Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-26 @ 8:09 PM
Study NCT ID:
NCT02566551
Status:
WITHDRAWN
Last Update Posted:
2019-07-12
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum urinary flow rate', 'timeFrame': '12 months', 'description': 'Change from baseline in maximum urinary flow rate (Qmax)'}, {'measure': 'Post-void residual urinary volume', 'timeFrame': '12 months', 'description': 'Change from baseline in post-void residual urinary volume (PVR)'}, {'measure': 'Detrusor pressure', 'timeFrame': '12 months', 'description': 'Change from baseline in detrusor pressure (Pdet)'}, {'measure': 'Mean prostate volume', 'timeFrame': '12 months', 'description': 'Change from baseline in mean prostate volume, as determined by transrectal US'}, {'measure': 'Structural and morphological changes in MRI', 'timeFrame': '12 months', 'description': 'Change from baseline in mean prostate volume, and structural and morphological changes as determined by MRI'}, {'measure': 'Prostate specific antigen', 'timeFrame': '12 months', 'description': 'Change from baseline in prostate specific antigen (PSA)'}, {'measure': 'Overall adverse events', 'timeFrame': '12 months', 'description': 'Overall adverse events'}, {'measure': 'Procedure related adverse events', 'timeFrame': '12 months', 'description': 'Procedure related adverse events'}], 'primaryOutcomes': [{'measure': 'Improvement of symptoms', 'timeFrame': '12 months', 'description': 'Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )'}], 'secondaryOutcomes': [{'measure': 'Improvement in QoL', 'timeFrame': '12 months', 'description': 'Improvement (change) of quality of life assessed by QoL score'}, {'measure': 'Duration of hospitalization post procedure', 'timeFrame': '3 weeks', 'description': 'Number of days of postprocedure hospitalization'}, {'measure': 'Preservation of erectile function', 'timeFrame': '12 months', 'description': 'Change from baseline in erectile function using the International Index of Erectile Function (IIEF)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostatic artery embolization', 'Transurethral resection of the prostate'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP).', 'detailedDescription': 'The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) and the improvement of QoL assessed by QoL questionnaire in patients undergoing prostatic artery embolization (PAE) to patients of similar characteristics undergoing conventional transurethral resection of the prostate (TURP).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients evaluated in the Urology Service because of BPH, candidate to TURP.\n\n* Signed informed consent\n* Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score \\> 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI\n* Patient must meet ONE of the following criteria:\n\n 1. Baseline Prostate Specific Antigen (PSA) \\<4 ng/mL (no prostate biopsy required)\n 2. Baseline PSA \\>4 ng/mL and ≤10 ng/mL AND free PSA \\> 15% of total PSA (no prostate biopsy required)\n 3. Baseline PSA \\>4 ng/mL and ≤10 ng/mL AND free PSA \\<15% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)\n 4. Baseline PSA \\>10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)\n\nExclusion Criteria:\n\n* Active urinary tract infection\n* Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study\n* Biopsy proven prostate or bladder cancer\n* The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:\n\n * Patients with digital rectal examination (DRE) findings suspicious for prostate cancer\n * Patients with baseline PSA levels \\> 10 ng/mL\n * Patients with baseline PSA levels \\>4 ng/mL and \\< 10 ng/mL AND free PSA \\< 15% of total PSA\n* Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)\n* Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition\n* Allergy to iodinated contrast agents\n* Hypersensitivity to gelatin products\n* Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate\n* Known major iliac arterial occlusive disease or any known condition that catheterization of the prostatic arteries or is a contraindication to embolization, as vasospasm, anatomical variations that imply a risk of embolization, bleeding, prostatic arteries diameter inferior to microcatheter profile, pelvic inflammatory disease\n* Contraindication to magnetic resonance imaging\n* History of prostatitis in the last 5 years, not totally controlled with medical treatment\n* History of pelvic irradiation or radical pelvic surgery\n* Coagulation disturbances not normalized by medical treatment"}, 'identificationModule': {'nctId': 'NCT02566551', 'briefTitle': 'Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.', 'organization': {'class': 'OTHER', 'fullName': 'Group of Research in Minimally Invasive Techniques'}, 'officialTitle': 'Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.', 'orgStudyIdInfo': {'id': 'GTM-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prostate artery embolization', 'description': 'Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm', 'interventionNames': ['Procedure: PAE', 'Device: Gelatin microspheres']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transurethral resection of the prostate', 'description': 'Transurethral resection of the prostate (TURP) A bipolar electrosurgery generator will be used to perform TURP', 'interventionNames': ['Procedure: TURP', 'Device: Bipolar electrosurgery generator']}], 'interventions': [{'name': 'PAE', 'type': 'PROCEDURE', 'otherNames': ['Prostate artery embolization', 'Prostate arteries embolization', 'Embolization of the prostate', 'Prostatic artery embolization'], 'description': 'Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.', 'armGroupLabels': ['Prostate artery embolization']}, {'name': 'Gelatin microspheres', 'type': 'DEVICE', 'otherNames': ['Embolization microspheres'], 'description': 'Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol', 'armGroupLabels': ['Prostate artery embolization']}, {'name': 'TURP', 'type': 'PROCEDURE', 'otherNames': ['Transurethral resection of the prostate', 'Transurethral prostatic resection'], 'description': 'Bipolar transurethral resection of the prostate', 'armGroupLabels': ['Transurethral resection of the prostate']}, {'name': 'Bipolar electrosurgery generator', 'type': 'DEVICE', 'otherNames': ['Transurethral prostatic resection'], 'description': 'A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)', 'armGroupLabels': ['Transurethral resection of the prostate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50003', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Miguel A De Gregorio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zaragoza. Chairman of Radiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Group of Research in Minimally Invasive Techniques', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clínico Universitario Lozano Blesa', 'class': 'OTHER'}, {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'José A. Guirola, MD', 'investigatorAffiliation': 'Group of Research in Minimally Invasive Techniques'}}}}