<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/NCT03264456</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300000291</org_study_id>
    <nct_id>NCT03264456</nct_id>
  </id_info>
  <brief_title>Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI</brief_title>
  <official_title>Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is great need for improved preoperative imaging in men with high-risk prostate cancer.&#xD;
      Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for&#xD;
      local, regional and whole body preoperative staging in a single imaging session using the&#xD;
      amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of&#xD;
      prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently&#xD;
      problematic. Conventional imaging is falsely negative for regional lymph node metastases in a&#xD;
      substantial fraction of men. In particular, approximately 35% of men with high-risk prostate&#xD;
      cancer will have biochemical recurrence even after optimal surgical resection. A major&#xD;
      benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18&#xD;
      fluciclovine PET includes having the patient undergo a single imaging study which provides&#xD;
      both anatomic and molecular characterization of the tumor, including metastases which would&#xD;
      potentially be missed by conventional anatomic imaging and size criteria. Additionally,&#xD;
      simultaneous acquisition will improve co-registration of the PET and MR data which is&#xD;
      valuable for small lesions and in anatomically complex regions. Although the use of&#xD;
      fluciclovine in the characterization of the primary PCa remains to be established, the&#xD;
      anatomic detail provided by conventional mpMRI will complement the detection of small volume&#xD;
      metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology&#xD;
      allows for the assessment of dynamic tracer uptake and washout during the whole body and&#xD;
      regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary&#xD;
      PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect&#xD;
      nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology&#xD;
      to develop new treatment algorithms for the optimal management of these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Actual">February 13, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</primary_completion_date>
  <phase>Phase 1/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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Primary Lesions Detected</measure>
    <time_frame>Baseline through 24 hr</time_frame>
    <description>Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI</measure>
    <time_frame>Baseline through 24 hours</time_frame>
    <description>Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI</measure>
    <time_frame>Baseline through 24 hours</time_frame>
    <description>Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up</measure>
    <time_frame>Baseline through 8 weeks</time_frame>
    <description>Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>[18F] Fluciclovine PET/MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>[18F] Fluciclovine PET/MRI</intervention_name>
    <description>[18F] fluciclovine PET/MRI</description>
    <arm_group_label>[18F] Fluciclovine PET/MRI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F] fluciclovine</intervention_name>
    <description>[18F] fluciclovine</description>
    <arm_group_label>[18F] Fluciclovine PET/MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or&#xD;
        serum PSA &gt; 20)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to tolerate or undergo PET/MRI&#xD;
&#xD;
          -  Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma,&#xD;
             Castleman's disease, etc.)&#xD;
&#xD;
          -  Recurrent prostate adenocarcinoma&#xD;
&#xD;
          -  Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI&#xD;
&#xD;
          -  Known allergy to glucagon or gadolinium-based contrast&#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>Samuel Galgano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>December 12, 2019</results_first_submitted>
  <results_first_submitted_qc>January 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2020</results_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Samuel Joseph Galgano</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>September 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03264456/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Three consented patients chose not to undergo the initial PET/MRI scan prior to the scan being performed. Additionally, one patient's images were lost to data corruption and the patient was not included in the final analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>[18F] Fluciclovine PET/MRI</title>
          <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer&#xD;
[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI&#xD;
[18F] fluciclovine: [18F] fluciclovine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </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>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>[18F] Fluciclovine PET/MRI</title>
          <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer&#xD;
[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI&#xD;
[18F] fluciclovine: [18F] fluciclovine</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.6" lower_limit="50" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Primary Lesions Detected</title>
        <description>Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI</description>
        <time_frame>Baseline through 24 hr</time_frame>
        <group_list>
          <group group_id="O1">
            <title>[18F] Fluciclovine PET/MRI</title>
            <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer&#xD;
[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI&#xD;
[18F] fluciclovine: [18F] fluciclovine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Primary Lesions Detected</title>
          <description>Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI</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="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI</title>
        <description>Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI</description>
        <time_frame>Baseline through 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>[18F] Fluciclovine PET/MRI</title>
            <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer&#xD;
[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI&#xD;
[18F] fluciclovine: [18F] fluciclovine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI</title>
          <description>Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI</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="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI</title>
        <description>Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.</description>
        <time_frame>Baseline through 24 hours</time_frame>
        <population>Total number of patients who demonstrated nodal metastatic disease on fluciclovine-PET/MRI</population>
        <group_list>
          <group group_id="O1">
            <title>[18F] Fluciclovine PET/MRI</title>
            <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer&#xD;
[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI&#xD;
[18F] fluciclovine: [18F] fluciclovine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI</title>
          <description>Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.</description>
          <population>Total number of patients who demonstrated nodal metastatic disease on fluciclovine-PET/MRI</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MR alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PET/MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Follow-up</title>
        <description>Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)</description>
        <time_frame>Baseline through 8 weeks</time_frame>
        <population>Number of patients in total cohort who underwent ADT</population>
        <group_list>
          <group group_id="O1">
            <title>[18F] Fluciclovine PET/MRI</title>
            <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer&#xD;
[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI&#xD;
[18F] fluciclovine: [18F] fluciclovine</description>
          </group>
        </group_list>
        <measure>
          <title>Follow-up</title>
          <description>Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)</description>
          <population>Number of patients in total cohort who underwent ADT</population>
          <units>standardized uptake values</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment maximum SUV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum SUV after 8 weeks of ADT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through 8 week follow-up scan</time_frame>
      <desc>Given that fluciclovine is a FDA clinically approved radiotracer with almost no risk of serious adverse events and all cause mortality, the expected risk of these in this study is effectively 0.</desc>
      <group_list>
        <group group_id="E1">
          <title>[18F] Fluciclovine PET/MRI</title>
          <description>[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer&#xD;
[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI&#xD;
[18F] fluciclovine: [18F] fluciclovine</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="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </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="14"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Samuel Galgano</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>2059341388</phone>
      <email>samuelgalgano@uabmc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264456
org study id: IRB-300000291
nct id: NCT03264456
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
There is great need for improved preoperative imaging in men with high-risk prostate cancer.
      Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for
      local, regional and whole body preoperative staging in a single imaging session using the
      amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of
      prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently
      problematic. Conventional imaging is falsely negative for regional lymph node metastases in a
      substantial fraction of men. In particular, approximately 35% of men with high-risk prostate
      cancer will have biochemical recurrence even after optimal surgical resection. A major
      benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18
      fluciclovine PET includes having the patient undergo a single imaging study which provides
      both anatomic and molecular characterization of the tumor, including metastases which would
      potentially be missed by conventional anatomic imaging and size criteria. Additionally,
      simultaneous acquisition will improve co-registration of the PET and MR data which is
      valuable for small lesions and in anatomically complex regions. Although the use of
      fluciclovine in the characterization of the primary PCa remains to be established, the
      anatomic detail provided by conventional mpMRI will complement the detection of small volume
      metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology
      allows for the assessment of dynamic tracer uptake and washout during the whole body and
      regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary
      PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect
      nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology
      to develop new treatment algorithms for the optimal management of these patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Patients With Primary Lesions Detected
time frame: Baseline through 24 hr
description: Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI
measure: Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI
time frame: Baseline through 24 hours
description: Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI
measure: Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI
time frame: Baseline through 24 hours
description: Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.
measure: Follow-up
time frame: Baseline through 8 weeks
description: Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)
arm group label: [18F] Fluciclovine PET/MRI
arm group type: Experimental
description: [18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
intervention type: Diagnostic Test
intervention name: [18F] Fluciclovine PET/MRI
description: [18F] fluciclovine PET/MRI
arm group label: [18F] Fluciclovine PET/MRI
intervention type: Drug
intervention name: [18F] fluciclovine
description: [18F] fluciclovine
arm group label: [18F] Fluciclovine PET/MRI
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel Galgano, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Samuel Joseph Galgano
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 