Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
346
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.
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
Clinique Saint Vincent
Besançon, France
RECRUITINGClinique Tivoli
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.
Time frame: 24 months
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
Time frame: 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
Time frame: 24 months
Real production cost (€) of F-HIFU and RP
Real production cost (€) of F-HIFU and RP evaluated by micro-costing
Time frame: 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
Time frame: 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.
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Bordeaux, France
CHU de Bordeaux
Bordeaux, France
RECRUITINGHopitaux civil de Colmar
Colmar, France
WITHDRAWNCHU Grenoble Alpes
Grenoble, France
RECRUITINGHopital prive drome ardeche
Guilherand-Granges, France
RECRUITINGHopital Claude HURIEZ
Lille, France
RECRUITINGHopital Privé La Louviere
Lille, France
RECRUITINGHopital Edouard Herriot Pavillon V
Lyon, France
RECRUITINGAPHM Nord Marseille
Marseille, France
RECRUITING...and 10 more locations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Inclusion and 1, 6, 12 and 24 months