Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer
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
- •Histologically confirmed adenocarcinoma of the prostate
- •High risk localized adenocarcinoma defined by at least one of the following criteria:
- •Clinical stage T2c, T3 or T4
- •Gleason score ≥ 8
- •Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
- •Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
- •No pelvic adenopathy ≥ 15 mm on CT or MRI,
- •Absence of bone and/or visceral metastasis
- •Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
- •Absence of prior pelvic radiotherapy,
- •Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
- •Age ≥ 18 years and ≤ 85 years
- •ECOG performance status ≤ 1,
- •Estimated life expectancy > 5 years
- •Membership of a social security system,
- •Signed informed consent.
排除标准
- •Prostate cancer histology other than adenocarcinoma,
- •pN1 patients (lymph node dissection after histologically proven)
- •PSA > 100 ng/ml
- •History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
- •Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
- •Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
- •Contra-indication to agonists or antagonists of LH-RH
- •Bilateral hip prosthesis,
- •Patients already included in another clinical trial with an experimental molecule,
- •Persons deprived of liberty or under guardianship
- •Unable to undergo medical test for geographical, social or psychological.
研究组 & 干预措施
Radiotherapy
Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
干预措施: Simultaneous integrated boost intensity-modulated arctherapy (Radiation)
Radiotherapy
Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
干预措施: Androgen deprivation (Drug)
结局指标
主要结局
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
时间窗: From start of radiotherapy to six months after the end of radiotherapy
Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
次要结局
- To evaluate the specific survival(for each patient from inclusion up to 5 years after the end of radiotherapy.)
- To evaluate the quality of life(inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.)
- Evaluate the 5-year biochemical-free survival(for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.)
- To evaluate the late urinary and rectal toxicities(for each patient every 6 months after the end of radiotherapy up to 5 years.)
- Evaluate the metastase-free survival(for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.)
- To evaluate the overall survival(for each patient from inclusion up to 5 years after the end of radiotherapy.)