Clinical trial NCT05710861: Cost-utility of Focal HIFU vs Prostatectomy
Official title: Randomized Medical-Economic Trial Comparing Focal HIFU Treatment to Total Prostatectomy in Patients With Intermediate Prognosis Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Localized Prostate cancer
Prostatectomy
Focal HIFU
Quality of life
Cost
ISUP 2
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 346
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups with a 1:1 allocation ratio
Primary purpose: TREATMENT

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 From version 4.0 of the protocol, randomisation will be adjusted to a 2:1 ratio and stratified by centre.

Eligibility criteria: 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 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,
* 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.

Primary outcomes:
measure: 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.
timeFrame: 24 months
Secondary outcomes:
measure: The per-year of preserved life differential cost between F-HIFU and RP
timeFrame: 48 months
measure: Differential cost between F-HIFU and open, lap or robotic RP
timeFrame: 24 months
measure: Real production cost (€) of F-HIFU and RP
timeFrame: 48 months
measure: Net benefit (€) for the Health Insurance
timeFrame: 48 months
measure: Survival with no salvage treatmente.
timeFrame: 12, 24 and 48 months
measure: Overall survival
timeFrame: 12, 24 and 48 months
measure: Cancer specific survival
timeFrame: 12, 24 and 48 months
measure: Androgen deprivation-free survival
timeFrame: 12, 24 and 48 months
measure: Urinary and sexual functions
timeFrame: Inclusion and 1, 6, 12 and 24 months
measure: Patient's quality of life
timeFrame: Inclusion and 1, 6, 12 and 24 months
measure: Urinary and sexual functions
timeFrame: Inclusion and 1, 6, 12 and 24 months
measure: Urinary and sexual functions
timeFrame: Inclusion and 1, 6, 12 and 24 months
measure: Patient's quality of life
timeFrame: Inclusion and 1, 6, 12 and 24 months
measure: Patient's quality of life
timeFrame: Inclusion and 1, 6, 12 and 24 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Clinique Saint Vincent
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Colmar
country: France
facility: Hopitaux civil de Colmar
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Guilherand-Granges
country: France
facility: Hopital prive drome ardeche
city: Lille
country: France
facility: Hopital Claude HURIEZ
city: Lille
country: France
facility: Hopital Privé La Louviere
city: Lyon
country: France
facility: Hopital Edouard Herriot Pavillon V
city: Marseille
country: France
facility: APHM Nord Marseille
city: Paris
country: France
facility: Hopital Cochin
city: Pierre-Bénite
country: France
facility: Hopital Lyon Sud HCL Bat 3C Centre
city: Périgueux
country: France
facility: Hopital Privé francheville
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix du Sud
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Jean-d'Angély
country: France
facility: CH Saintonge
city: Toulon
country: France
facility: Clinique Saint Michel
city: Toulouse
country: France
facility: CHU Toulouse rangueil
city: Vannes
country: France
facility: Clinique Oceane
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe à Pitre
Study officials:
affiliation: University Hospital, Bordeaux
name: Franck BLADOU, PROF
role: PRINCIPAL_INVESTIGATOR
References: