Cost-utility of Focal HIFU vs Prostatectomy (EMERHIT)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Localized Prostate cancer, Prostatectomy, Focal HIFU, Quality of life, Cost, ISUP 2
Eligibility Criteria
Inclusion Criteria: 50-75 yo male 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. Tumor visible on MRI and proven by systematic and targeted biopsies a according to the center's practices, regardless of the route used (transrectal or transpirenal) Patients under active surveillance in whom follow-up Prostate Biopsies reveal ISUP2 with less than 50% of Prostate Biopsies affected 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 social security system. Exclusion Criteria: Metastatic prostate cancer. Gleason score > 3+4 (ISUP>2). More than 50% of positive biopsies. 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.
Sites / Locations
- Polyclinique beaujolais
- Clinique Saint VincentRecruiting
- Clinique Tivoli
- CHU de BordeauxRecruiting
- CHU de BordeauxRecruiting
- Hopitaux civil de ColmarRecruiting
- Hopital prive drome ardecheRecruiting
- Hopital Claude HURIEZ
- Hopital Privé La LouviereRecruiting
- Hopital Edouard Herriot Pavillon VRecruiting
- APHM Nord MarseilleRecruiting
- Hopital Americain de Paris
- Hopital CochinRecruiting
- Institut Mutualiste Montsouris
- Hopital Lyon Sud HCL Bat 3C Centre
- Hopital Privé francheville
- Clinique La Croix du SudRecruiting
- CHU de Rennes
- Clinique Saint MichelRecruiting
- CHU Toulouse rangueilRecruiting
- Clinique OceaneRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
F-HIFU Group
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
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