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Prostatic HyperplasiaPhase 4NCT04588857

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

A Phase 4 study testing Dexamethasone and Saline in people with Prostatic Hyperplasia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 21 years and older, men only
Conditions the study is for
Prostatic Hyperplasia
What is being tested?
Dexamethasone and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteDenmark
Study dates
1 Mar 2021to 1 Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Petra Svarc, MD contact

+4591870618

petra.svarc@regionh.dk

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Petra Svarc, MD, 91870618, petra.svarc@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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

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.

Being tested
Dexamethasone, Saline
Keywords
Prostatic artery embolization, Benign prostatic hyperplasia, Postembolization syndrome
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

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

  • SalineDrug

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

Study groups in NCT04588857
Study groupRoleWhat they receive
Active drugExperimentaldexamethasone 24 mg i.v., single dose
Receives: Drug: Dexamethasone
PlaceboPlacebo comparatorsaline i.v., single dose
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body temperature

    Mean rectal body temperature, measured in degrees Celsius

    Measured: Measured by participant on Day 2 following PAE,

  2. 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

    Measured: During the first 5 days following PAE

  3. 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

    Measured: During the first 5 days following PAE

Secondary outcomes (16)

  1. Inflammatory response markers

    C-reactive protein, measured in mg/l

    Measured: Measured at baseline and 2 days following PAE

  2. Prostate specific antigen (PSA)

    PSA, measured in ng/ml

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

  3. Need for postprocedural medication

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

    Measured: During the first 5 days following PAE

  4. Hospital admission

    Incidence of hospital admission

    Measured: During the first 5 days following PAE

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

  6. 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: Measured at baseline, 1 month, 3 months, and 6 months following PAE

  7. Prostate volume

    Measured on transrectal US, in ml

    Measured: Measured at baseline, 3 and 6 months following PAE

  8. Peak urinary flow rate (Qmax)

    Qmax, measured in ml/s

    Measured: Measured at baseline, 3 and 6 months following PAE

  9. Mean urinary flow rate (Qmean)

    Qmean, measured in ml/s

    Measured: Measured at baseline, 3 and 6 months following PAE

  10. Residual urine

    Residual urine, measured in ml

    Measured: Measured at baseline, 3 and 6 months following PAE

  11. Urinary tract infections

    Incidence of urinary tract infections

    Measured: During the first 5 days following PAE

  12. Acute urinary retention

    Incidence of acute urinary retention

    Measured: During the first 5 days following PAE

  13. Side effects of PAE

    Incidence of side effects of PAE (PES excluded)

    Measured: During the first 5 days following PAE

  14. Dysuria

    Incidence of dysuria

    Measured: During the first 5 days following PAE

  15. Nausea and vomiting

    Incidence of nausea and vomiting

    Measured: During the first 5 days following PAE

  16. Blood glucose

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

    Measured: During the first 5 days following PAE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04588857
Sponsor's protocol ID
DEXAPAE
Status last verified
Mar 2022
First submitted
2 Oct 2020
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34725072

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone and Saline in people with Prostatic Hyperplasia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Petra Svarc, MD (+4591870618, petra.svarc@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body temperature (time frame: Measured by participant on Day 2 following PAE,). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04588857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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