<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/NCT02974075</url>
  </required_header>
  <id_info>
    <org_study_id>1460/2016</org_study_id>
    <nct_id>NCT02974075</nct_id>
  </id_info>
  <brief_title>Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy</brief_title>
  <official_title>Safety and Efficacy of Salvage Lymph Node Dissection in Prostate Cancer Patients With Nodal Recurrence After Radical Prostatectomy With Curative Intent - a Prospective Single Center Phase I/II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <brief_summary>
    <textblock>
      Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer&#xD;
      patients will develop biochemical recurrence after radical prostatectomy (RP), potentially&#xD;
      because of micro metastasis at the time of the primary surgery.&#xD;
&#xD;
      With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT,&#xD;
      which allow the localization of the site of recurrence, there is increasing interest in&#xD;
      metastasis directed therapies, such as salvage lymph node dissection.&#xD;
&#xD;
      The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating&#xD;
      prostate cancer patients with local recurrence after radical prostatectomy with curative&#xD;
      intent. Several retrospective series has been published to determine the local value of sLND.&#xD;
      Despite the first data seem to be feasible and promising, to date no prospective evaluation&#xD;
      has been made. Thus sLND is still experimental according to the guidelines and is considered&#xD;
      as an off label therapy.&#xD;
&#xD;
      This prospective single center phase I/II study was conducted to investigate the safety and&#xD;
      early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic&#xD;
      recurrence after radical prostatectomy (RP) with curative intention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Actual">November 2022</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>The rate of periperative complications within 90 days after surgery</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The Prostate specific antigen value after 6 weeks.</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Prostate Specific Antigen doubling time</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time until development of castration resistance</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time until development of distant metastasis</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Prostate Cancer Recurrent</condition>
  <arm_group>
    <arm_group_label>Salvage lymph node dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo extended pelvic salvage lymph node dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Salvage lymph node dissection</intervention_name>
    <description>Open pelvic surgery to dissect pelvic lymph nodes. The landmarks for dissection are: 1. Inferior mesenteric artery 2. Ilioinguinal nerve 3. Inguinal ligament 4. Dorsal pelvic floor 5. Urinary bladder</description>
    <arm_group_label>Salvage lymph node dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prostate cancer patients with lymph node metastasis in pelvic imaging&#xD;
&#xD;
          -  Status post radical prostatectomy with curative intent&#xD;
&#xD;
          -  Ability for informed consent&#xD;
&#xD;
          -  No sign for bone or visceral metastasis&#xD;
&#xD;
          -  Male &gt; 18 years&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male &lt; 18 years&#xD;
&#xD;
          -  No ability for informed consent&#xD;
&#xD;
          -  Sign for bone or visceral metastasis&#xD;
&#xD;
          -  Deep venous thrombosis or pulmonary embolism within the last 6 months before study&#xD;
             screening&#xD;
&#xD;
          -  ECOG performance status 2 or more&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shahrokh Francois Shariat, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dr. Bernhard Grubmüller</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_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/NCT02974075
org study id: 1460/2016
nct id: NCT02974075
lead sponsor: 
Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer
      patients will develop biochemical recurrence after radical prostatectomy (RP), potentially
      because of micro metastasis at the time of the primary surgery.

      With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT,
      which allow the localization of the site of recurrence, there is increasing interest in
      metastasis directed therapies, such as salvage lymph node dissection.

      The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating
      prostate cancer patients with local recurrence after radical prostatectomy with curative
      intent. Several retrospective series has been published to determine the local value of sLND.
      Despite the first data seem to be feasible and promising, to date no prospective evaluation
      has been made. Thus sLND is still experimental according to the guidelines and is considered
      as an off label therapy.

      This prospective single center phase I/II study was conducted to investigate the safety and
      early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic
      recurrence after radical prostatectomy (RP) with curative intention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of periperative complications within 90 days after surgery
time frame: 90 days
measure: The Prostate specific antigen value after 6 weeks.
time frame: 6 weeks
measure: Change in Prostate Specific Antigen doubling time
time frame: 2 years
measure: Time until development of castration resistance
time frame: 2 years
measure: Time until development of distant metastasis
time frame: 2 years
arm group label: Salvage lymph node dissection
arm group type: Experimental
description: Patients will undergo extended pelvic salvage lymph node dissection
intervention type: Procedure
intervention name: Salvage lymph node dissection
description: Open pelvic surgery to dissect pelvic lymph nodes. The landmarks for dissection are: 1. Inferior mesenteric artery 2. Ilioinguinal nerve 3. Inguinal ligament 4. Dorsal pelvic floor 5. Urinary bladder
arm group label: Salvage lymph node dissection
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shahrokh Francois Shariat, MD
role: Study Chair
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dr. Bernhard Grubmüller
investigator title: MD
mesh term: Prostatic Neoplasms
mesh term: Recurrence