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Recruiting NCT05710861

Cost-utility of Focal HIFU vs Prostatectomy

Trial Parameters

Condition Prostate Cancer
Sponsor University Hospital, Bordeaux
Study Type INTERVENTIONAL
Phase N/A
Enrollment 346
Sex MALE
Min Age 50 Years
Max Age 75 Years
Start Date 2023-03-06
Completion 2028-06-22
Interventions
F-HIFURadical Prostatectomy

Brief Summary

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

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 interme

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