Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT01726894
Status:
UNKNOWN
Last Update Posted:
2014-06-18
First Post:
2012-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018274', 'term': 'Electroporation'}], 'ancestors': [{'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2012-10-30', 'studyFirstSubmitQcDate': '2012-11-11', 'lastUpdatePostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Role of follow-up MRI', 'timeFrame': 'Six months', 'description': '• Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test'}, {'measure': 'Anxiety', 'timeFrame': 'Up to 1 year', 'description': '• Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer'}], 'primaryOutcomes': [{'measure': 'Safety Profile', 'timeFrame': 'Up to 1 year', 'description': 'Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.'}], 'secondaryOutcomes': [{'measure': 'Sexual Side Effects', 'timeFrame': 'Up to 1 year', 'description': '• Change in erectile function measured by the IIEF-15 questionnaire'}, {'measure': 'Continence side effect', 'timeFrame': 'Up to 1 year', 'description': '• Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire'}, {'measure': 'Rectal side effects', 'timeFrame': 'Up to 1 year', 'description': '• Number of patients with grade I-II-III type rectal toxicity'}, {'measure': 'Cancer Control', 'timeFrame': 'Six months', 'description': 'Number of patients having residual prostate cancer at 6 months biopsy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Focal Therapy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven prostate cancer, Gleason Score \\</=7\n* An anterior visible lesion on mpMRI, that is accessible to IRE treatment\n* Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones)\n* Absence of clinically significant disease outside of the planned treatment zone, from histopathology and/or mpMRI findings\n* Stage radiologicalT1-T2cN0M0 disease, as determined by local guidelines\n* Serum PSA \\</=15 ng/ml\n* Life expectancy of \\>/= 10 years\n* Signed informed consent by patient\n* An understanding of the English language sufficient to understand written and verbal information about the trial and consent process\n\nExclusion Criteria:\n\n* Men who have had previous radiation therapy\n* Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer\n* Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging\n* Men with a non-visible tumour on mpMRI\n* Men with an inability to tolerate a transrectal ultrasound\n* Men with latex allergies\n* Men who have undergone prior significant rectal surgery preventing insertion of the TRUS probe (decided on the type of surgery in individual cases)\n* Men who have had previous IRE, HIFU, cryosurgery, thermal or microwave therapy to the prostate.\n* Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.\n* Men not fit for major surgery as assessed by a Consultant Anaesthetist\n* Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)\n* Presence of metal implants/stents in the urethra\n* Men with renal impairment with a GFR of \\<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).'}, 'identificationModule': {'nctId': 'NCT01726894', 'acronym': 'Nano', 'briefTitle': 'Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation', 'organization': {'class': 'OTHER', 'fullName': 'University College London Hospitals'}, 'officialTitle': 'A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer', 'orgStudyIdInfo': {'id': '12/0399'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irreversible Electroporation', 'interventionNames': ['Device: Irreversible Electroporation']}], 'interventions': [{'name': 'Irreversible Electroporation', 'type': 'DEVICE', 'armGroupLabels': ['Irreversible Electroporation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Hashim U Ahmed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLH'}, {'name': 'Mark Emberton, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College London Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Mark Emberton', 'investigatorAffiliation': 'University College London Hospitals'}}}}