Cost-utility of Focal HIFU vs Prostatectomy

Prostate Cancer Clinical Trial

— EMERHIT  

Official title:

Randomized Medical-Economic Trial Comparing Focal HIFU Treatment to Total Prostatectomy in Patients With Intermediate Prognosis Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710861
• Other study ID #: CHUBX 2019/67
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: February 20, 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: Franck BLADOU, PROF
• Phone: +33557820162
• Email: franck.bladou[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 346
• Est. completion date: February 20, 2027
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• F-HIFU
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.

Procedure:
• Radical Prostatectomy
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

Locations

Country	Name	City	State
France	Polyclinique beaujolais	Arnas
France	Clinique Saint Vincent	Besançon
France	CHU de Bordeaux	Bordeaux
France	Clinique Tivoli	Bordeaux
France	Hopitaux civil de Colmar	Colmar
France	Hopital prive drome ardeche	Guilherand-Granges
France	Hopital Claude HURIEZ	Lille
France	Hopital Privé La Louviere	Lille
France	Hopital Edouard Herriot Pavillon V	Lyon
France	APHM Nord Marseille	Marseille
France	Hopital Americain de Paris	Neuilly-sur-Seine
France	Hopital Cochin	Paris
France	Hopital Privé francheville	Périgueux
France	Hopital Lyon Sud HCL Bat 3C Centre	Pierre-Bénite
France	Clinique La Croix du Sud	Quint-Fonsegrives
France	CHU de Rennes	Rennes
France	Clinique Saint Michel	Toulon
France	CHU Toulouse rangueil	Toulouse
France	Clinique Oceane	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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	48 months
Secondary	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	24 months
Secondary	Real production cost (€) of F-HIFU and RP	Real production cost (€) of F-HIFU and RP evaluated by micro-costing	48 months
Secondary	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	48 months
Secondary	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.	12, 24 and 48 months
Secondary	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	12, 24 and 48 months
Secondary	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	12, 24 and 48 months
Secondary	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	12, 24 and 48 months
Secondary	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	Inclusion and 1, 6, 12 and 24 months
Secondary	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	Inclusion and 1, 6, 12 and 24 months
Secondary	Urinary and sexual functions	Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnars IPSS	Inclusion and 1, 6, 12 and 24 months
Secondary	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	Inclusion and 1, 6, 12 and 24 months
Secondary	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	Inclusion and 1, 6, 12 and 24 months
Secondary	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	Inclusion and 1, 6, 12 and 24 months