Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

NACompletedINTERVENTIONAL
Enrollment

3,862

Participants

Timeline

Start Date

March 23, 2015

Primary Completion Date

August 24, 2022

Study Completion Date

August 24, 2022

Conditions
Prostate CancerUltrasound Therapy
Interventions
PROCEDURE

Radical Prostatectomy

The surgical approach can be open or laparoscopic. The procedure begins with lymph node dissection for the intermediate risk groups (PSA \> 10 ng/mL and/or presence of grade 4 Gleason score). Total prostatectomy includes removal of the seminal vesicles. It can preserve 1 or 2 neurovascular bundles, depending on the cancer stage and/or the choice expressed by the patient. The vesicourethral suture is either a running or interrupted suture, and there is drainage by a bladder catheter for at least 5 days.

PROCEDURE

High Intensity Focused Ultrasound (HIFU) Treatment

The treatment with High Intensity Focused Ultrasound (HIFU) evaluated in this study will be delivered by 2 types of medical devices currently available on the market, Ablatherm® and Focal One®. They are both computer-controlled and provided with an endo-rectal probe with integrated ultrasound, enabling planning and the monitoring of treatment of localized prostate cancer in realtime.

Trial Locations (49)

13008

Hôpital St Joseph, Marseille

13015

AP-AM, Marseille

13616

Centre Hospitalier d'Aix en Provence, Aix-en-Provence

17108

CH de Saintonge, Saintes

21000

Polyclinique du parc Drevon, Dijon

21079

CHU de Dijon, Dijon

25000

CHRU de Besançon, Besançon

25044

Clinique St Vincent, Besançon

30029

CHU de Nîmes, Nîmes

31059

CHU de Toulouse, Toulouse

31076

Clinique Pasteur, Toulouse

31400

Clinique St Jean du Languedoc, Toulouse

33000

Clinique Tivoli-Ducos, Bordeaux

33074

Clinique St Augustin, Bordeaux

33076

CHU de Bordeaux, Bordeaux

33200

Nouvelle clinique Bel Air, Bordeaux

34070

Clinique Beau Soleil, Montpellier

35033

CHU de rennes, Rennes

37170

Pôle Santé Léonard de Vinci, Chambray-lès-Tours

38043

CHU de Grenoble, Grenoble

43000

Clinique Bon Secours, Le Puy-en-Velay

44800

Clinique Nantes Atlantis, Saint-Herblain

51100

Clinique Courlancy, Reims

56000

Clinique Océanne, Vannes

59037

CHRU de Lille, Lille

59042

Clinique La Louvière, Lille

63050

PôleSanté République, Clermont-Ferrand

64100

Clinique St Etienne, Bayonne

67000

Clinique Rhéna, Strasbourg

68024

Hôpitaux civils de Colmar, Colmar

68100

Clinique Diaconat-Roosevelt, Mulhouse

69002

Hospices Civils de lyon, Lyon

69130

Cliniqe du Val d'Ouest, Écully

69400

Polyckinique du Beaujolais, Arnas

72018

Cliique du Pré, Le Mans

73011

CHR de Chambéry, Chambéry

75007

Fondation St Jean de Dieu - Clinique Oudinot, Paris

75008

Clinique Turin, Paris

75014

Hôpital St Joseph, Paris

75020

Hôpital TENON, Paris

75674

Institut Mutualiste Montsouris, Paris

75908

Hôpital Europeen Georges Pompidou, Paris

83000

Clinique St Michel, Toulon

87042

CHU de Limoges, Limoges

92150

Hôpital Foch, Suresnes

95300

CH de pontoise, Pontoise

97159

CHU de guadeloupe, Pointe-à-Pitre

07500

Hôpital Privé Drome Ardèche, Guilherand-Granges

06200

CHU de Nice, Nice

All Listed Sponsors
lead

Association Francaise d'Urologie

OTHER

NCT04307056 - Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY | Biotech Hunter | Biotech Hunter