<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/NCT01724619</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00015971</org_study_id>
    <secondary_id>CCCWFU 85111</secondary_id>
    <nct_id>NCT01724619</nct_id>
  </id_info>
  <brief_title>Update and Biodistribution of [F-18]FMDHT pET/CT in Normal Healthy Volunteers and Patients With Metastatic Prostate Cancer - A First in Human Subject Study With [F-18] FMDHT</brief_title>
  <official_title>Update and Biodistribution of [F-18]FMDHT pET/CT in Normal Healthy Volunteers and Patients With Metastatic Prostate Cancer - A First in Human Subject Study With [F-18] FMDHT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</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>
      Prostate cancer represents a significant health problem in the United States. This year&#xD;
      179,000 men in the United States will be diagnosed with prostate carcinoma and approximately&#xD;
      25% of them will die of the disease. In addition, the incidence and mortality of prostate&#xD;
      carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA)&#xD;
      levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless,&#xD;
      there is a significant false negative and false positive diagnosis since PSA levels elevate&#xD;
      in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications&#xD;
      and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels&#xD;
      within the normal range, thus confounding the diagnosis based on the PSA screening test.&#xD;
      Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided&#xD;
      prostate biopsy are logistically difficult and insensitive. These are further complicated by&#xD;
      equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or&#xD;
      normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer&#xD;
      related structures at a cellular level would enhance our understanding of the pathophysiology&#xD;
      of prostate cancer and would contribute to the detection, localization and quantification of&#xD;
      the disease and its metastases. This information will be invaluable in selecting the&#xD;
      appropriate treatment regimen.&#xD;
&#xD;
      This study will test the utility of [F-18]FMDHT to image prostate cancer and will evaluate if&#xD;
      this radiotracer can differentiate primary prostate cancer in the prostate gland from normal&#xD;
      prostate gland itself. More specifically, we will study the distribution kinetics of&#xD;
      [F-18]FMDHT in normal healthy humans and in patients with prostate cancer.&#xD;
&#xD;
      As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an&#xD;
      outside laboratory (ILS, Inc.) and the results of that study are attached as Appendix A.&#xD;
&#xD;
      Based on our and others data, we hypothesize that:&#xD;
&#xD;
        1. [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood&#xD;
           flow pattern and will clear rapidly from tissues with no AR.&#xD;
&#xD;
        2. [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR.&#xD;
&#xD;
        3. [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions&#xD;
           compared to surrounding normal prostate.&#xD;
&#xD;
      In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human'&#xD;
      biodistribution study in subjects with and without prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study tracer can no longer be obtained at our institution&#xD;
  </why_stopped>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To map diffusion and clearance rates of this marker in normal and cancerous tissue.</measure>
    <time_frame>Day 1</time_frame>
    <description>To obtain first-in-man biodistribution data for [F-18]FMDHT with PET/CT imaging in subjects with and without prostate cancer. The results of these tests will be in the form of scans. Distinguishing characteristics will be how quickly the marker clears from the tissues in the scans.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine if [F-18]FMDHT PET/CT uptake in the primary prostate tumor can be differentiated from normal surrounding prostate that will be confirmed with pathologic staining of biopsy or surgical specimens.</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>F-18] fluorinated dihydrotestosterone (FDHT) PET/CT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostate Cancer Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>F-18] fluorinated dihydrotestosterone (FDHT) PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[F-18] fluorinated dihydrotestosterone (FDHT)</intervention_name>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Prostate Cancer Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Normal Healthy Volunteers&#xD;
&#xD;
          -  Males age 30 years or older.&#xD;
&#xD;
          -  No prior history of cancer.&#xD;
&#xD;
          -  Willing to get a PSA evaluated. Normal subjects will be eligible if their PSA is in&#xD;
             the normal range for the particular lab where it is drawn. PSA drawn within 6 months&#xD;
             (before) of the FMDHT PET scan will be accepted.&#xD;
&#xD;
          -  Ability to tolerate PET imaging.&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
        Prostate Cancer Patients:&#xD;
&#xD;
          -  Patients with histologically confirmed adenocarcinoma of the prostate.&#xD;
&#xD;
          -  Patients with a clinical staging CT at the time of the first [F-18]FMDHT scan.&#xD;
&#xD;
          -  Patients with at least one single focus of metastatic disease (bone/lymph node or soft&#xD;
             tissue) confirmed on other clinical studies, preferably biopsy.&#xD;
&#xD;
          -  Patients with prior transurethral resection of the prostate are eligible.&#xD;
&#xD;
          -  Ability to tolerate PET imaging.&#xD;
&#xD;
          -  Males age 30 years or older.&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Willing to get a PSA evaluated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Normal Health Volunteers&#xD;
&#xD;
          -  Prior diagnosis of any cancer (except non-melanoma skin cancer).&#xD;
&#xD;
        Prostate Cancer Patients&#xD;
&#xD;
          -  Prior diagnosis of cancer except non-melanoma skin cancer.&#xD;
&#xD;
          -  Prior treatment (other than biopsy) for prostate cancer.&#xD;
&#xD;
          -  Received radiation therapy, hormonal therapy, surgery or cryotherapy for prostate&#xD;
             disease.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pradeep Garg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>July 2, 2018</last_update_submitted>
  <last_update_submitted_qc>July 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dihydrotestosterone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01724619
org study id: IRB00015971
secondary id: CCCWFU 85111
nct id: NCT01724619
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Prostate cancer represents a significant health problem in the United States. This year
      179,000 men in the United States will be diagnosed with prostate carcinoma and approximately
      25% of them will die of the disease. In addition, the incidence and mortality of prostate
      carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA)
      levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless,
      there is a significant false negative and false positive diagnosis since PSA levels elevate
      in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications
      and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels
      within the normal range, thus confounding the diagnosis based on the PSA screening test.
      Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided
      prostate biopsy are logistically difficult and insensitive. These are further complicated by
      equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or
      normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer
      related structures at a cellular level would enhance our understanding of the pathophysiology
      of prostate cancer and would contribute to the detection, localization and quantification of
      the disease and its metastases. This information will be invaluable in selecting the
      appropriate treatment regimen.

      This study will test the utility of [F-18]FMDHT to image prostate cancer and will evaluate if
      this radiotracer can differentiate primary prostate cancer in the prostate gland from normal
      prostate gland itself. More specifically, we will study the distribution kinetics of
      [F-18]FMDHT in normal healthy humans and in patients with prostate cancer.

      As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an
      outside laboratory (ILS, Inc.) and the results of that study are attached as Appendix A.

      Based on our and others data, we hypothesize that:

        1. [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood
           flow pattern and will clear rapidly from tissues with no AR.

        2. [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR.

        3. [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions
           compared to surrounding normal prostate.

      In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human'
      biodistribution study in subjects with and without prostate cancer.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: To map diffusion and clearance rates of this marker in normal and cancerous tissue.
time frame: Day 1
description: To obtain first-in-man biodistribution data for [F-18]FMDHT with PET/CT imaging in subjects with and without prostate cancer. The results of these tests will be in the form of scans. Distinguishing characteristics will be how quickly the marker clears from the tissues in the scans.
measure: To determine if [F-18]FMDHT PET/CT uptake in the primary prostate tumor can be differentiated from normal surrounding prostate that will be confirmed with pathologic staining of biopsy or surgical specimens.
time frame: Day 1
arm group label: Healthy Volunteers
arm group type: Experimental
description: F-18] fluorinated dihydrotestosterone (FDHT) PET/CT
arm group label: Prostate Cancer Patients
arm group type: Experimental
description: F-18] fluorinated dihydrotestosterone (FDHT) PET/CT
intervention type: Drug
intervention name: [F-18] fluorinated dihydrotestosterone (FDHT)
arm group label: Healthy Volunteers
arm group label: Prostate Cancer Patients
criteria: 
gender: Male
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pradeep Garg, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Dihydrotestosterone