<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/NCT02258087</url>
  </required_header>
  <id_info>
    <org_study_id>PROMOBRA-2013</org_study_id>
    <nct_id>NCT02258087</nct_id>
  </id_info>
  <brief_title>HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.</brief_title>
  <acronym>PROMOBRA</acronym>
  <official_title>Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Oncology, Hungary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Oncology, Hungary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators compare in a randomized clinical trial the results and side effects of&#xD;
      high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ&#xD;
      confined prostate cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in&#xD;
      the treatment of patients with low or selected intermediate risk, organ confined prostate&#xD;
      cancer.&#xD;
&#xD;
      There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with&#xD;
      several fractionation schedule treating the same group of patients. One phase II trial showed&#xD;
      its effectiveness given in one fraction of 19 Gy.&#xD;
&#xD;
      In the trial investigators randomly select patients to treat with either LDR prostate&#xD;
      brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.&#xD;
&#xD;
      Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate&#xD;
      risk group.&#xD;
&#xD;
      Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time&#xD;
      treatment planning. Dose constraints are defined for both methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute side effects</measure>
    <time_frame>6 months</time_frame>
    <description>Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic side effects</measure>
    <time_frame>from 6 months to five year</time_frame>
    <description>Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>5 years</time_frame>
    <description>Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>5 years</time_frame>
    <description>Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical relapse free survival (bRFS)</measure>
    <time_frame>5 years</time_frame>
    <description>Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional tumor free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Censoring an event when either local or regional relapse occurs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease specific survival (DSS)</measure>
    <time_frame>5 years</time_frame>
    <description>Censoring an event when patient dies due to prostate cancer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Adenocarcinoma of Prostate</condition>
  <arm_group>
    <arm_group_label>LDRPBT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HDRPBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>LDR Brachytherapy</intervention_name>
    <description>In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.</description>
    <arm_group_label>LDRPBT</arm_group_label>
    <other_name>Seed brachytherapy</other_name>
    <other_name>Permanent implantation prostate brachytherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>HDR Brachytherapy</intervention_name>
    <description>In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.</description>
    <arm_group_label>HDRPBT</arm_group_label>
    <other_name>temporary implant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) status &lt;=1&#xD;
&#xD;
          -  40-75 years old&#xD;
&#xD;
          -  expected life expectancy&gt;10 years&#xD;
&#xD;
          -  low risk prostate cancer (Prostate specific antigen (PSA)&lt;=10ng/ml, gleason score &lt;7,&#xD;
             T status&lt;=2a), less than 50 % positive biopsy cores&#xD;
&#xD;
          -  selected intermediate prostate cancer (PSA)=10-&lt;15ng/ml or gleason score =3+4(but not&#xD;
             4+3), or T2b-c, less than 50 % positive biopsy cores)&#xD;
&#xD;
          -  International prostate symptom score (IPSS) &lt;=15&#xD;
&#xD;
          -  Prostate volume&lt;=50cm3&#xD;
&#xD;
          -  no pubic interference&#xD;
&#xD;
          -  no prior prostate operation, except biopsy&#xD;
&#xD;
          -  no prior radiation to pelvis&#xD;
&#xD;
          -  patient signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;40 years or &gt;75 years old&#xD;
&#xD;
          -  PSA&gt;15 ng/ml gleason score 4+3 , score 8-10&#xD;
&#xD;
          -  ECOG&gt;=2&#xD;
&#xD;
          -  T3-4&#xD;
&#xD;
          -  percent core positivity &gt;50 %&#xD;
&#xD;
          -  TUR operation within six months prior to the brachytherapy prostate volume&lt;10 cm3 or&#xD;
             &gt;50 cm3 IPSS &gt;15&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Agoston, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIO, Hungary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Agoston, MD PHD</last_name>
    <phone>+361 2248600</phone>
    <phone_ext>3186</phone_ext>
    <email>agoston.p@oncol.hu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Csaba Polgar, MD, PHD</last_name>
    <email>polgar@oncol.hu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peter Agoston</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Agoston, MD, PHD</last_name>
      <phone>+3612248600</phone>
      <phone_ext>3186</phone_ext>
      <email>agoston.p@oncol.hu</email>
    </contact>
    <contact_backup>
      <last_name>Csaba Polgar, MD PHD</last_name>
      <email>polgar@oncol.hu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Oncology, Hungary</investigator_affiliation>
    <investigator_full_name>Peter Agoston</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</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/NCT02258087
org study id: PROMOBRA-2013
nct id: NCT02258087
lead sponsor: 
has dmc: No
Investigators compare in a randomized clinical trial the results and side effects of
      high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ
      confined prostate cancer patients.
Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in
      the treatment of patients with low or selected intermediate risk, organ confined prostate
      cancer.

      There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with
      several fractionation schedule treating the same group of patients. One phase II trial showed
      its effectiveness given in one fraction of 19 Gy.

      In the trial investigators randomly select patients to treat with either LDR prostate
      brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.

      Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate
      risk group.

      Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time
      treatment planning. Dose constraints are defined for both methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute side effects
time frame: 6 months
description: Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale
measure: Chronic side effects
time frame: from 6 months to five year
description: Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale
measure: quality of life
time frame: 5 years
description: Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30).
measure: quality of life
time frame: 5 years
description: Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire
measure: Biochemical relapse free survival (bRFS)
time frame: 5 years
description: Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase)
measure: Locoregional tumor free survival
time frame: 5 years
description: Censoring an event when either local or regional relapse occurs
measure: Disease specific survival (DSS)
time frame: 5 years
description: Censoring an event when patient dies due to prostate cancer
arm group label: LDRPBT
arm group type: Active Comparator
description: Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.
arm group label: HDRPBT
arm group type: Experimental
description: Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.
intervention type: Radiation
intervention name: LDR Brachytherapy
description: In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.
arm group label: LDRPBT
other name: Seed brachytherapy
other name: Permanent implantation prostate brachytherapy
intervention type: Radiation
intervention name: HDR Brachytherapy
description: In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.
arm group label: HDRPBT
other name: temporary implant
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Peter Agoston, MD, PHD
role: Principal Investigator
affiliation: NIO, Hungary
last name: Peter Agoston, MD PHD
phone: +361 2248600
phone ext: 3186
email: agoston.p@oncol.hu
last name: Csaba Polgar, MD, PHD
email: polgar@oncol.hu
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: National Institute of Oncology, Hungary
investigator full name: Peter Agoston
investigator title: MD, PhD
mesh term: Adenocarcinoma