<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/NCT01686958</url>
  </required_header>
  <id_info>
    <org_study_id>DOC-10246</org_study_id>
    <nct_id>NCT01686958</nct_id>
  </id_info>
  <brief_title>Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer</brief_title>
  <official_title>Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Profound Medical Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Profound Medical Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral&#xD;
      ultrasound therapy system is safe and feasible to ablate prostate tissue in men with&#xD;
      localized prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral&#xD;
      ultrasound therapy system. The technology is developed for patients with organ confined&#xD;
      prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of&#xD;
      prostate tissue.&#xD;
&#xD;
      The treatment is conducted completely within an MRI suite, which enables real-time&#xD;
      temperature images of the heated region to be acquired as the ultrasonic treatment is&#xD;
      delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over&#xD;
      the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the&#xD;
      pattern of thermal coagulation accurately and precisely in the prostate gland, thereby&#xD;
      reducing the risk of possible damage to important surrounding anatomy such as the rectum,&#xD;
      urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method,&#xD;
      therefore, has the potential to have lower complication rates than conventional therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2013</start_date>
  <completion_date type="Actual">June 11, 2019</completion_date>
  <primary_completion_date type="Actual">March 23, 2015</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 - Evaluate the Frequency of Treatment Related Adverse Events</measure>
    <time_frame>12 months from the Treatment Date</time_frame>
    <description>All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety - Evaluate the Severity of Treatment Related Adverse Events</measure>
    <time_frame>12 months from the Treatment Date</time_frame>
    <description>Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI).&#xD;
There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision</measure>
    <time_frame>On Treatment Date</time_frame>
    <description>Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment Efficacy - Biopsy</measure>
    <time_frame>12 months from the Treatment Date</time_frame>
    <description>Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Efficacy - PSA</measure>
    <time_frame>As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline</time_frame>
    <description>Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Efficacy - Quality of Life - Urinary Symptoms</measure>
    <time_frame>Baseline and 12-months post Treatment</time_frame>
    <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms.&#xD;
Total Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Efficacy - Quality of Life - Erectile Function</measure>
    <time_frame>Baseline and 12-months post Treatment</time_frame>
    <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms.&#xD;
Minimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Efficacy - Quality of Life - Bowel Habits</measure>
    <time_frame>Baseline and 12-months post Treatment</time_frame>
    <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms.&#xD;
Minimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>MR-Guided Transurethral US Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MR-Guided Transurethral US Ablation of Prostate Tissue</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MR-Guided Transurethral US Ablation of Prostate Tissue</intervention_name>
    <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.</description>
    <arm_group_label>MR-Guided Transurethral US Ablation</arm_group_label>
    <other_name>Prostate Ablation Device: PAD-105</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, age ≥65&#xD;
&#xD;
          -  Patient with low-risk, early-stage organ-confined prostate cancer (Stage T1c or T2a,&#xD;
             N0, M0).&#xD;
&#xD;
          -  Gleason score 6 (3+3)&#xD;
&#xD;
          -  Prostate-specific antigen (PSA) ≤ 10 ng/ml&#xD;
&#xD;
          -  Eligible for MR imaging (DOC-10252)&#xD;
&#xD;
          -  Meets the following criteria on pre-treatment transrectal ultrasound imaging:&#xD;
&#xD;
               1. No cysts or calcifications &gt; 1.0 cm in size&#xD;
&#xD;
               2. No evidence of extraprostatic extension or seminal vesicle invasion&#xD;
&#xD;
               3. Overall prostate size less than 5 cm in sagittal length and less than 7 cm in&#xD;
                  diameter&#xD;
&#xD;
          -  Biopsy confirmed adenocarcinoma of the prostate, performed at least 6 weeks prior to&#xD;
             and no more than 6 months prior to the scheduled treatment.&#xD;
&#xD;
          -  Eligible for General Anesthesia, as defined in American Society of Anesthesiologists&#xD;
             (ASA)&#xD;
&#xD;
          -  Normal rectal anatomy and rectal mucosa on digital rectal examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Abnormal coagulation and current anticoagulant therapy.&#xD;
&#xD;
          -  Acute or chronic Urinary Tract Infection&#xD;
&#xD;
          -  Interest in future fertility&#xD;
&#xD;
          -  History of allergy relevant medication or other&#xD;
&#xD;
          -  History of any other malignancy other than skin cancer&#xD;
&#xD;
          -  Patients with peripheral arterial disease with intermittent claudication or Leriches&#xD;
             Syndrome&#xD;
&#xD;
          -  Prior treatment of the prostate gland&#xD;
&#xD;
          -  Prior treatment with 5 alpha reductase inhibitor allowed (not as prostate cancer&#xD;
             treatment or prevention) as long as drug has been stopped for minimum 3 months&#xD;
&#xD;
          -  History of any major rectal or pelvic surgery&#xD;
&#xD;
          -  History of ulcerative colitis or other chronic inflammatory conditions affecting&#xD;
             rectum&#xD;
&#xD;
          -  History of documented clinical prostatitis requiring therapy within previous 6 months&#xD;
&#xD;
          -  History of urethral and bladder outlet disorders, including urethral stricture&#xD;
             disease, urethral diverticulae, bladder neck contracture, urethral fistulae which had&#xD;
             required prior urethrotomy, urethral stenting, urethroplasty or chronic indwelling&#xD;
             urethral catheter&#xD;
&#xD;
          -  Patients with artificial urinary sphincter or any penile implant (metallic or&#xD;
             non-metallic)&#xD;
&#xD;
          -  Neurologic bladder disorders&#xD;
&#xD;
          -  Untreated bladder stones&#xD;
&#xD;
          -  History of acute urinary retention&#xD;
&#xD;
          -  Confirmed or suspected bladder cancer&#xD;
&#xD;
          -  Urinary sphincter abnormalities&#xD;
&#xD;
          -  Active untreated gross hematuria for any cause&#xD;
&#xD;
          -  Post Void Residual (PVR) bladder volume &gt; 250 mL&#xD;
&#xD;
          -  Obstructing median lobe enlarged out of proportion to the rest of the prostate and&#xD;
             protruding significantly into the bladder&#xD;
&#xD;
        Additional exclusion criteria on file....&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Chin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Science Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Relle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ryan Berglund, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heinz P Schlemmer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Cancer Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Science Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>German Cancer Research Center (DKFZ)</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>August 28, 2018</results_first_submitted>
  <results_first_submitted_qc>October 24, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2018</results_first_posted>
  <last_update_submitted>January 29, 2020</last_update_submitted>
  <last_update_submitted_qc>January 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>High intensity transurethral ultrasound ablation</keyword>
  <keyword>MRI-guided</keyword>
  <keyword>Minimally invasive</keyword>
  <keyword>Real-time temperature feedback control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
          <description>Technology developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Study is a prospective, multi-center, single arm trial conducted in US, Canada and Europe. All subjects received the same treatment.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29">No. of patients who completed ALL assessments at 12 months post treatment; 1 pt only had PSA test.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline measures were only done for the patients who passed screening and eligibility criteria</population>
      <group_list>
        <group group_id="B1">
          <title>MR-Guided Transurethral US Ablation</title>
          <description>MR-Guided Transurethral US Ablation of Prostate Tissue&#xD;
MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Data was collected via a questionnaire completed by the patient at the Baseline Visit. Patients were asked to describe themselves by noting a &quot;X&quot; in one box only. Available options included; White/Caucasian; Black/African-American; Latino/Hispanic' Asian/Pacific Islander; Multi-Racial; Other.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Multi-racial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White/Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subjects with erections sufficient for penetration at Baseline</title>
          <description>Erectile dysfunction was defined as a score of 0-1 for Question 2 of the International Index of Erectile Function (IIEF-15). Patients with erections sufficient for penetration had a score greater than or equal to 2.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety - Evaluate the Frequency of Treatment Related Adverse Events</title>
        <description>All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.</description>
        <time_frame>12 months from the Treatment Date</time_frame>
        <population>The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.</population>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety - Evaluate the Frequency of Treatment Related Adverse Events</title>
          <description>All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.</description>
          <population>The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.</non_inferiority_desc>
            <other_analysis_desc>For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision</title>
        <description>Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.</description>
        <time_frame>On Treatment Date</time_frame>
        <population>The analysis population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.</population>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision</title>
          <description>Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.</description>
          <population>The analysis population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Thermal ablation accuracy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thermal ablation precision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Efficacy - Biopsy</title>
        <description>Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.</description>
        <time_frame>12 months from the Treatment Date</time_frame>
        <population>One patient did not complete the 12-month visit, therefore 29 patients were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Efficacy - Biopsy</title>
          <description>Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.</description>
          <population>One patient did not complete the 12-month visit, therefore 29 patients were included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive biopsy (clinically significant disease)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Overall absence of clinically significant disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Efficacy - PSA</title>
        <description>Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.</description>
        <time_frame>As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Efficacy - PSA</title>
          <description>Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.</description>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSA @ Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="3.8" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA @ 1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.5" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA @ 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.4" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA @ 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.4" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA @ 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.6" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Efficacy - Quality of Life - Urinary Symptoms</title>
        <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms.&#xD;
Total Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic</description>
        <time_frame>Baseline and 12-months post Treatment</time_frame>
        <population>One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Efficacy - Quality of Life - Urinary Symptoms</title>
          <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms.&#xD;
Total Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic</description>
          <population>One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IPSS @ Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="5" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IPSS @ 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="4" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Efficacy - Quality of Life - Erectile Function</title>
        <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms.&#xD;
Minimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction</description>
        <time_frame>Baseline and 12-months post Treatment</time_frame>
        <population>One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Efficacy - Quality of Life - Erectile Function</title>
          <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms.&#xD;
Minimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction</description>
          <population>One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IIEF-EF-15 @ Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="6" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IIEF-EF-15 @ 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="5" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Efficacy - Quality of Life - Bowel Habits</title>
        <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms.&#xD;
Minimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome</description>
        <time_frame>Baseline and 12-months post Treatment</time_frame>
        <population>One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound of Prostate Tissue Ablation</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Efficacy - Quality of Life - Bowel Habits</title>
          <description>Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms.&#xD;
Minimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome</description>
          <population>One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>UCLA-PCI-SF-BH @ Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="90" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UCLA-PCI-SF-BH @ 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety - Evaluate the Severity of Treatment Related Adverse Events</title>
        <description>Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI).&#xD;
There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.</description>
        <time_frame>12 months from the Treatment Date</time_frame>
        <population>The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.</population>
        <group_list>
          <group group_id="O1">
            <title>MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue</title>
            <description>The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.&#xD;
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety - Evaluate the Severity of Treatment Related Adverse Events</title>
          <description>Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI).&#xD;
There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.</description>
          <population>The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.</population>
          <units>% of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematuria - G1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" lower_limit="25" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematuria - G2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="0.8" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary tract infection - G2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" lower_limit="17" upper_limit="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Epididymitis - G3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="0.1" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary retention - G1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="2.1" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary retention - G2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="5.6" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Obstructive micturition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="2.1" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary incontinence - G1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="0.1" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary incontinence - G2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="2.1" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary stricture - G1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="0.1" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary stricture - G2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="0.1" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).</desc>
      <group_list>
        <group group_id="E1">
          <title>MR-Guided Transurethral US Ablation</title>
          <description>MR-Guided Transurethral US Ablation of Prostate Tissue&#xD;
MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Epididymitis</sub_title>
                <description>Patient diagnosed with epididymitis on left side, requiring antibiotics. Shortly thereafter patient developed a fever requiring hospital admission with changes to prescribed antibiotics.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <description>After removal of suprapubic catheter (SPC) as per protocol, the patient experienced retention and received an urethral catheter, but he continued experiencing retention, hence was hospitalized &amp; required a second SPC.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rectal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fecal straining</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Distended abdomen</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ear drainage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hematoma or Ecchymosis: Buttock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hemtoma or Ecchymosis: Femur</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hematoma or Ecchymosis: Sacral bone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Patient movement at onset of treatment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Raised lump: Back</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain: Back, hips, shoulder, upon catheter removal</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Suprapubic Catheter: bleeding around SPC, urine leaking around SPC, blocked SPC, catheter fell out</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary stricture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bladder inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bladder irritability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Edema: penile and/or scrotal</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Edema: testicular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hemorrhagic cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Increased post void urinary residual in bladder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Obstructive micturition</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Penile discharge or bleeding</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Prostate anatomical change or discoloration</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Prostate inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Prostate tissue sloughing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Scarred urethra</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urethral skin tags</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary hesitancy</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary sensation to void</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urine abnormality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain: Bladder, penile, perineal, prostate, urethral</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction or worsening erectile function</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ejaculation disorder</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hematospermia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Sponsor will review the publication text within twenty days of receipt, however, Sponsor can request changes if text contains Sponsor's Confidential Information, or text contains information for which the Sponsor wishes to obtain patent protection, whereupon such information will be removed or there will be a delay to the presentation or publication to enable the Sponsor to proceed with patent application for an additional 60 days or until patent application has been filed, whichever is earlier.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mathieu Burtnyk</name_or_title>
      <organization>Profound Medical</organization>
      <phone>647-476-1350 ext 408</phone>
      <email>mburtnyk@profoundmedical.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01686958
org study id: DOC-10246
nct id: NCT01686958
lead sponsor: 
has dmc: Yes
This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral
      ultrasound therapy system is safe and feasible to ablate prostate tissue in men with
      localized prostate cancer.
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral
      ultrasound therapy system. The technology is developed for patients with organ confined
      prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of
      prostate tissue.

      The treatment is conducted completely within an MRI suite, which enables real-time
      temperature images of the heated region to be acquired as the ultrasonic treatment is
      delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over
      the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the
      pattern of thermal coagulation accurately and precisely in the prostate gland, thereby
      reducing the risk of possible damage to important surrounding anatomy such as the rectum,
      urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method,
      therefore, has the potential to have lower complication rates than conventional therapies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety - Evaluate the Frequency of Treatment Related Adverse Events
time frame: 12 months from the Treatment Date
description: All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.
measure: Safety - Evaluate the Severity of Treatment Related Adverse Events
time frame: 12 months from the Treatment Date
description: Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI).
There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.
measure: Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision
time frame: On Treatment Date
description: Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.
measure: Treatment Efficacy - Biopsy
time frame: 12 months from the Treatment Date
description: Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.
measure: Treatment Efficacy - PSA
time frame: As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline
description: Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.
measure: Treatment Efficacy - Quality of Life - Urinary Symptoms
time frame: Baseline and 12-months post Treatment
description: Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms.
Total Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic
measure: Treatment Efficacy - Quality of Life - Erectile Function
time frame: Baseline and 12-months post Treatment
description: Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms.
Minimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction
measure: Treatment Efficacy - Quality of Life - Bowel Habits
time frame: Baseline and 12-months post Treatment
description: Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms.
Minimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome
arm group label: MR-Guided Transurethral US Ablation
arm group type: Experimental
description: MR-Guided Transurethral US Ablation of Prostate Tissue
intervention type: Device
intervention name: MR-Guided Transurethral US Ablation of Prostate Tissue
description: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
arm group label: MR-Guided Transurethral US Ablation
other name: Prostate Ablation Device: PAD-105
criteria: 
gender: Male
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: No
last name: Joseph Chin, MD
role: Principal Investigator
affiliation: London Health Science Center
last name: James Relle, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
last name: Ryan Berglund, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
last name: Heinz P Schlemmer, MD
role: Principal Investigator
affiliation: German Cancer Research Center
facility: 
facility: 
facility: 
country: Canada
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 