Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
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.
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms
 (LUTS) and affects > 50% of men >60 years. Moderate to severe symptoms prevalence is around
 14% in France, and the proportion of men with moderate to severe symptoms doubles with each
 decade of age. The first-line treatment of bothersome BPH-related LUTS is medical therapy as
 recommended by French and European guidelines. 5α reductase inhibitors (5-ARI) can be
 combined with alpha-blockers and allow reduction of the size of the prostate and LUTS
 improvement. The severity of symptoms is usually assessed using the International prostate
 symptom score (IPSS) which is the standard questionnaire for the objective assessment of
 LUTS.

 Recently, Prostatic Artery Embolization (PAE) has been proposed to treat symptomatic BPH with
 good safety and efficacy in single-centre studies (12-point IPSS reduction at 3 months
 maintained up to one year. In a randomized trial comparing PAE versus transurethral resection
 of prostate (TURP), Gao reported a 16-point IPSS reduction at 6 months, and an increase in
 the maximum urinary flow rate (Qmax) comprised between 12 ml/s and 24 ml/s at 6 months and up
 to 21 ml/s at 2 years. The complication rate is low (a few cases of bladder ulcer have been
 published) and the patient generally experiences mild post-embolization symptoms for few
 days.

 PAE can be performed during a one-day hospitalisation and could be very attractive to
 patients which have insufficient benefit of medical treatment or who have side effects
 affecting their quality of life. The most used device for PAE is Embosphere® (Merit Medical).
 It bears the European CE (Conforme aux Exigences) marking for this specific indication and
 approximately 500 patients have been treated with it worldwide. Nonetheless, no big
 randomized study has proven its efficacy compared with best medical treatment. A study
 comparing PAE using Embosphere® and surgery (TURP) is currently enrolling patients; no
 patients could be included in France because men with BPH refused to be potentially assigned
 the surgical arm.

 To properly evaluate PAE, the investigators designed the PARTEM trial, which has received the
 support of both the Societe Francaise de Radiologie (French society of radiology) and of the
 Association Francaise d'Urologie (French association of urology).

 PARTEM will compare prospectively the benefit of PAE using Embosphere® to the benefit of
 combined medical treatment (Combodart®: Dutasteride 0.5mg Tamsulosin 0.4mg) at 9 months with
 an extended follow up at 24 months in order to evaluate the stability of results in both
 groups.

 The investigators plan a multicentre, prospective, randomized, open label, parallel trial,
 comparing PAE to Combined Therapy (CT: alpha-blockers + 5-ARI treatment). Treatments will be
 allocated by minimization with a 1:1 ratio, based on study centre, IPSS score
 (moderate/severe) and prostate volume (< 80 g/≥80 g).

 This study is designed to demonstrate the superiority of PAE to decrease LUTS compared to
 best medical treatment.
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