Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

— PARTEM  

Official title:

Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869971
• Other study ID #: P150917
• Secondary ID: PHRC-15-5212016-
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: March 25, 2022

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 25, 2022
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Embosphere® (Prostatic Arteries Embolization)
Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres

Drug:
• Drug therapy
Combodart (dutasteride 0.5 mg/tamsulosin 0.4 mg)

Locations

Country	Name	City	State
France	CHU de Bordeaux groupe hospitalier Pellegrin	Bordeaux	Nouvelle-Aquitaine
France	AP-HP hopital Henri-Mondor	Creteil	Île-de-France
France	CHU de Limoges	Limoges	Nouvelle-Aquitaine
France	CHU de Lyon hopital Edouard Herriot	Lyon	Auvergne-Rhone-Alpes
France	AP-HM hopital de la Timone	Marseille	Provence-Alpes-Cote d'Azur
France	AP-HM hopital la Conception	Marseille	Provence-Alpes-Cote d'Azur
France	CHU Montpellier hopital Arnaud de Villeneuve	Montpellier	Languedoc-Roussillon-Midi-Pyrenees
France	CHU Montpellier hopital Lapeyronie	Montpellier	Languedoc-Roussillon-Midi-Pyrenees
France	AP-HP - Hôpital Saint-Louis	Paris	Île-de-France
France	AP-HP hopital Cochin	Paris	Île-de-France
France	AP-HP Hopital Europeen Georges Pompidou	Paris	Île-de-France
France	CHU de Lyon centre hospitalier Lyon Sud	Pierre-Benite	Auvergne-Rhone-Alpes
France	CHU Rennes hopital Pontchaillou	Rennes	Bretagne

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

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