Back to resultsEfficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Primary Purpose
Prostatic Hyperplasia
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Prostatic artery embolization, Benign prostatic hyperplasia, Postembolization syndrome
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)
Sites / Locations
- RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active drug
Placebo
Arm Description
dexamethasone 24 mg i.v., single dose
saline i.v., single dose
Outcomes
Primary Outcome Measures
Body temperature
Mean rectal body temperature, measured in degrees Celsius
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
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
Secondary Outcome Measures
Inflammatory response markers
C-reactive protein, measured in mg/l
Prostate specific antigen (PSA)
PSA, measured in ng/ml
Need for postprocedural medication
Use of analgesics, antipyretics and antiemetics (frequency and dosage)
Hospital admission
Incidence of hospital admission
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
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
Prostate volume
Measured on transrectal US, in ml
Peak urinary flow rate (Qmax)
Qmax, measured in ml/s
Mean urinary flow rate (Qmean)
Qmean, measured in ml/s
Residual urine
Residual urine, measured in ml
Urinary tract infections
Incidence of urinary tract infections
Acute urinary retention
Incidence of acute urinary retention
Side effects of PAE
Incidence of side effects of PAE (PES excluded)
Dysuria
Incidence of dysuria
Nausea and vomiting
Incidence of nausea and vomiting
Blood glucose
Self-measured fasting blood glucose in mmol/l, only in patients with diabetes
Full Information
NCT ID
NCT04588857
First Posted
October 2, 2020
Last Updated
March 21, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04588857
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
Keywords
Prostatic artery embolization, Benign prostatic hyperplasia, Postembolization syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active drug
Arm Type
Experimental
Arm Description
dexamethasone 24 mg i.v., single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
saline i.v., single dose
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.
Primary Outcome Measure Information:
Title
Body temperature
Description
Mean rectal body temperature, measured in degrees Celsius
Time Frame
Measured by participant on Day 2 following PAE,
Title
Postprocedural pain
Description
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
Time Frame
During the first 5 days following PAE
Title
Postprocedural quality of life
Description
Mean postprocedural quality of life measured on BPI-SF, score on a 0-10 scale, higher score indicates lower quality of life
Time Frame
During the first 5 days following PAE
Secondary Outcome Measure Information:
Title
Inflammatory response markers
Description
C-reactive protein, measured in mg/l
Time Frame
Measured at baseline and 2 days following PAE
Title
Prostate specific antigen (PSA)
Description
PSA, measured in ng/ml
Time Frame
Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE
Title
Need for postprocedural medication
Description
Use of analgesics, antipyretics and antiemetics (frequency and dosage)
Time Frame
During the first 5 days following PAE
Title
Hospital admission
Description
Incidence of hospital admission
Time Frame
During the first 5 days following PAE
Title
LUTS severity
Description
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
Time Frame
Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE
Title
Erectile function
Description
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
Time Frame
Measured at baseline, 1 month, 3 months, and 6 months following PAE
Title
Prostate volume
Description
Measured on transrectal US, in ml
Time Frame
Measured at baseline, 3 and 6 months following PAE
Title
Peak urinary flow rate (Qmax)
Description
Qmax, measured in ml/s
Time Frame
Measured at baseline, 3 and 6 months following PAE
Title
Mean urinary flow rate (Qmean)
Description
Qmean, measured in ml/s
Time Frame
Measured at baseline, 3 and 6 months following PAE
Title
Residual urine
Description
Residual urine, measured in ml
Time Frame
Measured at baseline, 3 and 6 months following PAE
Title
Urinary tract infections
Description
Incidence of urinary tract infections
Time Frame
During the first 5 days following PAE
Title
Acute urinary retention
Description
Incidence of acute urinary retention
Time Frame
During the first 5 days following PAE
Title
Side effects of PAE
Description
Incidence of side effects of PAE (PES excluded)
Time Frame
During the first 5 days following PAE
Title
Dysuria
Description
Incidence of dysuria
Time Frame
During the first 5 days following PAE
Title
Nausea and vomiting
Description
Incidence of nausea and vomiting
Time Frame
During the first 5 days following PAE
Title
Blood glucose
Description
Self-measured fasting blood glucose in mmol/l, only in patients with diabetes
Time Frame
During the first 5 days following PAE
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra Svarc, MD
Phone
+4591870618
Email
petra.svarc@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars B Lonn, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin A Røder, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Svarc, MD
Phone
91870618
Email
petra.svarc@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The results of this trial will be submitted for publication in a peer reviewed journal, in addition to reports at appropriate specialist conferences. The results of the trial will be disseminated regardless of the direction of effect.
The investigators intend to share de-identified individual participant data that underlie the results reported in the published article following reasonable requests to the principal investigator, and if in accordance with Danish law.
IPD Sharing Time Frame
Data will be made available beginning 9 months and ending 36 months after article publication.
IPD Sharing Access Criteria
Data will be made available to qualified scientific researchers who provide a methodologically sounds proposal following reasonable requests to the principal investigator.
Citations:
PubMed Identifier
34725072
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.
Results Reference
derived
Learn more about this trial
Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia
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