Comparing Focal HIFU and Prostatectomy for Prostate Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique Saint Vincent
  Besançon, France Recruiting
• Clinique Tivoli
  Bordeaux, France Recruiting
• CHU de Bordeaux
  Bordeaux, France Recruiting
• CHU Grenoble Alpes
  Grenoble, France Recruiting
• Hopital prive drome ardeche
  Guilherand-Granges, France Recruiting
• Hopital Claude HURIEZ
  Lille, France Recruiting

Study contacts

• Principal investigator: Franck BLADOU, PROF — University Hospital, Bordeaux
• Study coordinator: Franck BLADOU, PROF
• Email: franck.bladou@chu-bordeaux.fr
• Phone: +33557820162

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.