<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/NCT03228810</url>
  </required_header>
  <id_info>
    <org_study_id>16-007522</org_study_id>
    <nct_id>NCT03228810</nct_id>
  </id_info>
  <brief_title>Genetic Biomarker Discovery for Metastatic Prostate Cancer</brief_title>
  <official_title>ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients&#xD;
      with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from&#xD;
      metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be&#xD;
      collected before treatment. If patients receive androgen deprivation, then blood will be&#xD;
      collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or&#xD;
      surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment,&#xD;
      after which no further patient contact will occur.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">April 9, 2019</completion_date>
  <primary_completion_date type="Actual">April 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detect cell-free tumor DNA in patients with metastatic prostate cancer</measure>
    <time_frame>prior to treatment</time_frame>
    <description>tissue biopsy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Calculate cell-free tumor DNA in relation to metastasis-directed radiation and androgen deprivation therapy (ADT)</measure>
    <time_frame>before and immediately after ADT and at 3 months and 6 months after radiation</time_frame>
    <description>blood draw</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Men &gt;18 years old with metastatic prostate cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>(2) 10 mL tubes will be collected</description>
    <arm_group_label>Men &gt;18 years old with metastatic prostate cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tissue biopsy</intervention_name>
    <description>Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy</description>
    <arm_group_label>Men &gt;18 years old with metastatic prostate cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men with metastatic prostate cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men age 18 years old and older.&#xD;
&#xD;
          -  Histologically proven diagnosis of prostate cancer.&#xD;
&#xD;
          -  Radiographic evidence of non-regional lymph node involvement, pelvic lymph node&#xD;
             recurrence, and/or bone metastases.&#xD;
&#xD;
          -  Requiring a clinically directed biopsy or resection of tumor at Mayo Clinic Rochester.&#xD;
&#xD;
          -  Receiving local therapy for metastatic disease with radiation, ablative therapies,&#xD;
             and/or surgery at Mayo Clinic Rochester.&#xD;
&#xD;
          -  Willingness to provide blood sample prior to receipt of treatment, as well as after&#xD;
             neoadjuvant androgen deprivation therapy and at 3 months and 6 months after radiation,&#xD;
             ablation, or surgery.&#xD;
&#xD;
          -  Absence of a second active malignancy.&#xD;
&#xD;
          -  An understanding of the protocol and its requirements, risks, and discomforts.&#xD;
&#xD;
          -  The ability and willingness to sign an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability on the part of the patient to understand the informed consent or be&#xD;
             compliant with the protocol.&#xD;
&#xD;
          -  History of a serious or life-threatening allergic reaction to local anesthetics (i.e.,&#xD;
             lidocaine, xylocaine).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>John Cheville</investigator_full_name>
    <investigator_title>PI</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03228810
org study id: 16-007522
nct id: NCT03228810
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients
      with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from
      metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be
      collected before treatment. If patients receive androgen deprivation, then blood will be
      collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or
      surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment,
      after which no further patient contact will occur.
observational model: Case-Only
time perspective: Prospective
measure: Detect cell-free tumor DNA in patients with metastatic prostate cancer
time frame: prior to treatment
description: tissue biopsy
measure: Calculate cell-free tumor DNA in relation to metastasis-directed radiation and androgen deprivation therapy (ADT)
time frame: before and immediately after ADT and at 3 months and 6 months after radiation
description: blood draw
arm group label: Men >18 years old with metastatic prostate cancer
intervention type: Other
intervention name: Blood draw
description: (2) 10 mL tubes will be collected
arm group label: Men >18 years old with metastatic prostate cancer
intervention type: Procedure
intervention name: Tissue biopsy
description: Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy
arm group label: Men >18 years old with metastatic prostate cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: John Cheville
investigator title: PI
mesh term: Prostatic Neoplasms
sharing ipd: No