Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-07 @ 11:29 AM
Study NCT ID:
NCT02917161
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2016-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
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': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2016-09-24', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response', 'timeFrame': '6 weeks after PAE (at the time of RALP)', 'description': 'Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate.'}], 'secondaryOutcomes': [{'measure': 'Histological Tumor Regression Grade', 'timeFrame': '6 weeks after PAE (at the time of RALP)'}, {'measure': 'Surgical margins assessment (R0 /R1)', 'timeFrame': '6 weeks after PAE (at the time of RALP)', 'description': '\\- Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins.'}, {'measure': 'Assessment of Adverse Events of PAE according to CTCAE V4.03', 'timeFrame': 'At the time of PAE and 6 weeks afterwards'}, {'measure': 'Assessment of Adverse Events of PAE according to Clavien-Dindo classification', 'timeFrame': 'At the time of PAE and 6 weeks afterwards'}, {'measure': 'Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03', 'timeFrame': 'At the time of RALP, 6 weeks and 12 weeks later'}, {'measure': 'Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification', 'timeFrame': 'At the time of RALP, 6 weeks and 12 weeks later'}, {'measure': 'Change of prostate volume in MRI after PAE', 'timeFrame': 'Before and 6 weeks after PAE'}, {'measure': 'Change of tumor detection rate in MRI after PAE', 'timeFrame': 'Before and 6 weeks after PAE'}, {'measure': 'Change of tumor size in MRI after PAE', 'timeFrame': 'Before and 6 weeks after PAE'}, {'measure': 'Change of PIRADS classification in MRI after PAE', 'timeFrame': 'Before and 6 weeks after PAE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate', 'Prostatic Neoplams', 'Therapeutic Embolization', 'Prostatectomy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.\n\nThis proof of concept study assess the impact of PAE in patients with proven prostate cancer.', 'detailedDescription': 'MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.\n\nThis proof of concept study assess the impact of PAE in patients with proven prostate cancer.\n\nPAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.\n\nThe impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men 45 - 75 years old undergoing RALP\n* Patient has biopsy-proven prostate adenocarcinoma\n* Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe atherosclerosis\n* Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries\n* Tumor stage \\> cT2 assessed by clinical and MRI findings\n* Allergy to intravenous contrast media\n* Contraindication for MRI imaging\n* Renal failure (GFR\\<60ml/min)\n* History of pelvic irradiation or radical pelvic surgery'}, 'identificationModule': {'nctId': 'NCT02917161', 'briefTitle': 'Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'CTU 15/015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prostatic Artery Embolization (PAE)', 'description': 'PAE is performed 6weeks before RALP', 'interventionNames': ['Device: Prostatic Artery Embolization (PAE)']}], 'interventions': [{'name': 'Prostatic Artery Embolization (PAE)', 'type': 'DEVICE', 'description': 'PAE is performed 6 weeks before radical prostatectomy', 'armGroupLabels': ['Prostatic Artery Embolization (PAE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Lucerne, Department of Urology', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Urological Department, Cantonal Hospital of St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Dominik Abt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital St. Gallen'}, {'name': 'Livio Mordasini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital Luzerne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dominik Abt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Dominik Abt', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}