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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Clinique Saint Vincent
RECRUITING
Besançon
CHU de Bordeaux
RECRUITING
Bordeaux
Clinique Tivoli
RECRUITING
Bordeaux
Hopitaux civil de Colmar
RECRUITING
Colmar
CHU Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
Hopital prive drome ardeche
RECRUITING
Guilherand-granges
Hopital Claude HURIEZ
RECRUITING
Lille
Hopital Privé La Louviere
RECRUITING
Lille
Hopital Edouard Herriot Pavillon V
RECRUITING
Lyon
APHM Nord Marseille
RECRUITING
Marseille
Hopital Cochin
RECRUITING
Paris
Hopital Privé francheville
RECRUITING
Périgueux
Hopital Lyon Sud HCL Bat 3C Centre
RECRUITING
Pierre-bénite
Clinique La Croix du Sud
RECRUITING
Quint-fonsegrives
CHU de Rennes
RECRUITING
Rennes
CH Saintonge
NOT_YET_RECRUITING
Saint-jean-d'angély
Clinique Saint Michel
RECRUITING
Toulon
CHU Toulouse rangueil
RECRUITING
Toulouse
Clinique Oceane
RECRUITING
Vannes
Guadeloupe
CHU Pointe à Pitre
NOT_YET_RECRUITING
Pointe-à-pitre
Contact Information
Primary
Franck BLADOU, PROF
franck.bladou@chu-bordeaux.fr
+33557820162
Backup
Grégoire ROBERT, PROF
gregoire.robert@chu-bordeaux.fr
+335 56 79 55 47
Time Frame
Start Date: 2023-03-06
Estimated Completion Date: 2028-06-22
Participants
Target number of participants: 346
Treatments
Experimental: 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
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.