Randomized Medical-Economic Trial Comparing Focal HIFU Treatment to Total Prostatectomy in Patients With Intermediate Prognosis Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 346
- 试验地点
- 38
- 主要终点
- 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.
研究概览
简要总结
Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer
详细描述
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 From version 4.0 of the protocol, randomisation will be adjusted to a 2:1 ratio and stratified by centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Net benefit (€) for the Health Insurance(48 months)
- Overall survival(12, 24 and 48 months)
- Cancer specific survival(12, 24 and 48 months)
- 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)
- Androgen deprivation-free survival(12, 24 and 48 months)
- Real production cost (€) of F-HIFU and RP(48 months)
- Survival with no salvage treatmente.(12, 24 and 48 months)
- Urinary and sexual functions(Inclusion and 1, 6, 12 and 24 months)
- Patient's quality of life(Inclusion and 1, 6, 12 and 24 months)