<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/NCT03235557</url>
  </required_header>
  <id_info>
    <org_study_id>CYM Prostate CFB 1</org_study_id>
    <nct_id>NCT03235557</nct_id>
  </id_info>
  <brief_title>CyberKnife for Prostate Cancer Patients Aged 70 y or More</brief_title>
  <acronym>ProRobot</acronym>
  <official_title>Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More</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>
      Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.&#xD;
&#xD;
      Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate&#xD;
      Specific Antigen) &lt;30ng/ml.&#xD;
&#xD;
      Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5&#xD;
      fractions, in 10 days, considering CAPRA Scores&gt;5.&#xD;
&#xD;
      Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives :&#xD;
      PSA and MRI response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.&#xD;
&#xD;
      Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now&#xD;
      curative treatments were not proven to increase overall survival rates. Therefore, very&#xD;
      short, comfortable and safe treatments have to be designed to increase the pelvic control of&#xD;
      the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using&#xD;
      hypofractionation schemes.&#xD;
&#xD;
      Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives :&#xD;
      PSA and MRI response and quality of life evaluation.&#xD;
&#xD;
      Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA&lt;30ng/ml.&#xD;
&#xD;
      Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5&#xD;
      fractions, in 10 days, considering CAPRA Scores&gt;5.&#xD;
&#xD;
      Doses to the Organs At Risk (OAR) : Rectum wall : V36.25&lt;2%, V27&lt;20%, V23&lt;30%, V20&lt;35%.&#xD;
      Bladder wall : V36.25&lt;2%, V27&lt;20%, V20&lt;35%. Considering specifically the prescription of 37.5&#xD;
      Gray, the rectum and bladder wall: V37.5&lt;2%. Anytime, hot spots of 105 % of the prescription&#xD;
      dose must avoid the urethra.&#xD;
&#xD;
      Evaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA,&#xD;
      multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International&#xD;
      Index of Erectile Function).&#xD;
&#xD;
      Methodolgy : this is a three step prospective, observational study of 20 patients each step.&#xD;
      Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1&#xD;
      year must remain below 5% each.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Acute and late toxicity (Using the CTCAEv4)</measure>
    <time_frame>During 36 months after treatment</time_frame>
    <description>Using the CTCAEv4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSA evaluation</measure>
    <time_frame>at 4 and 6 months, than every 6 months for 3 years</time_frame>
    <description>PSA Dosage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digital rectal exam</measure>
    <time_frame>at 6, 12, 24 and 36 months</time_frame>
    <description>Clinical examination (digital rectal exam)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birads score evaluation</measure>
    <time_frame>at 36 months</time_frame>
    <description>Multiparametric prostatic MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IPSS evaluation</measure>
    <time_frame>at 12, 24 and 36 months</time_frame>
    <description>IPSS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IIEF5 evaluation</measure>
    <time_frame>at 12, 24 and 36 months</time_frame>
    <description>IIEF5 score</description>
  </secondary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Prostate Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly patients suffering prostatic adenocarcinoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  T1-T3b,&#xD;
&#xD;
          -  MRI pelvic nodes negative,&#xD;
&#xD;
          -  M0,&#xD;
&#xD;
          -  any Gleason Score,&#xD;
&#xD;
          -  PSA&lt;30ng/ml,&#xD;
&#xD;
          -  WHO (World Health Organisation) score&lt;2, IPSS≤15,&#xD;
&#xD;
          -  maximal urinary flow rate ≥15ml/s,&#xD;
&#xD;
          -  mean urinary flow rate ≥5ml/s,&#xD;
&#xD;
          -  multiparametric prostatic and pelvis MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prostatic volume &gt; 100cc,&#xD;
&#xD;
          -  TURP (transurethral prostatectomy) &lt;3 y,&#xD;
&#xD;
          -  any recurrent prostatitis within the last 3 years,&#xD;
&#xD;
          -  collagenose diseases,&#xD;
&#xD;
          -  ulcero-haemorrhagic rectocolitis or&#xD;
&#xD;
          -  crohn diseases&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>70 Years</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>
  <results_reference>
    <citation>Nickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which alpha/beta ratio and half-time of repair are useful for predicting outcomes in prostate cancer? Radiother Oncol. 2010 Dec;97(3):462-6. doi: 10.1016/j.radonc.2010.06.006. Epub 2010 Aug 17.</citation>
    <PMID>20724012</PMID>
  </results_reference>
  <results_reference>
    <citation>Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4.</citation>
    <PMID>21464418</PMID>
  </results_reference>
  <results_reference>
    <citation>King CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6.</citation>
    <PMID>21300474</PMID>
  </results_reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 15, 2015</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 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</keyword>
  <keyword>cancer</keyword>
  <keyword>radiation</keyword>
  <keyword>stereotactic</keyword>
  <keyword>CyberKnife</keyword>
  <keyword>elderly</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/NCT03235557
org study id: CYM Prostate CFB 1
nct id: NCT03235557
lead sponsor: 
has dmc: Yes
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.

      Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate
      Specific Antigen) <30ng/ml.

      Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5
      fractions, in 10 days, considering CAPRA Scores>5.

      Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives :
      PSA and MRI response.
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.

      Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now
      curative treatments were not proven to increase overall survival rates. Therefore, very
      short, comfortable and safe treatments have to be designed to increase the pelvic control of
      the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using
      hypofractionation schemes.

      Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives :
      PSA and MRI response and quality of life evaluation.

      Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA<30ng/ml.

      Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5
      fractions, in 10 days, considering CAPRA Scores>5.

      Doses to the Organs At Risk (OAR) : Rectum wall : V36.25<2%, V27<20%, V23<30%, V20<35%.
      Bladder wall : V36.25<2%, V27<20%, V20<35%. Considering specifically the prescription of 37.5
      Gray, the rectum and bladder wall: V37.5<2%. Anytime, hot spots of 105 % of the prescription
      dose must avoid the urethra.

      Evaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA,
      multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International
      Index of Erectile Function).

      Methodolgy : this is a three step prospective, observational study of 20 patients each step.
      Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1
      year must remain below 5% each.
observational model: Cohort
time perspective: Prospective
measure: Acute and late toxicity (Using the CTCAEv4)
time frame: During 36 months after treatment
description: Using the CTCAEv4
measure: PSA evaluation
time frame: at 4 and 6 months, than every 6 months for 3 years
description: PSA Dosage
measure: Digital rectal exam
time frame: at 6, 12, 24 and 36 months
description: Clinical examination (digital rectal exam)
measure: Birads score evaluation
time frame: at 36 months
description: Multiparametric prostatic MRI
measure: IPSS evaluation
time frame: at 12, 24 and 36 months
description: IPSS score
measure: IIEF5 evaluation
time frame: at 12, 24 and 36 months
description: IIEF5 score
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 70 Years
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
citation: Nickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which alpha/beta ratio and half-time of repair are useful for predicting outcomes in prostate cancer? Radiother Oncol. 2010 Dec;97(3):462-6. doi: 10.1016/j.radonc.2010.06.006. Epub 2010 Aug 17.
PMID: 20724012
citation: Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4.
PMID: 21464418
citation: King CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6.
PMID: 21300474
responsible party type: Sponsor
mesh term: Prostatic Neoplasms