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

NCT ID: NCT04588857

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active drug

dexamethasone 24 mg i.v., single dose

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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

Placebo

saline i.v., single dose

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

Dexamethasone

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Petra Svarc, MD

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars B Lonn, MD, PhD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Martin A Røder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Petra Svarc, MD

Role: CONTACT

petra.svarc@regionh.dk

+4591870618

Facility Contacts

Petra Svarc, MD

Role: primary

petra.svarc@regionh.dk

91870618

References

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.

Reference Type: DERIVED

PMID: 34725072 (View on PubMed)

Other Identifiers

DEXAPAE

Identifier Type: -

Identifier Source: org_study_id