NCT04307056已完成不适用
EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)
Association Francaise d'Urologie49 个研究点 分布在 2 个国家目标入组 3,862 人开始时间: 2015年3月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,862
- 试验地点
- 49
- 主要终点
- Recurrence-free survival
研究概览
简要总结
to compare the efficacy of HIFU treatment with standard treatment in two situations:
- as first-line cancer treatment, HIFU is compared to radical prostatectomy.
- for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0
- •classified as low or intermediate risk
- •Patient with PSA < 15 ng/ml, Gleason score ≤ 7 restricted to the form [3 + 4].
- •Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants
- •Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA > 10 ng/ml
- •Patient affiliated with health insurance or beneficiary of an equivalent plan
- •Inclusion criteria for the HIFU Arm
- •Patients 70 years of age or older
- •Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years
- •Inclusion Criteria for Total Prostatectomy Arm
- •Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.
- •NON-INCLUSION CRITERIA
- •Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol
- •Included patient simultaneously participating in another research study
排除标准
- 未提供
研究组 & 干预措施
HIFU
Experimental
Patients Treated with high intensity focused ultrasound (HIFU)
干预措施: High Intensity Focused Ultrasound (HIFU) Treatment (Procedure)
Prostatectomy
Active Comparator
Patients Treated by Radical Prostatectomy
干预措施: Radical Prostatectomy (Procedure)
结局指标
主要结局
Recurrence-free survival
时间窗: 30 months
The main objective for patients is to compare recurrence-free survival (i.e., the rate of salvage therapy by external beam radiotherapy and/or hormone therapy) in patients treated by HIFU and those treated by radical prostatectomy. The implementation of salvage therapy will be decided according to several non-exclusive criteria (positivity of margins (for patients with radical prostatectomy), PSA at 3 months, biologic recurrence (increase in PSA \> 0.2 ng/ml after radical surgery, \> Nadir +2 after HIFU), control biopsies positive, the appearance of metastases
次要结局
- urinary function(30 months after treatment)
- Evaluation of quality of life(30 months after treatment)
- Survival without metastases(30 months after treatment)
- The rate of local recurrence(3 months after treatment)
- Immediate or late complications(Day 0, Inclusion)
- immediate or late complications(30 months after treatment)
- The rate of patients in biochemical failure(30 months after treatment)
- sexual fonction(30 months after treatment)
- Immediate or late complications(6 weeks after treatment)
- immediate or late complications(3 months after treatment)
- immediate or late complications(6 months after treatment)
- immediate or late complications(12 months after treatment)
- immediate or late complications(18 months after treatment)
- immediate or late complications(24 months after treatment)
- urinary function(Day 0, Inclusion)
- urinary function(6 months after treatment)
- urinary function(12 months after treatment)
- urinary function(24 months after treatment)
- urinary function(18 months after treatment)
- sexual fonction(Day 0, Inclusion)
- sexual fonction(6 months after treatment)
- sexual fonction(12 months after treatment)
- sexual fonction(24 months after treatment)
- Evaluation of quality of life(Day 0, Inclusion)
- Evaluation of quality of life(6 months after treatment)
- Evaluation of quality of life(12 months after treatment)
- Evaluation of quality of life(18 months after treatment)
- Evaluation of quality of life(24 months after treatment)
- The rate of patients in biochemical failure(6 weeks after treatment)
- The rate of patients in biochemical failure(3 months after treatment)
- The rate of patients in biochemical failure(6 months after treatment)
- The rate of patients in biochemical failure(12 months after treatment)
- The rate of patients in biochemical failure(18 months after treatment)
- The rate of patients in biochemical failure(24 months after treatment)
- Survival without metastases(6 months after treatment)
- Survival without metastases(12 months after treatment)
- Survival without metastases(18 months after treatment)
- Survival without metastases(24 months after treatment)
研究者
研究点 (49)
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