Cost-utility of Focal HIFU vs Prostatectomy
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Radical ProstatectomyDevice: F-HIFU
- Registration Number
- NCT05710861
- Lead Sponsor
- University Hospital, Bordeaux
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 346
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prostatectomy Group Radical Prostatectomy 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 F-HIFU Group F-HIFU 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
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
Real production cost (€) of F-HIFU and RP 48 months Real production cost (€) of F-HIFU and RP 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.
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
Trial Locations
- Locations (19)
CHU de Bordeaux
🇫🇷Bordeaux, France
Hopital Claude HURIEZ
🇫🇷Lille, France
Hopital Edouard Herriot Pavillon V
🇫🇷Lyon, France
Clinique Tivoli
🇫🇷Bordeaux, France
Clinique Saint Vincent
🇫🇷Besançon, France
Polyclinique beaujolais
🇫🇷Arnas, France
Hopitaux civil de Colmar
🇫🇷Colmar, France
Hopital prive drome ardeche
🇫🇷Guilherand-Granges, France
APHM Nord Marseille
🇫🇷Marseille, France
Hopital Americain de Paris
🇫🇷Neuilly-sur-Seine, France
Hopital Privé La Louviere
🇫🇷Lille, 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 Toulouse rangueil
🇫🇷Toulouse, France
Clinique Oceane
🇫🇷Vannes, France
CHU de Rennes
🇫🇷Rennes, France
Clinique Saint Michel
🇫🇷Toulon, France