Compares focal HIFU treatment with surgery for prostate cancer

Trial details

Who runs it

University Hospital, Bordeaux

Trial code

NCT05710861

Record updated

9 April 2026

Original description

Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate CancerRead full original descriptionShow less

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

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

Inclusion: 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: Previous treatment anterior for the same cancer, whatever modality; Contra-indication to surgery or general anesthesia; Presence of implant (stent, catheter) less than 1 cm from the treatment area; Presence of a urinary artificial sphincter, a penile prosthesis or intraprostatic implant, i.e. urethral prosthesis; Previous anal or rectal surgery that may interfere with the anal probe introduction; Previous not controlled cancer and/or treated since less than 5 years (except basocellular skin cancer); Metastatic prostate cancer; Urinary or rectal fistula; Inflammatory bowel disease (colon or rectum); Latex allergy; Gleason score > 3+4 (ISUP>2); Adenoma prostate carcinoma Cribriform or intraductal; Contra-indication to pelvic MRI with gadolinium injection; Patient who refuse the one-year follow-up control biopsy after F-HIFU; 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; Bladder neck and/or urethral stenosis or sclerosis; Ongoing UTI (should be treated before the F-HIFU or the RP); Rectal wall thickness > 10 mm; Tumor not accessible to a F-HIFU treatment (tumors located in the fibro-muscular anterior zone); 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.

ClinicalTrials.gov NCT05710861