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Trial record 20 of 27 for:    dutasteride AND tamsulosin

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

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ClinicalTrials.gov Identifier: NCT02869971
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Embosphere® (Prostatic Arteries Embolization) Drug: Drug therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
Actual Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Change in IPSS score [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 3, 9, 18, 24 months ]
  2. IPSS [ Time Frame: 3, 18, 24 months ]
  3. Qmax [ Time Frame: 3, 9, 24 months ]
  4. International Index of Erectile Function (IIEF) score [ Time Frame: 3, 9, 18, 24 months ]
  5. prostate volume [ Time Frame: 3, 9, 24 months ]
  6. Prostate-Specific Antigen (PSA) level [ Time Frame: 3, 9, 18, 24 months ]
  7. Quality of life score [ Time Frame: 3, 9, 18, 24 months ]
    assessed by IPSS/Quality of Life (QoL) form

  8. Treatment units' account [ Time Frame: 3, 9 months ]
    adherence to treatment

  9. Adherence to treatment questionnaire [ Time Frame: 3, 9 months ]
    adherence to treatment

  10. number of PAE [ Time Frame: 24 months ]
  11. number of surgical treatment [ Time Frame: 24 months ]
  12. number of medication [ Time Frame: 3, 9, 18, 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869971


Contacts
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Contact: Marc Sapoval, MD marc.sapoval2@aphp.fr
Contact: Yvann FRIGOUT yvann.frigout@aphp.fr

Locations
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France
CHU de Lyon hopital Edouard Herriot Recruiting
Lyon, Auvergne-Rhone-Alpes, France, 69437
Contact: Paul Cezar Moldovan, MD       paul-cezar.moldovan@chu-lyon.fr   
CHU de Lyon centre hospitalier Lyon Sud Recruiting
Pierre-Benite, Auvergne-Rhone-Alpes, France, 69310
Contact: Alain Ruffion, MD       alain.ruffion@chu-lyon.fr   
CHU Rennes hopital Pontchaillou Recruiting
Rennes, Bretagne, France, 35033
Contact: Jean-Francois Heautot, MD       heautot@chu-rennes.fr   
Principal Investigator: Jean-Francois Heautot, MD         
Principal Investigator: Romain Mathieu, MD         
CHU Montpellier hopital Arnaud de Villeneuve Recruiting
Montpellier, Languedoc-Roussillon-Midi-Pyrenees, France, 34295
Contact: Helene Vernhet-Kovacsik, MD       h-vernhet@chu-montpellier.fr   
CHU Montpellier hopital Lapeyronie Recruiting
Montpellier, Languedoc-Roussillon-Midi-Pyrenees, France, 34295
Contact: Thibaut Murez, MD       t-murez@chu-montpellier.fr   
CHU de Bordeaux groupe hospitalier Pellegrin Recruiting
Bordeaux, Nouvelle-Aquitaine, France, 33076
Contact: Nicolas Grenier, MD       nicolas.grenier@chu-bordeaux.fr   
Principal Investigator: Nicolas Grenier, MD         
Principal Investigator: Gregoire Robert, MD         
CHU de Limoges Terminated
Limoges, Nouvelle-Aquitaine, France, 87042
CHU Angers Withdrawn
Angers, Pays De La Loire, France, 49933
AP-HM hopital la Conception Recruiting
Marseille, Provence-Alpes-Cote d'Azur, France, 13005
Contact: Gilles Karsenty, MD       gilles.karsenty@ap-hm.fr   
AP-HM hopital de la Timone Recruiting
Marseille, Provence-Alpes-Cote d'Azur, France, 13385
Contact: Vincent Vidal, MD       vincent.vidal@ap-hm.fr   
AP-HP hopital Henri-Mondor Recruiting
Creteil, Île-de-France, France, 94010
Contact: Hicham Kobeiter, MD       hicham.kobeiter@aphp.fr   
Principal Investigator: Hicham Kobeiter, MD         
Principal Investigator: Alexandre de la Taille, MD         
AP-HP - Hôpital Saint-Louis Recruiting
Paris, Île-de-France, France, 75010
Contact: François Desgrandchamps, MD       franois.desgrandchamps@aphp.fr   
AP-HP hopital Cochin Recruiting
Paris, Île-de-France, France, 75014
Contact: Nicolas Barry-Delongchamp, MD       nicolas.barry-delongchamps@aphp.fr   
AP-HP Hopital Europeen Georges Pompidou Recruiting
Paris, Île-de-France, France, 75908
Contact: Marc Sapoval, MD       marc.sapoval2@aphp.fr   
Principal Investigator: Marc Sapoval, MD         
Principal Investigator: Nicolas Thiounn, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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Principal Investigator: Marc Sapoval, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02869971    
Other Study ID Numbers: P150917
PHRC-15-521 ( Other Grant/Funding Number: French ministry of Health )
2016-A00247-44 ( Other Identifier: France: ANSM )
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prostatic artery embolization
Combined Therapy
IPSS
Additional relevant MeSH terms:
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Tamsulosin
Dutasteride
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists