Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 175
- 试验地点
- 11
- 主要终点
- GU and GI Toxicity
研究概览
简要总结
Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.
详细描述
Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.
Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).
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
- •Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
- •Gleason-grade ≤7, ISUP Grade Group 1-3
- •Guideline-based staging
- •Age ≥ 18 years
- •PSA < 20 ng/ml
- •Volume of the prostate < 80 cm³
- •IPSS-Score ≤ 12
- •Written informed consent
排除标准
- •History of prior pelvic radiotherapy
- •Previous transurethral resection, laser enucleation or prostate ablation
- •Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
- •Relevant comorbidity thought to adversely affect treatment compliance
- •Legal incapacity or lack of informed consent
研究组 & 干预措施
Hypofractionated Radiosurgery
3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 Gy
干预措施: Hypofractionated Radiosurgery (Radiation)
结局指标
主要结局
GU and GI Toxicity
时间窗: 12-15 months after radiotherapy
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
次要结局
- Acute toxicity(Through study completion)
- PSA(At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy)
- IPSS(Screening and 3, 6-9 and 12-15 months after radiotherapy)
- Quality of Life Score(At the time of inclusion and 12-15 months after radiotherapy)
- Decision Regret Score(At the time of inclusion and 12-15 months after radiotherapy)