E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign prostatic hyperplasia |
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E.1.1.1 | Medical condition in easily understood language |
Benign prostate enlargement |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004446 |
E.1.2 | Term | Benign prostatic hyperplasia |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
reduction in post-procedural fever and pain with dexamethasone in patients undergoing prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH) |
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E.2.2 | Secondary objectives of the trial |
reduction in post-procedural inflammatory response (C-reactive protein), PSA, medication use, lower urinary tract symptoms (LUTS), hospital readmission, acute urinary retention and urinary tract infections with dexamethasone in patients undergoing PAE for BPH |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Co-primary endpoints: - body temperature (measured rectally)
- difference in pain measured by Brief Pain Inventory - Short Form (BPI-SF)
- difference in quality of life (QoL) measured by Brief Pain Inventory - Short Form (BPI-SF) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- temperature - day 2 post-PAE - pain - first 5 days post-PAE - QoL - first 5 days post-PAE |
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E.5.2 | Secondary end point(s) |
• Postoperative inflammatory response markers (prostate specific antigen – PSA, C-reactive protein – CRP) • Need for postoperative medications (analgesics, antipyretics, antiemetics) • Incidence of admission to hospital • LUTS severity • Erectile function • Incidence of urinary tract infections • Incidence of side-effects to PAE • Incidence of acute urinary retention
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Postoperative inflammatory response markers: CRP - 2 days after PAE, PSA: 2 days, 1, 3 and 3 months post-PAE Postoperative medications: first 5 days post-PAE Incidence of admission to hospital: first 5 days post-PAE LUTS severity: measured by IPSS 5 days, 1, 3 and 6 months post-PAE Erectile function> measured by IIEF-5 1, 3 and 6 months post-PAE Urinary tract infections: first 5 days post-PAE Side-effects to PAE: first 5 days post-PAE Acute urinary retention: first 5 days post-PAE |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
sodium chloride 0,9% is used to maintain the blind |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |