[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619078":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":36,"studyPopulation":28,"armGroups":37,"interventions":45,"overallOfficials":62,"centralContacts":67,"locations":77,"responsibleParty":99,"collaborators":101,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":28,"studyType":121,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":80,"whyStopped":28,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary Outcome 1:","Number of Participants With Procedure-Related Adverse Events Time Frame: Up to 6 months after procedure Outcome Type: Safety\n\nMeasure Description:\n\nNumber and severity of procedure-related adverse events (AEs), graded according to CTCAE v5.0, to evaluate the safety profile of focal Micro-Ultrasound-Guided Focal Laser Ablation (MicroUS-gFLA) in patients with organ-confined intermediate-risk prostate cancer.\n\nUnit of Measure: Number of participants","From enrollment to the end of treatment at 6 months.",{"measure":14,"description":15,"timeFrame":16},"Primary Outcome 2: Technical Success Rate of MicroUS-gFLA","Primary Outcome 2: Technical Success Rate of MicroUS-gFLA\n\nTime Frame: At completion of procedure; confirmed during follow-up up to 6 months Outcome Type: Feasibility\n\nMeasure Description:\n\nProportion of procedures achieving technical success, defined as: successful visualization and MicroUS-guided trocar insertion into the target lesion, and completion of focal laser ablation exactly as planned, as confirmed by intra-procedural imaging and follow-up mpMRI and\u002For biopsy. Unit of Measure: Percentage of procedures","From enrollment to the end of treatment at 6 months",[18,21,25],{"measure":19,"description":20,"timeFrame":12},"Secondary Outcome 1 - Change in PSA Level From Baseline","Secondary Outcome 1 - Change in PSA Level From Baseline\n\nTime Frame: Baseline to 6 months Outcome Type: Efficacy\n\nMeasure Description:\n\nChange in serum prostate-specific antigen (PSA) level from baseline prior to ablation to 6-month follow-up.\n\nUnit of Measure: Change in PSA (ng\u002FmL)",{"measure":22,"description":23,"timeFrame":24},"Secondary Outcome 2: Change in Urinary Function (IPSS Score)","Secondary Outcome 2: Change in Urinary Function (IPSS Score)\n\nTime Frame: Baseline, 3 months, and 6 months Outcome Type: Functional\n\nMeasure Description:\n\nChange in urinary function measured using the International Prostate Symptom Score (IPSS).\n\nUnit of Measure: Change in score (IPSS scale)","From enrollment to the end of the treatment at 6 months",{"measure":26,"description":27,"timeFrame":16},"Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)","Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)\n\nTime Frame: Baseline, 3 months, and 6 months Outcome Type: Functional\n\nMeasure Description:\n\nChange in erectile function measured using the International Index of Erectile Function-15 (IIEF-15) questionnaire.\n\nUnit of Measure: Change in score (IIEF-15 scale)",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"NA","SINGLE_GROUP","6 Month, Prospective, Interventional, Open-label Single-Arm Effectiveness Study","TREATMENT",{"masking":35,"maskingDescription":28,"whoMasked":28},"NONE","Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Single-Arm Prospective Clinical Trial","EXPERIMENTAL","This is a single arm study where patients with intermediate risk MR visible locally confined prostate cancer will be treated with Micro-Ultrasound Guided Focal Laser Ablation. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months with PSA.",[43,44],"Procedure: 6 month, prospective, interventional single-arm safety and effectiveness study","Device: The TRANBERG|CLS Thermal therapy",[46,55],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"PROCEDURE","6 month, prospective, interventional single-arm safety and effectiveness study","x",[39],[52,53,54],"MicroUSgFLA treatment","Focal Laser Ablation treatment","Minimally invasive treatments for prostate cancer",{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DEVICE","The TRANBERG|CLS Thermal therapy","Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\\|Thermal Therapy",[39],[61],"ExactVu Micro-Ultrasound System",[63],{"name":64,"affiliation":65,"role":66},"Sangeet Ghai, MD","The Princess Margaret Cancer Foundation","PRINCIPAL_INVESTIGATOR",[68,74],{"name":69,"role":70,"phone":71,"phoneExt":72,"email":73},"Kateri Corr","CONTACT","416-946-4501","5501","kateri.corr@uhn.ca",{"name":64,"role":70,"phone":75,"phoneExt":28,"email":76},"416-340-4656","sangeet.ghai@uhn.ca",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"University Health Network - Princess Margaret Cancer Centre","RECRUITING","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":87,"coordinates":88},"Point",[89,90],-79.39864,43.70643,{"lat":90,"lon":89},[93,94,95,96],{"name":69,"role":70,"phone":71,"phoneExt":72,"email":73},{"name":64,"role":70,"phone":75,"phoneExt":28,"email":76},{"name":64,"role":66,"phone":28,"phoneExt":28,"email":28},{"name":97,"role":98,"phone":28,"phoneExt":28,"email":28},"Nathan Perlis, MD","SUB_INVESTIGATOR",{"type":100,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[102,105],{"name":103,"class":104},"Exact Imaging","INDUSTRY",{"name":106,"class":104},"Clinical Laserthermia Systems AB","100619078","micro-ultrasound-guided-focal-laser-ablation-for-intermediate-risk-prostate-cancer-safety--effectiveness-100619078",false,"NCT07339943","Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness","Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness","MicroUSgFLA","Inclusion Criteria:\n\n* Men 40-80 years of age.\n* Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).\n* PCa clinical stage T1c or T2.\n* MRI\u002FMicroUS site suspicious for cancer or cancer mapped to one prostate lobe.\n* Maximum dimension of MRI\u002FMicroUS visible tumour ≤15mm.\n* Suspicious site on Prostate MRI\u002FMicroUS must coincide with sector positive for cancer on biopsy.\n* Prostate specific antigen (PSA) level \\\u003C 15 ng\u002FmL.\n* IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.\n* Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.\n\nExclusion Criteria:\n\n* Maximum dimension of MRI\u002FMicroUS visible tumour \\> 15 mm.\n* Patients medically unfit for focal therapy of the prostate.\n* Patients who are unwilling or unable to give informed consent.\n* Patients who have received androgen suppression therapy.\n* Patients who have received or are receiving chemotherapy for prostate carcinoma.\n* Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment.\n* Patients who have undergone radiation therapy for PCa or to the pelvis.\n* Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies).\n* Patients with a history of non-compliance with medical therapy and\u002For medical recommendations.\n* Patients who are unwilling or unable to complete the patient self-assessment questionnaires.\n* Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.\n* Patients who have participated in a clinical study and\u002For received treatment with an investigational treatment and\u002For product within the past 90 days.\n* Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)","MALE","40 Years","85 Years",{"count":119,"type":120},7,"ESTIMATED","INTERVENTIONAL",[30],"This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.",[125,126],"Prostate Cancer (Adenocarcinoma)","Low and Intermediate Risk Prostate Cancer",[128,129,130,131,132],"Micro-Ultrasound Guided Focal Laser Ablation","Focal Therapy","Focal Laser Ablation","Minimally Invasive Treatment","Laser Therapy","2026-09-24",{"date":135,"type":136},"2026-09-25","ACTUAL",{"date":138,"type":136},"2025-04-30",{"date":140,"type":120},"2028-12-31",{"name":5,"class":6},1]