<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/NCT03263780</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2016-19-DASKIVICH-18F</org_study_id>
    <nct_id>NCT03263780</nct_id>
  </id_info>
  <brief_title>High Resolution PET-MRI Before Prostate Cancer HIFU</brief_title>
  <official_title>High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Timothy J. Daskivich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Earth Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective trial aims to determine if enhanced prostate imaging using two novel imaging&#xD;
      technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers&#xD;
      not seen on standard multiparametric prostate MRI in patients considered candidates for focal&#xD;
      HIFU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI&#xD;
      versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.&#xD;
&#xD;
      Participants with clinically localized, unilateral high grade prostate cancer (Gleason score&#xD;
      7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having&#xD;
      unrecognized high grade prostate cancer (overall Gleason score 6 with &gt; half of systematic&#xD;
      biopsy cores positive and &gt; 50% of core involvement in at least one core), interested in HIFU&#xD;
      would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.&#xD;
&#xD;
      Participants would then undergo a mapping biopsy using a standard sextant template plus&#xD;
      MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2017</start_date>
  <completion_date type="Actual">January 8, 2020</completion_date>
  <primary_completion_date type="Actual">January 8, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.</measure>
    <time_frame>At time of post-imaging biopsy</time_frame>
    <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.</measure>
    <time_frame>At time of post-imaging biopsy</time_frame>
    <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Negative Biopsy Rate (Number of Participants With Negative Biopsy)</measure>
    <time_frame>6 months following standard HIFU therapy</time_frame>
    <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of High Grade Cancer (Number of Patients With High Grade Cancer)</measure>
    <time_frame>6 months following standard HIFU therapy</time_frame>
    <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>18F-Fluciclovine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10mCi +/-20% 18F-fluciclovine injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-Fluciclovine</intervention_name>
    <description>Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)</description>
    <arm_group_label>18F-Fluciclovine</arm_group_label>
    <other_name>Axumin</other_name>
    <other_name>prostate-cancer-specific radiotracer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prostate biopsy consisting of ≥ 10 tissue cores sampled&#xD;
&#xD;
          -  PSA &lt;/=20 ng/mL&#xD;
&#xD;
          -  cT1-cT2c&#xD;
&#xD;
          -  Either overall gleason score &gt;/= 7 with Gleason grade 4 or 5 component localized to&#xD;
             one lobe (i.e. right or left) OR overall Gleason score 6 with &gt;/= half of systematic&#xD;
             biopsy cores positive and &gt;/= 50% of core involvement in at least one core&#xD;
&#xD;
          -  Patient considering focal HIFU therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous local therapy for prostate cancer&#xD;
&#xD;
          -  Inability to receive PET tracer&#xD;
&#xD;
          -  Inability to receive MRI&#xD;
&#xD;
          -  Suggestion of extracapsular extension or seminal vesicle invasion on imaging&#xD;
&#xD;
          -  Estimated creatinine clearance &lt;45 mL/min (Cockcroft-Gault equation)&#xD;
&#xD;
          -  Any other condition which, in the investigator's option, may make the patient a poor&#xD;
             candidate for participation in a clinical trial.&#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>Timothy Daskivich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>December 17, 2020</results_first_submitted>
  <results_first_submitted_qc>February 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Timothy J. Daskivich</investigator_full_name>
    <investigator_title>Staff Physician I, Division of Urology; Urologic Oncologist; Director, Health Services Research, Department of Surgery Cedars Sinai Medical Center</investigator_title>
  </responsible_party>
  <keyword>Diagnostic imaging</keyword>
  <keyword>High-Intensity Focused Ultrasound</keyword>
  <keyword>HIFU</keyword>
  <keyword>18F-Fluciclovine</keyword>
  <keyword>high resolution diffusion-weighted imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <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>June 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03263780/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Opened to accrual on 12/07/2017 with first subject enrolled on study 12/18/2017. A total of 21 patients consented, one withdrew consent prior to intervention and was replaced, 13 were evaluable for primary outcome measure, however 11 subjects of the total target accrual of 20 subjects completed study with the last subject off treatment/off study as of 1/8/2020.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>18F-Fluciclovine</title>
          <description>10mCi +/-20% 18F-fluciclovine injection&#xD;
18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)&#xD;
Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11">13 evaluable for primary outcome, but 11 total completed study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ineligible (incomplete post-HIFU)</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>18F-Fluciclovine</title>
          <description>10mCi +/-20% 18F-fluciclovine injection&#xD;
18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="51" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.8" spread="7.54"/>
                  </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="13"/>
                  </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="13"/>
                  </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>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="1"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.</title>
        <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</description>
        <time_frame>At time of post-imaging biopsy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-Fluciclovine</title>
            <description>10mCi +/-20% 18F-fluciclovine injection&#xD;
18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)&#xD;
Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.</title>
          <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</description>
          <units>Total biopsy-proven cancers (Gleason 6+)</units>
          <param>Number</param>
          <units_analyzed>Total biopsy-proven cancers (Gleason 6+)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Total biopsy-proven cancers (Gleason 6+)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET &amp; hrMRI (PIRADS 3-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET &amp; hrMRI (PIRADS 4-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.056</p_value>
            <p_value_desc>mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.19</ci_lower_limit>
            <ci_upper_limit>0.46</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.56</p_value>
            <p_value_desc>mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.060</p_value>
            <p_value_desc>mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.17</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.083</p_value>
            <p_value_desc>mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.39</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.</title>
        <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</description>
        <time_frame>At time of post-imaging biopsy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-Fluciclovine</title>
            <description>10mCi +/-20% 18F-fluciclovine injection&#xD;
18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)&#xD;
Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.</title>
          <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 6+)&#xD;
mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 6+)</description>
          <units>Total biopsy-proven cancers (Gleason 7+)</units>
          <param>Number</param>
          <units_analyzed>Total biopsy-proven cancers (Gleason 7+)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Total biopsy-proven cancers (Gleason 7+)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET &amp; hrMRI (PIRADS 3-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET &amp; hrMRI (PIRADS 4-5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.096</p_value>
            <p_value_desc>mpMRI vs hrMRI and PET (PIRADS 3-5 &amp; Gleason 7+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.317</p_value>
            <p_value_desc>mpMRI vs hrMRI or PET (PIRADS 3-5 &amp; Gleason 7+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.063</p_value>
            <p_value_desc>mpMRI vs hrMRI and PET (PIRADS 4-5 &amp; Gleason 7+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.317</p_value>
            <p_value_desc>mpMRI vs hrMRI or PET (PIRADS 4-5 &amp; Gleason 7+)</p_value_desc>
            <method>Durkalski's Chi-square test</method>
            <param_type>Sensitivity</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
            <estimate_desc>We did not present standard deviation as the variability is already incorporated in the provided confidence interval.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Biopsy Rate (Number of Participants With Negative Biopsy)</title>
        <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.</description>
        <time_frame>6 months following standard HIFU therapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-Fluciclovine</title>
            <description>10mCi +/-20% 18F-fluciclovine injection&#xD;
18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)&#xD;
Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Biopsy Rate (Number of Participants With Negative Biopsy)</title>
          <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of High Grade Cancer (Number of Patients With High Grade Cancer)</title>
        <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.</description>
        <time_frame>6 months following standard HIFU therapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-Fluciclovine</title>
            <description>10mCi +/-20% 18F-fluciclovine injection&#xD;
18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)&#xD;
Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of High Grade Cancer (Number of Patients With High Grade Cancer)</title>
          <description>A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.</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="11"/>
              </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_list>

    <reported_events>
      <time_frame>Up to 6 months following standard HIFU therapy.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>18F-Fluciclovine</title>
          <description>10mCi +/-20% 18F-fluciclovine injection&#xD;
18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)&#xD;
Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>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="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="13"/>
              </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>Timothy Daskivich, M.D.</name_or_title>
      <organization>Cedars-Sinai Medical Center</organization>
      <phone>310-423-4700</phone>
      <email>timothy.daskivich@cshs.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/NCT03263780
org study id: IIT2016-19-DASKIVICH-18F
nct id: NCT03263780
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging
      technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers
      not seen on standard multiparametric prostate MRI in patients considered candidates for focal
      HIFU.
This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI
      versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

      Participants with clinically localized, unilateral high grade prostate cancer (Gleason score
      7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having
      unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic
      biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU
      would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.

      Participants would then undergo a mapping biopsy using a standard sextant template plus
      MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
time frame: At time of post-imaging biopsy
description: A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:
mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+)
mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+)
measure: Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
time frame: At time of post-imaging biopsy
description: A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:
mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+)
mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+)
measure: Negative Biopsy Rate (Number of Participants With Negative Biopsy)
time frame: 6 months following standard HIFU therapy
description: A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.
measure: Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
time frame: 6 months following standard HIFU therapy
description: A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.
arm group label: 18F-Fluciclovine
arm group type: Experimental
description: 10mCi +/-20% 18F-fluciclovine injection
intervention type: Drug
intervention name: 18F-Fluciclovine
description: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
arm group label: 18F-Fluciclovine
other name: Axumin
other name: prostate-cancer-specific radiotracer
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy Daskivich, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Timothy J. Daskivich
investigator title: Staff Physician I, Division of Urology; Urologic Oncologist; Director, Health Services Research, Department of Surgery Cedars Sinai Medical Center
mesh term: Prostatic Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 