Compares focal HIFU treatment with surgery for prostate cancer
Tests focal HIFU against full prostate removal in men with prostate cancer.
Key facts
- Who runs it
- University Hospital, Bordeaux
- Where
- Besançon, Bordeaux, Colmar, Grenoble, Guilherand-Granges, Lille, Lyon, Marseille, Paris, Périgueux, Pierre-Bénite, Quint-Fonsegrives, Rennes, Saint-Jean-d'Angély, Toulon, Toulouse, and Vannes, FranceSee the 19 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- Cost-utility of Focal HIFU vs Prostatectomy
- Status
- Recruiting
- People taking part
- 346 people, planned
- Started
- 6 Mar 2023
- Expected to end
- 22 Jun 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- F-HIFU
- Radical Prostatectomy
- Record updated
- 9 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has not been treated and is at favorable intermediate risk. It compares focal HIFU treatment with removal of the prostate.
- Age
- The record gives 45-75 years in the criteria and 50 Years to 75 Years in the age fields.
- Sex
- Men only.
- Disease stage
- Localized prostate adenocarcinoma, maximum Gleason score 3+4 (ISUP 2), on one side in at most 2 contiguous sextants. A Gleason 3+3 (ISUP 1) focus is allowed. Stage T1c-T2, PSA below 20 ng/ml, prostate volume below 150 ml.
- Earlier treatment
- No earlier treatment of this cancer. Men on active surveillance whose follow-up biopsies show this risk level can also join.
- Biomarker or test result
- Tumor visible on MRI and proven by biopsy. PSA below 20 ng/ml.
Main reasons for not taking part
- Cancer that has spread (metastatic)
- Gleason score above 3+4 (ISUP above 2), or cribriform or intraductal cancer
- Cannot have pelvic MRI with gadolinium, surgery or general anesthesia
- Rectal or anal problems that block the probe, or inflammatory bowel disease
- Another cancer not controlled or treated less than 5 years ago (except basal cell skin cancer)
The registry criteria, word for word
Show all 33 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 75 years old?
Where in France
Also in 1 other country, 1 site
- Clinique Saint vincentBesançon, FranceContact: Vincent BAILY, MDTaking people
- CHU de BordeauxBordeaux, FranceContact: Franck BladouTaking people
- Clinique TivoliBordeaux, FranceContact: Gilles PASTICIER, MDTaking people
- Hopitaux civil de ColmarColmar, FranceContact: Franck BLADOU, PROFNo longer taking part
- CHU Grenoble AlpesGrenoble, FranceContact: FIARD Gaelle, PrTaking people
- Hopital Privé Drome-ArdecheGuilherand-Granges, FranceContact: Ibrahim BAH-CLOZEL, MDTaking people
- Hopital Claude HuriezLille, FranceContact: Jonathan OLIVIER, DrTaking people
- Hôpital Privé La LouviereLille, FranceContact: Pierre COLIN, MDTaking people
- Hopital Edouard Herriot Pavillon VLyon, FranceContact: Marc COLOMBEL, PROFTaking people
- APHM Nord MarseilleMarseille, FranceContact: Harry TOLEDANO, MDTaking people
- Hôpital CochinParis, FranceContact: Nicolas BARY DELONGCHAMPS, PROFTaking people
- Hopital Privé franchevillePérigueux, FranceContact: Richard Mallet, DrTaking people
- Hopital Lyon Sud HCL Bat 3C CentrePierre-Bénite, FranceContact: Alain RUFFION, PROFTaking people
- Clinique La Croix Du SudQuint-Fonsegrives, FranceContact: Guillaume PLOUSSARD, MDTaking people
- CHU de RennesRennes, FranceContact: Romain MATHIEU, PrTaking people
- CH SaintongeSaint-Jean-d'Angély, FranceContact: EMERIAU Damien, DrTaking people
- Clinique Saint MichelToulon, FranceContact: Stephane MALLIK, MDTaking people
- CHU Toulouse-RangueilToulouse, FranceContact: Florian LACLERGERIE, DrTaking people
- Clinique OceaneVannes, FranceContact: Cyril GERARD, MDTaking people
About the trial
What the trial wants to find out
Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer
The 2 groups in the trial
- F-HIFU GroupTreatment being tested
50 to 75 years old patients fit for a Radical Prostatectomy when active surveillance is not recommended and who do not want a radiation therapy: harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm, with a tumor visible on MRI and biopsy-proven with systematic and targeted biopsy with at least 2 biopsies per target and 12 systematic biopsies, Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven, T1c-T2 stage, PSA \<20 ng/ml, prostate volume less than 100 ml, fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form, affiliated or beneficiary patient to the French social security system
Treatment: F-HIFU
- Prostatectomy GroupExisting treatment, for comparison
50 to 75 years old patients fit for a Radical Prostatectomy when active surveillance is not recommended and who do not want a radiation therapy: harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm, with a tumor visible on MRI and biopsy-proven with systematic and targeted biopsy with at least 2 biopsies per target and 12 systematic biopsies, Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven, T1c-T2 stage, PSA \<20 ng/ml, prostate volume less than 100 ml, fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form, affiliated or beneficiary patient to the French social security system
Treatment: Radical Prostatectomy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Medical-Economic Trial Comparing Focal HIFU Treatment to Total Prostatectomy in Patients With Intermediate Prognosis Prostate Cancer
- Plain-language title
- Compares focal HIFU treatment with surgery for prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05710861, who can take part
- Record updated
- 9 April 2026