<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/NCT03795337</url>
  </required_header>
  <id_info>
    <org_study_id>ZKS-121-08</org_study_id>
    <secondary_id>ARO-2018-4</secondary_id>
    <nct_id>NCT03795337</nct_id>
  </id_info>
  <brief_title>Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)</brief_title>
  <acronym>HYPOSTAT-II</acronym>
  <official_title>Hypofractionated Radiosurgery for Localised Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Schleswig-Holstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Luebeck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saphir Radiosurgery Center Northern Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Schleswig-Holstein</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe&#xD;
      and feasible.&#xD;
&#xD;
      Investigators initiated this multicenter phase II prospective trial to analyse feasibility&#xD;
      (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised&#xD;
      prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2&#xD;
      after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application&#xD;
      rate of 35,00 Gy).&#xD;
&#xD;
      Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks,&#xD;
      3 months, 6 months, 1 year and every year thereafter after last day of radiation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">June 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>Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score</measure>
    <time_frame>3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.</measure>
    <time_frame>4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Specific Antigen (PSA)</measure>
    <time_frame>At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Prostate Symptom Score (IPSS)</measure>
    <time_frame>At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC Quality of Life Questionnaire (QLQ) C30</measure>
    <time_frame>At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Hypofractionated Radiosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 fractions with 7 Gy, total dose 35 Gy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypofractionated Radiosurgery</intervention_name>
    <description>Image-guided stereotactic Linac based RT preferable with &quot;dedicated radiosurgery system&quot; such as CyberKnife</description>
    <arm_group_label>Hypofractionated Radiosurgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0&#xD;
&#xD;
          -  Gleason-grade ≤7&#xD;
&#xD;
          -  Guideline-based staging&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  PSA &lt; 15 ng / ml&#xD;
&#xD;
          -  Volume of the prostate &lt; 80 cm³&#xD;
&#xD;
          -  IPSS-Score ≤ 12&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age ≤ 60 years&#xD;
&#xD;
          -  History of prior pelvic radiotherapy&#xD;
&#xD;
          -  Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),&#xD;
&#xD;
          -  Immunosuppressive therapy&#xD;
&#xD;
          -  Relevant comorbidity thought to adversely affect treatment compliance,&#xD;
&#xD;
          -  Legal incapacity or lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juergen Dunst, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Schleswig-Holstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexander Muacevic, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>European CyberKnife Center Munich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juergen Dunst, Prof.</last_name>
    <phone>+494315973011</phone>
    <phone_ext>3011</phone_ext>
    <email>Juergen.Dunst@uksh.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Oliver Blanck, Dr.</last_name>
    <phone>+4943123989970</phone>
    <phone_ext>0</phone_ext>
    <email>blanck@saphir-rc.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Arne Grün, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Kaul, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christian Baues, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karolina Jablonska, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saphir Radiosurgery Center Frankfurt am Main</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60528</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital Frankfurt, Department of Radiation Therapy and Oncology</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Georgios Chatzikonstantinou, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Detlef Imhoff, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saphir Radiosurgery Center Northern Germany</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Medical Center Schleswig-Holstein</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Juergen Dunst, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Krug David, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Schulz Christian, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>European Cyberknife Center Munich</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alexander Muacevic, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alfred Haidenberger, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Markus Kufeld, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
    <investigator_full_name>Juergen Dunst, Prof.</investigator_full_name>
    <investigator_title>Clinical Professor, Director, Head of Department</investigator_title>
  </responsible_party>
  <keyword>Hypofractionation</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>long-term toxicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT03795337
org study id: ZKS-121-08
secondary id: ARO-2018-4
nct id: NCT03795337
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe
      and feasible.

      Investigators initiated this multicenter phase II prospective trial to analyse feasibility
      (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised
      prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2
      after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.
Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application
      rate of 35,00 Gy).

      Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks,
      3 months, 6 months, 1 year and every year thereafter after last day of radiation).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
time frame: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
measure: Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
time frame: 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
measure: Prostate Specific Antigen (PSA)
time frame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
measure: International Prostate Symptom Score (IPSS)
time frame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
measure: EORTC Quality of Life Questionnaire (QLQ) C30
time frame: At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
arm group label: Hypofractionated Radiosurgery
arm group type: Experimental
description: 5 fractions with 7 Gy, total dose 35 Gy
intervention type: Radiation
intervention name: Hypofractionated Radiosurgery
description: Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
arm group label: Hypofractionated Radiosurgery
criteria: 
gender: Male
gender based: Yes
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Juergen Dunst, Prof.
role: Principal Investigator
affiliation: University Hospital Schleswig-Holstein
last name: Alexander Muacevic, Prof.
role: Principal Investigator
affiliation: European CyberKnife Center Munich
last name: Juergen Dunst, Prof.
phone: +494315973011
phone ext: 3011
email: Juergen.Dunst@uksh.de
last name: Oliver Blanck, Dr.
phone: +4943123989970
phone ext: 0
email: blanck@saphir-rc.com
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Schleswig-Holstein
investigator full name: Juergen Dunst, Prof.
investigator title: Clinical Professor, Director, Head of Department
mesh term: Prostatic Neoplasms