<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/NCT03814252</url>
  </required_header>
  <id_info>
    <org_study_id>T275/2018</org_study_id>
    <nct_id>NCT03814252</nct_id>
  </id_info>
  <brief_title>Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer</brief_title>
  <acronym>PRO-TULSA-PC</acronym>
  <official_title>Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-guided Transurethral Ultrasound Ablation for Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turku University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Magnetic resonance imaging (MRI) has improved detection of clinically significant prostate&#xD;
      cancer (PCa). MRI-guided transurethral ultrasound ablation (MRI-TULSA) system incorporates&#xD;
      precise diagnosis and simultaneous ablation of prostate tissue enabling lesion-targeted&#xD;
      treatment of PCa. Lesion-based treatment strategy spares surrounding healthy tissues from&#xD;
      injury, which may improve the outcome of genitourinary function. This study further&#xD;
      investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible&#xD;
      biopsy-proven PCa with MRI-TULSA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Improving diagnostic methods and screening of men with prostate specific antigen (PSA) has&#xD;
      led to earlier detection of prostate cancer (PCa) with more favorable disease&#xD;
      characteristics. To decrease overtreatment, low risk cases are increasingly treated with&#xD;
      active surveillance; nevertheless some of them progress requiring interventions.&#xD;
      Intermediate- and high-risk cases need active treatments to improve survival. However,&#xD;
      despite desirable local control, the standard therapies including radical prostatectomy and&#xD;
      radiation therapy, carry a risk of treatment related adverse effects to genitourinary and&#xD;
      bowel functions. There is an eminent need for efficient PCa therapies with minimal effect on&#xD;
      genitourinary function and quality of life. To date most studied mini-invasive technologies&#xD;
      have used extremities of temperatures to treat PCa including high intensity focused&#xD;
      ultrasound and cryoablation.&#xD;
&#xD;
      Magnetic resonance imaging (MRI) has improved PCa diagnosis. Novel MRI techniques enable&#xD;
      localization and visualization of clinically significant PCa. Further, MRI can be used for&#xD;
      guidance of targeted biopsy from suspicious lesion enhancing detection of clinically&#xD;
      significant PCa and pinpointing a target for image guided therapies. Also, increased use of&#xD;
      MRI may lead to more MRI-visible tumors encountered in clinical practice developing an unmet&#xD;
      need for image guided therapies.&#xD;
&#xD;
      MRI guided transurethral ultrasound ablation (MRI-TULSA) - treatment system offers treatment&#xD;
      strategy incorporating precise diagnosis and targeted therapy. It has been evaluated for&#xD;
      whole-gland ablation of localized PCa. Further, lesion-targeted MRI-TULSA has been proved to&#xD;
      be feasible and safe for treating MRI-visible-biopsy-concordant histologically significant&#xD;
      PCa in our phase 1 treat-and-3-week-resect study (not published yet). This current study&#xD;
      further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible&#xD;
      biopsy-proven PCa with MRI-TULSA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severe adverse event free survival</measure>
    <time_frame>3 months</time_frame>
    <description>The primary safety outcome is the freedom from severe adverse events over 3 months follow up: Clavien Dindo Classification of surgical complication is graded from 1 (mild) to 5 (death). Severe adverse events are regarded as events graded ≥3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oncological efficacy: Disease free survival</measure>
    <time_frame>12 months</time_frame>
    <description>The primary oncological efficacy outcome, disease free survival (DFS), is the freedom from any histologically proven clinically significant prostate cancer as assessed from both 10-12-core systematic biopsies and MRI-directed 2-4-core in field biopsies at 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary continence status</measure>
    <time_frame>3, 6 and 12 months</time_frame>
    <description>Urinary continence status as measured by Expanded Prostate Cancer Index Composite (EPIC) item 5 ≥ 2 (patient filled and reported outcome measure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall urinary symptom score</measure>
    <time_frame>3, 6 and 12 months</time_frame>
    <description>Symptom severity as measured by International Prostate Symptom Score (IPSS) (patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile function sufficient for penetration</measure>
    <time_frame>3, 6 and 12 months</time_frame>
    <description>Erectile dysfunction status as measured by International Index of Erectile Function item 2 ≥ 2 (erection firmness sufficient for penetration)(patient filled and reported outcome measure). Not applicable for subject with baseline score &lt; 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall erectile function</measure>
    <time_frame>3, 6 and 12 months</time_frame>
    <description>Erectile function as measure by International Index of Erectile Function-5 (IIEF-5)(patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological failure free survival</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Presence of a highly suspicious lesion in treatment field on prostate MRI at 6 or 12 months (Likert suspicion level ≥ 4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ablation failure free survival</measure>
    <time_frame>12 months</time_frame>
    <description>In field (ablated area) biopsy-confirmed histologically viable cancer.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Localized Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Lesion-targeted ablation with MRI-TULSA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Targeted lesion based thermoablation of MRI-visible biopsy proven clinically significant prostate cancer. Ablative effect is aimed to cover lesion with 5 mm MRI based healthy tissue overlap wherever possible but not compromising viability of critical tissues, mainly the wall of rectum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI-TULSA</intervention_name>
    <description>The technology is developed to ablate targeted prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.&#xD;
TULSA-PRO (Profound Medical Inc, Toronto, Canada): PAD-105, integrated into a 3 Tesla MR-system (Ingenia 3.0 Tesla, Philips Healthcare, Best, Netherlands)</description>
    <arm_group_label>Lesion-targeted ablation with MRI-TULSA</arm_group_label>
    <other_name>MRI guided transurethral ultrasound ablation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Language spoken: Finnish, English or Swedish&#xD;
&#xD;
          -  Mental status: Patients must be able to understand the meaning of the study&#xD;
&#xD;
          -  Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved&#xD;
             informed consent documents in the presence of the designated staff.&#xD;
&#xD;
          -  Biopsy-confirmed acinar adenocarcinoma of the prostate&#xD;
&#xD;
          -  Gleason score ≥ 3+4/International Society of Urological Pathology grade group ≥ 2&#xD;
&#xD;
          -  High volume Gleason score 6 as determined on biopsies (&gt;2 positive cancer core or ≥&#xD;
             50% cancer in a core)&#xD;
&#xD;
          -  Patient presenting low volume Gleason score 6 disease and refuses active surveillance&#xD;
&#xD;
          -  Non-metastatic disease; high-risk patients according to European Association of&#xD;
             Urology risk group stratification will undergo F-Prostate specific membrane&#xD;
             antigen-Positron Emission Tomography/Computer Tomography to exclude distant metastasis&#xD;
&#xD;
          -  Lesion visible on MRI (Prostate Imaging Reporting and Data System v2 4-5)&#xD;
&#xD;
          -  Eligible for general anesthesia (American Society of Anesthesiologists (ASA)≤ 3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)&#xD;
&#xD;
               -  Acute unresolved urinary tract infection&#xD;
&#xD;
               -  Claustrophobia&#xD;
&#xD;
               -  Hip replacement surgery or other metal in the pelvic area&#xD;
&#xD;
               -  Known allergy to gadolinium&#xD;
&#xD;
               -  Inability to insert urinary catheter&#xD;
&#xD;
               -  Suspected tumor on baseline MRI further than 30 mm or within 3 mm of the&#xD;
                  prostatic urethra&#xD;
&#xD;
               -  Prostate calcifications or cysts obstructing planned ultrasound beam path within&#xD;
                  the targeted tissue volume&#xD;
&#xD;
               -  Any other conditions that might compromise patient safety, based on the clinical&#xD;
                  judgment of the responsible urologist&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Boström, M.D.Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, VSSHP, University of Turku</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Urology, VSSHP, University of Turku</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <reference>
    <citation>Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-Specific Antigen-Based Screening for Prostate Cancer: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 May 8;319(18):1914-1931. doi: 10.1001/jama.2018.3712.</citation>
    <PMID>29801018</PMID>
  </reference>
  <reference>
    <citation>Klotz L, Vesprini D, Sethukavalan P, Jethava V, Zhang L, Jain S, Yamamoto T, Mamedov A, Loblaw A. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol. 2015 Jan 20;33(3):272-7. doi: 10.1200/JCO.2014.55.1192. Epub 2014 Dec 15.</citation>
    <PMID>25512465</PMID>
  </reference>
  <reference>
    <citation>Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.</citation>
    <PMID>27626136</PMID>
  </reference>
  <reference>
    <citation>Wilt TJ, Jones KM, Barry MJ, Andriole GL, Culkin D, Wheeler T, Aronson WJ, Brawer MK. Follow-up of Prostatectomy versus Observation for Early Prostate Cancer. N Engl J Med. 2017 Jul 13;377(2):132-142. doi: 10.1056/NEJMoa1615869.</citation>
    <PMID>28700844</PMID>
  </reference>
  <reference>
    <citation>Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593.</citation>
    <PMID>24597866</PMID>
  </reference>
  <reference>
    <citation>Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14. Erratum In: N Engl J Med. 2023 Jun 8;388(23):2208.</citation>
    <PMID>27626365</PMID>
  </reference>
  <reference>
    <citation>Valerio M, Cerantola Y, Eggener SE, Lepor H, Polascik TJ, Villers A, Emberton M. New and Established Technology in Focal Ablation of the Prostate: A Systematic Review. Eur Urol. 2017 Jan;71(1):17-34. doi: 10.1016/j.eururo.2016.08.044. Epub 2016 Aug 29.</citation>
    <PMID>27595377</PMID>
  </reference>
  <reference>
    <citation>Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.</citation>
    <PMID>28110982</PMID>
  </reference>
  <reference>
    <citation>Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.</citation>
    <PMID>29552975</PMID>
  </reference>
  <reference>
    <citation>Chin JL, Billia M, Relle J, Roethke MC, Popeneciu IV, Kuru TH, Hatiboglu G, Mueller-Wolf MB, Motsch J, Romagnoli C, Kassam Z, Harle CC, Hafron J, Nandalur KR, Chronik BA, Burtnyk M, Schlemmer HP, Pahernik S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. Eur Urol. 2016 Sep;70(3):447-55. doi: 10.1016/j.eururo.2015.12.029. Epub 2016 Jan 6.</citation>
    <PMID>26777228</PMID>
  </reference>
  <reference>
    <citation>Ramsay E, Mougenot C, Staruch R, Boyes A, Kazem M, Bronskill M, Foster H, Sugar L, Haider M, Klotz L, Chopra R. Evaluation of Focal Ablation of Magnetic Resonance Imaging Defined Prostate Cancer Using Magnetic Resonance Imaging Controlled Transurethral Ultrasound Therapy with Prostatectomy as the Reference Standard. J Urol. 2017 Jan;197(1):255-261. doi: 10.1016/j.juro.2016.06.100. Epub 2016 Aug 18.</citation>
    <PMID>27545572</PMID>
  </reference>
  <reference>
    <citation>Chopra R, Colquhoun A, Burtnyk M, N'djin WA, Kobelevskiy I, Boyes A, Siddiqui K, Foster H, Sugar L, Haider MA, Bronskill M, Klotz L. MR imaging-controlled transurethral ultrasound therapy for conformal treatment of prostate tissue: initial feasibility in humans. Radiology. 2012 Oct;265(1):303-13. doi: 10.1148/radiol.12112263. Epub 2012 Aug 28.</citation>
    <PMID>22929332</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Localized prostate cancer</keyword>
  <keyword>Transurethral ultrasound ablation</keyword>
  <keyword>Image guided</keyword>
  <keyword>Magnetic resonance imaging guided</keyword>
  <keyword>Lesion-targeted</keyword>
  <keyword>Focal therapy</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>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03814252
org study id: T275/2018
nct id: NCT03814252
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Magnetic resonance imaging (MRI) has improved detection of clinically significant prostate
      cancer (PCa). MRI-guided transurethral ultrasound ablation (MRI-TULSA) system incorporates
      precise diagnosis and simultaneous ablation of prostate tissue enabling lesion-targeted
      treatment of PCa. Lesion-based treatment strategy spares surrounding healthy tissues from
      injury, which may improve the outcome of genitourinary function. This study further
      investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible
      biopsy-proven PCa with MRI-TULSA.
Improving diagnostic methods and screening of men with prostate specific antigen (PSA) has
      led to earlier detection of prostate cancer (PCa) with more favorable disease
      characteristics. To decrease overtreatment, low risk cases are increasingly treated with
      active surveillance; nevertheless some of them progress requiring interventions.
      Intermediate- and high-risk cases need active treatments to improve survival. However,
      despite desirable local control, the standard therapies including radical prostatectomy and
      radiation therapy, carry a risk of treatment related adverse effects to genitourinary and
      bowel functions. There is an eminent need for efficient PCa therapies with minimal effect on
      genitourinary function and quality of life. To date most studied mini-invasive technologies
      have used extremities of temperatures to treat PCa including high intensity focused
      ultrasound and cryoablation.

      Magnetic resonance imaging (MRI) has improved PCa diagnosis. Novel MRI techniques enable
      localization and visualization of clinically significant PCa. Further, MRI can be used for
      guidance of targeted biopsy from suspicious lesion enhancing detection of clinically
      significant PCa and pinpointing a target for image guided therapies. Also, increased use of
      MRI may lead to more MRI-visible tumors encountered in clinical practice developing an unmet
      need for image guided therapies.

      MRI guided transurethral ultrasound ablation (MRI-TULSA) - treatment system offers treatment
      strategy incorporating precise diagnosis and targeted therapy. It has been evaluated for
      whole-gland ablation of localized PCa. Further, lesion-targeted MRI-TULSA has been proved to
      be feasible and safe for treating MRI-visible-biopsy-concordant histologically significant
      PCa in our phase 1 treat-and-3-week-resect study (not published yet). This current study
      further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible
      biopsy-proven PCa with MRI-TULSA.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Severe adverse event free survival
time frame: 3 months
description: The primary safety outcome is the freedom from severe adverse events over 3 months follow up: Clavien Dindo Classification of surgical complication is graded from 1 (mild) to 5 (death). Severe adverse events are regarded as events graded ≥3.
measure: Oncological efficacy: Disease free survival
time frame: 12 months
description: The primary oncological efficacy outcome, disease free survival (DFS), is the freedom from any histologically proven clinically significant prostate cancer as assessed from both 10-12-core systematic biopsies and MRI-directed 2-4-core in field biopsies at 12 months.
measure: Urinary continence status
time frame: 3, 6 and 12 months
description: Urinary continence status as measured by Expanded Prostate Cancer Index Composite (EPIC) item 5 ≥ 2 (patient filled and reported outcome measure)
measure: Overall urinary symptom score
time frame: 3, 6 and 12 months
description: Symptom severity as measured by International Prostate Symptom Score (IPSS) (patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.
measure: Erectile function sufficient for penetration
time frame: 3, 6 and 12 months
description: Erectile dysfunction status as measured by International Index of Erectile Function item 2 ≥ 2 (erection firmness sufficient for penetration)(patient filled and reported outcome measure). Not applicable for subject with baseline score < 2.
measure: Overall erectile function
time frame: 3, 6 and 12 months
description: Erectile function as measure by International Index of Erectile Function-5 (IIEF-5)(patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.
measure: Radiological failure free survival
time frame: 6 and 12 months
description: Presence of a highly suspicious lesion in treatment field on prostate MRI at 6 or 12 months (Likert suspicion level ≥ 4).
measure: Ablation failure free survival
time frame: 12 months
description: In field (ablated area) biopsy-confirmed histologically viable cancer.
arm group label: Lesion-targeted ablation with MRI-TULSA
arm group type: Experimental
description: Intervention: Targeted lesion based thermoablation of MRI-visible biopsy proven clinically significant prostate cancer. Ablative effect is aimed to cover lesion with 5 mm MRI based healthy tissue overlap wherever possible but not compromising viability of critical tissues, mainly the wall of rectum.
intervention type: Device
intervention name: MRI-TULSA
description: The technology is developed to ablate targeted prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.
TULSA-PRO (Profound Medical Inc, Toronto, Canada): PAD-105, integrated into a 3 Tesla MR-system (Ingenia 3.0 Tesla, Philips Healthcare, Best, Netherlands)
arm group label: Lesion-targeted ablation with MRI-TULSA
other name: MRI guided transurethral ultrasound ablation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Peter Boström, M.D.Ph.D.
role: Principal Investigator
affiliation: Department of Urology, VSSHP, University of Turku
facility: 
country: Finland
citation: Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-Specific Antigen-Based Screening for Prostate Cancer: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 May 8;319(18):1914-1931. doi: 10.1001/jama.2018.3712.
PMID: 29801018
citation: Klotz L, Vesprini D, Sethukavalan P, Jethava V, Zhang L, Jain S, Yamamoto T, Mamedov A, Loblaw A. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol. 2015 Jan 20;33(3):272-7. doi: 10.1200/JCO.2014.55.1192. Epub 2014 Dec 15.
PMID: 25512465
citation: Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.
PMID: 27626136
citation: Wilt TJ, Jones KM, Barry MJ, Andriole GL, Culkin D, Wheeler T, Aronson WJ, Brawer MK. Follow-up of Prostatectomy versus Observation for Early Prostate Cancer. N Engl J Med. 2017 Jul 13;377(2):132-142. doi: 10.1056/NEJMoa1615869.
PMID: 28700844
citation: Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593.
PMID: 24597866
citation: Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14. Erratum In: N Engl J Med. 2023 Jun 8;388(23):2208.
PMID: 27626365
citation: Valerio M, Cerantola Y, Eggener SE, Lepor H, Polascik TJ, Villers A, Emberton M. New and Established Technology in Focal Ablation of the Prostate: A Systematic Review. Eur Urol. 2017 Jan;71(1):17-34. doi: 10.1016/j.eururo.2016.08.044. Epub 2016 Aug 29.
PMID: 27595377
citation: Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
PMID: 28110982
citation: Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
PMID: 29552975
citation: Chin JL, Billia M, Relle J, Roethke MC, Popeneciu IV, Kuru TH, Hatiboglu G, Mueller-Wolf MB, Motsch J, Romagnoli C, Kassam Z, Harle CC, Hafron J, Nandalur KR, Chronik BA, Burtnyk M, Schlemmer HP, Pahernik S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. Eur Urol. 2016 Sep;70(3):447-55. doi: 10.1016/j.eururo.2015.12.029. Epub 2016 Jan 6.
PMID: 26777228
citation: Ramsay E, Mougenot C, Staruch R, Boyes A, Kazem M, Bronskill M, Foster H, Sugar L, Haider M, Klotz L, Chopra R. Evaluation of Focal Ablation of Magnetic Resonance Imaging Defined Prostate Cancer Using Magnetic Resonance Imaging Controlled Transurethral Ultrasound Therapy with Prostatectomy as the Reference Standard. J Urol. 2017 Jan;197(1):255-261. doi: 10.1016/j.juro.2016.06.100. Epub 2016 Aug 18.
PMID: 27545572
citation: Chopra R, Colquhoun A, Burtnyk M, N'djin WA, Kobelevskiy I, Boyes A, Siddiqui K, Foster H, Sugar L, Haider MA, Bronskill M, Klotz L. MR imaging-controlled transurethral ultrasound therapy for conformal treatment of prostate tissue: initial feasibility in humans. Radiology. 2012 Oct;265(1):303-13. doi: 10.1148/radiol.12112263. Epub 2012 Aug 28.
PMID: 22929332
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No