Cost-utility of Focal HIFU vs Prostatectomy (EMERHIT)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Radical Prostatectomy; Device: F-HIFU

Study type: Interventional

Funder types: Other

Identifiers

NCT05710861

CHUBX 2019/67

Details and patient eligibility

About

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

Full description

Standard treatment option of intermediate risk (ISUP2) prostate cancer (PC) is either radical prostatectomy (RP) or radiation therapy (RT). An attractive option for selected patients and for the health care system would be to spare the preserved gland to decrease urinary, sexual and digestive side effects of whole-gland treatments keeping with a good cancer control. For these reasons, focal treatments have been developed in localized PC. The principal objective of the EMERHIT study is to estimate, from the health system point of view, the efficiency (cost/utility study) of focal HIFU (F-HIFU) for intermediate risk PC compared to RP (either by open, laparoscopic or robotic surgical approach) at 24 months. It will be a multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups :

• (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

Enrollment: 346 estimated patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 biopsies with an ISUP2 score,
• 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

• 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).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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346 participants in 2 patient groups

F-HIFU Group

Experimental group

Description:

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:

Device: F-HIFU

Prostatectomy Group

Active Comparator group

Description:

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:

Procedure: Radical Prostatectomy