Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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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). The 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.

Official Title
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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

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment or not patient preference Moderate to severe urinary symptoms on IPSS (IPSS score 8 or over) Qmax <=15ml/sec, based on flowmetry Unsuitable for TURP or refuses surgery Ability to understand and the willingness to sign an informed consent Prostate volume > 80 milliliters 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 Indwelling or intermittent catheter is allowed Exclusion Criteria: History of bladder cancer Previous pelvic radiation for cancer treatment Current bladder stones Significant bladder diverticula Current urethral strictures or bladder neck contracture Neurologic conditions such as multiple sclerosis, Parkinson's disease and other neurological diseases known to affect bladder function Neurogenic bladder without obstruction Active urinary tract infection at the time of intervention unless in case of regular catheter dependence and thought to represent colonization Documented bacterial prostatitis in the last year Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist) Allergy to iodinated contrast media Renal failure (eGFR < 30ml/min) High bleeding risk (spontaneous INR > 1.6) Contraindication to conscious sedation (if requested by participant) Allergy to dexamethasone Positive HIV, hepatitis B or C Immunological disease (except topically treated skin or respiratory diseases) Glaucoma Active peptic or duodenal ulcer Systemic fungal infections Immunosuppressive treatment (systemic) Current treatment of cancer (except low risk prostate cancer)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active drug<br>dexamethasone 24 mg i.v., single dose | Drug: Dexamethasone<br>* The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.<br>|
| Placebo Comparator: Placebo<br>saline i.v., single dose | Drug: Saline<br>* The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | Mean rectal body temperature, measured in degrees Celsius | Measured by participant on Day 2 following PAE, | 
| Postprocedural pain | 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 | During the first 5 days following PAE | 
| Postprocedural quality of life | Mean postprocedural quality of life measured on BPI-SF, score on a 0-10 scale, higher score indicates lower quality of life | During the first 5 days following PAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response markers | C-reactive protein, measured in mg/l | Measured at baseline and 2 days following PAE | 
| Prostate specific antigen (PSA) | PSA, measured in ng/ml | Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE | 
| Need for postprocedural medication | Use of analgesics, antipyretics and antiemetics (frequency and dosage) | During the first 5 days following PAE | 
| Hospital admission | Incidence of hospital admission | During the first 5 days following PAE | 
| LUTS severity | 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 | Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE | 
| Erectile function | 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 | Measured at baseline, 1 month, 3 months, and 6 months following PAE | 
| Prostate volume | Measured on transrectal US, in ml | Measured at baseline, 3 and 6 months following PAE | 
| Peak urinary flow rate (Qmax) | Qmax, measured in ml/s | Measured at baseline, 3 and 6 months following PAE | 
| Mean urinary flow rate (Qmean) | Qmean, measured in ml/s | Measured at baseline, 3 and 6 months following PAE | 
| Residual urine | Residual urine, measured in ml | Measured at baseline, 3 and 6 months following PAE | 
| Urinary tract infections | Incidence of urinary tract infections | During the first 5 days following PAE | 
| Acute urinary retention | Incidence of acute urinary retention | During the first 5 days following PAE | 
| Side effects of PAE | Incidence of side effects of PAE (PES excluded) | During the first 5 days following PAE | 
| Dysuria | Incidence of dysuria | During the first 5 days following PAE | 
| Nausea and vomiting | Incidence of nausea and vomiting | During the first 5 days following PAE | 
| Blood glucose | Self-measured fasting blood glucose in mmol/l, only in patients with diabetes | During the first 5 days following PAE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic artery embolization, Benign prostatic hyperplasia, Postembolization syndrome