Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical treatment with alpha-blockers.

The secondary objectives of this study are to:

• Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well as the side effects of the 2 strategies;

• Report the safety of PAE;

• Evaluate patient's adherence to medical treatment;

• Analyse the costs of each strategy and report the incremental efficiency (incremental cost utility ratio) of prostatic artery embolization compared to medical treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France

Criteria

Inclusion Criteria:

• Men aged>= 50 and <=85 years AND

• Moderate to severe LUTS defined as IPSS > 11, and QoL > 3 AND

• No improvement after an alpha blocker treatment line (Tamsulosin 0.4 mg p.d. during 1 month) AND

• Prostatic volume >=50 ml AND

• Affiliated to a French health insurance system

Exclusion Criteria:

• Severe allergy to iodine contrast agent

• Treatment with 5-ARI on the last 6 months

• Suspected prostate cancer requiring specific management

• On-going prostatitis

• On-going urinary retention

• On-going acute urinary infection

• Acontractile detrusor

• Neurogenic lower urinary tract dysfunction

• Urethral stenosis

• Bladder diverticulum

• Bladder stone with surgical indication

• Patient refusing PAE

• Creatinine clearance <40 ml/min

• Severe liver failure

• Contra-indication to alpha-blockers

• Hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin (including case of tamsulosin induced angioedema), soya, peanut or one of the excipients

• Hypersensitivity to gelatin or collagen

• Patients ineligible for pelvic angiography

• History of orthostatic hypotension

• Patient unable or unwilling to provide written informed consent

• Patient under legal protection