Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
PARTEM
3 other identifiers
interventional
90
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2016
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2022
CompletedMay 3, 2022
April 1, 2022
4.3 years
July 19, 2016
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in IPSS score
9 months
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Embolization
EXPERIMENTALProstatic Arteries Embolization
Combined Therapy
ACTIVE COMPARATORCombodart® : dutasteride 0.5 mg/tamsulosin 0.4 mg per day
Interventions
Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
CHU de Lyon hopital Edouard Herriot
Lyon, Auvergne-Rhône-Alpes, 69437, France
CHU de Lyon centre hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France
CHU Rennes hopital Pontchaillou
Rennes, Brittany Region, 35033, France
CHU de Bordeaux groupe hospitalier Pellegrin
Bordeaux, Nouvelle-Aquitaine, 33076, France
CHU de Limoges
Limoges, Nouvelle-Aquitaine, 87042, France
CHU Montpellier hopital Arnaud de Villeneuve
Montpellier, Occitanie, 34295, France
CHU Montpellier hopital Lapeyronie
Montpellier, Occitanie, 34295, France
AP-HM hopital la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France
AP-HM hopital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
AP-HP hopital Henri-Mondor
Créteil, Île-de-France Region, 94010, France
AP-HP - Hôpital Saint-Louis
Paris, Île-de-France Region, 75010, France
AP-HP hopital Cochin
Paris, Île-de-France Region, 75014, France
AP-HP Hopital Europeen Georges Pompidou
Paris, Île-de-France Region, 75908, France
Related Publications (1)
Sapoval M, Thiounn N, Descazeaud A, Dean C, Ruffion A, Pagnoux G, Duarte RC, Robert G, Petitpierre F, Karsenty G, Vidal V, Murez T, Vernhet-Kovacsik H, de la Taille A, Kobeiter H, Mathieu R, Heautot JF, Droupy S, Frandon J, Barry Delongchamps N, Korb-Savoldelli V, Durand-Zaleski I, Pereira H, Chatellier G; PARTEM study group. Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial. Lancet Reg Health Eur. 2023 Jun 26;31:100672. doi: 10.1016/j.lanepe.2023.100672. eCollection 2023 Aug.
PMID: 37415648DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Sapoval, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2016
First Posted
August 17, 2016
Study Start
August 1, 2016
Primary Completion
December 3, 2020
Study Completion
March 25, 2022
Last Updated
May 3, 2022
Record last verified: 2022-04