Trial Title:
Cost-utility of Focal HIFU vs Prostatectomy
NCT ID:
NCT05710861
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Localized Prostate cancer
Prostatectomy
Focal HIFU
Quality of life
Cost
ISUP 2
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicentric pragmatic clinical trial, comparative, with no insu, randomized in two
parallel groups with a 1:1 allocation ratio
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
F-HIFU
Description:
A F-HIFU treatment will be performed with the Focal-One® machine according to the
predefined treatment area for each patient using the standard procedure in place in each
therapeutic center and according to the user's manual edited by the company, under
locoregional or general anaesthesia.
Arm group label:
F-HIFU Group
Intervention type:
Procedure
Intervention name:
Radical Prostatectomy
Description:
A Radical Prostatectomy will be performed according to the standard procedure in place in
each center, under general anaesthesia, through an open, laparoscopic or robot-assisted
laparoscopic approach
Arm group label:
Prostatectomy Group
Summary:
Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy
in Patients with Favorable Intermediate Risk Prostate Cancer
Detailed description:
Standard treatment option of intermediate risk (ISUP2) prostate cancer (PC) is either
radical prostatectomy (RP) or radiation therapy (RT). An attractive option for selected
patients and for the health care system would be to spare the preserved gland to decrease
urinary, sexual and digestive side effects of whole-gland treatments keeping with a good
cancer control. For these reasons, focal treatments have been developed in localized PC.
The principal objective of the EMERHIT study is to estimate, from the health system point
of view, the efficiency (cost/utility study) of focal HIFU (F-HIFU) for intermediate risk
PC compared to RP (either by open, laparoscopic or robotic surgical approach) at 24
months. It will be a multicentric pragmatic clinical trial, comparative, with no insu,
randomized in two parallel groups :
- (1) F-HIFU treatment
- (2) RP Randomization will be equal (ratio 1:1), stratified on the centers and
performed maximum at 2 months before the procedure. The comparison to the SNDS data
will use the NIR of the patients selected for the study. The use of the SNDS data
will allow, on top of the estimation of the care cost, to increase the patient's
follow-up (with no supplemental visit) and measure, at 48 months, costs, mortality
rate and cancer control measures
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 45-75 yo male harboring a non-treated localized prostatic adenocarcinoma of maximum
Gleason score 3+4, ISUP 2 unilateral on at most maximum 2 contiguous sextants
(favorable intermediate risk),with or without ipsilateral or contralateral focus of
score 3+3 (ISUP1).
- Tumor visible on MRI and proven by systematic and/or targeted biopsies according to
the center's practices, regardless of the route used (transrectal or transpirenal)
- Or patients under active surveillance whose follow-up prostate biopsies reveal
unilateral ISUP2 on at most 2 contiguous sextants (favorable intermediate risk),
with or without ipsilateral or contralateral Gleason 3+3 focus (ISUP1)
- Patients with several suspicious foci on MRI may be be included if only one of these
foci is confirmed by targeted biopsies biopsies with an ISUP2 score,
- stage T1c-T2,
- with PSA <20 ng/ml,
- with prostate volume less than 150 ml,
- patient clearly informed of the study and having agreed, with sufficient time for
reflection to participate by signing the study's informed consent form,
- patient affiliated to or benefiting from a social security scheme
Exclusion Criteria:
- Metastatic prostate cancer.
- Gleason score > 3+4 (ISUP>2).
- Adenoma prostate carcinoma Cribriform or intraductal.
- Previous treatment anterior for the same cancer, whatever modality.
- Contra-indication to pelvic MRI with gadolinium injection.
- Contra-indication to surgery or general anesthesia.
- Patient who refuse the one-year follow-up control biopsy after F-HIFU.
- Presence of implant (stent, catheter) less than 1 cm from the treatment area.
- Urinary or rectal fistula.
- Anal or rectal stenosis or any other abnormality that may interfere with the Focal
One® endorectal probe introduction.
- Anatomic abnormality of the rectum or rectal mucosa.
- Presence of a urinary artificial sphincter, a penile prosthesis or intraprostatic
implant, i.e. urethral prosthesis.
- Bladder neck and/or urethral stenosis or sclerosis.
- Inflammatory bowel disease (colon or rectum).
- Ongoing UTI (should be treated before the F-HIFU or the RP).
- Previous anal or rectal surgery that may interfere with the anal probe introduction.
- Latex allergy.
- Rectal wall thickness > 10 mm.
- Tumor not accessible to a F-HIFU treatment (tumors located in the fibro-muscular
anterior zone).
- Previous not controlled cancer and/or treated since less than 5 years (except
basocellular skin cancer).
- Patient not able to understand the trial objectives or refusing to adhere to the
trial instructions.
- Patients under law-protection.
- Patient in an ongoing research trial.
- Patient with a severe health or psychologic problem that could impair the protocol
pathway.
Gender:
Male
Minimum age:
50 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Polyclinique beaujolais
Address:
City:
Arnas
Zip:
69400
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Stephane CHASSAGNE, MD
Phone:
+33 9 70 75 55 57
Investigator:
Last name:
Stephane CHASSAGNE, MD
Email:
Principal Investigator
Facility:
Name:
Clinique Saint Vincent
Address:
City:
Besançon
Zip:
25000
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent BAILY, MD
Phone:
+33 3 81 47 21 44
Email:
docteur.bailly.urologie@gmail.com
Investigator:
Last name:
Vincent BAILY, MD
Email:
Principal Investigator
Facility:
Name:
Clinique Tivoli
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Contact:
Last name:
Gilles PASTICIER, MD
Phone:
+33 5 56 90 91 16
Investigator:
Last name:
Gilles PASTICIER, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Bordeaux
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck Bladou
Phone:
05 57 82 03 40
Email:
franck.bladou@chu-bordeaux.fr
Facility:
Name:
Hopitaux civil de Colmar
Address:
City:
Colmar
Zip:
68024
Country:
France
Status:
Recruiting
Contact:
Last name:
Ludovic OBRINGER, MD
Phone:
+33 3 89 12 41 92
Email:
ludovic.obringer@ch-colmar.fr
Investigator:
Last name:
Ludovic OBRINGER, MD
Email:
Principal Investigator
Facility:
Name:
Hopital prive drome ardeche
Address:
City:
Guilherand-Granges
Zip:
07500
Country:
France
Status:
Recruiting
Contact:
Last name:
Ibrahim BAH-CLOZEL, MD
Phone:
+33 4 75 75 23 52
Investigator:
Last name:
Ibrahim BAH-CLOZEL, MD
Email:
Principal Investigator
Facility:
Name:
Hopital Claude HURIEZ
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Recruiting
Contact:
Last name:
Arnaud VILLERS, Prof
Phone:
+33 3 20 44 42 35
Investigator:
Last name:
Arnaud VILLERS, Prof
Email:
Principal Investigator
Facility:
Name:
Hopital Privé La Louviere
Address:
City:
Lille
Zip:
59800
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre COLIN, MD
Phone:
+33 3 20 12 12 90
Email:
docpierrecolin@gmail.com
Investigator:
Last name:
Pierre COLIN, MD
Email:
Principal Investigator
Facility:
Name:
Hopital Edouard Herriot Pavillon V
Address:
City:
Lyon
Zip:
69437
Country:
France
Status:
Recruiting
Contact:
Last name:
Sebastien CROUZET, PROF
Phone:
+33 4 72 11 03 25
Email:
sebastien.crouzet@chu-lyon.fr
Investigator:
Last name:
Sebastien CROUZET, PROF
Email:
Principal Investigator
Facility:
Name:
APHM Nord Marseille
Address:
City:
Marseille
Zip:
13015
Country:
France
Status:
Recruiting
Contact:
Last name:
Harry TOLEDANO, MD
Phone:
+33 4 91 96 88 48
Email:
harry.toledano@ap-hm.fr
Investigator:
Last name:
Harry TOLEDANO, MD
Email:
Principal Investigator
Facility:
Name:
Hopital Americain de Paris
Address:
City:
Neuilly-sur-Seine
Zip:
92200
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aurel MESSAS, MD
Phone:
+33 1 46 41 26 93
Investigator:
Last name:
Aurel MESSAS, MD
Email:
Principal Investigator
Facility:
Name:
Hopital Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Contact:
Last name:
Nicolas BARY DELONGCHAMPS, PROF
Phone:
+33 1 58 41 27 83
Email:
nicolas.barrydelongchamps@aphp.fr
Investigator:
Last name:
Nicolas BARY DELONGCHAMPS, PROF
Email:
Principal Investigator
Facility:
Name:
Hopital Lyon Sud HCL Bat 3C Centre
Address:
City:
Pierre-Bénite
Zip:
69310
Country:
France
Status:
Recruiting
Contact:
Last name:
Alain RUFFION, PROF
Phone:
+33 4 72 67 88 37
Email:
alain.ruffion@chu-lyon.fr
Investigator:
Last name:
Alain RUFFION, PROF
Email:
Principal Investigator
Facility:
Name:
Hopital Privé francheville
Address:
City:
Périgueux
Zip:
204004
Country:
France
Status:
Recruiting
Contact:
Last name:
Richard Mallet, Dr
Email:
richard@mallet@gmail.com
Facility:
Name:
Clinique La Croix du Sud
Address:
City:
Quint-Fonsegrives
Zip:
31130
Country:
France
Status:
Recruiting
Contact:
Last name:
Guillaume PLOUSSARD, MD
Investigator:
Last name:
Guillaume PLOUSSARD, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Rennes
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
Romain MATHIEU, pr
Email:
romain.mathieu@chu-rennes.fr
Facility:
Name:
Clinique Saint Michel
Address:
City:
Toulon
Zip:
83100
Country:
France
Status:
Recruiting
Contact:
Last name:
Stephane MALLIK, MD
Phone:
+33 4 98 00 18 69
Investigator:
Last name:
Stephane MALLIK, MD
Email:
Principal Investigator
Facility:
Name:
CHU Toulouse rangueil
Address:
City:
Toulouse
Zip:
31400
Country:
France
Status:
Recruiting
Contact:
Last name:
Matthieu ROUMIGUIE, MD
Phone:
+33 5 81 32 33 05
Email:
roumiguie.m@chu-toulouse.fr
Investigator:
Last name:
Matthieu ROUMIGUIE, MD
Email:
Principal Investigator
Facility:
Name:
Clinique Oceane
Address:
City:
Vannes
Zip:
56000
Country:
France
Status:
Recruiting
Contact:
Last name:
Cyril GERARD, MD
Phone:
+33 2 97 63 44 70
Email:
drcgerard@aim.com
Investigator:
Last name:
Cyril GERARD, MD
Email:
Principal Investigator
Start date:
March 6, 2023
Completion date:
February 20, 2027
Lead sponsor:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Source:
University Hospital, Bordeaux
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05710861
