<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/NCT02971358</url>
  </required_header>
  <id_info>
    <org_study_id>1461/2016</org_study_id>
    <nct_id>NCT02971358</nct_id>
  </id_info>
  <brief_title>Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer</brief_title>
  <official_title>Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer - 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>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading&#xD;
      cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men&#xD;
      have died from prostate cancer. Although radiation and surgery are quite effective for&#xD;
      localized disease, there is no effective cure for men who present with metastatic prostate&#xD;
      cancer as the 5-year relative survival rate is only 28%.&#xD;
&#xD;
      Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the&#xD;
      standard first-line therapy in men with metastatic disease but castration-recurrent prostate&#xD;
      cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops,&#xD;
      secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.&#xD;
&#xD;
      Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must&#xD;
      be explored to improve the clinical outcome. In this regard, recently emerging data suggest&#xD;
      that local tumor control may enhance the effectiveness of subsequent systemic therapies.&#xD;
      Therefore, in this proposal, the investigators have designed a Phase I/II study in which they&#xD;
      will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men&#xD;
      with newly diagnosed mPCa.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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 perioperative complications within 90 days after surgery (Clavien-Dindo-classification)</measure>
    <time_frame>90</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to start androgen deprivation therapy</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Locally Advanced and Metastatic Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Radical prostatectomy arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm the investigators will include patients with locally advanced or metastatic prostate cancer, who will undergo cytoreductive radical prostatectomy with extended lymph node dissection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical prostatectomy</intervention_name>
    <description>Standard radical prostatectomy with extended lymph node dissection is performed.</description>
    <arm_group_label>Radical prostatectomy arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adenocarcinoma of the prostate&#xD;
&#xD;
          -  Very high risk PCA (PSA ≥ 20 oder Gleason Score ≥ 8 oder ≥ cT3) and/or&#xD;
             oligometastasierte PCA (T any N positive M any, oder T any N any M positive)&#xD;
&#xD;
          -  ≤5 bone metastasis&#xD;
&#xD;
          -  ≤75 years&#xD;
&#xD;
          -  Ability for informed consent&#xD;
&#xD;
          -  Clinically no infiltration into the rectum or pelvic wall&#xD;
&#xD;
          -  Clinically no visceral metastasis&#xD;
&#xD;
          -  Male, &gt;18 Jahre&#xD;
&#xD;
          -  Fit for surgery&#xD;
&#xD;
          -  ECOG Performance Status 0 oder 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male, &lt; 18 Jahre&#xD;
&#xD;
          -  &gt; 5 bone metastasis&#xD;
&#xD;
          -  &gt; 75 years&#xD;
&#xD;
          -  No ability for informed consent&#xD;
&#xD;
          -  Clinically infiltration into the rectum or pelvic wall&#xD;
&#xD;
          -  Not fit for surgery&#xD;
&#xD;
          -  Clinically visceral metastasis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernhard Grubmüller, MD</last_name>
      <phone>004314040026150</phone>
      <email>bernhard.grubmueller@meduniwien.ac.at</email>
    </contact>
  </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 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02971358
org study id: 1461/2016
nct id: NCT02971358
lead sponsor: 
has dmc: No
Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading
      cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men
      have died from prostate cancer. Although radiation and surgery are quite effective for
      localized disease, there is no effective cure for men who present with metastatic prostate
      cancer as the 5-year relative survival rate is only 28%.

      Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the
      standard first-line therapy in men with metastatic disease but castration-recurrent prostate
      cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops,
      secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.

      Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must
      be explored to improve the clinical outcome. In this regard, recently emerging data suggest
      that local tumor control may enhance the effectiveness of subsequent systemic therapies.
      Therefore, in this proposal, the investigators have designed a Phase I/II study in which they
      will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men
      with newly diagnosed mPCa.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
time frame: 90
measure: Time to start androgen deprivation therapy
time frame: 2 years
arm group label: Radical prostatectomy arm
arm group type: Experimental
description: In this arm the investigators will include patients with locally advanced or metastatic prostate cancer, who will undergo cytoreductive radical prostatectomy with extended lymph node dissection.
intervention type: Procedure
intervention name: Radical prostatectomy
description: Standard radical prostatectomy with extended lymph node dissection is performed.
arm group label: Radical prostatectomy arm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
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
sharing ipd: Undecided