<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/NCT03011606</url>
  </required_header>
  <id_info>
    <org_study_id>9211QM</org_study_id>
    <nct_id>NCT03011606</nct_id>
  </id_info>
  <brief_title>Robotic Surgery After Focal Ablation Therapy</brief_title>
  <acronym>RAFT</acronym>
  <official_title>Robotic Surgery After Focal Ablation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The toxicity of traditional prostate cancer therapies including radical surgery and external&#xD;
      beam radiation is well known. This has prompted a move towards focal therapy where only the&#xD;
      cancerous part of the prostate is treated.&#xD;
&#xD;
      To date, studies have demonstrated very promising outcomes following focal therapy with the&#xD;
      majority of men maintaining their urinary and sexual function after therapy.&#xD;
&#xD;
      In a small proportion of men, disease recurs after focal therapy. The optimal treatment for&#xD;
      men with recurrent disease after focal therapy is yet to be defined. Patients may undergo&#xD;
      further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland&#xD;
      therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU)&#xD;
      or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate&#xD;
      is removed.&#xD;
&#xD;
      To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after&#xD;
      focal therapy has not been formally studied.&#xD;
&#xD;
      Traditionally, the side effects of surgery and radiation therapy performed in patients that&#xD;
      have already undergone previous prostate cancer treatment have been considerable with high&#xD;
      rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a&#xD;
      significant area of the prostate untreated, the investigators believe surgery after focal&#xD;
      prostate therapy will be associated with a much lower incidence of urinary and sexual&#xD;
      dysfunction.&#xD;
&#xD;
      The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in&#xD;
      men that have undergone prior focal ablation therapy. In addition, the investigators wish to&#xD;
      perform a number of basic science studies to attempt to better understand why the patient has&#xD;
      experienced recurrent prostate cancer after focal therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">October 21, 2019</completion_date>
  <primary_completion_date type="Actual">October 21, 2019</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>Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V)</measure>
    <time_frame>Up to 12 months following surgical procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Toxicity profile prior to surgery</measure>
    <time_frame>Prior to surgery (at -6 to 0 weeks screening visit)</time_frame>
    <description>This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed prior to surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toxicity profile following surgery</measure>
    <time_frame>Up to 12 months following surgery</time_frame>
    <description>This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed at 3-monthly intervals for 12 months following surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oncological outcome</measure>
    <time_frame>Up to 12 months following surgical procedure</time_frame>
    <description>Will be quantified using Biochemical-free survival. Biochemical recurrence after surgery will be defined according to American Urological Association (AUA) guidance e.g. a post-surgical serum Prostate Specific Antigen (PSA) &gt;=0.2 on 2 separate occasions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oncological outcome</measure>
    <time_frame>Up to 12 months following surgical procedure</time_frame>
    <description>Will be quantified using need for androgen-ablation therapy. Androgen ablation therapy will include the commencement of Bicalutamide or Goserelin therapy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Robotic surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm. All Registered patients will undergo robotic surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic Surgery</intervention_name>
    <description>Robotic Surgery after Focal Ablation Therapy</description>
    <arm_group_label>Robotic surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Willingness to provide informed consent&#xD;
&#xD;
          2. Males aged 18 years and over&#xD;
&#xD;
          3. Histological confirmed recurrent/residual adenocarcinoma of the prostate with Gleason&#xD;
             score following primary focal prostate cancer ablation therapy. Biopsy must have been&#xD;
             performed within 6 months of screening for the study&#xD;
&#xD;
          4. Prior focal ablation therapy using either High Intensity Focused Ultrasound (HIFU),&#xD;
             Cryotherapy, brachytherapy, electroporation or Photodynamic therapy&#xD;
&#xD;
          5. Serum Prostate Specific Antigen (PSA) must be below 20&#xD;
&#xD;
          6. Absence of metastatic disease&#xD;
&#xD;
          7. Life expectancy ≥ 10 years&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          9. MRI imaging to suggest urinary sphincter has not been incorporated in prior ablation&#xD;
             therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious co-existing medical illness such as chronic active autoimmune disease (within&#xD;
             the last 6 months).&#xD;
&#xD;
          2. Other active malignancy over the last 5 years that has required systemic therapy&#xD;
             excluding:&#xD;
&#xD;
               1. Adjuvant therapy in the curative setting&#xD;
&#xD;
               2. Non-melanoma skin cancer&#xD;
&#xD;
               3. superficial transitional cell carcinoma&#xD;
&#xD;
          3. No willingness to comply with the procedural requirements of this protocol&#xD;
&#xD;
          4. Coagulopathy/ Cirrhosis&#xD;
&#xD;
          5. Severe obesity defined as a BMI greater than 45&#xD;
&#xD;
          6. Inability to tolerate general anaesthesia&#xD;
&#xD;
          7. Prior pelvic fracture&#xD;
&#xD;
          8. Extensive tethering of the rectum caused by prior ablation therapy&#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>Paul Cathcart</last_name>
    <role>Study Chair</role>
    <affiliation>Queen Mary University London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guys and St Thomas' Hospital, London</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 28, 2015</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate</keyword>
  <keyword>ablation</keyword>
  <keyword>focal</keyword>
  <keyword>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/NCT03011606
org study id: 9211QM
nct id: NCT03011606
lead sponsor: 
has dmc: No
The toxicity of traditional prostate cancer therapies including radical surgery and external
      beam radiation is well known. This has prompted a move towards focal therapy where only the
      cancerous part of the prostate is treated.

      To date, studies have demonstrated very promising outcomes following focal therapy with the
      majority of men maintaining their urinary and sexual function after therapy.

      In a small proportion of men, disease recurs after focal therapy. The optimal treatment for
      men with recurrent disease after focal therapy is yet to be defined. Patients may undergo
      further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland
      therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU)
      or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate
      is removed.

      To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after
      focal therapy has not been formally studied.

      Traditionally, the side effects of surgery and radiation therapy performed in patients that
      have already undergone previous prostate cancer treatment have been considerable with high
      rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a
      significant area of the prostate untreated, the investigators believe surgery after focal
      prostate therapy will be associated with a much lower incidence of urinary and sexual
      dysfunction.

      The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in
      men that have undergone prior focal ablation therapy. In addition, the investigators wish to
      perform a number of basic science studies to attempt to better understand why the patient has
      experienced recurrent prostate cancer after focal therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V)
time frame: Up to 12 months following surgical procedure
measure: Toxicity profile prior to surgery
time frame: Prior to surgery (at -6 to 0 weeks screening visit)
description: This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed prior to surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.
measure: Toxicity profile following surgery
time frame: Up to 12 months following surgery
description: This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed at 3-monthly intervals for 12 months following surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.
measure: Oncological outcome
time frame: Up to 12 months following surgical procedure
description: Will be quantified using Biochemical-free survival. Biochemical recurrence after surgery will be defined according to American Urological Association (AUA) guidance e.g. a post-surgical serum Prostate Specific Antigen (PSA) >=0.2 on 2 separate occasions.
measure: Oncological outcome
time frame: Up to 12 months following surgical procedure
description: Will be quantified using need for androgen-ablation therapy. Androgen ablation therapy will include the commencement of Bicalutamide or Goserelin therapy.
arm group label: Robotic surgery
arm group type: Experimental
description: Single arm. All Registered patients will undergo robotic surgery
intervention type: Procedure
intervention name: Robotic Surgery
description: Robotic Surgery after Focal Ablation Therapy
arm group label: Robotic surgery
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Cathcart
role: Study Chair
affiliation: Queen Mary University London
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms