Clinical trial NCT04588857: Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Keywords: Prostatic artery embolization
Benign prostatic hyperplasia
Postembolization syndrome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 60
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Body temperature
timeFrame: Measured by participant on Day 2 following PAE,
measure: Postprocedural pain
timeFrame: During the first 5 days following PAE
measure: Postprocedural quality of life
timeFrame: During the first 5 days following PAE
Secondary outcomes:
measure: Inflammatory response markers
timeFrame: Measured at baseline and 2 days following PAE
measure: Prostate specific antigen (PSA)
timeFrame: Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE
measure: Need for postprocedural medication
timeFrame: During the first 5 days following PAE
measure: Hospital admission
timeFrame: During the first 5 days following PAE
measure: LUTS severity
timeFrame: Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE
measure: Erectile function
timeFrame: Measured at baseline, 1 month, 3 months, and 6 months following PAE
measure: Prostate volume
timeFrame: Measured at baseline, 3 and 6 months following PAE
measure: Peak urinary flow rate (Qmax)
timeFrame: Measured at baseline, 3 and 6 months following PAE
measure: Mean urinary flow rate (Qmean)
timeFrame: Measured at baseline, 3 and 6 months following PAE
measure: Residual urine
timeFrame: Measured at baseline, 3 and 6 months following PAE
measure: Urinary tract infections
timeFrame: During the first 5 days following PAE
measure: Acute urinary retention
timeFrame: During the first 5 days following PAE
measure: Side effects of PAE
timeFrame: During the first 5 days following PAE
measure: Dysuria
timeFrame: During the first 5 days following PAE
measure: Nausea and vomiting
timeFrame: During the first 5 days following PAE
measure: Blood glucose
timeFrame: During the first 5 days following PAE
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars B Lonn, MD, PhD
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Martin A Røder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.