<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/NCT03284151</url>
  </required_header>
  <id_info>
    <org_study_id>CYM6 Prostate CFB2</org_study_id>
    <nct_id>NCT03284151</nct_id>
  </id_info>
  <brief_title>Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma</brief_title>
  <official_title>Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse, Luxembourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Francois Baclesse, Luxembourg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to&#xD;
      quantify the delay between the focused treatment and the salvage procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to&#xD;
      quantify the delay between the focused treatment and the salvage procedure.&#xD;
&#xD;
      Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response,&#xD;
      toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The&#xD;
      International Index of Erectile Function (IIEF5) scores).&#xD;
&#xD;
      Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the&#xD;
      whole gland.&#xD;
&#xD;
      Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.&#xD;
&#xD;
      Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days.&#xD;
      Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35&lt;2cc. Bladder&#xD;
      neck and urethra: V35&lt;1cc.&#xD;
&#xD;
      Salvage treatments: in such a context, salvage surgery or salvage intensity modulation&#xD;
      radiation therapy (IMRT) treatments can in theory remain valid and safe options.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Delay between the initial diagnosis and date of salvage treatment</measure>
    <time_frame>through study completion, up to 36 months</time_frame>
    <description>Delay between the initial diagnosis and date of salvage treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSA evaluation</measure>
    <time_frame>3, 6, 12, 18, 24, 30, 36 months</time_frame>
    <description>PSA dosage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birads score evaluation</measure>
    <time_frame>12, 24, 36 months</time_frame>
    <description>Multiparametric prostatic MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute and late toxicity</measure>
    <time_frame>3, 6, 12, 18, 24, 30, 36 months</time_frame>
    <description>Acute and late toxicity using the CTCAEv4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IPSS evaluation</measure>
    <time_frame>12, 24, 36 months</time_frame>
    <description>IPSS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IIEF5 evaluation</measure>
    <time_frame>12, 24, 36 months</time_frame>
    <description>IIEF5 score</description>
  </secondary_outcome>
  <enrollment type="Actual">26</enrollment>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Cyberknife</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prostatic adenocarcinoma Capra≤2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12&#xD;
             prostatic zones. Lesions&gt;3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥&#xD;
             5ml/s, post micturation volume ≤80ml, IPSS score ≤15.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck&#xD;
             stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent&#xD;
             prostatitis within the last 3 years.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Nickers, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre Francois Baclesse</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michel Untereiner, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Francois Baclesse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Francois Baclesse</name>
      <address>
        <city>Esch Sur Alzette</city>
        <zip>4005</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Luxembourg</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>June 20, 2022</last_update_submitted>
  <last_update_submitted_qc>June 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>good prognosis</keyword>
  <keyword>focused treatment</keyword>
  <keyword>Cyberknife</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <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/NCT03284151
org study id: CYM6 Prostate CFB2
nct id: NCT03284151
lead sponsor: 
has dmc: Yes
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to
      quantify the delay between the focused treatment and the salvage procedure.
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to
      quantify the delay between the focused treatment and the salvage procedure.

      Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response,
      toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The
      International Index of Erectile Function (IIEF5) scores).

      Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the
      whole gland.

      Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.

      Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days.
      Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35<2cc. Bladder
      neck and urethra: V35<1cc.

      Salvage treatments: in such a context, salvage surgery or salvage intensity modulation
      radiation therapy (IMRT) treatments can in theory remain valid and safe options.
observational model: Cohort
time perspective: Prospective
measure: Delay between the initial diagnosis and date of salvage treatment
time frame: through study completion, up to 36 months
description: Delay between the initial diagnosis and date of salvage treatment
measure: PSA evaluation
time frame: 3, 6, 12, 18, 24, 30, 36 months
description: PSA dosage
measure: Birads score evaluation
time frame: 12, 24, 36 months
description: Multiparametric prostatic MRI
measure: Acute and late toxicity
time frame: 3, 6, 12, 18, 24, 30, 36 months
description: Acute and late toxicity using the CTCAEv4
measure: IPSS evaluation
time frame: 12, 24, 36 months
description: IPSS score
measure: IIEF5 evaluation
time frame: 12, 24, 36 months
description: IIEF5 score
intervention type: Radiation
intervention name: Cyberknife
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Philippe Nickers, MD, PhD
role: Study Chair
affiliation: Centre Francois Baclesse
last name: Michel Untereiner, MD
role: Study Director
affiliation: Centre Francois Baclesse
facility: 
country: Luxembourg
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Adenocarcinoma