Study Results
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Basic Information
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RECRUITING
NA
346 participants
INTERVENTIONAL
2023-03-06
2028-06-22
Brief Summary
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Detailed Description
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* (1) F-HIFU treatment
* (2) RP Randomization will be equal (ratio 1:1), stratified on the centers and performed maximum at 2 months before the procedure. The comparison to the SNDS data will use the NIR of the patients selected for the study. The use of the SNDS data will allow, on top of the estimation of the care cost, to increase the patient's follow-up (with no supplemental visit) and measure, at 48 months, costs, mortality rate and cancer control measures From version 4.0 of the protocol, randomisation will be adjusted to a 2:1 ratio and stratified by centre.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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F-HIFU Group
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
F-HIFU
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.
Prostatectomy Group
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
Radical Prostatectomy
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
Interventions
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F-HIFU
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.
Radical Prostatectomy
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
75 Years
MALE
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Franck BLADOU, PROF
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Clinique Saint Vincent
Besançon, , France
Clinique Tivoli
Bordeaux, , France
CHU de Bordeaux
Bordeaux, , France
Hopitaux civil de Colmar
Colmar, , France
CHU Grenoble Alpes
Grenoble, , France
Hopital prive drome ardeche
Guilherand-Granges, , France
Hopital Claude HURIEZ
Lille, , France
Hopital Privé La Louviere
Lille, , France
Hopital Edouard Herriot Pavillon V
Lyon, , France
APHM Nord Marseille
Marseille, , France
Hopital Cochin
Paris, , France
Hopital Privé francheville
Périgueux, , France
Hopital Lyon Sud HCL Bat 3C Centre
Pierre-Bénite, , France
Clinique La Croix du Sud
Quint-Fonsegrives, , France
CHU de Rennes
Rennes, , France
CH Saintonge
Saint-Jean-d'Angély, , France
Clinique Saint Michel
Toulon, , France
CHU Toulouse rangueil
Toulouse, , France
Clinique Oceane
Vannes, , France
CHU Pointe à Pitre
Pointe-à-Pitre, , Guadeloupe
Countries
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Central Contacts
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Facility Contacts
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Gilles PASTICIER, MD
Role: primary
FIARD Gaelle, Pr
Role: primary
Ibrahim BAH-CLOZEL, MD
Role: primary
Arnaud VILLERS, Prof
Role: primary
Guillaume PLOUSSARD, MD
Role: primary
EMERIAU Damien, Dr
Role: primary
Stephane MALLIK, MD
Role: primary
BRUREAU Laurent, Dr
Role: primary
Other Identifiers
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CHUBX 2019/67
Identifier Type: -
Identifier Source: org_study_id
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