NCT05710861

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
38mo left

Started Mar 2023

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
2 countries

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Mar 2023Jun 2029

First Submitted

Initial submission to the registry

January 16, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2029

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

January 16, 2023

Last Update Submit

April 8, 2026

Conditions

Prostate Cancer

Keywords

Localized Prostate cancerProstatectomyFocal HIFUQuality of lifeCostISUP 2

Outcome Measures

Primary Outcomes (1)

  • The cost/utility ratio expressed as differential cost per QALY in favor of F-HIFU compared to RP (open, lap or robot) at 24 months.

    Utility will be measured at baseline and at 6, 12 and 24 months using the EQ-5D-5L self-administered questionnaire. Costs will be estimated from the perspective of the French health system. They will be collected by probabilistic matching with data from the SNDS using data from the inclusion hospitalization of each patient included in the the trial.

    24 months

Secondary Outcomes (14)

  • The per-year of preserved life differential cost between F-HIFU and RP

    48 months

  • Differential cost between F-HIFU and open, lap or robotic RP

    24 months

  • Real production cost (€) of F-HIFU and RP

    48 months

  • Net benefit (€) for the Health Insurance

    48 months

  • Survival with no salvage treatmente.

    12, 24 and 48 months

  • +9 more secondary outcomes

Study Arms (2)

F-HIFU Group

EXPERIMENTAL

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

Device: F-HIFU

Prostatectomy Group

ACTIVE COMPARATOR

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

Procedure: Radical Prostatectomy

Interventions

F-HIFUDEVICE

A F-HIFU treatment will be performed with the Focal-One® machine according to the predefined treatment area for each patient using the standard procedure in place in each therapeutic center and according to the user's manual edited by the company, under locoregional or general anaesthesia.

F-HIFU Group
Radical ProstatectomyPROCEDURE

A Radical Prostatectomy will be performed according to the standard procedure in place in each center, under general anaesthesia, through an open, laparoscopic or robot-assisted laparoscopic approach

Prostatectomy Group

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Clinique Saint Vincent

Besançon, 25000, France

RECRUITING

Clinique Tivoli

Bordeaux, 33000, France

RECRUITING

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

Hopitaux civil de Colmar

Colmar, 68024, France

WITHDRAWN

CHU Grenoble Alpes

Grenoble, France

RECRUITING

Hopital prive drome ardeche

Guilherand-Granges, 07500, France

RECRUITING

Hopital Claude HURIEZ

Lille, 59000, France

RECRUITING

Hopital Privé La Louviere

Lille, 59800, France

RECRUITING

Hopital Edouard Herriot Pavillon V

Lyon, 69437, France

RECRUITING

APHM Nord Marseille

Marseille, 13015, France

RECRUITING

Hopital Cochin

Paris, 75014, France

RECRUITING

Hopital Privé francheville

Périgueux, 204004, France

RECRUITING

Hopital Lyon Sud HCL Bat 3C Centre

Pierre-Bénite, 69310, France

RECRUITING

Clinique La Croix du Sud

Quint-Fonsegrives, 31130, France

RECRUITING

CHU de Rennes

Rennes, France

RECRUITING

CH Saintonge

Saint-Jean-d'Angély, France

RECRUITING

Clinique Saint Michel

Toulon, 83100, France

RECRUITING

CHU Toulouse rangueil

Toulouse, 31400, France

RECRUITING

Clinique Oceane

Vannes, 56000, France

RECRUITING

CHU Pointe à Pitre

Pointe-à-Pitre, Guadeloupe

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Franck BLADOU, PROF

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Franck BLADOU, PROF

CONTACT

+33557820162franck.bladou@chu-bordeaux.fr

Grégoire ROBERT, PROF

CONTACT

+335 56 79 55 47gregoire.robert@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups with a 1:1 allocation ratio
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 2, 2023

Study Start

March 6, 2023

Primary Completion (Estimated)

June 22, 2029

Study Completion (Estimated)

June 22, 2029

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

GU(1)FR(19)