<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/NCT02192788</url>
  </required_header>
  <id_info>
    <org_study_id>SBRT-SG 05</org_study_id>
    <nct_id>NCT02192788</nct_id>
  </id_info>
  <brief_title>Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer</brief_title>
  <official_title>Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo de Investigación Clínica en Oncología Radioterapia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo de Investigación Clínica en Oncología Radioterapia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to probe the effect of SBRT as a treatment oligometastases of prostate&#xD;
      cancer, regardless of basal treatment received, and I know the response, biochemical control,&#xD;
      the progression-free survival as well as their impact on quality of life.&#xD;
&#xD;
      Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated&#xD;
      by SBRT.&#xD;
&#xD;
      Secondary Objectives: Analyzing biochemical progression rates, progression-free survival,&#xD;
      chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of&#xD;
      patients before and after treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2021</completion_date>
  <primary_completion_date type="Actual">July 2021</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>Number of patients without disease progression of prostate cancer treated by SBRT</measure>
    <time_frame>5 years</time_frame>
    <description>Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival measured with Kaplan-Meier method</measure>
    <time_frame>patients will be followed up an average of 5 years</time_frame>
    <description>the time to death will be defined as the time between the date when the patient is treated with SBRT and the date of death, or the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with an adverse events.</measure>
    <time_frame>3 months after the SBRT treatment</time_frame>
    <description>Analyze toxicities in every patient during the first 3 months after the treatment with SBRT. Every significant Adverse Event will be graded as CTC-AE v.4.03. For Pain related adverse events, visual analogic scale (VAS) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free disease progression survival measured with Kaplan-Meier method</measure>
    <time_frame>the patients will be followed up an expected average of 5 years</time_frame>
    <description>the time to disease progression will be defined as the time between the date when the patient is treated with SBRT and the date of biochemical (PSA increased upper to 2 ng/mL) o radiological progression or the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire FACT-P</measure>
    <time_frame>baseline and 3rd month after the SBRT treatment.</time_frame>
    <description>The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Oligometastatic Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stereotactic Body Radiation Therapy for Oligometastases (SBRT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy for Oligometastases</intervention_name>
    <arm_group_label>SBRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed prostate cancer, who are currently being&#xD;
             oligometastases / oligorrecurrencia after primary treatment for their disease.&#xD;
&#xD;
          -  Aged ≥ 18 years&#xD;
&#xD;
          -  Time to biochemical recurrence more than 1 year&#xD;
&#xD;
          -  PSA doubling time&gt; 3 months&#xD;
&#xD;
          -  Less than 5 bone metastases location (including spinal) or lymph node.&#xD;
&#xD;
          -  Without other metastases or recurrences by Choline PET or / and NMR Diffusion Length.&#xD;
&#xD;
          -  Signed and dated written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients currently treatment with abiraterone, enzalutamide, chemotherapy,&#xD;
             immunotherapy or radioisotopes.&#xD;
&#xD;
          -  Patients unwilling or unable to comply with protocol requirements and scheduled&#xD;
             visits.&#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>Antonio J Conde Moreno, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grupo de Investigación Clínica en Oncología Radioterapia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GICOR</name>
      <address>
        <city>Madrid</city>
        <state>Las Rozas</state>
        <zip>28290</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Rey Juan Carlos</name>
      <address>
        <city>Móstoles</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Lucia</name>
      <address>
        <city>Cartagena</city>
        <state>Murcia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto catalan de Oncología</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.P. Castellón</name>
      <address>
        <city>Castellón De La Plana</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Negrin</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica QUIRON</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital central de la defensa Gomez Ulla</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ruber Internacional</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de la Princesa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Navarra</name>
      <address>
        <city>Navarro</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ERESA H. General de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Do Mexoeiro</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Grupo de Investigación Clínica en Oncología Radioterapia</investigator_affiliation>
    <investigator_full_name>Antonio J Conde Moreno</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>SBRT</keyword>
  <keyword>Oligometastases</keyword>
  <keyword>Prostate Cancer</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/NCT02192788
org study id: SBRT-SG 05
nct id: NCT02192788
lead sponsor: 
has dmc: No
This study aims to probe the effect of SBRT as a treatment oligometastases of prostate
      cancer, regardless of basal treatment received, and I know the response, biochemical control,
      the progression-free survival as well as their impact on quality of life.

      Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated
      by SBRT.

      Secondary Objectives: Analyzing biochemical progression rates, progression-free survival,
      chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of
      patients before and after treatment
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients without disease progression of prostate cancer treated by SBRT
time frame: 5 years
description: Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage
measure: Overall Survival measured with Kaplan-Meier method
time frame: patients will be followed up an average of 5 years
description: the time to death will be defined as the time between the date when the patient is treated with SBRT and the date of death, or the last follow-up visit.
measure: Number of patients with an adverse events.
time frame: 3 months after the SBRT treatment
description: Analyze toxicities in every patient during the first 3 months after the treatment with SBRT. Every significant Adverse Event will be graded as CTC-AE v.4.03. For Pain related adverse events, visual analogic scale (VAS) will be used.
measure: Free disease progression survival measured with Kaplan-Meier method
time frame: the patients will be followed up an expected average of 5 years
description: the time to disease progression will be defined as the time between the date when the patient is treated with SBRT and the date of biochemical (PSA increased upper to 2 ng/mL) o radiological progression or the last follow-up visit.
measure: Quality of life questionnaire FACT-P
time frame: baseline and 3rd month after the SBRT treatment.
description: The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.
arm group label: SBRT
arm group type: Experimental
description: Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy for Oligometastases
arm group label: SBRT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio J Conde Moreno, MD
role: Principal Investigator
affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
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country: Spain
responsible party type: Principal Investigator
investigator affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
investigator full name: Antonio J Conde Moreno
investigator title: MD
mesh term: Prostatic Neoplasms