<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/NCT03238066</url>
  </required_header>
  <id_info>
    <org_study_id>Prostata-BT-HT</org_study_id>
    <nct_id>NCT03238066</nct_id>
  </id_info>
  <brief_title>Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy</brief_title>
  <acronym>Prostata-BT-HT</acronym>
  <official_title>A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent&#xD;
      prostate carcinoma following external beam radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent&#xD;
      prostate carcinoma following external beam radiation therapy:&#xD;
&#xD;
      Salvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22,&#xD;
      43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31)&#xD;
      Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior&#xD;
      to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs&#xD;
      should not exceed 43˚C&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2015</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Rate of late GI/GU grade 3 and more toxicities</measure>
    <time_frame>up to 60 Months in Follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of acute GI/GU treatment-related adverse events</measure>
    <time_frame>up to 24 months after start of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to biochemical failure</measure>
    <time_frame>up to 60 Months in Follow up</time_frame>
    <description>defined rise of PSA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 60 Months in Follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>up to 60 Months in Follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>up to 60 Months in Follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical patterns of tumor recurrence</measure>
    <time_frame>up to 60 Months in Follow up</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">77</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The physician can choose either HDR or PDR brachytherapy.&#xD;
If HDR BT is chosen:&#xD;
d1: hyperthermia (IHT) 60 minutes + 10Gy HDR brachytherapy (HDRBT) d22: IHT 60 minutes + 10 Gy HDRBT d43: IHT 60 minutes + 10 Gy HDRBT&#xD;
If PDR BT is chosen:&#xD;
d1-3: IHT 60 minutes + 30Gy PDRBT d29-31: IHT 60 minutes + 30Gy PDRBT</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Brachytherapy</intervention_name>
    <description>HDR/PDR brachytherapy</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperthermia</intervention_name>
    <description>Interstitial hyperthermia</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically-confirmed locally recurrent prostate cancer - biopsy performed &lt; 6&#xD;
             months before registration;&#xD;
&#xD;
          -  Histology: Adenocarcinoma, every Gleason score (2-10)&#xD;
&#xD;
          -  Initial treatment (EBRT) completed &gt; 24 months prior to biopsy;&#xD;
&#xD;
          -  Androgen deprivation therapy for prostate cancer should be discontinued at least 3&#xD;
             months prior to patient registration&#xD;
&#xD;
          -  Staging performed within 12 weeks prior to registration:&#xD;
&#xD;
               -  Local stage evaluated by DRE, TRUS or - if necessary - mpMRI (T1b, T1c, T2a, T2b,&#xD;
                  T2c, T3a, T3b);&#xD;
&#xD;
               -  Negative lymph nodes by imaging studies (at least one of these: choline PET scan,&#xD;
                  pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0);&#xD;
&#xD;
               -  Negative bone scan (M0);&#xD;
&#xD;
          -  PSA-DT &gt; 6 months (PSA measurements taken of the 12 months prior to registration)&#xD;
&#xD;
          -  Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS)&#xD;
             &lt; 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers;&#xD;
&#xD;
          -  Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in&#xD;
             Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.&#xD;
&#xD;
        In TRUS volume study performed 0-4 weeks before registration patient meets eligibility&#xD;
        criteria for prostate brachytherapy as follows:&#xD;
&#xD;
          -  Prostate/tumor volume &lt;60ml&#xD;
&#xD;
          -  The distance rear prostate edge - rectal mucosa &gt;5mm&#xD;
&#xD;
          -  Interference of pubic arch ruled out&#xD;
&#xD;
          -  If local stage T3b: it must be possible to cover by the brachytherapy dose cancer&#xD;
             infiltration&#xD;
&#xD;
               -  Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for&#xD;
                  915 MHz frequency antennas)&#xD;
&#xD;
               -  The patient is suitable for spinal or general anesthesia&#xD;
&#xD;
               -  Age &gt; 18 y.&#xD;
&#xD;
               -  Life expectancy &gt; 5 years&#xD;
&#xD;
               -  absence of any psychological, familial, sociological or geographical condition&#xD;
                  potentially hampering compliance with the study protocol and follow-up schedule;&#xD;
                  those conditions should be discussed with the patient before registration in the&#xD;
                  trial&#xD;
&#xD;
               -  The patient must sign a study-specific informed consent form before study&#xD;
                  registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe, active comorbidities:&#xD;
&#xD;
               -  Decompensated congestive heart disease&#xD;
&#xD;
               -  Chronic obstructive pulmonary disease exacerbation, respiratory failure&#xD;
&#xD;
               -  Hepatic insufficiency resulting in coagulation defects or clinical jaundice&#xD;
&#xD;
          -  Other active malignancy or treatment of invasive or hematological malignancy&#xD;
&#xD;
          -  Evidence of extraprostatic disease at local recurrence:&#xD;
&#xD;
               -  Local stage T4&#xD;
&#xD;
               -  Histologic or radiologic evidence of lymph node metastases (N1 or pN1)&#xD;
&#xD;
               -  Presence of distant metastases (M1)&#xD;
&#xD;
          -  Any of the following prior therapies:&#xD;
&#xD;
               -  TURP within 6 months prior to registration&#xD;
&#xD;
               -  Prostatic salvage cryosurgery performed at least 6 months before registration&#xD;
&#xD;
               -  HIFU performed at least 6 months before registration&#xD;
&#xD;
               -  Androgen deprivation therapy within 3 months prior to registration&#xD;
&#xD;
          -  Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in&#xD;
             Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vratislav Strnad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Medical Director of the Dept. of Radiooncology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vratislav Strnad, MD</last_name>
    <phone>++49(0)9131-85</phone>
    <phone_ext>33419</phone_ext>
    <email>vratislav.strnad@uk-erlangen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Studiensekretariat</last_name>
    <phone>++49(0)9131-85</phone>
    <phone_ext>33968</phone_ext>
    <email>st-studiensekretariat@uk-erlangen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Strahlenklinik im Universitaetsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vratislav Strnad, MD</last_name>
      <phone>++49(0)9131-85</phone>
      <phone_ext>33419</phone_ext>
      <email>vratislav.strnad@uk-erlangen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centrum Radiotherapii</name>
      <address>
        <city>Kraków</city>
        <zip>31-826</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrzej Kukielka, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maria Sklodowska-Curie Institute - Oncology Center</name>
      <address>
        <city>Warszaw</city>
        <zip>02-034</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mateusz Dabkowski, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 1, 2015</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Vratislav Strnad</investigator_full_name>
    <investigator_title>Assistant Medical Director of the Dept. of Radiooncology</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>Hyperthermia</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/NCT03238066
org study id: Prostata-BT-HT
nct id: NCT03238066
lead sponsor: 
has dmc: No
Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent
      prostate carcinoma following external beam radiation therapy.
Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent
      prostate carcinoma following external beam radiation therapy:

      Salvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22,
      43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31)
      Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior
      to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs
      should not exceed 43˚C
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of late GI/GU grade 3 and more toxicities
time frame: up to 60 Months in Follow up
measure: Rate of acute GI/GU treatment-related adverse events
time frame: up to 24 months after start of recruitment
measure: Time to biochemical failure
time frame: up to 60 Months in Follow up
description: defined rise of PSA
measure: Overall survival
time frame: up to 60 Months in Follow up
measure: Disease-free survival
time frame: up to 60 Months in Follow up
measure: Disease-specific survival
time frame: up to 60 Months in Follow up
measure: Clinical patterns of tumor recurrence
time frame: up to 60 Months in Follow up
arm group label: Treatment Arm
arm group type: Experimental
description: The physician can choose either HDR or PDR brachytherapy.
If HDR BT is chosen:
d1: hyperthermia (IHT) 60 minutes + 10Gy HDR brachytherapy (HDRBT) d22: IHT 60 minutes + 10 Gy HDRBT d43: IHT 60 minutes + 10 Gy HDRBT
If PDR BT is chosen:
d1-3: IHT 60 minutes + 30Gy PDRBT d29-31: IHT 60 minutes + 30Gy PDRBT
intervention type: Radiation
intervention name: Brachytherapy
description: HDR/PDR brachytherapy
arm group label: Treatment Arm
intervention type: Other
intervention name: Hyperthermia
description: Interstitial hyperthermia
arm group label: Treatment Arm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vratislav Strnad, MD
role: Principal Investigator
affiliation: Assistant Medical Director of the Dept. of Radiooncology
last name: Vratislav Strnad, MD
phone: ++49(0)9131-85
phone ext: 33419
email: vratislav.strnad@uk-erlangen.de
last name: Studiensekretariat
phone: ++49(0)9131-85
phone ext: 33968
email: st-studiensekretariat@uk-erlangen.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
country: Poland
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: Vratislav Strnad
investigator title: Assistant Medical Director of the Dept. of Radiooncology
mesh term: Prostatic Neoplasms
mesh term: Hyperthermia