Prostate CancerEMERHITNCT05710861
Cost-utility of Focal HIFU vs Prostatectomy
A study testing F-HIFU and Radical Prostatectomy in people with Prostate Cancer, run by University Hospital, Bordeaux at 20 sites in 2 countries.
Trial summary
Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- F-HIFU and Radical Prostatectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 6 Mar 2023to 22 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 with an ISUP2 score. If more than one suspected site on MRI is confirmed by targeted biopsies, these should be unilateral ISUP2 on a maximum of 2 contiguous sextants (favourable intermediate risk), with or without an ipsilateral or contralateral site with a Gleason score of 3+3 (ISUP1).
- stage T1c-T2,
- with PSA <20 ng/ml,
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 2 countries
France19 sites, 18 recruiting
- Recruiting
Clinique Saint Vincent
Besançon, 25000
Vincent BAILY, MD, +33 3 81 47 21 44, docteur.bailly.urologie@gmail.com
Vincent BAILY, MD
- Recruiting
Clinique Tivoli
Bordeaux, 33000
Gilles PASTICIER, MD, +33 5 56 90 91 16
Gilles PASTICIER, MD
- Recruiting
CHU de Bordeaux
Bordeaux, 33076
Franck Bladou, 05 57 82 03 40, franck.bladou@chu-bordeaux.fr
Franck BLADOU, Pr
- Withdrawn
Hopitaux civil de Colmar
Colmar, 68024
- Recruiting
CHU Grenoble Alpes
Grenoble
FIARD Gaelle, Pr, GFiard@chu-grenoble.fr
Gaelle FIARD, Pr
- Recruiting
Hopital prive drome ardeche
Guilherand-Granges, 07500
Ibrahim BAH-CLOZEL, MD, +33 4 75 75 23 52
Ibrahim BAH-CLOZEL, MD
- Recruiting
Hopital Claude HURIEZ
Lille, 59000
Jonathan OLIVIER, Dr, +33 3 20 44 43 98, jonathan.olivier@chu-lille.fr
Jonathan OLIVIER, Dr
- Recruiting
Hopital Privé La Louviere
Lille, 59800
Pierre COLIN, MD, +33 3 20 12 12 90, docpierrecolin@gmail.com
Pierre COLIN, MD
- Recruiting
Hopital Edouard Herriot Pavillon V
Lyon, 69437
Marc COLOMBEL, PROF, +33 4 72 11 62 89, marc.colombel@chu-lyon.fr
Marc COLOMBEL, PROF
- Recruiting
APHM Nord Marseille
Marseille, 13015
Harry TOLEDANO, MD, +33 4 91 96 88 48, harry.toledano@ap-hm.fr
Harry TOLEDANO, MD
- Recruiting
Hopital Cochin
Paris, 75014
Nicolas BARY DELONGCHAMPS, PROF, +33 1 58 41 27 83, nicolas.barrydelongchamps@aphp.fr
Nicolas BARY DELONGCHAMPS, PROF
- Recruiting
Hopital Privé francheville
Périgueux, 204004
Richard Mallet, Dr, richard@mallet@gmail.com
Richard MALLET, Dr
- Recruiting
Hopital Lyon Sud HCL Bat 3C Centre
Pierre-Bénite, 69310
Alain RUFFION, PROF, +33 4 72 67 88 37, alain.ruffion@chu-lyon.fr
Alain RUFFION, PROF
- Recruiting
Clinique La Croix du Sud
Quint-Fonsegrives, 31130
Guillaume PLOUSSARD, MD
Guillaume PLOUSSARD, MD
- Recruiting
CHU de Rennes
Rennes
Romain MATHIEU, Pr, romain.mathieu@chu-rennes.fr
romain MATHIEU, Pr
- Recruiting
CH Saintonge
Saint-Jean-d'Angély
EMERIAU Damien, Dr, d.emeriau@ch-saintonge.fr
Damien EMERIAU, Dr
- Recruiting
Clinique Saint Michel
Toulon, 83100
Stephane MALLIK, MD, +33 4 98 00 18 69
Stephane MALLIK, MD
- Recruiting
CHU Toulouse rangueil
Toulouse, 31400
Florian LACLERGERIE, Dr, 05 61 32 39 39, LACLERGERIE.F@chu-toulouse.fr
Florian LACLERGERIE, Dr
- Recruiting
Clinique Oceane
Vannes, 56000
Cyril GERARD, MD, +33 2 97 63 44 70, drcgerard@aim.com
Cyril GERARD, MD
Guadeloupe1 site, 1 recruiting
- Not yet recruiting
CHU Pointe à Pitre
Pointe-à-Pitre
BRUREAU Laurent, Dr
About this study
Official title: Randomized Medical-Economic Trial Comparing Focal HIFU Treatment to Total Prostatectomy in Patients With Intermediate Prognosis Prostate Cancer
Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer
Read the 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 From version 4.0 of the protocol, randomisation will be adjusted to a 2:1 ratio and stratified by centre.
- Conditions
- Prostate Cancer
- Being tested
- F-HIFU, Radical Prostatectomy
- Keywords
- Localized Prostate cancer, Prostatectomy, Focal HIFU, Quality of life, Cost, ISUP 2
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-HIFUDevice
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.
Radical ProstatectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| F-HIFU Group | Experimental | 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 Receives: Device: F-HIFU |
| Prostatectomy Group | Active comparator | 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 Receives: Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (14)
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
Measured: 48 months
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
Measured: 24 months
Real production cost (€) of F-HIFU and RP
Real production cost (€) of F-HIFU and RP evaluated by micro-costing
Measured: 48 months
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
Measured: 48 months
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.
Measured: 12, 24 and 48 months
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
Measured: 12, 24 and 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
Measured: 12, 24 and 48 months
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
Measured: 12, 24 and 48 months
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
Measured: Inclusion and 1, 6, 12 and 24 months
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
Measured: Inclusion and 1, 6, 12 and 24 months
Urinary and sexual functions
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnars IPSS
Measured: Inclusion and 1, 6, 12 and 24 months
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
Measured: Inclusion and 1, 6, 12 and 24 months
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
Measured: Inclusion and 1, 6, 12 and 24 months
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
Measured: Inclusion and 1, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start6 Mar 2023
- Primary completion22 Jun 2029 (estimated)
- Study completion22 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups with a 1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck BLADOU, PROF, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710861
- Sponsor's protocol ID
- CHUBX 2019/67
- Acronym
- EMERHIT
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No