Hypofractionated Radiosurgery for Localised Prostate Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 475
- 试验地点
- 16
- 主要终点
- Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
研究概览
简要总结
Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.
Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.
详细描述
Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).
Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter 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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
- •Gleason-grade ≤7
- •Guideline-based staging
- •Age ≥ 60 years
- •PSA < 15 ng / ml
- •Volume of the prostate < 80 cm³
- •IPSS-Score ≤ 12
- •Written informed consent
排除标准
- •Age ≤ 60 years
- •History of prior pelvic radiotherapy
- •Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
- •Immunosuppressive therapy
- •Relevant comorbidity thought to adversely affect treatment compliance,
- •Legal incapacity or lack of informed consent
研究组 & 干预措施
Hypofractionated Radiosurgery
5 fractions with 7 Gy, total dose 35 Gy
干预措施: Hypofractionated Radiosurgery (Radiation)
结局指标
主要结局
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
时间窗: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
次要结局
- International Prostate Symptom Score (IPSS)(At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy)
- Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.(4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy)
- EORTC Quality of Life Questionnaire (QLQ) C30(At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy)
- Prostate Specific Antigen (PSA)(At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy)
研究者
Juergen Dunst, Prof.
Clinical Professor, Director, Head of Department
University Hospital Schleswig-Holstein