Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia (PARTEM)

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Embosphere® (Prostatic Arteries Embolization); Drug: Drug therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Auvergne-Rhone-Alpes
    • Lyon, Auvergne-Rhone-Alpes, France, 69437
      • CHU de Lyon Hopital Edouard Herriot
    • Pierre-Benite, Auvergne-Rhone-Alpes, France, 69310
      • CHU de Lyon centre hospitalier Lyon Sud
  • Bretagne
    • Rennes, Bretagne, France, 35033
      • Chu Rennes Hopital Pontchaillou
  • Languedoc-Roussillon-Midi-Pyrenees
    • Montpellier, Languedoc-Roussillon-Midi-Pyrenees, France, 34295
      • CHU Montpellier Hôpital Arnaud de Villeneuve
    • Montpellier, Languedoc-Roussillon-Midi-Pyrenees, France, 34295
      • CHU Montpellier Hôpital Lapeyronie
  • Nouvelle-Aquitaine
    • Bordeaux, Nouvelle-Aquitaine, France, 33076
      • CHU de Bordeaux Groupe Hospitalier Pellegrin
    • Limoges, Nouvelle-Aquitaine, France, 87042
      • CHU de Limoges
  • Provence-Alpes-Cote d'Azur
    • Marseille, Provence-Alpes-Cote d'Azur, France, 13005
      • AP-HM hopital la Conception
    • Marseille, Provence-Alpes-Cote d'Azur, France, 13385
      • AP-HM Hopital de la Timone
  • Île-de-France
    • Creteil, Île-de-France, France, 94010
      • AP-HP hopital Henri-Mondor
    • Paris, Île-de-France, France, 75010
      • AP-HP - Hôpital Saint-Louis
    • Paris, Île-de-France, France, 75014
      • AP-HP Hôpital Cochin
    • Paris, Île-de-France, France, 75908
      • AP-HP Hôpital Européen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization; Prostatic Arteries Embolization	Device: Embosphere® (Prostatic Arteries Embolization); Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres
Active Comparator: Combined Therapy; Combodart® : dutasteride 0.5 mg/tamsulosin 0.4 mg per day	Drug: Drug therapy; Combodart (dutasteride 0.5 mg/tamsulosin 0.4 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in IPSS score	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events		3, 9, 18, 24 months
IPSS		3, 18, 24 months
Qmax		3, 9, 24 months
International Index of Erectile Function (IIEF) score		3, 9, 18, 24 months
prostate volume		3, 9, 24 months
Prostate-Specific Antigen (PSA) level		3, 9, 18, 24 months
Quality of life score	assessed by IPSS/Quality of Life (QoL) form	3, 9, 18, 24 months
Treatment units' account	adherence to treatment	3, 9 months
Adherence to treatment questionnaire	adherence to treatment	3, 9 months
number of PAE		24 months
number of surgical treatment		24 months
number of medication		3, 9, 18, 24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Marc Sapoval, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 3, 2020
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Prostatic artery embolization; Combined Therapy; IPSS
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: P150917; PHRC-15-521 (Other Grant/Funding Number: French ministry of Health); 2016-A00247-44 (Other Identifier: France: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No