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Cost-utility of Focal HIFU vs Prostatectomy

NCT05710861 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2026-04-09

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

F-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.

PROCEDURE

Radical 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

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Franck BLADOU, PROF · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2029-06-22
Completion
2029-06-22

Countries

  • France
  • Guadeloupe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05710861 on ClinicalTrials.gov