Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D Ultrasound System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Implant for the first time, in a clinical situation, iodine 125 implants in a planned target volume, using a 3D echo-mapping fusion guidance system of positive biopsies.
研究概览
简要总结
The objective of the FOCUS-Boost project is to implant for the first time with a 3D ultrasound image fusion registration system (3D echo) implant of iodine 125 with precision in a target volume determined by positive biopsies.
详细描述
The interstitial brachytherapy procedure for the prostate does not allow for a robust focal treatment to accurately deliver additional dose to the tumour volume. FOCUS BOOST allows the precise implantation of 125 iodine implant with greater accuracy (using a 3D ultrasound image fusion registration system) in a target volume.
For this purpose, positive biopsies, performed in this research protocol, will be used prior to surgery. Prostate brachytherapy will be optimised thanks to the TRINITY® system and its guidance quality, by increasing the dose of the intra-prostate tumour volume (BOOST) without increasing the total dose delivered to the prostate. Increasing the dose to the tumour target volume could improve disease control and decrease the risk of recurrence.
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
- •At least 18 years
- •Patient to be treated with brachytherapy
- •Patient with low or favorable intermediate risk prostate adenocarcinoma ISUP 1 and 2, G6 (3+3) or G7 (3+4)
- •Life expectancy of more than 10 years
- •PSA (prostate-specific antigen) < 15 ng/ml
- •cT1c or cT2a or cT2b
- •Prostate volume ≤ 60 cc
- •ECOG Performance status 0-2
- •Patient is affiliated to a health insurance system
- •Patient who has signed consent form
排除标准
- •Patient with urinary function disorders IPSS> 14
- •Prostate volume > 60cc.
- •Gleason 7(4+3) or Gleason score ≥8
- •PSA ≥ 15 ng/ml
- •Patient with metastases
- •Hormone therapy with antiandrogen or LHRH analogue
- •History of abdominopelvic irradiation
- •Inflammatory digestive disease (haemorrhagic rectocolitis, Crohn's disease)
- •Interventional study in progress that may interfere with the present study
- •Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code)
研究组 & 干预措施
Intervention
Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D system
干预措施: Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D (Other)
结局指标
主要结局
Implant for the first time, in a clinical situation, iodine 125 implants in a planned target volume, using a 3D echo-mapping fusion guidance system of positive biopsies.
时间窗: 24 hours
To evaluate the number of successful/failed iodine 125 implants (BOOST implants) implanted in the CTV-boost (Clinical Target Volume) defined from the mapping of positive biopsies. The maximum number of BOOST implant implanted will be 4 implants, depending on the size of the target: 10 mm\< target ≤ 15 mm = 2 implants; 15 mm \< target ≤ 20mm = 3 implants; 20 mm \< target ≤ 30 mm = 4 implants; Success is defined as "the centre of the implant is in the target volume". Failure is defined as "the centre of the implant is outside the target volume". The primary endpoint is evaluated on the ultrasound acquisition performed with the Trinity® Perine probe, at the end of the BOOST implant insertion procedure
次要结局
- Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score(12 months)
- Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry(12 months)
- To assess the efficacy of the treatment at M6 and M12.(12 months)
- To check the absence of overdose in the prostate at D0 and M1.(1 month)
- Assess quality of life (inclusion, M1, M3, M6, M12).(12 months)
- To check the absence of overdose in organs at risk (bladder, urethra, rectum) at D0 and M1.(1 month)
- Assess sexual health (inclusion, M1, M3, M6, M12).(12 months)
- Measure the duration of the complete procedure, the additional act (BOOST) and the final ultrasound acquisition performed at the end of the procedure (when performed).(24 hours)
- (For the last 5 patients): Estimate the quality of the registration after insertion of the implants.(24 hours)
- Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires(12 months)
- Dose to CTV-dosi at 150%(1 month)