Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
研究概览
简要总结
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days.
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
- •Age ≤ 85years.
- •WHO performance status ≤
- •PSA>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
- •Histologically proven prostate adenocarcinoma
- •No pathologic lymph nodes on CT/ MRI scan.
- •No distant metastases.
- •No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
- •No malignant tumours in the previous 5 years.
- •Combined HT according to risk factors.
- •Informed consent.
排除标准
- •Prostate size greater than 60cc.
- •Previous TURP less than 6 weeks before radiotherapy.
- •Previous prostate surgery other than TURP.
- •Diabetes *.
- •Use of anticoagulants drugs *.
- •Chronic inflammatory bowel disease *.
- •Previous pelvic irradiation.
- •Inability to obtain written informed consent.
研究组 & 干预措施
SBRT in 4 fraction
Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT
干预措施: SBRT (Other)
结局指标
主要结局
Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
时间窗: up to 5 years
Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
Tumour response to local radiation therapy by assessing freedom from biochemical failure.
时间窗: up to 5 years
Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).
次要结局
未报告次要终点
研究者
Michele Tedeschi
Head of Clinical Trial Department
Istituto Clinico Humanitas