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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588857
• Other study ID #: DEXAPAE
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: Rigshospitalet, Denmark
• Contact: Petra Svarc, MD
• Phone: +4591870618
• Email: petra.svarc[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Dexamethasone
The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.
• Saline
The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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