EMERHIT: Cost-utility of Focal HIFU vs Prostatectomy

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05710861

Collaborator

(none)

346

Enrollment

Locations

Arms

Anticipated Duration (Months)

18.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: F-HIFU Procedure: Radical Prostatectomy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

346 participants

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 ratioMulticentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups with a 1:1 allocation ratio

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 20, 2023

Anticipated Primary Completion Date :

Feb 20, 2025

Anticipated Study Completion Date :

Feb 20, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F-HIFU Group 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	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.
Active Comparator: Prostatectomy Group 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	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

Arm

Intervention/Treatment

Experimental: F-HIFU Group

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

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.

Active Comparator: Prostatectomy Group

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

Outcome Measures

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. [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 [48 months]
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 [24 months]
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 [48 months]
Real production cost (€) of F-HIFU and RP evaluated by micro-costing
Net benefit (€) for the Health Insurance [48 months]
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. [12, 24 and 48 months]
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 [12, 24 and 48 months]
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 [12, 24 and 48 months]
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 [12, 24 and 48 months]
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 [Inclusion and 1, 6, 12 and 24 months]
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 [Inclusion and 1, 6, 12 and 24 months]
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 [Inclusion and 1, 6, 12 and 24 months]
Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnars IPSS
Urinary and sexual functions [Inclusion and 1, 6, 12 and 24 months]
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 [Inclusion and 1, 6, 12 and 24 months]
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 [Inclusion and 1, 6, 12 and 24 months]
Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires EQ-5D-5L

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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 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 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital Prive de Provence	Aix-en-Provence	France	13080
2	Polyclinique beaujolais	Arnas	France	69400
3	Clinique Saint Vincent	Besançon	France	25000
4	Clinique Tivoli	Bordeaux	France	33000
5	Hopitaux civil de Colmar	Colmar	France	68024
6	Hopital prive drome ardeche	Guilherand-Granges	France	07500
7	Hopital Claude HURIEZ	Lille	France	59000
8	Hopital Privé La Louviere	Lille	France	59800
9	Hopital Edouard Herriot Pavillon V	Lyon	France	69437
10	APHM Nord Marseille	Marseille	France	13015
11	Hopital Americain de Paris	Neuilly-sur-Seine	France	92200
12	CHU Nice Hopital Pasteur 2	Nice	France	06001
13	Hopital Cochin	Paris	France	75014
14	Institut Mutualiste Montsouris	Paris	France	75014
15	Hopital Lyon Sud HCL Bat 3C Centre	Pierre-Bénite	France	69310
16	Clinique La Croix du Sud	Quint-Fonsegrives	France	31130
17	Clinique Saint Michel	Toulon	France	83100
18	CHU Toulouse rangueil	Toulouse	France	31400
19	Clinique Oceane	Vannes	France	56000