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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04588857
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: Dexamethasone; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Body temperature [Measured by participant on Day 2 following PAE,]

   Mean rectal body temperature, measured in degrees Celsius

2. Postprocedural pain [During the first 5 days following PAE]

   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

3. Postprocedural quality of life [During the first 5 days following PAE]

   Mean postprocedural quality of life measured on BPI-SF, score on a 0-10 scale, higher score indicates lower quality of life

Secondary Outcome Measures

1. Inflammatory response markers [Measured at baseline and 2 days following PAE]

   C-reactive protein, measured in mg/l

2. Prostate specific antigen (PSA) [Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE]

   PSA, measured in ng/ml

3. Need for postprocedural medication [During the first 5 days following PAE]

   Use of analgesics, antipyretics and antiemetics (frequency and dosage)

4. Hospital admission [During the first 5 days following PAE]

   Incidence of hospital admission

5. LUTS severity [Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE]

   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

6. Erectile function [Measured at baseline, 1 month, 3 months, and 6 months following PAE]

   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

7. Prostate volume [Measured at baseline, 3 and 6 months following PAE]

   Measured on transrectal US, in ml

8. Peak urinary flow rate (Qmax) [Measured at baseline, 3 and 6 months following PAE]

   Qmax, measured in ml/s

9. Mean urinary flow rate (Qmean) [Measured at baseline, 3 and 6 months following PAE]

   Qmean, measured in ml/s

10. Residual urine [Measured at baseline, 3 and 6 months following PAE]

    Residual urine, measured in ml

11. Urinary tract infections [During the first 5 days following PAE]

    Incidence of urinary tract infections

12. Acute urinary retention [During the first 5 days following PAE]

    Incidence of acute urinary retention

13. Side effects of PAE [During the first 5 days following PAE]

    Incidence of side effects of PAE (PES excluded)

14. Dysuria [During the first 5 days following PAE]

    Incidence of dysuria

15. Nausea and vomiting [During the first 5 days following PAE]

    Incidence of nausea and vomiting

16. Blood glucose [During the first 5 days following PAE]

    Self-measured fasting blood glucose in mmol/l, only in patients with diabetes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Study Director: Lars B Lonn, MD, PhD, Rigshospitalet, Denmark
• Principal Investigator: Martin A Røder, MD, PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Petra Svarc, MD, PhD student, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT04588857
• Other Study ID Numbers: DEXAPAE
• First Posted: Oct 19, 2020
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Petra Svarc, MD, PhD student, Rigshospitalet, Denmark: Prostatic artery embolization; Benign prostatic hyperplasia; Postembolization syndrome
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Dexamethasone

Study Results

No Results Posted as of Mar 22, 2022