IGRT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2025</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 Participants With Biochemical Failure at 5 Years</measure>
    <time_frame>5 years</time_frame>
    <description>Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Control</measure>
    <time_frame>6 and 9 months following radiotherapy</time_frame>
    <description>An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute and Late Rectal and Urinary Complications</measure>
    <time_frame>5 years</time_frame>
    <description>Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Free of Biochemical Progression</measure>
    <time_frame>5 years</time_frame>
    <description>Biochemical disease-free survival according to the Phoenix definition (PSA &gt;2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score</measure>
    <time_frame>5 years</time_frame>
    <description>Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival (DFS)</measure>
    <time_frame>5 years</time_frame>
    <description>Survival free of any event including biochemical failure, local failure, distant metastasis or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verification of Safety Margins</measure>
    <time_frame>5 years</time_frame>
    <description>Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>IGRT/VMAT focal therapy boost to DIL</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IGRT/VMAT focal therapy boost to DIL</intervention_name>
    <description>Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy</description>
    <arm_group_label>IGRT/VMAT focal therapy boost to DIL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male &gt; 18 years old with histologic diagnostic of prostate adenocarcinoma&#xD;
&#xD;
          -  Clinical stage cT2a-T3b N0-1 M0 (AJCC 7 th edition)&#xD;
&#xD;
          -  PSA (prostate-specific antigen) &lt; 100 ng/ml&#xD;
&#xD;
          -  Gleason score 6-10&#xD;
&#xD;
          -  Life expectancy &gt; 5 years&#xD;
&#xD;
          -  Patients who accept the radiotherapy treatment&#xD;
&#xD;
          -  Patients provided written informed consent before participating in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transurethral resection of the prostate or prior prostate surgery&#xD;
&#xD;
          -  Previous pelvic radiotherapy&#xD;
&#xD;
          -  Urethral stenosis with or without prior dilations&#xD;
&#xD;
          -  IPSS&gt;15&#xD;
&#xD;
          -  Rectal diverticuli or rectal vascular malformations&#xD;
&#xD;
          -  Metastatic disease&#xD;
&#xD;
          -  Severe psychiatric or medical conditions that could hamper both treatment and&#xD;
             follow-up&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario de la Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
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  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <results_first_submitted>August 4, 2021</results_first_submitted>
  <results_first_submitted_qc>August 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2023</results_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>VMAT</keyword>
  <keyword>Dominant Intraprostatic Lesion</keyword>
  <keyword>Intensity modulated radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03030625/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IGRT/VMAT Focal Therapy Boost to DIL</title>
          <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </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>IGRT/VMAT Focal Therapy Boost to DIL</title>
          <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.0" lower_limit="67.7" upper_limit="76.0"/>
                  </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="30"/>
                  </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="30"/>
                  </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>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical T stage</title>
          <description>Clinical stage assessed by TNM ajcc seventh edition considering T2 less invasive than T3</description>
          <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="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>T2: Tumor confinent whitin prostate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T3: Tumor extends through the prostate capsule</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gleason group (ISUP 2014/WHO 2016)</title>
          <description>Gleason group classification for prostate cancer were used considering Group 1 as less aggressive and Group 5 most aggressive</description>
          <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="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Group 1:</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Group 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Group 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Group 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Group 5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-treatment PSA (ng/ml)</title>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.5" lower_limit="5.5" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Biochemical Failure at 5 Years</title>
        <description>Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IGRT/VMAT Focal Therapy Boost to DIL</title>
            <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy: 35 daily fractions of 2.17 Gy with a concomitant focal boost to the intraprostatic nodule of 2.43 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Biochemical Failure at 5 Years</title>
          <description>Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Local Control</title>
        <description>An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.</description>
        <time_frame>6 and 9 months following radiotherapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IGRT/VMAT Focal Therapy Boost to DIL</title>
            <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Local Control</title>
          <description>An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acute and Late Rectal and Urinary Complications</title>
        <description>Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IGRT/VMAT Focal Therapy Boost to DIL</title>
            <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Acute and Late Rectal and Urinary Complications</title>
          <description>Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute rectal</title>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade &gt;2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute urinary</title>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade &gt;2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Late rectal</title>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade &gt;2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Late urinary</title>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade &gt;2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Free of Biochemical Progression</title>
        <description>Biochemical disease-free survival according to the Phoenix definition (PSA &gt;2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.</description>
        <time_frame>5 years</time_frame>
        <population>Localized prostate cancer (PCa) of intermediate and high risk</population>
        <group_list>
          <group group_id="O1">
            <title>IGRT/VMAT Focal Therapy Boost to DIL</title>
            <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy: 35 daily fractions of 2.17 Gy with a concomitant focal boost to the intraprostatic nodule of 2.43 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Free of Biochemical Progression</title>
          <description>Biochemical disease-free survival according to the Phoenix definition (PSA &gt;2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.</description>
          <population>Localized prostate cancer (PCa) of intermediate and high risk</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score</title>
        <description>Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains</description>
        <time_frame>5 years</time_frame>
        <population>No clinical data were collected for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>IGRT/VMAT Focal Therapy Boost to DIL</title>
            <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score</title>
          <description>Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains</description>
          <population>No clinical data were collected for this outcome.</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>Disease-free Survival (DFS)</title>
        <description>Survival free of any event including biochemical failure, local failure, distant metastasis or death</description>
        <time_frame>5 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Verification of Safety Margins</title>
        <description>Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula</description>
        <time_frame>5 years</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IGRT/VMAT Focal Therapy Boost to DIL</title>
          <description>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria&#xD;
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy</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="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>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="27" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute rectal toxicity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Late rectal toxicity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute urinary toxicity</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Late urinary toxicity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Almudena Zapatero Laborda</name_or_title>
      <organization>Hospital Universitario de La Princesa</organization>
      <phone>+34 915 20 22 00</phone>
      <email>almudena.zapatero@salud.madrid.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/NCT03030625
org study id: CaP-VMAT-DIL
nct id: NCT03030625
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to determine the efficacy and safety of the implementation of a
      program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in
      men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN)
      eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital
      Universitario de La Princesa), within the established dose escalation protocol with intensity
      modulated image-guided radiotherapy (IMRT / IGRT).
The aim of this study was to determine the efficacy and safety of the implementation of a
      program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in
      men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN)
      eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital
      Universitario de La Princesa), within the established dose escalation protocol with intensity
      modulated image-guided radiotherapy (IMRT / IGRT).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Biochemical Failure at 5 Years
time frame: 5 years
description: Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)
measure: Local Control
time frame: 6 and 9 months following radiotherapy
description: An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.
measure: Acute and Late Rectal and Urinary Complications
time frame: 5 years
description: Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).
measure: Number of Participants Free of Biochemical Progression
time frame: 5 years
description: Biochemical disease-free survival according to the Phoenix definition (PSA >2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.
measure: Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score
time frame: 5 years
description: Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains
measure: Disease-free Survival (DFS)
time frame: 5 years
description: Survival free of any event including biochemical failure, local failure, distant metastasis or death
measure: Verification of Safety Margins
time frame: 5 years
description: Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula
arm group label: IGRT/VMAT focal therapy boost to DIL
arm group type: Other
description: Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria
intervention type: Radiation
intervention name: IGRT/VMAT focal therapy boost to DIL
description: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy
arm group label: IGRT/VMAT focal therapy boost to DIL
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
citation: Arrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11.
PMID: 22331003
citation: Cellini N, Morganti AG, Mattiucci GC, Valentini V, Leone M, Luzi S, Manfredi R, Dinapoli N, Digesu' C, Smaniotto D. Analysis of intraprostatic failures in patients treated with hormonal therapy and radiotherapy: implications for conformal therapy planning. Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):595-9. doi: 10.1016/s0360-3016(02)02795-5.
PMID: 12062602
citation: Pucar D, Hricak H, Shukla-Dave A, Kuroiwa K, Drobnjak M, Eastham J, Scardino PT, Zelefsky MJ. Clinically significant prostate cancer local recurrence after radiation therapy occurs at the site of primary tumor: magnetic resonance imaging and step-section pathology evidence. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):62-9. doi: 10.1016/j.ijrobp.2007.03.065.
PMID: 17707266
citation: Mouraviev V, Villers A, Bostwick DG, Wheeler TM, Montironi R, Polascik TJ. Understanding the pathological features of focality, grade and tumour volume of early-stage prostate cancer as a foundation for parenchyma-sparing prostate cancer therapies: active surveillance and focal targeted therapy. BJU Int. 2011 Oct;108(7):1074-85. doi: 10.1111/j.1464-410X.2010.10039.x. Epub 2011 Apr 13.
PMID: 21489116
citation: Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.
PMID: 16648499
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responsible party type: Sponsor
mesh term: Prostatic Neoplasms
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