<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/NCT03830788</url>
  </required_header>
  <id_info>
    <org_study_id>2016-2-10-003</org_study_id>
    <nct_id>NCT03830788</nct_id>
  </id_info>
  <brief_title>Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy</brief_title>
  <acronym>TEMPOS</acronym>
  <official_title>Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center Eugene Marquis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Center Eugene Marquis</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study&#xD;
      comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly&#xD;
      focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized&#xD;
      in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five&#xD;
      fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm&#xD;
      consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective&#xD;
      of this health economics study is to perform a cost-utility analysis of SBRT compared to&#xD;
      &quot;standard&quot; Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The&#xD;
      endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as&#xD;
      primary criterion, expressed in cost per quality adjusted life year (QALY) gained.&#xD;
      Cost-effectiveness analyses are performed as secondary objective with Incremental&#xD;
      Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost&#xD;
      per Life Year Gained. A long term evaluation is also performed, including a cost-utility,&#xD;
      cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the&#xD;
      erectile dysfunction up to 5 years after treatment, an evaluation of acute and late&#xD;
      genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5&#xD;
      years after treatment.&#xD;
&#xD;
      Eight patients/year/center are expected to be recruited in 2 years in about twenty&#xD;
      participating centers.&#xD;
&#xD;
      In total, to our knowledge, this study will be the first health economic evaluation which&#xD;
      compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate&#xD;
      cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and&#xD;
      complementary information to decision makers in order (i) to recommend the best strategy to&#xD;
      adopt; (ii) to estimate the budget impact on the French National Health Insurance of the&#xD;
      generalization of the cost-effective strategy. Finally, this study will allow to assess and&#xD;
      compare accurately the erectile dysfunction after both treatment modalities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 4, 2019</start_date>
  <completion_date type="Anticipated">October 4, 2030</completion_date>
  <primary_completion_date type="Anticipated">October 4, 2029</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cost-utility analysis of SBRT compared to &quot;standard&quot; Iodine 125 brachytherapy</measure>
    <time_frame>3 years after treatment.</time_frame>
    <description>The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-utility analysis of SBRT compared to &quot;standard&quot; iodine-125 brachytherapy</measure>
    <time_frame>5 years after treatment</time_frame>
    <description>The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-utility analysis of avoided erectile dysfunction cost</measure>
    <time_frame>3 and 5 years after treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Brachytherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stereotactic body radiotherapy (SBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>radiation by SBRT: SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate. The prostate can be tracked/localized/treated thanks to the Cyberknife or a conventional linac equipped with an ExacTrac or a Calypso4D system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation by brachytherapy</intervention_name>
    <description>Brachytherapy by Iodine 125 delivering 144 Gy to the prostate</description>
    <arm_group_label>Brachytherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation by SBRT</intervention_name>
    <description>SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate.</description>
    <arm_group_label>stereotactic body radiotherapy (SBRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main inclusion criteria&#xD;
&#xD;
          -  Biopsy proven prostate adenocarcinoma,&#xD;
&#xD;
          -  Low risk prostate cancer according to d'Amico (T1-T2a and PSA &lt;10 ng/ml, and Gleason&#xD;
             score 6) or intermediate risk prostate cancer according d'Amico but excluding tumor&#xD;
             with Gleason score 7 (4 + 3),&#xD;
&#xD;
          -  Indication of a curative treatment by brachytherapy validated in multidisciplinary&#xD;
             consultation meeting,&#xD;
&#xD;
        Main exclusion criteria&#xD;
&#xD;
          -  Androgen deprivation therapy,&#xD;
&#xD;
          -  Contraindication for prostate Iodine 125 brachytherapy (Prostate volume &gt; 50 cc,&#xD;
             impossibility if general anesthesia).&#xD;
&#xD;
          -  Contraindication for Resonance Magnetic Imagery (RMI) (claustrophobia, pacemaker)&#xD;
&#xD;
          -  Participation to another research which could have an impact on the study treatment&#xD;
             and the outcomes&#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>Renaud De Crevoisier, PR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Eugène Marquis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martine Gestin, PhD</last_name>
    <phone>+33(0)299253036</phone>
    <email>m.gestin@rennes.unicancer.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinique Claude Bernard</name>
      <address>
        <city>Albi</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Laurent Votron, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Paul Sargos, MD</last_name>
    </contact>
    <investigator>
      <last_name>Paul Sargos</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Polyclinique Bordeaux-Aquitaine</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>François Guichard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CLCC Georges-François Leclerc</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Magali Quivrin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre de Cobalthérapie Hartman</name>
      <address>
        <city>Levallois-Perret</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Laurent Chauveinc, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Lyon Sud</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sonia Gaudioz</last_name>
      <email>sonia.gaudioz@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Olivier CHAPET</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut régional du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Carmen Llacer-Moscardo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Olivier Chapet, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Grégoire Bouché, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Eugene Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renaud De Crevoisier, MD</last_name>
      <phone>+33 (0)2 99 25 30 31</phone>
      <email>r.de-crevoisier@rennes.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Renaud De Crevoisier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest - Site Gauducheau</name>
      <address>
        <city>Saint-Herblain</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Stéphane Supiot, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie Lucien Neuwirth</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Julien Langrand-Escure, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Régaud</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Pierre Graff-Cailleaud, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Tours - Hôpital Bretonneau</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Gilles Calais, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Didier Peiffert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pierre Blanchard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SBRT</keyword>
  <keyword>brachytherapy</keyword>
  <keyword>localized low-risk and intermediate risk prostate cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03830788
org study id: 2016-2-10-003
nct id: NCT03830788
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study
      comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly
      focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized
      in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five
      fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm
      consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective
      of this health economics study is to perform a cost-utility analysis of SBRT compared to
      "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The
      endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as
      primary criterion, expressed in cost per quality adjusted life year (QALY) gained.
      Cost-effectiveness analyses are performed as secondary objective with Incremental
      Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost
      per Life Year Gained. A long term evaluation is also performed, including a cost-utility,
      cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the
      erectile dysfunction up to 5 years after treatment, an evaluation of acute and late
      genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5
      years after treatment.

      Eight patients/year/center are expected to be recruited in 2 years in about twenty
      participating centers.

      In total, to our knowledge, this study will be the first health economic evaluation which
      compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate
      cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and
      complementary information to decision makers in order (i) to recommend the best strategy to
      adopt; (ii) to estimate the budget impact on the French National Health Insurance of the
      generalization of the cost-effective strategy. Finally, this study will allow to assess and
      compare accurately the erectile dysfunction after both treatment modalities.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy
time frame: 3 years after treatment.
description: The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.
measure: Cost-utility analysis of SBRT compared to "standard" iodine-125 brachytherapy
time frame: 5 years after treatment
description: The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.
measure: Cost-utility analysis of avoided erectile dysfunction cost
time frame: 3 and 5 years after treatment
arm group label: Brachytherapy
arm group type: Active Comparator
description: radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
arm group label: stereotactic body radiotherapy (SBRT)
arm group type: Experimental
description: radiation by SBRT: SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate. The prostate can be tracked/localized/treated thanks to the Cyberknife or a conventional linac equipped with an ExacTrac or a Calypso4D system.
intervention type: Radiation
intervention name: Radiation by brachytherapy
description: Brachytherapy by Iodine 125 delivering 144 Gy to the prostate
arm group label: Brachytherapy
intervention type: Radiation
intervention name: Radiation by SBRT
description: SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate.
arm group label: stereotactic body radiotherapy (SBRT)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renaud De Crevoisier, PR
role: Principal Investigator
affiliation: Centre Eugène Marquis
last name: Martine Gestin, PhD
phone: +33(0)299253036
email: m.gestin@rennes.unicancer.fr
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Erectile Dysfunction
sharing ipd: No