Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 7
- 主要终点
- Change from baseline in rectal functions
研究概览
简要总结
hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
详细描述
The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Prostate adenocarcinoma proved by histology
- •With at least one of this intermediate-risk criterias:
- •and/or PSA between 10 et 20 ng/ml
- •and/or Gleason score = 7
- •Prostatic volume ≤ 80 cc
- •No adenopathy(lymph node < 1.5 cm on scanner or MRI and/or in lymph node dissection)
- •No metastasis (bone scan)
- •Age >= 18 ans
- •No prior pelvic irradiation
- •No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy > 3 months)
- •Performance status (ECOG) < 1
- •No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation
- •Life expectancy >= 10 weeks
- •Patient affiliated to health insurance
- •Informed consent signed by the patient
排除标准
- •Cancer no histologically proved
- •Unfavorable-risk(T2c and/or PSA > 20 ng/ml and/or Gleason > 7)
- •Favorable-risk(T1c T2a and PSA < 10 ng/ml and Gleason < 7)
- •T3 and T4
- •History of cancer uncontrolled and/or treated since less of 5 years (except basal cell carcinoma of the skin)
- •Contraindication to MRI
- •IPSS score > 10
- •Recurrent or metastatic disease
- •Allergy to gold
- •Patient already included in another therapeutic trial with an experimental molecule
- •Unable for medical follow-up (geographic, social or mental reasons)
研究组 & 干预措施
Boost by CyberKnife
干预措施: First part of treatment : Conformal irradiation (Radiation)
Boost by CyberKnife
干预措施: Fiducials placement (Procedure)
Boost by CyberKnife
干预措施: Second part : hypofractionated stereotactic boost (Radiation)
Boost by linear accelerator
干预措施: First part of treatment : Conformal irradiation (Radiation)
Boost by linear accelerator
干预措施: Fiducials placement (Procedure)
Boost by linear accelerator
干预措施: Second part : hypofractionated stereotactic boost (Radiation)
结局指标
主要结局
Change from baseline in rectal functions
时间窗: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
* Assessment of rectal toxicity according to the NCI-CTCAE v4.0 scale. * Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Change from baseline in urinary function.
时间窗: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
* Assessment of urinary toxicity according to the NCI-CTCAE v4.0 scale. * Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
次要结局
- Local control of prostate cancer(3 years)
- PSA kinetics(Between radiotherapy and boost, and after treatment : every 3 months)
- Technical criteria : Fiducial placement (yes/no)(During the time of treatment)
- Urinary discomfort(Up to 5 years after treatment)
- Technical criteria : Cumulative dosimetry (1 time/ 2 times)(During the time of treatment)
- Technical criteria : duration of boost(During the treatment)
- Sexual toxicity(Up to 5 years after treatment)
- Technical criteria : boost schedule (yes/no)(During the time of treatment)
- Global and metastase-free survival(Up to 5 years after treatment)