<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/NCT02978014</url>
  </required_header>
  <id_info>
    <org_study_id>CCR 4359</org_study_id>
    <nct_id>NCT02978014</nct_id>
  </id_info>
  <brief_title>A Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy</brief_title>
  <acronym>POPS</acronym>
  <official_title>A Randomised Controlled Phase II Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Cancer Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Marsden NHS Foundation 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>
      A two-arm randomised controlled trial in patients receiving post-prostatectomy radiotherapy&#xD;
      in the adjuvant or salvage setting, with patients randomised to receive daily ProSpare&#xD;
      (obturator) guided IMRT or Centre standard (non-obturator) guided IMRT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgery to remove the prostate gland is one of the ways of treating prostate cancer. Some&#xD;
      patients receive radiotherapy after surgery if the cancer may not have been completely&#xD;
      removed. Radiotherapy to the area where the prostate was can cause side effects, which can&#xD;
      cause bowel and bladder symptoms as well as reducing sexual function.&#xD;
&#xD;
      Radiotherapy alone is also a standard treatment for prostate cancer. At the Royal Marsden&#xD;
      Hospital and Institute of Cancer Research the investigators have designed and patented a&#xD;
      device called ProSpare to improve the accuracy of radiotherapy. The device has already been&#xD;
      developed and tested in over 80 patients having prostate radiotherapy and was well tolerated.&#xD;
      Treatment accuracy was improved and the radiation dose to the rectum was reduced. Patients&#xD;
      have given very valuable feedback and comments about ProSpare's design and use, which the&#xD;
      investigators have incorporated in the final design. It is now important to test ProSpare in&#xD;
      a multi-centre randomised controlled trial. The investigators aim to determine whether&#xD;
      ProSpare will reduce the side effects reported by patients having radiotherapy after&#xD;
      prostatectomy.&#xD;
&#xD;
      The ProSpare device is inserted by the patient into the rectum for each daily radiotherapy&#xD;
      treatment. The disposable device stays in place for about 15 minutes each day. The curve in&#xD;
      the device is designed to follow the shape of the rectum and it stays in the correct place by&#xD;
      securely locating in the anal sphincter. ProSpare contains small &quot;markers&quot; - steel ball&#xD;
      bearings - which can be &quot;seen&quot; on the standard scans taken before a radiotherapy treatment.&#xD;
      Treatment is adjusted before each daily treatment to account for patient movement and&#xD;
      radiotherapy set-up variation. As a result, treatment is more accurate than using the&#xD;
      standard methods of radiotherapy localisation. This means the radiotherapy &quot;safety margins&quot;&#xD;
      which are placed around the prostate bed can be reduced. The dose to the rectum and bladder&#xD;
      as well as the structures that are associated with erectile function will be reduced. This&#xD;
      may lead to an improvement in the side effects caused by radiotherapy.&#xD;
&#xD;
      Other ways to identify the treatment target area for such image guided radiotherapy (IGRT)&#xD;
      includes the insertion of fiducial markers - usually in the form of gold seeds into the&#xD;
      prostate or prostate bed. This has become standard practice in some radiotherapy centres for&#xD;
      prostate radiotherapy but is technically complex for prostate bed radiotherapy and not&#xD;
      routinely used. ProSpare has the additional advantage of being non-invasive and without the&#xD;
      risk of infection associated with fiducial insertion.&#xD;
&#xD;
      Patients will be randomly selected to either have standard treatment or use ProSpare daily&#xD;
      with adjusted set-up margins. During and after treatment, patients will be asked questions&#xD;
      and given questionnaires to complete, asking about bowel, urinary and sexual function. The&#xD;
      investigators will look at the results in each group and see if treatment with ProSpare has a&#xD;
      benefit in improving the side effects from radiotherapy. If a benefit is seen, the aim will&#xD;
      be for ProSpare guided radiotherapy to become part of the standard treatment for prostate bed&#xD;
      radiotherapy nationally and internationally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EPIC Bowel Scores for Bowel, Urinary and Sexual domains</measure>
    <time_frame>Two years</time_frame>
    <description>Difference between groups in EPIC scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life measures</measure>
    <time_frame>Two and Five years</time_frame>
    <description>Six Patient Reported Outcome Measure (PROM) questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosimetric analysis</measure>
    <time_frame>Two years</time_frame>
    <description>Analysis of dose/toxicity axis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">245</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>ProSpare Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ProSpare (obturator) image guided IMRT (i.e. radiotherapy administered to patients with the ProSpare device inserted in the rectum)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-ProSpare Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care (non-obturator) image guided IMRT (i.e. radiotherapy administered to patients without the ProSpare device inserted in the rectum)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProSpare</intervention_name>
    <description>A novel rectal obturator (ProSpare) acting as a non-invasive daily on-line image guided tool, a rectal spacer and a prostate bed stabiliser</description>
    <arm_group_label>ProSpare Arm</arm_group_label>
    <other_name>Rectal obturator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Patient has undergone radical prostatectomy&#xD;
&#xD;
          2. Histologically confirmed prostatic cancer&#xD;
&#xD;
          3. Patient due to receive post-operative prostate bed radiotherapy either in the adjuvant&#xD;
             or salvage* setting&#xD;
&#xD;
          4. WHO performance status 0-1 at randomization&#xD;
&#xD;
          5. Age &gt; 18 years&#xD;
&#xD;
          6. Written informed consent&#xD;
&#xD;
          7. Able to independently complete patient questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lymph node or distant metastases from prostate cancer&#xD;
&#xD;
          2. Prior pelvic radiotherapy&#xD;
&#xD;
          3. Previous invasive cancer in the past 3 years, with the exception of non-melanoma skin&#xD;
             cancer&#xD;
&#xD;
          4. Symptomatic haemorrhoids or other anal conditions which affect adequate insertion and&#xD;
             retention of the rectal obturator&#xD;
&#xD;
          5. Planned chemotherapy within 2 months of completion of adjuvant or salvage radiotherapy&#xD;
&#xD;
          6. Musculoskeletal conditions which limit flexibility or mobility and will make patient&#xD;
             self insertion of ProSpare™ difficult&#xD;
&#xD;
          7. Comorbid conditions likely to impact on advisability of prostate bed radiotherapy&#xD;
             (e.g. inflammatory bowel disease, previous colorectal surgery, significant bladder&#xD;
             instability or urinary incontinence)&#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>Dr Julia Murray</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden Hospital / Institute of Cancer Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sijy Pillai</last_name>
    <phone>+44 208 915 6666</phone>
    <email>POPS@rmh.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beacon Centre, Musgrove Park Hospital</name>
      <address>
        <city>Taunton</city>
        <state>Somerset</state>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dr Emma Gray</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sijy Pillai</last_name>
      <phone>+44 208 915 6666</phone>
      <email>POPS@rmh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Dr Julia Murray</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Yvonne Rimmer</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital NHS Foundation Trust</name>
      <address>
        <city>Guildford</city>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Chee Goh</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>East Suffolk and North Essex NHS Trust</name>
      <address>
        <city>Ipswich</city>
        <zip>IP4 5PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Christopher Scrase</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Reena Davda</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Free Hampstead NHS Trust</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dr Sarah Needleman</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHSFT</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sijy Pillai</last_name>
      <email>POPS@rmh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>East and North Hertfordshire NHS Trust, Mount Vernon Cancer Centre</name>
      <address>
        <city>Middlesex</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof Peter Hoskin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospital NHSFT</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Jenny Nobes</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>April 16, 2021</last_update_submitted>
  <last_update_submitted_qc>April 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Obturator</keyword>
  <keyword>Toxicity</keyword>
  <keyword>Bowel</keyword>
  <keyword>Urinary</keyword>
  <keyword>Sexual</keyword>
  <keyword>PROM</keyword>
  <keyword>EPIC</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>
    <ipd_description>We have not made a plan to share IPD at this stage but will finalise this following the first meeting of the Trial Management Group in Spring 2017</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/NCT02978014
org study id: CCR 4359
nct id: NCT02978014
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A two-arm randomised controlled trial in patients receiving post-prostatectomy radiotherapy
      in the adjuvant or salvage setting, with patients randomised to receive daily ProSpare
      (obturator) guided IMRT or Centre standard (non-obturator) guided IMRT.
Surgery to remove the prostate gland is one of the ways of treating prostate cancer. Some
      patients receive radiotherapy after surgery if the cancer may not have been completely
      removed. Radiotherapy to the area where the prostate was can cause side effects, which can
      cause bowel and bladder symptoms as well as reducing sexual function.

      Radiotherapy alone is also a standard treatment for prostate cancer. At the Royal Marsden
      Hospital and Institute of Cancer Research the investigators have designed and patented a
      device called ProSpare to improve the accuracy of radiotherapy. The device has already been
      developed and tested in over 80 patients having prostate radiotherapy and was well tolerated.
      Treatment accuracy was improved and the radiation dose to the rectum was reduced. Patients
      have given very valuable feedback and comments about ProSpare's design and use, which the
      investigators have incorporated in the final design. It is now important to test ProSpare in
      a multi-centre randomised controlled trial. The investigators aim to determine whether
      ProSpare will reduce the side effects reported by patients having radiotherapy after
      prostatectomy.

      The ProSpare device is inserted by the patient into the rectum for each daily radiotherapy
      treatment. The disposable device stays in place for about 15 minutes each day. The curve in
      the device is designed to follow the shape of the rectum and it stays in the correct place by
      securely locating in the anal sphincter. ProSpare contains small "markers" - steel ball
      bearings - which can be "seen" on the standard scans taken before a radiotherapy treatment.
      Treatment is adjusted before each daily treatment to account for patient movement and
      radiotherapy set-up variation. As a result, treatment is more accurate than using the
      standard methods of radiotherapy localisation. This means the radiotherapy "safety margins"
      which are placed around the prostate bed can be reduced. The dose to the rectum and bladder
      as well as the structures that are associated with erectile function will be reduced. This
      may lead to an improvement in the side effects caused by radiotherapy.

      Other ways to identify the treatment target area for such image guided radiotherapy (IGRT)
      includes the insertion of fiducial markers - usually in the form of gold seeds into the
      prostate or prostate bed. This has become standard practice in some radiotherapy centres for
      prostate radiotherapy but is technically complex for prostate bed radiotherapy and not
      routinely used. ProSpare has the additional advantage of being non-invasive and without the
      risk of infection associated with fiducial insertion.

      Patients will be randomly selected to either have standard treatment or use ProSpare daily
      with adjusted set-up margins. During and after treatment, patients will be asked questions
      and given questionnaires to complete, asking about bowel, urinary and sexual function. The
      investigators will look at the results in each group and see if treatment with ProSpare has a
      benefit in improving the side effects from radiotherapy. If a benefit is seen, the aim will
      be for ProSpare guided radiotherapy to become part of the standard treatment for prostate bed
      radiotherapy nationally and internationally.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: EPIC Bowel Scores for Bowel, Urinary and Sexual domains
time frame: Two years
description: Difference between groups in EPIC scores
measure: Quality of Life measures
time frame: Two and Five years
description: Six Patient Reported Outcome Measure (PROM) questionnaires
measure: Dosimetric analysis
time frame: Two years
description: Analysis of dose/toxicity axis
arm group label: ProSpare Arm
arm group type: Experimental
description: ProSpare (obturator) image guided IMRT (i.e. radiotherapy administered to patients with the ProSpare device inserted in the rectum)
arm group label: Non-ProSpare Arm
arm group type: No Intervention
description: Standard of Care (non-obturator) image guided IMRT (i.e. radiotherapy administered to patients without the ProSpare device inserted in the rectum)
intervention type: Device
intervention name: ProSpare
description: A novel rectal obturator (ProSpare) acting as a non-invasive daily on-line image guided tool, a rectal spacer and a prostate bed stabiliser
arm group label: ProSpare Arm
other name: Rectal obturator
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Julia Murray
role: Principal Investigator
affiliation: Royal Marsden Hospital / Institute of Cancer Research
last name: Sijy Pillai
phone: +44 208 915 6666
email: POPS@rmh.nhs.uk
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
ipd description: We have not made a plan to share IPD at this stage but will finalise this following the first meeting of the Trial Management Group in Spring 2017