Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Embosphere® (Prostatic Arteries Embolization); Drug therapy
Intervention type(s): Device; Drug
Intervention description(s): Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres; Combodart (dutasteride 0.5 mg/tamsulosin 0.4 mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostatic artery embolization; Combined Therapy; IPSS