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Comparing Focal HIFU and Prostatectomy for Prostate Cancer Treatment

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

NA · University Hospital, Bordeaux · NCT05710861

This study is testing whether a new ultrasound treatment for prostate cancer can work as well as surgery while causing fewer side effects and lowering healthcare costs for men with a specific type of prostate cancer.

Quick facts

PhaseNA
Study typeInterventional
Enrollment346 (estimated)
Ages50 Years to 75 Years
SexMale
SponsorUniversity Hospital, Bordeaux (other)
Drugs / interventionsradiation
Locations20 sites (Besançon and 19 other locations)
Trial IDNCT05710861 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the cost-effectiveness of focal high-intensity focused ultrasound (F-HIFU) compared to radical prostatectomy (RP) in men with favorable intermediate risk prostate cancer. It is a multicentric, randomized trial where participants will be assigned to either F-HIFU treatment or RP, with a focus on assessing quality of life and healthcare costs over a 24-month period. The study aims to determine if F-HIFU can provide similar cancer control while reducing side effects associated with traditional whole-gland treatments. Data will be collected from various centers and analyzed to compare outcomes and costs effectively.

Who should consider this trial

Good fit: Ideal candidates are males aged 45-75 with localized prostate adenocarcinoma classified as favorable intermediate risk.

Not a fit: Patients with advanced prostate cancer or those not meeting the specific Gleason score and staging criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a less invasive treatment option for prostate cancer that minimizes side effects while maintaining effective cancer control.

How similar studies have performed: Previous studies have shown promise in using focal therapies for localized prostate cancer, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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 Criteria:

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

Where this trial is running

Besançon and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Prostate Cancer, Localized Prostate cancer, Prostatectomy, Focal HIFU, Quality of life, Cost, ISUP 2

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.