Randomized controlled trial on the use of dexamethasone or placebo in reduction of the postembolization syndrome after prostatic artery embolization for benign prostate gland enlargement

Phase 1

• Conditions: Benign prostatic hyperplasia; MedDRA version: 21.1Level: PTClassification code 10004446Term: Benign prostatic hyperplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2020-000915-53-DK
• Lead Sponsor: Department of Radiology, Rigshospitalet, Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-27
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 60

Inclusion 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 equal or over 8)
- 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 is allowed.
- Indwelling catheter or intermittent catheter is allowed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

EXCLUSION CRITERIA:
- History of bladder cancer
- Previous pelvic radiation for cancer treatment
- 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
- 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
- Allergy to dexamethasone
- Positive HIV, hepatitis B or C
- Immunoinflammatory disease (except topically treated skin or respiratory diseases)
- Glaucoma
- Active peptic or duodenal ulcer
- Systemic fungal infections
- Immunosuppressive treatment
- Current treatment of cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified