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Spots Global Cancer Trial Database for Cost-utility of Focal HIFU vs Prostatectomy

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Trial Identification

Brief Title: 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 ID: NCT05710861

Conditions

Prostate Cancer

Study Description

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

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Polyclinique beaujolais, Arnas, , France

Clinique Saint Vincent, Besançon, , France

Clinique Tivoli, Bordeaux, , France

CHU de Bordeaux, 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 Lyon Sud HCL Bat 3C Centre, Pierre-Bénite, , France

Hopital Privé francheville, Périgueux, , 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, , France

Contact Details

Name: Franck BLADOU, PROF

Affiliation: University Hospital, Bordeaux

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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