<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/NCT02968784</url>
  </required_header>
  <id_info>
    <org_study_id>PCa006</org_study_id>
    <nct_id>NCT02968784</nct_id>
  </id_info>
  <brief_title>Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer</brief_title>
  <official_title>Focal ExAblate™ MR-Guided Focused Ultrasound (MRgFUS) Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer (OC-IRPC): Evaluation of Safety and Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InSightec</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InSightec</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can&#xD;
      significantly postpone or eliminate the need of patients with organ confined intermediate&#xD;
      risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or&#xD;
      Radiation therapy) for their disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the proportion of patients with organ-confined intermediate risk&#xD;
      prostate cancer (OC-IRPC) undergoing focal ExAblate™ MRgFUS prostate treatment that will be&#xD;
      free of clinically significant PCa which requires definitive treatment at 2 years after&#xD;
      completion of their ExAblate™ treatment and to demonstrate the safety of focal ExAblate™&#xD;
      MRgFUS treatment.&#xD;
&#xD;
      Clinically significant PCa requiring definitive treatment is defined as pathology findings&#xD;
      from whole-gland, imaging-guided, extended mapping biopsy of Gleason Score (GS) &gt; 7&#xD;
&#xD;
      The primary efficacy endpoint in this trial, measured at 24 months with whole-gland extended&#xD;
      imaging-guided mapping biopsy, is Response scored dichotomously for each subject as follows:&#xD;
&#xD;
        -  Response = 0 (&quot;Failure&quot;): Positive mapping biopsy defined as Gleason Score &gt; 7&#xD;
           (indicating definitive treatment) in any part of their prostate gland&#xD;
&#xD;
        -  Response = 1 (&quot;Success&quot;): Negative mapping biopsy defined as Gleason Score &lt; 7.&#xD;
&#xD;
      Safety of ExAblate™ treatment will be determined by evaluation of the incidence and severity&#xD;
      of device related complications from the first treatment day visit throughout entire&#xD;
      follow-up duration.&#xD;
&#xD;
      All adverse events will be captured and recorded. However, the safety of the ExAblate™&#xD;
      treatment will be defined by the incidence and severity of treatment or device related&#xD;
      adverse events, grades III - V (CTCAE version 4.03; 2010-06-14).&#xD;
&#xD;
      Secondary Effectiveness Outcomes:&#xD;
&#xD;
        1. % of patients with negative 5-month follow-up biopsy results in the treated part of the&#xD;
           prostate&#xD;
&#xD;
        2. Treatment effect on patients' Quality of Life (QoL), the following validated&#xD;
           self-reported urogenital functioning assessment instruments will be used before and&#xD;
           following treatment at pre-specified intervals.&#xD;
&#xD;
             1. Urinary symptoms - IPSS&#xD;
&#xD;
             2. Urinary continence - ICIQ-UI-SF&#xD;
&#xD;
             3. Sexual function - IIEF-15&#xD;
&#xD;
        3. PSA levels and post-treatment PSA kinetics will also be assessed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor Decision&#xD;
  </why_stopped>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">February 2, 2023</completion_date>
  <primary_completion_date type="Actual">February 2, 2023</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>The primary efficacy endpoint in this trial measured with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously; success vs. failure</measure>
    <time_frame>24 months post treatment</time_frame>
    <description>Response will be based on mapping biopsy defined by Gleason 7 Score in any part of the prostate gland</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>24 months post treatment</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of patients with negative biopsy</measure>
    <time_frame>5 months post treatment</time_frame>
    <description>% of patients with negative 5-month follow-up biopsy results in the treated part of the prostate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life - urinary symptoms - IPSS questionnaire score</measure>
    <time_frame>24 months post treatment</time_frame>
    <description>Treatment effect on patients' Quality of Life (QoL), i.e., urinary symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life - urinary continence - ICIQ-SF questionnaire score</measure>
    <time_frame>24 months post treatment</time_frame>
    <description>Treatment effect on patients' Quality of Life, (QoL), i.e., urinary continence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life - sexual function - IIEF-15 questionnaire score</measure>
    <time_frame>24 months</time_frame>
    <description>Treatment effect on patients' Quality of Life, (QoL), i.e.,sexual function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Specific Antigen (PSA)</measure>
    <time_frame>24 months post treatment</time_frame>
    <description>PSA levels and post-treatment PSA kinetics will be assessed</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>ExAblate MRgFUS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 50% of the prostate gland will be treated. Treatment will include the Index lesion which is visible on MRI + tumor free margins of 3-mm; tumor free margins will not extend beyond the posterior aspect of the prostate capsule.&#xD;
Urethral and bilateral neurovascular bundle preservation will be preferred whenever clinically justified.&#xD;
Additional foci in the same hemisphere that are confirmed by biopsy and are &lt; Gleason Score 7 (up to 3+4 or 4+3) or suspected to be positive for malignancy based on multi parametric-MRI) will also be included in the treated volume, providing total treatment volume does not exceed 50% of the gland.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ExAblate MRgFUS</intervention_name>
    <description>ExAblate treatment of prostate cancer less than or equal to Grade 7</description>
    <arm_group_label>ExAblate MRgFUS</arm_group_label>
    <other_name>Focused Ultrasound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PSA ≤ 20 ng/ml&#xD;
&#xD;
          -  Histologically proven PCa on imaging-guided transrectal or transperineal extended&#xD;
             mapping biopsy&#xD;
&#xD;
          -  Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to&#xD;
             T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive&#xD;
             treatment, who may currently be on wtachful waiting or active surveillance and not in&#xD;
             need of imminent therapy&#xD;
&#xD;
          -  Gleason Score 7 (3+4 or 4+3) based on mapping prostate biopsy with no more than 15mm&#xD;
             cancer in maximal linear dimension in any single core&#xD;
&#xD;
          -  Single hemilateral index Gleason 7 lesion identified in the prostate based on biopsy&#xD;
             mapping with supporting MRI findings; may have secondary Gleason 6 lesion on&#xD;
             ipisilateral or contralateral side confirmed with biopsy and/or MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any Contraindication to MRI, such as: over-size limitations avoiding patient's&#xD;
             positioning in the bore of MRI scanner, claustrophobia, implanted ferromagnetic&#xD;
             materials or foreign objects, or known contraindication to utilization of MRI contrast&#xD;
             agent (e.g., Gadolinium/Magnevist)&#xD;
&#xD;
          -  History of prostatectomy, radiation therapy to the pelvis for any other malignancy,&#xD;
             brachytherapy, Cryotherapy, US-guided HIFU, orchiectomy, prostate photodynamic&#xD;
             therapy, or prostate cancer-specific chemotherapy&#xD;
&#xD;
          -  Patient under androgen deprivation therapy (ADT), alpha reductase inhibitors, and/or&#xD;
             other hormonal treatment within the past 6 months&#xD;
&#xD;
          -  Any rectal disease, pathology, anomaly, injury, previous treatment, or scarring which&#xD;
             could change acoustic properties of the rectal wall, or might prevent safe probe&#xD;
             insertion (e.g., inflammatory bowel disease, fistula, stenosis, fibrosis, or&#xD;
             symptomatic hemorrhoids&#xD;
&#xD;
          -  History of an invasive malignancy other than basal or squamous skin cancers in the&#xD;
             last 5 years&#xD;
&#xD;
          -  Existing urethral or bladder neck contracture/stricture&#xD;
&#xD;
          -  Prostatitis NIH categories I, II and III&#xD;
&#xD;
          -  Implant near (&lt;1cm) the prostate&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangeet Ghai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital of Shanghai</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital</name>
      <address>
        <city>London</city>
        <zip>W2 INY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>China</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Korea, Republic of</country>
  </removed_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>MRgFUS</keyword>
  <keyword>ExAblate</keyword>
  <keyword>Focused Ultrasound</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>Undecided</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/NCT02968784
org study id: PCa006
nct id: NCT02968784
lead sponsor: 
has dmc: No
This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can
      significantly postpone or eliminate the need of patients with organ confined intermediate
      risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or
      Radiation therapy) for their disease.
This study will evaluate the proportion of patients with organ-confined intermediate risk
      prostate cancer (OC-IRPC) undergoing focal ExAblate™ MRgFUS prostate treatment that will be
      free of clinically significant PCa which requires definitive treatment at 2 years after
      completion of their ExAblate™ treatment and to demonstrate the safety of focal ExAblate™
      MRgFUS treatment.

      Clinically significant PCa requiring definitive treatment is defined as pathology findings
      from whole-gland, imaging-guided, extended mapping biopsy of Gleason Score (GS) > 7

      The primary efficacy endpoint in this trial, measured at 24 months with whole-gland extended
      imaging-guided mapping biopsy, is Response scored dichotomously for each subject as follows:

        -  Response = 0 ("Failure"): Positive mapping biopsy defined as Gleason Score > 7
           (indicating definitive treatment) in any part of their prostate gland

        -  Response = 1 ("Success"): Negative mapping biopsy defined as Gleason Score < 7.

      Safety of ExAblate™ treatment will be determined by evaluation of the incidence and severity
      of device related complications from the first treatment day visit throughout entire
      follow-up duration.

      All adverse events will be captured and recorded. However, the safety of the ExAblate™
      treatment will be defined by the incidence and severity of treatment or device related
      adverse events, grades III - V (CTCAE version 4.03; 2010-06-14).

      Secondary Effectiveness Outcomes:

        1. % of patients with negative 5-month follow-up biopsy results in the treated part of the
           prostate

        2. Treatment effect on patients' Quality of Life (QoL), the following validated
           self-reported urogenital functioning assessment instruments will be used before and
           following treatment at pre-specified intervals.

             1. Urinary symptoms - IPSS

             2. Urinary continence - ICIQ-UI-SF

             3. Sexual function - IIEF-15

        3. PSA levels and post-treatment PSA kinetics will also be assessed
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary efficacy endpoint in this trial measured with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously; success vs. failure
time frame: 24 months post treatment
description: Response will be based on mapping biopsy defined by Gleason 7 Score in any part of the prostate gland
measure: Adverse events
time frame: 24 months post treatment
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
measure: Percent of patients with negative biopsy
time frame: 5 months post treatment
description: % of patients with negative 5-month follow-up biopsy results in the treated part of the prostate
measure: Quality of Life - urinary symptoms - IPSS questionnaire score
time frame: 24 months post treatment
description: Treatment effect on patients' Quality of Life (QoL), i.e., urinary symptoms
measure: Quality of Life - urinary continence - ICIQ-SF questionnaire score
time frame: 24 months post treatment
description: Treatment effect on patients' Quality of Life, (QoL), i.e., urinary continence
measure: Quality of Life - sexual function - IIEF-15 questionnaire score
time frame: 24 months
description: Treatment effect on patients' Quality of Life, (QoL), i.e.,sexual function
measure: Prostate Specific Antigen (PSA)
time frame: 24 months post treatment
description: PSA levels and post-treatment PSA kinetics will be assessed
arm group label: ExAblate MRgFUS
arm group type: Experimental
description: Up to 50% of the prostate gland will be treated. Treatment will include the Index lesion which is visible on MRI + tumor free margins of 3-mm; tumor free margins will not extend beyond the posterior aspect of the prostate capsule.
Urethral and bilateral neurovascular bundle preservation will be preferred whenever clinically justified.
Additional foci in the same hemisphere that are confirmed by biopsy and are < Gleason Score 7 (up to 3+4 or 4+3) or suspected to be positive for malignancy based on multi parametric-MRI) will also be included in the treated volume, providing total treatment volume does not exceed 50% of the gland.
intervention type: Device
intervention name: ExAblate MRgFUS
description: ExAblate treatment of prostate cancer less than or equal to Grade 7
arm group label: ExAblate MRgFUS
other name: Focused Ultrasound
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Sangeet Ghai, MD
role: Principal Investigator
affiliation: Toronto General Hospital
facility: 
facility: 
facility: 
facility: 
country: Canada
country: China
country: United Kingdom
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Undecided