<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/NCT02243033</url>
  </required_header>
  <id_info>
    <org_study_id>DMI-Laser-001</org_study_id>
    <secondary_id>WIRB Pr. No.: 20140945</secondary_id>
    <nct_id>NCT02243033</nct_id>
  </id_info>
  <brief_title>Phase II Laser Focal Therapy of Prostate Cancer</brief_title>
  <acronym>LITT or FLA</acronym>
  <official_title>A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HALO Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HALO Diagnostics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Target recruitment: 1000 subjects. The purpose of this research study is to continue to&#xD;
      investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal&#xD;
      therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize&#xD;
      that laser focal therapy can be used to achieve oncologic control in carefully selected&#xD;
      patients.&#xD;
&#xD;
      MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses&#xD;
      light to heat a target area to try to destroy cancerous cells.&#xD;
&#xD;
      The laser system that will be used is called the Visualase® Thermal Therapy System. This&#xD;
      system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers.&#xD;
      However; this study is the first time this system has been studied for use in the treatment&#xD;
      of prostate cancer with a trans-rectal approach.&#xD;
&#xD;
      MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM&#xD;
      trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and&#xD;
      Drug Administration (FDA) for such uses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laser-induced interstitial thermal therapy (LITT) is a novel form of controlled, targeted&#xD;
      thermal ablation that may offer measurable advantages over other ablative therapies for focal&#xD;
      prostate therapy. Because LITT is magnetic resonance (MR) compatible, it enables an imaging&#xD;
      advantage over other surgical or ablation techniques that utilize transrectal ultrasound to&#xD;
      target and monitor treatment. MR imaging provides excellent soft-tissue contrast and&#xD;
      three-dimensional (3D) anatomical imaging in any arbitrary plane, which can help to improve&#xD;
      treatment planning and targeting. Additionally, MR-based temperature monitoring allows&#xD;
      real-time feedback during MRI-guided thermal therapy as both deposition of light energy and&#xD;
      MR signal acquisition can be performed simultaneously without degradation in the MR signal.&#xD;
      Also, being in the MR diagnostic environment allows use of post- treatment imaging to verify&#xD;
      tissue damage. Because MR images clearly depict the prostate anatomy and the surrounding&#xD;
      critical structures, MR imaging has been incorporated into planning for external- beam&#xD;
      radiotherapy, brachytherapy, and other treatments of the prostate. In addition to these basic&#xD;
      features, Multiparametric prostate MRI (mpMRI) may be used to identify regions of disease in&#xD;
      the prostate and better target therapy.&#xD;
&#xD;
      In this study, the investigators propose to evaluate the efficacy of a novel, FDA-approved&#xD;
      thermal therapy and feedback system (Visualase® Thermal Therapy System) for the treatment of&#xD;
      biopsy confirmed and MR-imageable prostate lesions. This system has been used in humans for&#xD;
      the treatment of brain, bone (spine), thyroid, and liver cancers. Early feasibility studies&#xD;
      for prostate cancer used a transperineal approach; however it is now being evaluated for the&#xD;
      primary treatment of prostate cancer using a transrectal approach. This system allows&#xD;
      delivery of laser energy while the patient is simultaneously being imaged by an MRI unit. The&#xD;
      system's real-time MR thermal imaging (MRTI) provides information on the thermal dose&#xD;
      delivered to the target, resulting in a more precise and controlled delivery which has&#xD;
      previously not been possible with other ablative therapies. The investigators hypothesize the&#xD;
      system can be integrated into a practical and feasible outpatient treatment paradigm for&#xD;
      focal treatment of localized prostate cancer and allow patients to avoid the complications&#xD;
      associated with radical whole-gland therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">November 2036</completion_date>
  <primary_completion_date type="Anticipated">May 2036</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and adverse events</measure>
    <time_frame>1 yr. post treatment</time_frame>
    <description>Number of subjects reporting serious adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of treatment</measure>
    <time_frame>1 yr. post treatment</time_frame>
    <description>MR-guided biopsy results of treated area and PSA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to biochemical recurrence</measure>
    <time_frame>Up to 20 years</time_frame>
    <description>PSA measurement</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to metastasis</measure>
    <time_frame>Up to 20 years</time_frame>
    <description>Imaging utilizing PET/CT or other modality</description>
  </other_outcome>
  <other_outcome>
    <measure>Cause of death</measure>
    <time_frame>Up to 20 years</time_frame>
    <description>Death certificate or report from partner/spouse/primary care physician</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Visualase</arm_group_label>
    <description>MR-guided laser focal therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MR-guided laser focal therapy</intervention_name>
    <description>Placement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis.</description>
    <arm_group_label>Visualase</arm_group_label>
    <other_name>Visualase</other_name>
    <other_name>Tranberg</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men with prostate cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Treatment Naïve patients:&#xD;
&#xD;
          -  Male, 45 years of age or older.&#xD;
&#xD;
          -  Diagnosis of prostate adenocarcinoma.&#xD;
&#xD;
          -  Clinical stage T1c or T2a.&#xD;
&#xD;
          -  Gleason score of 7 (3+4 or 4+3) or less.&#xD;
&#xD;
          -  Three or fewer biopsy cores with prostate cancer.&#xD;
&#xD;
          -  PSA density not exceeding 0.375.&#xD;
&#xD;
          -  One, two, or three tumor suspicious regions identified on multiparametric MRI.&#xD;
&#xD;
          -  Negative radiographic indication of extra-capsular extent.&#xD;
&#xD;
          -  Karnofsky performance status of at least 70.&#xD;
&#xD;
          -  Estimated survival of 5 years or greater, as determined by treating physician.&#xD;
&#xD;
          -  Tolerance for anesthesia/sedation.&#xD;
&#xD;
          -  Ability to give informed consent.&#xD;
&#xD;
          -  At least 6 weeks since any previous prostate biopsy.&#xD;
&#xD;
          -  MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with&#xD;
             Gleason score of 7 (3+4 or 4+3) or less.&#xD;
&#xD;
        Salvage candidates will be accepted upon physician referral.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.&#xD;
&#xD;
          -  Severe lower urinary tract symptoms as measured by an International Prostate Symptom&#xD;
             Score (IPSS) of 20 or greater&#xD;
&#xD;
          -  History of other primary non-skin malignancy within previous three years.&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Smoker&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John F. Feller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HALO Diagnostics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernadette M. Greenwood, MSc</last_name>
    <role>Study Director</role>
    <affiliation>HALO Diagnostics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Desert Medical Imaging</name>
      <address>
        <city>Indian Wells</city>
        <state>California</state>
        <zip>92210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.halodx.com</url>
    <description>HALODx</description>
  </link>
  <reference>
    <citation>Greenwood, B. et al.: Transrectal interventional MRI: initial prostate biopsy experience. SPIE Proceedings, 2010.</citation>
  </reference>
  <reference>
    <citation>Hakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7.</citation>
    <PMID>17987573</PMID>
  </reference>
  <reference>
    <citation>Menon M, Tewari A, Peabody JO, Shrivastava A, Kaul S, Bhandari A, Hemal AK. Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases. Urol Clin North Am. 2004 Nov;31(4):701-17. doi: 10.1016/j.ucl.2004.06.011.</citation>
    <PMID>15474597</PMID>
  </reference>
  <reference>
    <citation>Valerio M, Emberton M, Ahmed HU. Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol. 2014 Nov 10;32(32):3680-1. doi: 10.1200/JCO.2014.56.7792. Epub 2014 Aug 18. No abstract available.</citation>
    <PMID>25135989</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>Focal therapy</keyword>
  <keyword>Laser therapy</keyword>
  <keyword>Transrectal</keyword>
  <keyword>MRI-guided</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>Yes</sharing_ipd>
    <ipd_description>Publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Bi-annaually at the meetings of the International Laser Network until study closure.</ipd_time_frame>
    <ipd_access_criteria>Scientists and physicians studying or performing laser focal therapy.</ipd_access_criteria>
  </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/NCT02243033
org study id: DMI-Laser-001
secondary id: WIRB Pr. No.: 20140945
nct id: NCT02243033
lead sponsor: 
has dmc: No
Target recruitment: 1000 subjects. The purpose of this research study is to continue to
      investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal
      therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize
      that laser focal therapy can be used to achieve oncologic control in carefully selected
      patients.

      MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses
      light to heat a target area to try to destroy cancerous cells.

      The laser system that will be used is called the Visualase® Thermal Therapy System. This
      system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers.
      However; this study is the first time this system has been studied for use in the treatment
      of prostate cancer with a trans-rectal approach.

      MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM
      trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and
      Drug Administration (FDA) for such uses.
Laser-induced interstitial thermal therapy (LITT) is a novel form of controlled, targeted
      thermal ablation that may offer measurable advantages over other ablative therapies for focal
      prostate therapy. Because LITT is magnetic resonance (MR) compatible, it enables an imaging
      advantage over other surgical or ablation techniques that utilize transrectal ultrasound to
      target and monitor treatment. MR imaging provides excellent soft-tissue contrast and
      three-dimensional (3D) anatomical imaging in any arbitrary plane, which can help to improve
      treatment planning and targeting. Additionally, MR-based temperature monitoring allows
      real-time feedback during MRI-guided thermal therapy as both deposition of light energy and
      MR signal acquisition can be performed simultaneously without degradation in the MR signal.
      Also, being in the MR diagnostic environment allows use of post- treatment imaging to verify
      tissue damage. Because MR images clearly depict the prostate anatomy and the surrounding
      critical structures, MR imaging has been incorporated into planning for external- beam
      radiotherapy, brachytherapy, and other treatments of the prostate. In addition to these basic
      features, Multiparametric prostate MRI (mpMRI) may be used to identify regions of disease in
      the prostate and better target therapy.

      In this study, the investigators propose to evaluate the efficacy of a novel, FDA-approved
      thermal therapy and feedback system (Visualase® Thermal Therapy System) for the treatment of
      biopsy confirmed and MR-imageable prostate lesions. This system has been used in humans for
      the treatment of brain, bone (spine), thyroid, and liver cancers. Early feasibility studies
      for prostate cancer used a transperineal approach; however it is now being evaluated for the
      primary treatment of prostate cancer using a transrectal approach. This system allows
      delivery of laser energy while the patient is simultaneously being imaged by an MRI unit. The
      system's real-time MR thermal imaging (MRTI) provides information on the thermal dose
      delivered to the target, resulting in a more precise and controlled delivery which has
      previously not been possible with other ablative therapies. The investigators hypothesize the
      system can be integrated into a practical and feasible outpatient treatment paradigm for
      focal treatment of localized prostate cancer and allow patients to avoid the complications
      associated with radical whole-gland therapy.
observational model: Cohort
time perspective: Prospective
measure: Safety and adverse events
time frame: 1 yr. post treatment
description: Number of subjects reporting serious adverse events.
measure: Efficacy of treatment
time frame: 1 yr. post treatment
description: MR-guided biopsy results of treated area and PSA.
measure: Time to biochemical recurrence
time frame: Up to 20 years
description: PSA measurement
measure: Time to metastasis
time frame: Up to 20 years
description: Imaging utilizing PET/CT or other modality
measure: Cause of death
time frame: Up to 20 years
description: Death certificate or report from partner/spouse/primary care physician
arm group label: Visualase
description: MR-guided laser focal therapy
intervention type: Device
intervention name: MR-guided laser focal therapy
description: Placement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis.
arm group label: Visualase
other name: Visualase
other name: Tranberg
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 90 Years
healthy volunteers: No
last name: John F. Feller, MD
role: Principal Investigator
affiliation: HALO Diagnostics
last name: Bernadette M. Greenwood, MSc
role: Study Director
affiliation: HALO Diagnostics
facility: 
country: United States
url: http://www.halodx.com
description: HALODx
citation: Greenwood, B. et al.: Transrectal interventional MRI: initial prostate biopsy experience. SPIE Proceedings, 2010.
citation: Hakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7.
PMID: 17987573
citation: Menon M, Tewari A, Peabody JO, Shrivastava A, Kaul S, Bhandari A, Hemal AK. Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases. Urol Clin North Am. 2004 Nov;31(4):701-17. doi: 10.1016/j.ucl.2004.06.011.
PMID: 15474597
citation: Valerio M, Emberton M, Ahmed HU. Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol. 2014 Nov 10;32(32):3680-1. doi: 10.1200/JCO.2014.56.7792. Epub 2014 Aug 18. No abstract available.
PMID: 25135989
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: Publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Bi-annaually at the meetings of the International Laser Network until study closure.
ipd access criteria: Scientists and physicians studying or performing laser focal therapy.