Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-29 @ 10:40 AM
Study NCT ID:
NCT03504995
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2018-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA level', 'timeFrame': '3 months, 6 months, 9 months, 12 months.', 'description': 'Stable decrese of PSA level after surgery (\\<1 ng/ml)'}, {'measure': 'Complications', 'timeFrame': '1 year', 'description': 'Short and long term surgical complications'}], 'secondaryOutcomes': [{'measure': 'IPSS (International Prostate Symptom Score, range from 5 to 30)', 'timeFrame': '1 year', 'description': 'International Prostate Symptom Score'}, {'measure': 'QoL (Quality of Life score, range 1-6)', 'timeFrame': '1 year', 'description': 'Quality of Life Score'}, {'measure': 'Qmax', 'timeFrame': '1 year', 'description': 'Maximal urine flow rate'}, {'measure': 'IIEF', 'timeFrame': '1 year', 'description': 'International Index of Erectile Function - Erectile function assessment (range 1-5)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prostate', 'Irreversible Electroporation', 'Prostate Cancer'], 'conditions': ['Prostate Cancer', 'Prostate Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '17668932', 'type': 'BACKGROUND', 'citation': 'Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.'}, {'pmid': '29594551', 'type': 'BACKGROUND', 'citation': 'Scheltema MJ, Chang JI, Bohm M, van den Bos W, Blazevski A, Gielchinsky I, Kalsbeek AMF, van Leeuwen PJ, Nguyen TV, de Reijke TM, Siriwardana AR, Thompson JE, de la Rosette JJ, Stricker PD. Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy. World J Urol. 2018 Sep;36(9):1383-1389. doi: 10.1007/s00345-018-2281-z. Epub 2018 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer.\n\nIrreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.', 'detailedDescription': 'Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.\n\nMoreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally.\n\nThis study is a prospective and non-randomized with one group of 10 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol).\n\nBefore the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci.\n\nObjectives of the study: to asses safety of IRE in patients with localized PCa, to asses short-term oncologic efficacy of IRE in patients with localized PCa, to asses functional outcomes after IRE.\n\nAll patients will be followed up for 1 year (each 3 months).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Verified with MR-fusion biopsy localized Pca\n* PSA \\< 15 ng/ml\n* Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2\n* Life expectancy \\> 10 years\n* No post-void residual urine or infravesical obstruction\n\nExclusion Criteria:\n\n* patients with artificial cardiac pacemaker\n* patients without rectum\n* patients not eligible for general anesthesia\n* PIRADS\\<3\n* patients after primary Pca treatment\n* hormonal therapy six months before the study\n* radiotherapy of pelvic organs\n* urinary infection\n* extracapsular Pca\n* patients with metastatic lesions'}, 'identificationModule': {'nctId': 'NCT03504995', 'briefTitle': 'Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'I.M. Sechenov First Moscow State Medical University'}, 'officialTitle': 'Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer.', 'orgStudyIdInfo': {'id': 'Sechenov-IRE18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRE patients', 'description': "patients who will underwent 'Focal irreversible electroporation of the prostate cancer'", 'interventionNames': ['Device: Focal irreversible electroporation of the prostate cancer']}], 'interventions': [{'name': 'Focal irreversible electroporation of the prostate cancer', 'type': 'DEVICE', 'description': 'Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.', 'armGroupLabels': ['IRE patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Clinic of Urology, Sechenov University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Dmitry Enikeev, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'I.M. Sechenov First Moscow State Medcal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director for Science of RI of Uronephrology and Reproductive Health', 'investigatorFullName': 'Dmitry Enikeev, MD, PhD', 'investigatorAffiliation': 'I.M. Sechenov First Moscow State Medical University'}}}}