RecruitingNot ApplicableNCT05710861

Cost-utility of Focal HIFU vs Prostatectomy

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


Sponsor

University Hospital, Bordeaux

Enrollment

346 participants

Start Date

Mar 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for low-risk localized prostate cancer: focal HIFU (high-intensity focused ultrasound, which destroys only the cancerous part of the prostate) versus radical prostatectomy (complete surgical removal of the prostate), looking at which is more cost-effective and what quality of life each provides. **You may be eligible if...** - You are a man aged 45–75 with localized prostate cancer (not spread beyond the gland) - Your cancer is low-to-intermediate risk (Gleason score no higher than 3+4, on only one side) - Your PSA level is below 20 ng/mL and prostate volume is under 150 mL - Your cancer is visible on MRI and confirmed by biopsy - You are affiliated with a social security scheme **You may NOT be eligible if...** - Your cancer has spread beyond the prostate (metastatic) - Your Gleason score is higher than 3+4 (more aggressive cancer) - You have a specific aggressive cancer subtype (cribriform or intraductal) - You have had prior cancer treatment - You cannot have an MRI with contrast dye or cannot undergo anesthesia - You have certain urinary implants or anatomical issues that prevent HIFU Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEF-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.

PROCEDURERadical 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


Locations(20)

Clinique Saint Vincent

Besançon, France

Clinique Tivoli

Bordeaux, France

CHU de Bordeaux

Bordeaux, France

Hopitaux civil de Colmar

Colmar, France

CHU Grenoble Alpes

Grenoble, 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 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 de Rennes

Rennes, France

CH Saintonge

Saint-Jean-d'Angély, France

Clinique Saint Michel

Toulon, France

CHU Toulouse rangueil

Toulouse, France

Clinique Oceane

Vannes, France

CHU Pointe à Pitre

Pointe-à-Pitre, Guadeloupe

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NCT05710861


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