Actively Recruiting
Cost-utility of Focal HIFU vs Prostatectomy
Led by University Hospital, Bordeaux · Updated on 2026-04-09
346
Participants Needed
20
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer
CONDITIONS
Official Title
Cost-utility of Focal HIFU vs Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 45 to 75 years
- Diagnosed with non-treated localized prostatic adenocarcinoma with maximum Gleason score 3+4, ISUP 2 unilateral on at most 2 contiguous sextants (favorable intermediate risk)
- Tumor visible on MRI and confirmed by biopsy
- Or under active surveillance with unilateral ISUP 2 on at most 2 contiguous sextants
- Stage T1c or T2
- PSA less than 20 ng/ml
- Prostate volume less than 150 ml
- Patient informed and consents to participate
- Affiliated with or benefiting from a social security scheme
You will not qualify if you...
- Metastatic prostate cancer
- Gleason score greater than 3+4 (ISUP>2)
- Presence of cribriform or intraductal adenoma prostate carcinoma
- Prior treatment for the same cancer
- Contraindications to pelvic MRI with gadolinium
- Contraindications to surgery or general anesthesia
- Refusal of one-year follow-up biopsy after F-HIFU
- Implants (stent, catheter) less than 1 cm from treatment area
- Urinary or rectal fistula
- Anal or rectal stenosis or abnormalities interfering with probe introduction
- Anatomic abnormalities of rectum or mucosa
- Presence of urinary artificial sphincter, penile prosthesis, or intraprostatic implant
- Bladder neck or urethral stenosis or sclerosis
- Inflammatory bowel disease
- Ongoing urinary tract infection
- Previous anal or rectal surgery interfering with probe
- Latex allergy
- Rectal wall thickness greater than 10 mm
- Tumor inaccessible to F-HIFU (fibro-muscular anterior zone)
- Previous uncontrolled cancer or treated less than 5 years ago (except basal cell skin cancer)
- Inability to understand trial objectives or adhere to instructions
- Under legal protection
- Participation in another ongoing research trial
- Severe health or psychological problems impairing protocol adherence
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Clinique Saint Vincent
Besançon, France, 25000
Actively Recruiting
2
Clinique Tivoli
Bordeaux, France, 33000
Actively Recruiting
3
CHU de Bordeaux
Bordeaux, France, 33076
Actively Recruiting
4
Hopitaux civil de Colmar
Colmar, France, 68024
Withdrawn
5
CHU Grenoble Alpes
Grenoble, France
Actively Recruiting
6
Hopital prive drome ardeche
Guilherand-Granges, France, 07500
Actively Recruiting
7
Hopital Claude HURIEZ
Lille, France, 59000
Actively Recruiting
8
Hopital Privé La Louviere
Lille, France, 59800
Actively Recruiting
9
Hopital Edouard Herriot Pavillon V
Lyon, France, 69437
Actively Recruiting
10
APHM Nord Marseille
Marseille, France, 13015
Actively Recruiting
11
Hopital Cochin
Paris, France, 75014
Actively Recruiting
12
Hopital Privé francheville
Périgueux, France, 204004
Actively Recruiting
13
Hopital Lyon Sud HCL Bat 3C Centre
Pierre-Bénite, France, 69310
Actively Recruiting
14
Clinique La Croix du Sud
Quint-Fonsegrives, France, 31130
Actively Recruiting
15
CHU de Rennes
Rennes, France
Actively Recruiting
16
CH Saintonge
Saint-Jean-d'Angély, France
Actively Recruiting
17
Clinique Saint Michel
Toulon, France, 83100
Actively Recruiting
18
CHU Toulouse rangueil
Toulouse, France, 31400
Actively Recruiting
19
Clinique Oceane
Vannes, France, 56000
Actively Recruiting
20
CHU Pointe à Pitre
Pointe-à-Pitre, Guadeloupe
Not Yet Recruiting
Research Team
F
Franck BLADOU, PROF
CONTACT
G
Grégoire ROBERT, PROF
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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