<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/NCT02224911</url>
  </required_header>
  <id_info>
    <org_study_id>14-000409</org_study_id>
    <secondary_id>JCCCID436</secondary_id>
    <secondary_id>NCI-2015-01487</secondary_id>
    <nct_id>NCT02224911</nct_id>
  </id_info>
  <brief_title>Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer</brief_title>
  <acronym>LITT</acronym>
  <official_title>Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial&#xD;
      thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as&#xD;
      well as to gather data for the design of future studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2014</start_date>
  <completion_date type="Actual">October 21, 2019</completion_date>
  <primary_completion_date type="Actual">October 21, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absence of prostate cancer in the MRI target area as measure of efficacy.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Laser Interstitial Thermal Therapy</arm_group_label>
    <description>This is a minimally invasive procedure for focal treatment of prostate cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser Interstitial Thermal Therapy</intervention_name>
    <arm_group_label>Laser Interstitial Thermal Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion&#xD;
        technology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤&#xD;
             T2b)&#xD;
&#xD;
               -  Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months&#xD;
                  of study treatment, if indicated by PSA &gt;10&#xD;
&#xD;
               -  Age 40 years to 85 years of age&#xD;
&#xD;
               -  Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a&#xD;
&#xD;
                    -  Region of interest (ROI) of MRI suspicion level 3 or higher&#xD;
&#xD;
                    -  ROI located proximal to the external sphincter by a margin of at least 2 cm&#xD;
&#xD;
               -  Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2&#xD;
                  MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI&#xD;
&#xD;
                    -  Histologically-confirmed adenocarcinoma from targeted biopsy cores (≥ 2&#xD;
                       cores)&#xD;
&#xD;
                    -  Overall Gleason score not to exceed 3+4&#xD;
&#xD;
               -  Subjects desire focal therapy and declined conventional treatment (active&#xD;
                  surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone&#xD;
                  therapy)&#xD;
&#xD;
               -  Signed informed consent for the LITT treatment through the 12 month follow up&#xD;
                  visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant cancer outside of MRI target (ROI) area, defined as Gleason score &gt;&#xD;
             3+4&#xD;
&#xD;
          -  &lt; 10 years life expectancy&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) criteria of IV or higher&#xD;
&#xD;
          -  Unfit for conscious sedation anesthesia&#xD;
&#xD;
          -  Active bleeding disorder as determined by abnormal prothrombin time, partial&#xD;
             thromboplastin time, INR or platelet count (as determined by institutional lab&#xD;
             parameters) at the time of screening&#xD;
&#xD;
          -  Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily&#xD;
             reversed or stopped for a window of at least 7 days peri-procedure&#xD;
&#xD;
          -  Active urinary tract infection&#xD;
&#xD;
          -  Prostate abscess, chronic or acute prostatitis, or neurogenic bladder&#xD;
&#xD;
          -  Any prior treatment for prostate cancer&#xD;
&#xD;
               -  Radical prostatectomy&#xD;
&#xD;
               -  Radiation therapy (external beam or brachytherapy)&#xD;
&#xD;
               -  Cryotherapy&#xD;
&#xD;
               -  High intensity focused ultrasound treatment&#xD;
&#xD;
               -  Photodynamic therapy&#xD;
&#xD;
               -  Androgen deprivation therapy&#xD;
&#xD;
          -  Prior prostate, bladder neck, or urethral stricture surgery&#xD;
&#xD;
               -  Any prostate debulking procedure, including: transurethral resection of prostate,&#xD;
                  photovaporization, or electrovaporization&#xD;
&#xD;
               -  Transurethral incision of bladder neck&#xD;
&#xD;
               -  Urethral stricture dilation or reconstruction&#xD;
&#xD;
          -  Any current 5-alpha reductase inhibitors (history of use ≥ 6 months prior to MRI is&#xD;
             acceptable)&#xD;
&#xD;
          -  Prior significant rectal surgery (hemorrhoidectomy is acceptable)&#xD;
&#xD;
          -  Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion&#xD;
             of transrectal device&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  Urinary tract or rectal fistula&#xD;
&#xD;
          -  Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible&#xD;
             prosthesis)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pantuck Alan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Raman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.</citation>
    <PMID>23335087</PMID>
  </reference>
  <reference>
    <citation>Carter HB, Kettermann A, Warlick C, Metter EJ, Landis P, Walsh PC, Epstein JI. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007 Dec;178(6):2359-64; discussion 2364-5. doi: 10.1016/j.juro.2007.08.039. Epub 2007 Oct 22.</citation>
    <PMID>17936806</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>focal therapy</keyword>
  <keyword>prostate cancer treatment</keyword>
  <keyword>laser treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224911
org study id: 14-000409
secondary id: JCCCID436
secondary id: NCI-2015-01487
nct id: NCT02224911
lead sponsor: 
has dmc: Yes
This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial
      thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as
      well as to gather data for the design of future studies.
observational model: Case-Only
time perspective: Prospective
measure: Number of participants with adverse events as a measure of safety and tolerability
time frame: 12 months
measure: Absence of prostate cancer in the MRI target area as measure of efficacy.
time frame: 12 months
arm group label: Laser Interstitial Thermal Therapy
description: This is a minimally invasive procedure for focal treatment of prostate cancer.
intervention type: Device
intervention name: Laser Interstitial Thermal Therapy
arm group label: Laser Interstitial Thermal Therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Pantuck Alan, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Steven Raman, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
citation: Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
PMID: 23335087
citation: Carter HB, Kettermann A, Warlick C, Metter EJ, Landis P, Walsh PC, Epstein JI. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007 Dec;178(6):2359-64; discussion 2364-5. doi: 10.1016/j.juro.2007.08.039. Epub 2007 Oct 22.
PMID: 17936806
responsible party type: Sponsor
mesh term: Prostatic Neoplasms