NCT01902680已完成2 期
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
研究概览
简要总结
This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up).
The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men of more than 18 years old
- •Patient with localized prostate cancer with a good prognosis (AMICO classification), ie satisfying the following conditions according to the urologist medical record transmitted:
- •Lesion classified T1c or T2a based on digital rectal exam
- •histologically proven diagnosis of prostatic adenocarcinoma with a Gleason score ≤ 6
- •Serum Prostatic Specific Antigen (PSA) <10ng/ml
- •Patient for whom the Multidisciplinary Consultative Meeting (RCP) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
- •Patient with good micturating function at inclusion, defined by IPSS score <10 (IPSS Questionnaire)
- •Patient for whom the result of centralized PSA assay confirms a serum level < 10ng/ml
- •Patient for whom the unique and intracapsular character of the target area (area to be treated) was confirmed on pre implantation multimodal MRI imaging (ESUR Score ≥ 9) and whose major axis has a size ≤ 20 mm
- •Patient with a Gleason score on the target ≤ 6 (3 +3) confirmed on biopsies performed using KOELIS ® system and with no other derogatory criteria such as the invasion of the entire core or the presence of a grade 4 or perineural emboli
- •Patients without history of transurethral resection that could have significantly modified the anatomy of the gland nor obstructive adenoma
- •Patient who accepts, at the end of the study, the principle of active surveillance for the rest of the gland and the treated area according to the current standard protocol
- •Patient with life expectancy > 10 years
- •Informed consent obtained and signed before any specific procedure in the study
- •Patient affiliated to social security regimen
排除标准
- •Image in favour of the crossing of the capsule, based on pre-implantation multimodal MRI (stage T2 MRI only)
- •Image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal MRI (stage T2 MRI only)
- •Multifocal lesions (ESUR ≥ 9/15) to the pre-implantation multimodal MRI and for which biopsies have shown the cancerous nature
- •Lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal MRI
- •Patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
- •Patient with current indication against prostate brachytherapy, including a significant limitation of the mobility of the hips, a prostate volume greater than 60 cm3 (measured by planimetry MRI) or a significant dysuria (IPSS ≥ 10)
- •Patient unable to follow procedures, visits, examinations described in the the study
- •Patient with absolute indication against imaging tests (significant claustrophobia, wearing a heart valve, pacemaker, ..)
- •Man of childbearing age who do not want follow the instructions about sexual activities and condom use during the days following the treatment of brachytherapy and / or unwilling to hold (him or her partner) effective contraception for the duration of the study
- •Any concomitant or previous malignant disease in the past five years with the exception of superficial basal cell carcinoma or non-metastatic of the skin
- •Any prior systemic chemotherapy within 5 years prior to inclusion for malignant disease in the medical history
- •Any coexisting medical condition that in the opinion of the investigator could be a risk in this study
- •Patient protected by law
研究组 & 干预措施
Focal brachytherapy
Experimental
Focal brachytherapy with permanent I125 localized implant.
干预措施: Focal brachytherapy (Radiation)
结局指标
主要结局
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
时间窗: 3 years
Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30
次要结局
- Progression-free-survival according to Phoenix criterion(3 years)
- Toxicity evaluation(3 years)
- Quality of life study using 3 Patient questionnaires(3 years)
- Absence of tumor residuals in the target treated zone(3 years)
研究者
研究点 (1)
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