Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer

Hospices Civils de Lyon28 个研究点分布在 1 个国家目标入组 108 人开始时间: 2018年10月2日最近更新: 2026年8月4日

适应症

干预措施

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方: Hospices Civils de Lyon
入组人数: 108
试验地点: 28
主要终点: patient proportion who needed to seek radical treatment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.

The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.

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: None

入排标准

年龄范围: 50 Years 至 80 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
•Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score >
•Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
•Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:
•If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
•If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
•A maximum tumor length> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
•Gleason 6 score (risk group 1 of the D'Amico classification).
•Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
•PSA ≤ 15ng / ml.
•Patient affiliated with health insurance or beneficiary of an equivalent plan.

排除标准

•Contraindications to treatment with HIFU-F:
•Tumor not accessible.
•Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
•History of pelvic irradiation
•Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
•Fistula of the urinary tract or rectum.
•Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
•Anatomical abnormality of the rectum or rectal mucosa.
•Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
•History of intestinal inflammatory pathology.
•Uro-genital infection in progress (the infection to be treated before HIFU treatment).
•Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
•Allergy to latex.
•Thickness of the rectal wall> 10mm.
•TURP indication. Bladder neck incision is allowed .
•Patient with a medical contraindication to Sonovue® injection.
•Patient with a medical contraindication on MRI.
•Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
•History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
•History of sclerosis of the bladder neck or urethral stenosis.
•Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
•Patients with unstable neurological pathology.
•Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
•Legal person protected by law.
•Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

研究组 & 干预措施

HIFU treatment

Experimental

65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.