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Cost-utility of Focal HIFU vs Prostatectomy (EMERHIT)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
F-HIFU
Radical Prostatectomy
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Localized Prostate cancer, Prostatectomy, Focal HIFU, Quality of life, Cost, ISUP 2

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 50-75 yo male harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm. Tumor visible on MRI and proven by systematic and targeted biopsies a according to the center's practices, regardless of the route used (transrectal or transpirenal) Patients under active surveillance in whom follow-up Prostate Biopsies reveal ISUP2 with less than 50% of Prostate Biopsies affected Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven. T1c-T2 stage. PSA <20 ng/ml. Prostate volume less than 100 ml. Fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form. Affiliated or beneficiary patient to the social security system. Exclusion Criteria: Metastatic prostate cancer. Gleason score > 3+4 (ISUP>2). More than 50% of positive biopsies. 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.

Sites / Locations

  • Polyclinique beaujolais
  • Clinique Saint VincentRecruiting
  • Clinique Tivoli
  • CHU de BordeauxRecruiting
  • CHU de BordeauxRecruiting
  • Hopitaux civil de ColmarRecruiting
  • Hopital prive drome ardecheRecruiting
  • Hopital Claude HURIEZ
  • Hopital Privé La LouviereRecruiting
  • Hopital Edouard Herriot Pavillon VRecruiting
  • APHM Nord MarseilleRecruiting
  • Hopital Americain de Paris
  • Hopital CochinRecruiting
  • Institut Mutualiste Montsouris
  • Hopital Lyon Sud HCL Bat 3C Centre
  • Hopital Privé francheville
  • Clinique La Croix du SudRecruiting
  • CHU de Rennes
  • Clinique Saint MichelRecruiting
  • CHU Toulouse rangueilRecruiting
  • Clinique OceaneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

F-HIFU Group

Prostatectomy Group

Arm Description

50 to 75 years old patients fit for a Radical Prostatectomy when active surveillance is not recommended and who do not want a radiation therapy: harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm, with a tumor visible on MRI and biopsy-proven with systematic and targeted biopsy with at least 2 biopsies per target and 12 systematic biopsies, Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven, T1c-T2 stage, PSA <20 ng/ml, prostate volume less than 100 ml, fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form, affiliated or beneficiary patient to the French social security system

50 to 75 years old patients fit for a Radical Prostatectomy when active surveillance is not recommended and who do not want a radiation therapy: harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm, with a tumor visible on MRI and biopsy-proven with systematic and targeted biopsy with at least 2 biopsies per target and 12 systematic biopsies, Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven, T1c-T2 stage, PSA <20 ng/ml, prostate volume less than 100 ml, fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form, affiliated or beneficiary patient to the French social security system

Outcomes

Primary Outcome Measures

The cost/utility ratio expressed as differential cost per QALY in favor of F-HIFU compared to RP (open, lap or robot) at 24 months.
Utility will be measured at baseline and at 6, 12 and 24 months using the EQ-5D-5L self-administered questionnaire. Costs will be estimated from the perspective of the French health system. They will be collected by probabilistic matching with data from the SNDS using data from the inclusion hospitalization of each patient included in the the trial.

Secondary Outcome Measures

The per-year of preserved life differential cost between F-HIFU and RP
The per-year of preserved life differential cost at 48 months between F-HIFU and RP from the SNDS database evaluated by micro-costing
Differential cost between F-HIFU and open, lap or robotic RP
Differential cost of per-QALY improved at 24 months between F-HIFU and open, lap or robotic RP evaluated by micro-costing
Real production cost (€) of F-HIFU and RP
Real production cost (€) of F-HIFU and RP evaluated by micro-costing
Net benefit (€) for the Health Insurance
Net benefit (€) for the Health Insurance of a diffusion of F-HIFU into the French Health System for patients with favorable intermediate risk PC evaluated by micro-costing
Survival with no salvage treatmente.
Survival with no salvage treatment at 12, 24 and 48 months, evaluated in part from the SNDS database. Optional salvage treatments possibly being: a second F-HIFU, RP or radiotherapy with or without androgen deprivation. All salvage treatments, except the F-HIFU, are already reimbursed by the French Health System and available in the SNDS database.
Overall survival
Overall survival at 12, 24 and 48 months measured from the inclusion date to the date of death, all causes of death being included or the date of the last visit or at 48 months
Cancer specific survival
Cancer specific survival at 12, 24 and 48 month measured from the date of inclusion to the date of death due to the progression of PC or the date of the last visit. Causes of death are available in the SNDS database since it is implemented by the CEpiDC
Androgen deprivation-free survival
Androgen deprivation-free survival (equivalent to metastasis-free survival) at 12, 24 and 48 month measured from the inclusion date to the first prescription of androgen deprivation therapy or the date of the last visit
Urinary and sexual functions
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnaires EPIC-26
Patient's quality of life
Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires EORTC QLQ C30
Urinary and sexual functions
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnars IPSS
Urinary and sexual functions
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnaires IIEF-5
Patient's quality of life
Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires QLQ PR25
Patient's quality of life
Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires EQ-5D-5L

Full Information

First Posted
January 16, 2023
Last Updated
October 13, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05710861
Brief Title
Cost-utility of Focal HIFU vs Prostatectomy
Acronym
EMERHIT
Official Title
Randomized Medical-Economic Trial Comparing Focal HIFU Treatment to Total Prostatectomy in Patients With Intermediate Prognosis Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
February 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Localized Prostate cancer, Prostatectomy, Focal HIFU, Quality of life, Cost, ISUP 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups with a 1:1 allocation ratio
Masking
Participant
Allocation
Randomized
Enrollment
346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F-HIFU Group
Arm Type
Experimental
Arm Description
50 to 75 years old patients fit for a Radical Prostatectomy when active surveillance is not recommended and who do not want a radiation therapy: harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm, with a tumor visible on MRI and biopsy-proven with systematic and targeted biopsy with at least 2 biopsies per target and 12 systematic biopsies, Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven, T1c-T2 stage, PSA <20 ng/ml, prostate volume less than 100 ml, fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form, affiliated or beneficiary patient to the French social security system
Arm Title
Prostatectomy Group
Arm Type
Active Comparator
Arm Description
50 to 75 years old patients fit for a Radical Prostatectomy when active surveillance is not recommended and who do not want a radiation therapy: harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm, with a tumor visible on MRI and biopsy-proven with systematic and targeted biopsy with at least 2 biopsies per target and 12 systematic biopsies, Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven, T1c-T2 stage, PSA <20 ng/ml, prostate volume less than 100 ml, fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form, affiliated or beneficiary patient to the French social security system
Intervention Type
Device
Intervention Name(s)
F-HIFU
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Radical Prostatectomy
Intervention 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
Primary Outcome Measure Information:
Title
The cost/utility ratio expressed as differential cost per QALY in favor of F-HIFU compared to RP (open, lap or robot) at 24 months.
Description
Utility will be measured at baseline and at 6, 12 and 24 months using the EQ-5D-5L self-administered questionnaire. Costs will be estimated from the perspective of the French health system. They will be collected by probabilistic matching with data from the SNDS using data from the inclusion hospitalization of each patient included in the the trial.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
The per-year of preserved life differential cost between F-HIFU and RP
Description
The per-year of preserved life differential cost at 48 months between F-HIFU and RP from the SNDS database evaluated by micro-costing
Time Frame
48 months
Title
Differential cost between F-HIFU and open, lap or robotic RP
Description
Differential cost of per-QALY improved at 24 months between F-HIFU and open, lap or robotic RP evaluated by micro-costing
Time Frame
24 months
Title
Real production cost (€) of F-HIFU and RP
Description
Real production cost (€) of F-HIFU and RP evaluated by micro-costing
Time Frame
48 months
Title
Net benefit (€) for the Health Insurance
Description
Net benefit (€) for the Health Insurance of a diffusion of F-HIFU into the French Health System for patients with favorable intermediate risk PC evaluated by micro-costing
Time Frame
48 months
Title
Survival with no salvage treatmente.
Description
Survival with no salvage treatment at 12, 24 and 48 months, evaluated in part from the SNDS database. Optional salvage treatments possibly being: a second F-HIFU, RP or radiotherapy with or without androgen deprivation. All salvage treatments, except the F-HIFU, are already reimbursed by the French Health System and available in the SNDS database.
Time Frame
12, 24 and 48 months
Title
Overall survival
Description
Overall survival at 12, 24 and 48 months measured from the inclusion date to the date of death, all causes of death being included or the date of the last visit or at 48 months
Time Frame
12, 24 and 48 months
Title
Cancer specific survival
Description
Cancer specific survival at 12, 24 and 48 month measured from the date of inclusion to the date of death due to the progression of PC or the date of the last visit. Causes of death are available in the SNDS database since it is implemented by the CEpiDC
Time Frame
12, 24 and 48 months
Title
Androgen deprivation-free survival
Description
Androgen deprivation-free survival (equivalent to metastasis-free survival) at 12, 24 and 48 month measured from the inclusion date to the first prescription of androgen deprivation therapy or the date of the last visit
Time Frame
12, 24 and 48 months
Title
Urinary and sexual functions
Description
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnaires EPIC-26
Time Frame
Inclusion and 1, 6, 12 and 24 months
Title
Patient's quality of life
Description
Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires EORTC QLQ C30
Time Frame
Inclusion and 1, 6, 12 and 24 months
Title
Urinary and sexual functions
Description
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnars IPSS
Time Frame
Inclusion and 1, 6, 12 and 24 months
Title
Urinary and sexual functions
Description
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnaires IIEF-5
Time Frame
Inclusion and 1, 6, 12 and 24 months
Title
Patient's quality of life
Description
Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires QLQ PR25
Time Frame
Inclusion and 1, 6, 12 and 24 months
Title
Patient's quality of life
Description
Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires EQ-5D-5L
Time Frame
Inclusion and 1, 6, 12 and 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50-75 yo male harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm. Tumor visible on MRI and proven by systematic and targeted biopsies a according to the center's practices, regardless of the route used (transrectal or transpirenal) Patients under active surveillance in whom follow-up Prostate Biopsies reveal ISUP2 with less than 50% of Prostate Biopsies affected Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven. T1c-T2 stage. PSA <20 ng/ml. Prostate volume less than 100 ml. Fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form. Affiliated or beneficiary patient to the social security system. Exclusion Criteria: Metastatic prostate cancer. Gleason score > 3+4 (ISUP>2). More than 50% of positive biopsies. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franck BLADOU, PROF
Phone
+33557820162
Email
franck.bladou@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Grégoire ROBERT, PROF
Phone
+335 56 79 55 47
Email
gregoire.robert@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck BLADOU, PROF
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique beaujolais
City
Arnas
ZIP/Postal Code
69400
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane CHASSAGNE, MD
Phone
+33 9 70 75 55 57
First Name & Middle Initial & Last Name & Degree
Stephane CHASSAGNE, MD
Facility Name
Clinique Saint Vincent
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent BAILY, MD
Phone
+33 3 81 47 21 44
Email
docteur.bailly.urologie@gmail.com
First Name & Middle Initial & Last Name & Degree
Vincent BAILY, MD
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles PASTICIER, MD
Phone
+33 5 56 90 91 16
First Name & Middle Initial & Last Name & Degree
Gilles PASTICIER, MD
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Bladou
Phone
05 57 82 03 40
Email
franck.bladou@chu-bordeaux.fr
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck bladou, Pr
Email
franck.bladou@chu-bordeaux.fr
Facility Name
Hopitaux civil de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic OBRINGER, MD
Phone
+33 3 89 12 41 92
Email
ludovic.obringer@ch-colmar.fr
First Name & Middle Initial & Last Name & Degree
Ludovic OBRINGER, MD
Facility Name
Hopital prive drome ardeche
City
Guilherand-Granges
ZIP/Postal Code
07500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim BAH-CLOZEL, MD
Phone
+33 4 75 75 23 52
First Name & Middle Initial & Last Name & Degree
Ibrahim BAH-CLOZEL, MD
Facility Name
Hopital Claude HURIEZ
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud VILLERS, Prof
Phone
+33 3 20 44 42 35
First Name & Middle Initial & Last Name & Degree
Arnaud VILLERS, Prof
Facility Name
Hopital Privé La Louviere
City
Lille
ZIP/Postal Code
59800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre COLIN, MD
Phone
+33 3 20 12 12 90
Email
docpierrecolin@gmail.com
First Name & Middle Initial & Last Name & Degree
Pierre COLIN, MD
Facility Name
Hopital Edouard Herriot Pavillon V
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien CROUZET, PROF
Phone
+33 4 72 11 03 25
Email
sebastien.crouzet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Sebastien CROUZET, PROF
Facility Name
APHM Nord Marseille
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry TOLEDANO, MD
Phone
+33 4 91 96 88 48
Email
harry.toledano@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Harry TOLEDANO, MD
Facility Name
Hopital Americain de Paris
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurel MESSAS, MD
Phone
+33 1 46 41 26 93
First Name & Middle Initial & Last Name & Degree
Aurel MESSAS, MD
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas BARY DELONGCHAMPS, PROF
Phone
+33 1 58 41 27 83
Email
nicolas.barrydelongchamps@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nicolas BARY DELONGCHAMPS, PROF
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Macek PETR, MD
Phone
+33 1 56 61 62 63
Email
Petr.Macek@imm.fr
First Name & Middle Initial & Last Name & Degree
Macek PETR, MD
Facility Name
Hopital Lyon Sud HCL Bat 3C Centre
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain RUFFION, PROF
Phone
+33 4 72 67 88 37
Email
alain.ruffion@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Alain RUFFION, PROF
Facility Name
Hopital Privé francheville
City
Périgueux
ZIP/Postal Code
204004
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Mallet, Dr
Email
richard@mallet@gmail.com
Facility Name
Clinique La Croix du Sud
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume PLOUSSARD, MD
First Name & Middle Initial & Last Name & Degree
Guillaume PLOUSSARD, MD
Facility Name
CHU de Rennes
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain MATHIEU, pr
Email
romain.mathieu@chu-rennes.fr
Facility Name
Clinique Saint Michel
City
Toulon
ZIP/Postal Code
83100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane MALLIK, MD
Phone
+33 4 98 00 18 69
First Name & Middle Initial & Last Name & Degree
Stephane MALLIK, MD
Facility Name
CHU Toulouse rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu ROUMIGUIE, MD
Phone
+33 5 81 32 33 05
Email
roumiguie.m@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Matthieu ROUMIGUIE, MD
Facility Name
Clinique Oceane
City
Vannes
ZIP/Postal Code
56000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril GERARD, MD
Phone
+33 2 97 63 44 70
Email
drcgerard@aim.com
First Name & Middle Initial & Last Name & Degree
Cyril GERARD, MD

12. IPD Sharing Statement

Learn more about this trial

Cost-utility of Focal HIFU vs Prostatectomy

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