<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/NCT02264379</url>
  </required_header>
  <id_info>
    <org_study_id>STR - Oli-P - 2014</org_study_id>
    <nct_id>NCT02264379</nct_id>
  </id_info>
  <brief_title>Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma</brief_title>
  <acronym>Oli-P</acronym>
  <official_title>Effectiveness and Toxicity of a Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the outcomes of patients treated with an high dose&#xD;
      radiation regimen using either stereotactic hypofractionated or normofractionated&#xD;
      radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a&#xD;
      desired result or effect) and safety in this setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Groups:&#xD;
&#xD;
      If the patient found to be eligible to take part in this study, the patient will be assigned&#xD;
      to a study group based on the size of the lesion(s) and the discretion of the responsible&#xD;
      physician. Up to 71 patients will be enrolled in the study.&#xD;
&#xD;
      If the patient is treated with standard radiotherapy, the patient will receive 25 fractions&#xD;
      of 2 Gy to the metastases, the treatment duration will be 5 weeks.&#xD;
&#xD;
      If the patient is treated with image-guided hypofractionated radiotherapy, the patient will&#xD;
      receive 3 fractions of 10 Gy to the metastases, the treatment duration will be 1 week.&#xD;
&#xD;
      Radiation Planning and Treatment:&#xD;
&#xD;
      During all radiation treatments, the images that are taken during the treatment will be&#xD;
      closely analyzed after treatment is over. The patient will have 3 to 25 radiation treatments&#xD;
      per metastasis depending on the discretion of the responsible physician.&#xD;
&#xD;
      The rest of the radiation treatment planning and treatment delivery appointments will be&#xD;
      unchanged. The dose given to the tumor and number of treatments the patient will receive,&#xD;
      will be determined by the discretion of the responsible physician, and is not affected by&#xD;
      taking part in this study.&#xD;
&#xD;
      Follow-Up Visits:&#xD;
&#xD;
      After the radiation treatment schedule ends, the patient will return for follow-up visits at&#xD;
      the following time points:&#xD;
&#xD;
        -  At 3 months&#xD;
&#xD;
        -  Then, every 3 months for 1 year, and then&#xD;
&#xD;
        -  1 time a year after that, for as long as possible Additional follow up visits may be&#xD;
           scheduled, if the responsible physician thinks they are needed.&#xD;
&#xD;
      At these visits, the following tests and procedures will be performed:&#xD;
&#xD;
        -  Any updates to the medical history of the patient will be recorded and the patient will&#xD;
           be asked about any side effects the patient may be having.&#xD;
&#xD;
        -  The patient's performance status will be recorded.&#xD;
&#xD;
        -  The patient's complete symptom questionnaires will be reviewed.&#xD;
&#xD;
        -  The patient will have a clinical examination&#xD;
&#xD;
        -  The patient will have follow-up imaging (such as an MRI) to check the status of the&#xD;
           disease.&#xD;
&#xD;
      This is an observational study. Radiation therapy is delivered using CE-certified and&#xD;
      commercially available methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">August 2021</completion_date>
  <primary_completion_date type="Actual">October 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Late Toxicity at year 2 after ablatvie radiotherapy</measure>
    <time_frame>24 months after therapy</time_frame>
    <description>The toxicity will be scored (CTCAE 4.03) at each follow up visit, the status will be recorded by clinical examination and radiological imaging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early toxicity</measure>
    <time_frame>until day 90 after start radiotherapy</time_frame>
    <description>The toxicity will be scored (CTCAE 4.03) at 3 months follow up visit, the status will be recorded by clinical examination and radiological imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QLQ-C30 and QLQ-PR25) during Follow-up</measure>
    <time_frame>24 months after end of therapy</time_frame>
    <description>QoL will be assessed with the QoL-Questionaires QLQ-C30 and QLQ-PR25 at baseline, 3, 12 and 24 months after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local control of irradiated tumor manifestations</measure>
    <time_frame>24 months after end of therapy</time_frame>
    <description>The tumor response will be evaluated (RECIST) at follow up visit 3,12 and 24 months after end of treatment, the status will be recorded by clinical examination and radiological imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapy-free survival</measure>
    <time_frame>24 months after end of therapy</time_frame>
    <description>Therapy-free survival will be assessed as time from start of radiation to start of systemic treatment or androgen deprivation. The status will be assessed at each follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA relapse-free survival</measure>
    <time_frame>24 months after end of therapy</time_frame>
    <description>PSA relapse-free survival will be assessed as time from start of radiation to PSA-rise more than 20% above baseline. PSA - value will be assessed by blood testing.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">73</enrollment>
  <condition>Oligometastatic Disease</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>normal fractionated irradiation</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>hypo fractionated irradiation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>normal fractionated irradiation</intervention_name>
    <description>25*2 Gy (once a day, 5 days a week)</description>
    <arm_group_label>normal fractionated irradiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>hypo fractionated irradiation</intervention_name>
    <description>3*10 Gy (once a day, 2-3 days a week)</description>
    <arm_group_label>hypo fractionated irradiation</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood before therapy, at the end of radiotherapy, three months after the end of radiotherapy&#xD;
      and at progress before starting further treatment&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with oligometastases (1-5) and state after local therapy of prostate cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with good general condition (WHO 0-1)&#xD;
&#xD;
          -  No comorbidities which limit the further life expectancy of the patient to &lt;5 years&#xD;
             (opinion of the physician)&#xD;
&#xD;
          -  Histologically confirmed prostate cancer&#xD;
&#xD;
          -  State after definitive local therapy, such as radical prostatectomy or definitive&#xD;
             radiotherapy (even after neo-/-adjuvant hormone therapy, after postoperative&#xD;
             radiotherapy)&#xD;
&#xD;
          -  PSA relapse after primary therapy or radiological unique metastasis, present complete&#xD;
             staging (up to 8 weeks old) by CT thorax/ abdomen/ pelvis and bone scan alternatively&#xD;
             a hybrid imaging PET (positron emission tomography) (acetate PET, PET-PSMA, NAFL-PET)&#xD;
             and CT / MRI is sufficient&#xD;
&#xD;
          -  Imaging detection of individual metastases (up to 5, depending on the situation) that&#xD;
             a Radiation therapy are available (histological confirmation of the MET is not&#xD;
             required)&#xD;
&#xD;
          -  No parallel participation to further clinical therapeutic trials to 4 weeks and after&#xD;
             radiation&#xD;
&#xD;
          -  Consent of the patient and written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe comorbidity which limit the further life expectancy of the patient to &lt;5 years&#xD;
             (opinion of the physician)&#xD;
&#xD;
          -  PSA in PSA relapse&gt; 10ng/ml&#xD;
&#xD;
          -  Ongoing androgen deprivation at the time of study inclusion&#xD;
&#xD;
          -  not been carried out local therapy&#xD;
&#xD;
          -  no histological confirmation of prostate cancer&#xD;
&#xD;
          -  lack of compliance&#xD;
&#xD;
          -  absence of consent of the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Hölscher, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology</name>
      <address>
        <city>Tübingen</city>
        <zip>72016</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technische Universität Dresden</investigator_affiliation>
    <investigator_full_name>Tobias Hölscher</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Oligometastatic Disease</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Stereotactic Radiotherapy</keyword>
  <keyword>androgensensitive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT02264379
org study id: STR - Oli-P - 2014
nct id: NCT02264379
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the outcomes of patients treated with an high dose
      radiation regimen using either stereotactic hypofractionated or normofractionated
      radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a
      desired result or effect) and safety in this setting.
Study Groups:

      If the patient found to be eligible to take part in this study, the patient will be assigned
      to a study group based on the size of the lesion(s) and the discretion of the responsible
      physician. Up to 71 patients will be enrolled in the study.

      If the patient is treated with standard radiotherapy, the patient will receive 25 fractions
      of 2 Gy to the metastases, the treatment duration will be 5 weeks.

      If the patient is treated with image-guided hypofractionated radiotherapy, the patient will
      receive 3 fractions of 10 Gy to the metastases, the treatment duration will be 1 week.

      Radiation Planning and Treatment:

      During all radiation treatments, the images that are taken during the treatment will be
      closely analyzed after treatment is over. The patient will have 3 to 25 radiation treatments
      per metastasis depending on the discretion of the responsible physician.

      The rest of the radiation treatment planning and treatment delivery appointments will be
      unchanged. The dose given to the tumor and number of treatments the patient will receive,
      will be determined by the discretion of the responsible physician, and is not affected by
      taking part in this study.

      Follow-Up Visits:

      After the radiation treatment schedule ends, the patient will return for follow-up visits at
      the following time points:

        -  At 3 months

        -  Then, every 3 months for 1 year, and then

        -  1 time a year after that, for as long as possible Additional follow up visits may be
           scheduled, if the responsible physician thinks they are needed.

      At these visits, the following tests and procedures will be performed:

        -  Any updates to the medical history of the patient will be recorded and the patient will
           be asked about any side effects the patient may be having.

        -  The patient's performance status will be recorded.

        -  The patient's complete symptom questionnaires will be reviewed.

        -  The patient will have a clinical examination

        -  The patient will have follow-up imaging (such as an MRI) to check the status of the
           disease.

      This is an observational study. Radiation therapy is delivered using CE-certified and
      commercially available methods.
observational model: Case-Control
time perspective: Prospective
measure: Late Toxicity at year 2 after ablatvie radiotherapy
time frame: 24 months after therapy
description: The toxicity will be scored (CTCAE 4.03) at each follow up visit, the status will be recorded by clinical examination and radiological imaging.
measure: Early toxicity
time frame: until day 90 after start radiotherapy
description: The toxicity will be scored (CTCAE 4.03) at 3 months follow up visit, the status will be recorded by clinical examination and radiological imaging.
measure: Quality of life (QLQ-C30 and QLQ-PR25) during Follow-up
time frame: 24 months after end of therapy
description: QoL will be assessed with the QoL-Questionaires QLQ-C30 and QLQ-PR25 at baseline, 3, 12 and 24 months after treatment.
measure: Local control of irradiated tumor manifestations
time frame: 24 months after end of therapy
description: The tumor response will be evaluated (RECIST) at follow up visit 3,12 and 24 months after end of treatment, the status will be recorded by clinical examination and radiological imaging.
measure: Therapy-free survival
time frame: 24 months after end of therapy
description: Therapy-free survival will be assessed as time from start of radiation to start of systemic treatment or androgen deprivation. The status will be assessed at each follow-up visit.
measure: PSA relapse-free survival
time frame: 24 months after end of therapy
description: PSA relapse-free survival will be assessed as time from start of radiation to PSA-rise more than 20% above baseline. PSA - value will be assessed by blood testing.
arm group label: normal fractionated irradiation
arm group label: hypo fractionated irradiation
intervention type: Radiation
intervention name: normal fractionated irradiation
description: 25*2 Gy (once a day, 5 days a week)
arm group label: normal fractionated irradiation
intervention type: Radiation
intervention name: hypo fractionated irradiation
description: 3*10 Gy (once a day, 2-3 days a week)
arm group label: hypo fractionated irradiation
Blood before therapy, at the end of radiotherapy, three months after the end of radiotherapy
      and at progress before starting further treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tobias Hölscher, Dr.
role: Principal Investigator
affiliation: Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technische Universität Dresden
investigator full name: Tobias Hölscher
investigator title: Dr.
mesh term: Prostatic Neoplasms
sharing ipd: No