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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

Device: Embosphere® (Prostatic Arteries Embolization)

Drug: Drug therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02869971

PHRC-15-521 (Other Grant/Funding Number)

2016-A00247-44 (Other Identifier)

P150917

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Male

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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