Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 6:20 AM
Study NCT ID:
NCT04588857
Status:
UNKNOWN
Last Update Posted:
2022-03-22
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia
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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body temperature', 'timeFrame': 'Measured by participant on Day 2 following PAE,', 'description': 'Mean rectal body temperature, measured in degrees Celsius'}, {'measure': 'Postprocedural pain', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Mean postprocedural pain measured on Brief Pain Inventory Short Form (BPI-SF), score on a 0-10 scale, higher score indicates higher level of pain'}, {'measure': 'Postprocedural quality of life', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Mean postprocedural quality of life measured on BPI-SF, score on a 0-10 scale, higher score indicates lower quality of life'}], 'secondaryOutcomes': [{'measure': 'Inflammatory response markers', 'timeFrame': 'Measured at baseline and 2 days following PAE', 'description': 'C-reactive protein, measured in mg/l'}, {'measure': 'Prostate specific antigen (PSA)', 'timeFrame': 'Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE', 'description': 'PSA, measured in ng/ml'}, {'measure': 'Need for postprocedural medication', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Use of analgesics, antipyretics and antiemetics (frequency and dosage)'}, {'measure': 'Hospital admission', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Incidence of hospital admission'}, {'measure': 'LUTS severity', 'timeFrame': 'Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE', 'description': 'Measured on International Prostate Symptom Score (IPSS) questionnaire, each answer is scored from 0 to 5 for a maximum score of 35 points, higher score indicates more pronounced symptoms'}, {'measure': 'Erectile function', 'timeFrame': 'Measured at baseline, 1 month, 3 months, and 6 months following PAE', 'description': 'Measured on International Index of Erectile Function (IIEF-5) questionnaire, each answer is scored from 1 to 5 for a maximum score of 25 points, higher score indicates more pronounced symptoms'}, {'measure': 'Prostate volume', 'timeFrame': 'Measured at baseline, 3 and 6 months following PAE', 'description': 'Measured on transrectal US, in ml'}, {'measure': 'Peak urinary flow rate (Qmax)', 'timeFrame': 'Measured at baseline, 3 and 6 months following PAE', 'description': 'Qmax, measured in ml/s'}, {'measure': 'Mean urinary flow rate (Qmean)', 'timeFrame': 'Measured at baseline, 3 and 6 months following PAE', 'description': 'Qmean, measured in ml/s'}, {'measure': 'Residual urine', 'timeFrame': 'Measured at baseline, 3 and 6 months following PAE', 'description': 'Residual urine, measured in ml'}, {'measure': 'Urinary tract infections', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Incidence of urinary tract infections'}, {'measure': 'Acute urinary retention', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Incidence of acute urinary retention'}, {'measure': 'Side effects of PAE', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Incidence of side effects of PAE (PES excluded)'}, {'measure': 'Dysuria', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Incidence of dysuria'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Incidence of nausea and vomiting'}, {'measure': 'Blood glucose', 'timeFrame': 'During the first 5 days following PAE', 'description': 'Self-measured fasting blood glucose in mmol/l, only in patients with diabetes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostatic artery embolization', 'Benign prostatic hyperplasia', 'Postembolization syndrome'], 'conditions': ['Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '34725072', 'type': 'DERIVED', 'citation': "Svarc P, Stroomberg HV, Juhl Jensen R, Frevert S, Hakan Lindh M, Taudorf M, Brasso K, Lonn L, Roder MA. Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia: protocol for a single-centre, randomised, double-blind, placebo-controlled trial-the 'DEXAPAE' study. BMJ Open. 2021 Nov 1;11(11):e047878. doi: 10.1136/bmjopen-2020-047878."}]}, 'descriptionModule': {'briefSummary': 'Benign prostatic hyperplasia (BPH) is a frequent cause of lower urinary tract symptoms (LUTS) in men. One fourth of men older than 70 have moderate to severe LUTS that impair their quality of life (QOL). Prostatic artery embolization (PAE) is a new minimally invasive technique proven effective in reducing LUTS comparable to the mainstay treatment - the transurethral resection of the prostate (TURP).\n\nThe most common side effect of PAE is a collection of inflammation-related symptoms known as the postembolization syndrome (PES). The symptoms include pelvic pain, fever, nausea, and transient worsening of LUTS (painful and difficult urination). PES is a self-limiting condition that is treated symptomatically with painkillers and antipyretics. However, PES can be so severe that the patients experience high fever, shivers, dysuria and urgency mimicking a septicemia from the urinary tract. It is a clinical challenge to avoid exposure to unnecessary antibiotics treatment in those situations. A subset of patients may need admission to the hospital for observation, especially in case of fever. Usually, PES resolves within a week after PAE. Steroids have been successfully used to reduce the incidence and severity of PES after a number of procedures in interventional radiology. The investigators postulate that steroids can have a similar effect in reducing PES after PAE. In this study, the efficacy of single high dose postprocedural dexamethasone (DEXA) administration in reducing PES after PAE will be evaluated, compared to placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment or not patient preference\n* Moderate to severe urinary symptoms on IPSS (IPSS score 8 or over)\n* Qmax \\<=15ml/sec, based on flowmetry\n* Unsuitable for TURP or refuses surgery\n* Ability to understand and the willingness to sign an informed consent\n* Prostate volume \\> 80 milliliters\n* Men with low-risk prostate cancer (T1c, Gleason score \\<=6 on a maximum of 3 biopsies) who have LUTS due to a large BPH component are eligible\n* Indwelling or intermittent catheter is allowed\n\nExclusion Criteria:\n\n* History of bladder cancer\n* Previous pelvic radiation for cancer treatment\n* Current bladder stones\n* Significant bladder diverticula\n* Current urethral strictures or bladder neck contracture\n* Neurologic conditions such as multiple sclerosis, Parkinson's disease and other neurological diseases known to affect bladder function\n* Neurogenic bladder without obstruction\n* Active urinary tract infection at the time of intervention unless in case of regular catheter dependence and thought to represent colonization\n* Documented bacterial prostatitis in the last year\n* Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist)\n* Allergy to iodinated contrast media\n* Renal failure (eGFR \\< 30ml/min)\n* High bleeding risk (spontaneous INR \\> 1.6)\n* Contraindication to conscious sedation (if requested by participant)\n* Allergy to dexamethasone\n* Positive HIV, hepatitis B or C\n* Immunological disease (except topically treated skin or respiratory diseases)\n* Glaucoma\n* Active peptic or duodenal ulcer\n* Systemic fungal infections\n* Immunosuppressive treatment (systemic)\n* Current treatment of cancer (except low risk prostate cancer)"}, 'identificationModule': {'nctId': 'NCT04588857', 'briefTitle': 'Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Randomized Double-blind Placebo-controlled Trial on the Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'DEXAPAE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active drug', 'description': 'dexamethasone 24 mg i.v., single dose', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'saline i.v., single dose', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.', 'armGroupLabels': ['Active drug']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Petra Svarc, MD', 'role': 'CONTACT', 'email': 'petra.svarc@regionh.dk', 'phone': '91870618'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Petra Svarc, MD', 'role': 'CONTACT', 'email': 'petra.svarc@regionh.dk', 'phone': '+4591870618'}], 'overallOfficials': [{'name': 'Lars B Lonn, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Martin A Røder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be made available beginning 9 months and ending 36 months after article publication.', 'ipdSharing': 'YES', 'description': 'The results of this trial will be submitted for publication in a peer reviewed journal, in addition to reports at appropriate specialist conferences. The results of the trial will be disseminated regardless of the direction of effect.\n\nThe investigators intend to share de-identified individual participant data that underlie the results reported in the published article following reasonable requests to the principal investigator, and if in accordance with Danish law.', 'accessCriteria': 'Data will be made available to qualified scientific researchers who provide a methodologically sounds proposal following reasonable requests to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Petra Svarc, MD', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}