<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/NCT02254746</url>
  </required_header>
  <id_info>
    <org_study_id>CHUV-DO-HYPORT-2013</org_study_id>
    <nct_id>NCT02254746</nct_id>
  </id_info>
  <brief_title>A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer</brief_title>
  <official_title>A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation&#xD;
      Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is&#xD;
      the irradiation of the entire prostate gland with or without seminal vesicles accompanied or&#xD;
      not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of&#xD;
      hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and&#xD;
      highly efficient outpatient therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective phase I:&#xD;
&#xD;
      To irradiate the prostate gland which might albeit contain microscopic disease with&#xD;
      tumoricidal doses of SBRT, and to escalate the dose of SBRT in the visible prostatic tumor&#xD;
      towards the best tumoricidal dose without exceeding the normal tissue tolerance and toxicity&#xD;
      in patients with organ confined T2-T3 N0 prostate carcinoma.&#xD;
&#xD;
      Primary objective phase II:&#xD;
&#xD;
      To determine the rate of acute toxicity grade 2 or more defined as toxicity occurring&#xD;
      immediately after the first fraction of radiotherapy and up to 90 days after the start of&#xD;
      radiotherapy treatment.&#xD;
&#xD;
      Secondary objectives phase II:&#xD;
&#xD;
        -  To determine efficacy measured by PSA failure using Phoenix definition.&#xD;
&#xD;
        -  To determine long-term late toxicity (&gt;90 days after treatment start).&#xD;
&#xD;
      Exploratory endpoint phase II:&#xD;
&#xD;
      • To determine the feasibility of achieving dose constraints in the organs at risk using high&#xD;
      technology radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Maximum tolerated dose (phase I)</measure>
    <time_frame>During the first 30 days from the start of treatment</time_frame>
    <description>Observation of dose-limiting toxicities (DLT) defined as any treatment-related grade ≥ 3 acute toxicity occurring in the radiation field or irradiated volumes in the following categories GI or GU. In addition, any other grade 4 or 5 toxicity attributed to the therapy constitutes a DLT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toxicity (phase II)</measure>
    <time_frame>90 days after the first fraction of radiotherapy treatment</time_frame>
    <description>Acute GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy (phase II)</measure>
    <time_frame>3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years)</time_frame>
    <description>PSA failure using Phoenix definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity (phase II)</measure>
    <time_frame>&gt; 90 days and up to 5 years from the start of protocol treatment</time_frame>
    <description>Long term GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Phase I (dose escalation)/ Phase II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I&#xD;
Prostate tumor: starting dose 9 Gy per fraction in 5 fractions (total 45 Gy) and subsequent dose escalation up to 10 Gy.&#xD;
Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions (no dose escalation). Total 36.25 Gy.&#xD;
Phase II&#xD;
Additional patients will be treated at either the maximum tolerated dose (MTD) or at the highest dose level as determined by the investigators from the Phase I portion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy (SBRT)</intervention_name>
    <arm_group_label>Phase I (dose escalation)/ Phase II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients must be willing and capable to provide informed consent&#xD;
&#xD;
          -  Histologic confirmation of prostate adenocarcinoma&#xD;
&#xD;
          -  T2-T3 tumors, N0 (clinically by no evidence of metastatic lymph nodes on CT or MRI)&#xD;
&#xD;
          -  No direct evidence of regional or distant metastases&#xD;
&#xD;
          -  PSA less than or equal to 50 μg/ml&#xD;
&#xD;
          -  Visible gross tumor at the prostate endorectal coil MRI.&#xD;
&#xD;
          -  The ultrasound or MRI based volume estimation of the patient's prostate gland no&#xD;
             greater than 70g or 70cc&#xD;
&#xD;
          -  No significant urinary obstructive symptoms; IPSS score must be ≤ 15 (alpha blockers&#xD;
             allowed)&#xD;
&#xD;
          -  Patient must have undergone an endorectal coil magnetic resonance image (MRI) of the&#xD;
             prostatic gland (before rectal spacer if any),&#xD;
&#xD;
          -  Patient must have undergone the following assessments in case of PSA ≥ 20μg/L, and/or&#xD;
             T3 tumor and/or Gleason Score ≥ 8:&#xD;
&#xD;
               -  bone scan&#xD;
&#xD;
               -  Chest abdominal and pelvis computed tomography (CT) scan&#xD;
&#xD;
          -  If tumor is localized at less than 3 mm from the rectum a rectal spacer is mandatory.&#xD;
             Patient accepts the rectal spacer to be injected before treatment starts&#xD;
&#xD;
          -  Patient accepts to have one planning MRI after the injection of rectal spacer (without&#xD;
             endorectal coil)&#xD;
&#xD;
          -  Patient accepts the preparation of the bladder (bladder full), before the planning&#xD;
             MRI, planning CT and then before each treatment fraction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous radiotherapy in the pelvis&#xD;
&#xD;
          -  Tumor localized at less than 3 mm from the urethra&#xD;
&#xD;
          -  History of inflammatory colitis (including Crohn's disease and ulcerative colitis)&#xD;
&#xD;
          -  Prior cancer in the pelvis&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol and follow-up schedule; those conditions&#xD;
             should be discussed with the patient before inclusion in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernanda Herrera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Dr Fernanda Herrera</investigator_full_name>
    <investigator_title>Cheffe de clinique</investigator_title>
  </responsible_party>
  <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/NCT02254746
org study id: CHUV-DO-HYPORT-2013
nct id: NCT02254746
lead sponsor: 
has dmc: Yes
The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation
      Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is
      the irradiation of the entire prostate gland with or without seminal vesicles accompanied or
      not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of
      hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and
      highly efficient outpatient therapy.
Primary objective phase I:

      To irradiate the prostate gland which might albeit contain microscopic disease with
      tumoricidal doses of SBRT, and to escalate the dose of SBRT in the visible prostatic tumor
      towards the best tumoricidal dose without exceeding the normal tissue tolerance and toxicity
      in patients with organ confined T2-T3 N0 prostate carcinoma.

      Primary objective phase II:

      To determine the rate of acute toxicity grade 2 or more defined as toxicity occurring
      immediately after the first fraction of radiotherapy and up to 90 days after the start of
      radiotherapy treatment.

      Secondary objectives phase II:

        -  To determine efficacy measured by PSA failure using Phoenix definition.

        -  To determine long-term late toxicity (>90 days after treatment start).

      Exploratory endpoint phase II:

      • To determine the feasibility of achieving dose constraints in the organs at risk using high
      technology radiotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (phase I)
time frame: During the first 30 days from the start of treatment
description: Observation of dose-limiting toxicities (DLT) defined as any treatment-related grade ≥ 3 acute toxicity occurring in the radiation field or irradiated volumes in the following categories GI or GU. In addition, any other grade 4 or 5 toxicity attributed to the therapy constitutes a DLT.
measure: Toxicity (phase II)
time frame: 90 days after the first fraction of radiotherapy treatment
description: Acute GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.
measure: Efficacy (phase II)
time frame: 3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years)
description: PSA failure using Phoenix definition
measure: Toxicity (phase II)
time frame: > 90 days and up to 5 years from the start of protocol treatment
description: Long term GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.
arm group label: Phase I (dose escalation)/ Phase II
arm group type: Experimental
description: Phase I
Prostate tumor: starting dose 9 Gy per fraction in 5 fractions (total 45 Gy) and subsequent dose escalation up to 10 Gy.
Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions (no dose escalation). Total 36.25 Gy.
Phase II
Additional patients will be treated at either the maximum tolerated dose (MTD) or at the highest dose level as determined by the investigators from the Phase I portion of the study.
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy (SBRT)
arm group label: Phase I (dose escalation)/ Phase II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Fernanda Herrera, MD
role: Principal Investigator
affiliation: CHUV
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Dr Fernanda Herrera
investigator title: Cheffe de clinique
mesh term: Adenocarcinoma