<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/NCT03253978</url>
  </required_header>
  <id_info>
    <org_study_id>14190SJ-SS</org_study_id>
    <nct_id>NCT03253978</nct_id>
  </id_info>
  <brief_title>SPORT High-Risk Trial Evaluating SABR in Prostate Cancer</brief_title>
  <acronym>SPORT</acronym>
  <official_title>A Randomised Feasibility Study Evaluating Stereotactic Prostate Radiotherapy In High-Risk Localised Prostate Cancer With or Without Elective Nodal Irradiation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Belfast Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Belfast Health and Social Care Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to&#xD;
      deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the&#xD;
      effect of SABR on levels of markers of radiation exposure and bowel damage, along with other&#xD;
      potential markers of outcome and side effects. Quality of life and any side effects that&#xD;
      develop during and after treatment will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to&#xD;
      deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the&#xD;
      effect of SABR on levels of markers of radiation exposure and bowel damage, along with other&#xD;
      potential markers of outcome and side effects. Quality of life and any side effects that&#xD;
      develop during and after treatment will also be assessed.&#xD;
&#xD;
      Participants will be treated with five treatments (instead of the standard 37). This is more&#xD;
      convenient for them and also allows the treatment of many more people in the same time frame,&#xD;
      which should improve the timely delivery of radiotherapy for all patients.&#xD;
&#xD;
      Thirty men with high-risk prostate cancer will be enrolled into the study. They will all be&#xD;
      treated with hormone therapy and radiotherapy to the prostate and seminal vesicles. In&#xD;
      addition, half of the men will receive an additional dose of radiation to their pelvis. Gold&#xD;
      markers will be placed in the prostate before radiotherapy to allow precise targeting of the&#xD;
      prostate during treatment. CT scans are taken before and after each treatment to ensure the&#xD;
      accuracy of its delivery.&#xD;
&#xD;
      Blood urine and prostate tissue samples will be taken before, during and after radiotherapy.&#xD;
      Side effects and quality of life will also by assessed during this time.&#xD;
&#xD;
      Ultimately, this may allow us to predict which men are at increased risk of side effects from&#xD;
      radiotherapy and allow closer monitoring, earlier intervention and perhaps alternative&#xD;
      treatments in some cases. This should improve the control of prostate cancer and reduce the&#xD;
      risk of serious treatment-related side effects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 18, 2016</start_date>
  <completion_date type="Anticipated">April 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A randomised feasibility study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Not applicable - no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adequate recruitment rate</measure>
    <time_frame>24 months</time_frame>
    <description>adequate recruitment rate (30 patients in 24 months)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute toxicity of SABR</measure>
    <time_frame>90 days of completion of SABR</time_frame>
    <description>Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute quality of life during and after SABR</measure>
    <time_frame>90 days after completion of SABR</time_frame>
    <description>Acute quality of life during and after SABR (as assessed by EPIC and IPSS scores until 90 days after completion of SABR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of SABR plans delivered as planned and on schedule</measure>
    <time_frame>29 days (treatment period)</time_frame>
    <description>Number of SABR plans delivered as planned and on schedule</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of acute toxicity in each treatment group</measure>
    <time_frame>until 90 days post completion of radiotherapy</time_frame>
    <description>Quantification of acute toxicity in each treatment group to enable calculation of the sample size for the Phase II RCT (using CTCAE v4.03 scores measured until 90days post completion of radiotherapy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late toxicity of SABR</measure>
    <time_frame>from 90 days and up to ten years post completion of SABR</time_frame>
    <description>Late toxicity of SABR (as assessed by GI and GU RTOG late toxicity scores from 90 days to ten years post completion of SABR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late patient-reported quality of life</measure>
    <time_frame>up to ten years post completion of SABR</time_frame>
    <description>Late patient-reported quality of life (as assessed by EPIC and IPSS scores from 90 days to ten years post completion of SABR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of PSA failure</measure>
    <time_frame>up to ten years post completion of SABR</time_frame>
    <description>Rate of PSA failure as assessed by Phoenix criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate cancer-specific survival</measure>
    <time_frame>up to ten years post completion of SABR</time_frame>
    <description>Prostate cancer-specific survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to ten years post completion of SABR</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>SABR to prostate / seminal vesicles with pelvic ENI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36.25Gy / 5 fractions to prostate and seminal vesicles with additional SABR (25Gy /5 fractions) delivered to the pelvic nodes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SABR to prostate and seminal vesicles only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>36.25Gy / 5 fractions to prostate and seminal vesicles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotatic Radiotherapy</intervention_name>
    <description>SABR to prostate / seminal nodes</description>
    <arm_group_label>SABR to prostate / seminal vesicles with pelvic ENI</arm_group_label>
    <arm_group_label>SABR to prostate and seminal vesicles only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with histologically confirmed prostate adenocarcinoma who elect for radical&#xD;
        radiotherapy, with at least one of the following features:&#xD;
&#xD;
          -  clinical stage T3a N0 M0&#xD;
&#xD;
          -  Gleason score 7 (4+3) or above&#xD;
&#xD;
          -  PSA &gt; 20&#xD;
&#xD;
        No evidence of nodal or distant metastatic disease&#xD;
&#xD;
        WHO performance status 0-2&#xD;
&#xD;
        Life expectancy of at least 5 years&#xD;
&#xD;
        Men greater than or equal to 18 years&#xD;
&#xD;
        Ability to understand and willingness to sign a written informed consent document&#xD;
        (completed prior to registration and subsequent randomization), along with willingness to&#xD;
        co-operate with follow-up&#xD;
&#xD;
        Planned to receive 12-36 months of ADT as part of standard treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        T stage greater than or equal to T3b / T4&#xD;
&#xD;
        Prostate volume &gt; 90cc&#xD;
&#xD;
        Current evidence of:&#xD;
&#xD;
          -  inflammatory bowel disease or other chronic bowel disorder&#xD;
&#xD;
          -  Autoimmune disease&#xD;
&#xD;
          -  Active uncontrolled bacterial, viral or fungal infection&#xD;
&#xD;
          -  Serious uncontrolled concomitant disease&#xD;
&#xD;
          -  Known coagulopathy or bleeding diasthesis&#xD;
&#xD;
          -  Anticoagulation medication (if unsafe to insert for seed insertion)&#xD;
&#xD;
          -  Bilateral hip prosthesis or fixation which would interfere with standard radiation&#xD;
             beam configuration&#xD;
&#xD;
          -  Concurrent experimental or cytotoxic drugs&#xD;
&#xD;
          -  Allergy to gold&#xD;
&#xD;
          -  Severe lower urinary tract symptoms - International Prostate Symptom Score (IPSS) &gt; 19&#xD;
&#xD;
          -  Any other contra-indication to hormonal therapy or radical radiotherapy.&#xD;
&#xD;
        History of:&#xD;
&#xD;
          -  Previous major abdominal surgery or history of bowel adhesions&#xD;
&#xD;
          -  Prior pelvic radiotherapy&#xD;
&#xD;
          -  Active malignancy within the preceding five years (other than basal cell carcinoma)&#xD;
&#xD;
        Evidence of:&#xD;
&#xD;
        - Castrate-resistance (rising PSA with castrate levels of testosterone on LHRHa and&#xD;
        anti-androgen)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Men with newly diagnosed high-risk localized prostate cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suneil Jain, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Belfast Health and Social Care Trust</name>
      <address>
        <city>Belfast</city>
        <state>Co. Antrim</state>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <ipd_description>We would welcome collaboration with other researchers as long as full ethical approval was granted</ipd_description>
  </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/NCT03253978
org study id: 14190SJ-SS
nct id: NCT03253978
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to
      deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the
      effect of SABR on levels of markers of radiation exposure and bowel damage, along with other
      potential markers of outcome and side effects. Quality of life and any side effects that
      develop during and after treatment will also be assessed.
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to
      deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the
      effect of SABR on levels of markers of radiation exposure and bowel damage, along with other
      potential markers of outcome and side effects. Quality of life and any side effects that
      develop during and after treatment will also be assessed.

      Participants will be treated with five treatments (instead of the standard 37). This is more
      convenient for them and also allows the treatment of many more people in the same time frame,
      which should improve the timely delivery of radiotherapy for all patients.

      Thirty men with high-risk prostate cancer will be enrolled into the study. They will all be
      treated with hormone therapy and radiotherapy to the prostate and seminal vesicles. In
      addition, half of the men will receive an additional dose of radiation to their pelvis. Gold
      markers will be placed in the prostate before radiotherapy to allow precise targeting of the
      prostate during treatment. CT scans are taken before and after each treatment to ensure the
      accuracy of its delivery.

      Blood urine and prostate tissue samples will be taken before, during and after radiotherapy.
      Side effects and quality of life will also by assessed during this time.

      Ultimately, this may allow us to predict which men are at increased risk of side effects from
      radiotherapy and allow closer monitoring, earlier intervention and perhaps alternative
      treatments in some cases. This should improve the control of prostate cancer and reduce the
      risk of serious treatment-related side effects
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: A randomised feasibility study
primary purpose: Treatment
masking: None (Open Label)
masking description: Not applicable - no masking
measure: Adequate recruitment rate
time frame: 24 months
description: adequate recruitment rate (30 patients in 24 months)
measure: Acute toxicity of SABR
time frame: 90 days of completion of SABR
description: Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR)
measure: Acute quality of life during and after SABR
time frame: 90 days after completion of SABR
description: Acute quality of life during and after SABR (as assessed by EPIC and IPSS scores until 90 days after completion of SABR)
measure: Number of SABR plans delivered as planned and on schedule
time frame: 29 days (treatment period)
description: Number of SABR plans delivered as planned and on schedule
measure: Quantification of acute toxicity in each treatment group
time frame: until 90 days post completion of radiotherapy
description: Quantification of acute toxicity in each treatment group to enable calculation of the sample size for the Phase II RCT (using CTCAE v4.03 scores measured until 90days post completion of radiotherapy)
measure: Late toxicity of SABR
time frame: from 90 days and up to ten years post completion of SABR
description: Late toxicity of SABR (as assessed by GI and GU RTOG late toxicity scores from 90 days to ten years post completion of SABR)
measure: Late patient-reported quality of life
time frame: up to ten years post completion of SABR
description: Late patient-reported quality of life (as assessed by EPIC and IPSS scores from 90 days to ten years post completion of SABR)
measure: Rate of PSA failure
time frame: up to ten years post completion of SABR
description: Rate of PSA failure as assessed by Phoenix criteria
measure: Prostate cancer-specific survival
time frame: up to ten years post completion of SABR
description: Prostate cancer-specific survival
measure: Overall survival
time frame: up to ten years post completion of SABR
description: Overall survival
arm group label: SABR to prostate / seminal vesicles with pelvic ENI
arm group type: Experimental
description: 36.25Gy / 5 fractions to prostate and seminal vesicles with additional SABR (25Gy /5 fractions) delivered to the pelvic nodes.
arm group label: SABR to prostate and seminal vesicles only
arm group type: Active Comparator
description: 36.25Gy / 5 fractions to prostate and seminal vesicles.
intervention type: Radiation
intervention name: Stereotatic Radiotherapy
description: SABR to prostate / seminal nodes
arm group label: SABR to prostate / seminal vesicles with pelvic ENI
arm group label: SABR to prostate and seminal vesicles only
criteria: 
gender: Male
gender based: Yes
gender description: Men with newly diagnosed high-risk localized prostate cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suneil Jain, Dr
role: Principal Investigator
affiliation: Chief Investigator
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
ipd description: We would welcome collaboration with other researchers as long as full ethical approval was granted