NCT04909294进行中（未招募）不适用
Multicenter Phase II Study Evaluating the Efficacy and Safety of a Stereotaxic Prostatic Radiotherapy Delivered on Linac MRI, With Integrated Boost in the Case of an Index Tumor, in Patients With Prostate Adenocarcinoma of Favorable, Intermediate or Risky Risk. High Risk Very Localized.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Late gastrointestinal and urinary toxicity grade ≥ 2
研究概览
简要总结
Stereotaxic prostatic radiotherapy on Linac MRI, with monitoring of movements of the pelvic organs per fraction on the prostate in real time, in 4 sessions, with integrated boost on the index tumor (if it is visible on the diagnostic MRI), could reduce the digestive, urinary and sexual toxicities accumulated at 5 years and guarantee excellent local tumor control, for patients with localized prostate cancer, with a favorable prognosis, intermediate or very local high risk, according to the D'Amico classification.
The benefits that patients participating in this research could obtain are:
- Better disease control efficiency
- A reduction in the duration of treatment to 4 radiotherapy sessions (2 weeks maximum) instead of 40 sessions (8 weeks) for usual treatment.
- Avoid the risks associated with the implantation of prostate markers necessary for stereotaxic radiotherapy on a standard accelerator (anesthetic risks, infectious risks, hemorrhagic risks, pain risks)
- Better quality of life
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostate adenocarcinoma
- •WHO performance index ≤ 1
- •Patient presenting one of the following cases:
- •Low risk: ≤ T2a and Gleason 6 (3 + 3) and PSA <10 ng / ml
- •Intermediate risk: T2b-T2c or Gleason 7 or PSA <15 ng / ml
- •High localized risk: T3a and Gleason ≤7 and PSA <15 ng / ml
- •Disease presenting a risk of lymph node involvement <15%
- •Absence of pelvic or lumbar aortic lymphadenopathy
- •Absence of bone or visceral metastasis
- •IPSS score <15 or ≤ 7
- •Prostate volume estimated by MRI or ultrasound < 90cc
- •If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion.
- •Absence of prior pelvic radiotherapy
- •No surgical treatment for prostate cancer
排除标准
- •Prostate cancer of histology other than adenocarcinoma
- •Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator
- •Patient diagnosed N1 during imaging workup or pN1
- •Serum PSA level ≥ 15 ng / ml
- •IPSS score ≥ 15 or IPSS score> 7 if alpha blocking urological treatment in progress
- •Prostate volume estimated on MRI or ultrasound> 90 cc
- •Involvement of seminal vesicles on MRI
- •History of cancer in the 5 years preceding entry into the trial
- •History of transurethral resection of the prostate less than 6 months compared to the expected date of start of radiotherapy
- •rectal surgery
- •pelvic irradiation
- •Patient treated with antineoplastic or medication which may include Methotrexate
- •Hormone therapy started for more than 60 days at the time of inclusion
- •Severe uncontrolled hypertension
- •Patient followed or treated for severe or unstable angina, or having presented a myocardial infarction in the 6 months preceding the randomization
- •Patient on immunosuppressant
- •Patient with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium
结局指标
主要结局
Late gastrointestinal and urinary toxicity grade ≥ 2
时间窗: 5 years
toxicities graded according to the NCI-CTCAE-V5.0
次要结局
未报告次要终点
研究者
研究点 (2)
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