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

NCT04588857 | Unknown Phase 4 DMC

• 1 other identifier: DEXAPAE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia

Keywords

Prostatic artery embolization; Benign prostatic hyperplasia; Postembolization syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Inflammatory response markers

  Measured at baseline and 2 days following PAE

• Prostate specific antigen (PSA)

  Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE

• Need for postprocedural medication

  During the first 5 days following PAE

• Hospital admission

  During the first 5 days following PAE

• LUTS severity

  Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE

Study Arms (2)

Active drug

EXPERIMENTAL

dexamethasone 24 mg i.v., single dose

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

saline i.v., single dose

Drug: Saline

Interventions

Dexamethasone DRUG

The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.

Active drug

Saline DRUG

The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 34725072 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lars B Lonn, MD, PhD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Martin A Røder, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Svarc, MD

CONTACT

+4591870618; petra.svarc@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 19, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available beginning 9 months and ending 36 months after article publication.
• Access Criteria: Data will be made available to qualified scientific researchers who provide a methodologically sounds proposal following reasonable requests to the principal investigator.

Locations

DK (1)