<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/NCT01727284</url>
  </required_header>
  <id_info>
    <org_study_id>12-002245</org_study_id>
    <nct_id>NCT01727284</nct_id>
  </id_info>
  <brief_title>MR-Guided Cryoablation of Prostate Bed Recurrences</brief_title>
  <official_title>Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to see if MR-guided cryoablation can effectively treat&#xD;
      prostate tumor recurrences.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 12, 2012</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Prostate Tumors</condition>
  <arm_group>
    <arm_group_label>MR-guided cryoablation (freezing of tissue and/or tumors)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MR-guided cryoablation</intervention_name>
    <arm_group_label>MR-guided cryoablation (freezing of tissue and/or tumors)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with &quot;biopsy proven&quot; soft tissue tumor recurrences of prostate fossa&#xD;
&#xD;
          -  Surgery is not a desirable alternative therapy at the time of enrollment&#xD;
&#xD;
          -  Radiation therapy has failed or not indicated or can be safely postponed&#xD;
&#xD;
          -  Tumor size is &lt; 5 cm at its largest diameter&#xD;
&#xD;
          -  Tumor does not encompass the rectal wall or external urethral sphincter&#xD;
&#xD;
          -  Patient is able to undergo MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Woodrum, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer Murphy</last_name>
    <phone>507-538-0540</phone>
    <email>Murphy.Jennifer@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Desirae Howe-Clayton</last_name>
    <phone>507-255-0111</phone>
    <email>Howe.Desirae@mayo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Murphy</last_name>
      <phone>507-538-0540</phone>
      <email>Murphy.Jennifer@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>David A Woodrum, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>September 2023</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>David A. Woodrum</investigator_full_name>
    <investigator_title>Assistant Professor of Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</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/NCT01727284
org study id: 12-002245
nct id: NCT01727284
lead sponsor: 
has dmc: No
The purpose of this research is to see if MR-guided cryoablation can effectively treat
      prostate tumor recurrences.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up
time frame: 3 years
arm group label: MR-guided cryoablation (freezing of tissue and/or tumors)
arm group type: Other
intervention type: Procedure
intervention name: MR-guided cryoablation
arm group label: MR-guided cryoablation (freezing of tissue and/or tumors)
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 100 Years
healthy volunteers: No
last name: David Woodrum, MD, PhD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Jennifer Murphy
phone: 507-538-0540
email: Murphy.Jennifer@mayo.edu
last name: Desirae Howe-Clayton
phone: 507-255-0111
email: Howe.Desirae@mayo.edu
facility: 
status: Recruiting
contact: 
investigator: 
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: David A. Woodrum
investigator title: Assistant Professor of Radiology
mesh term: Recurrence
sharing ipd: No