Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-31 @ 4:31 PM
Study NCT ID:
NCT03996005
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-11', 'releaseDate': '2025-11-18'}, {'releaseDate': '2025-12-15'}], 'estimatedResultsFirstSubmitDate': '2025-11-18'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.', 'timeFrame': '1 year', 'description': 'Clinically significant cancer (CSC) defined by at least one of the following criteria:\n\n* Gleason score ≥ 7\n* cancer core length \\> 3 mm regardless of Gleason score\n* \\> 2 positive cores.'}], 'secondaryOutcomes': [{'measure': 'Biochemical response', 'timeFrame': 'Month 3', 'description': 'PSA'}, {'measure': 'Biochemical response', 'timeFrame': 'Month 6', 'description': 'PSA'}, {'measure': 'Biochemical response', 'timeFrame': 'Month 12', 'description': 'PSA'}, {'measure': 'Presence of any CSC on biopsy at 1-year follow-up', 'timeFrame': 'at 1-year follow-up', 'description': 'Pathology analysis of the biopsy'}, {'measure': 'Radical treatment free survival', 'timeFrame': 'at 1-year follow-up', 'description': 'Evaluation of the complication according to Dindo-Clavien'}, {'measure': 'Adverse events, clinical tolerance', 'timeFrame': 'at 1-year follow-up'}, {'measure': 'Urinary continence', 'timeFrame': 'Month 3', 'description': 'Urinary continence evaluation by using the USP scale'}, {'measure': 'Urinary continence', 'timeFrame': 'Month 6', 'description': 'Urinary continence evaluation by using the USP scale'}, {'measure': 'Urinary continence', 'timeFrame': 'Month 12', 'description': 'Urinary continence evaluation by using the USP scale'}, {'measure': 'Erectile function', 'timeFrame': 'Month 3', 'description': 'Erectile function evaluated by using the IIEF15 scale'}, {'measure': 'Erectile function', 'timeFrame': 'Month 6', 'description': 'Erectile function evaluated by using the IIEF15 scale'}, {'measure': 'Erectile function', 'timeFrame': 'Month 12', 'description': 'Erectile function evaluated by using the IIEF15 scale'}, {'measure': 'Quality of life EORTC QLQ-C30 scale.', 'timeFrame': 'Month 3', 'description': 'EORTC QLQ-C30 scale.'}, {'measure': 'Quality of life EORTC QLQ-C30 scale.', 'timeFrame': 'Month 6', 'description': 'EORTC QLQ-C30 scale.'}, {'measure': 'Quality of life EORTC QLQ-C30 scale.', 'timeFrame': 'Month 12', 'description': 'EORTC QLQ-C30 scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MRI Guided Transurethral Ultrasound Ablation', 'Localized Prostate Cancer', 'Ablation Therapy']}, 'referencesModule': {'references': [{'pmid': '40441432', 'type': 'BACKGROUND', 'citation': 'Tricard T, Cazzato RL, Schroeder A, De Mathelin M, Barhoumi C, Gaillard V, Sauleau E, Gangi A, Lang H. Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation (TULSA) of Localized Prostate Cancer: A prospective Trial. J Vasc Interv Radiol. 2025 Sep;36(9):1401-1408. doi: 10.1016/j.jvir.2025.05.024. Epub 2025 May 27.'}]}, 'descriptionModule': {'briefSummary': 'Primary purpose :\n\nEvaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer.\n\nPrimary Objective:\n\nAbsence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.\n\nSecondary Objectives:\n\n1. Biochemical response\n2. Presence of any CSC on biopsy at 1- and 2-year follow-up\n3. Radical treatment free survival\n4. Adverse events, clinical tolerance\n5. Urinary continence\n6. Erectile function\n7. Quality of life'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patient ≥ 50 years old\n* Histologically confirmed adenocarcinoma of the prostate\n* Gleason ≤ 7 (3 + 4) ; Grade group ≤ 2 according to Epstein\n* Clinically \\<T3, N0, M0\n* PSA \\< 15 ng/mL\n* Prostate volume \\<100g\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy higher than 12 months in the judgement of the investigator\n* Radiological TNM (prostate MRI) T ≤ 2 (absence of extra-capsular extension, absence of seminal vesicle invasion), N = 0, M = 0\n* First line of treatment or relapse after initial radiotherapy\n* Willing to give signed, informed consent freely\n* Able to adhere to the follow-up schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Contraindication to MRI\n* Contraindication to general anesthesia\n* Presence or history of any other malignancy except for non-melanoma skin cancer adequately treated at least 2 years before study entry\n* Unreversible haemostasis disorder'}, 'identificationModule': {'nctId': 'NCT03996005', 'acronym': 'MRI-TULSAP', 'briefTitle': 'MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer', 'orgStudyIdInfo': {'id': '7429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI Guided Transurethral Ultrasound', 'description': 'Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'interventionNames': ['Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue']}], 'interventions': [{'name': 'Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'type': 'PROCEDURE', 'description': 'Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'armGroupLabels': ['MRI Guided Transurethral Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires de strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Thibault TRICARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-18', 'type': 'RELEASE'}, {'date': '2025-12-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital, Strasbourg, France'}}}}