Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 897
- 试验地点
- 1
- 主要终点
- Quality of life (prostate-associated, 12 weeks vs baseline)
研究概览
简要总结
As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation.
The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •histology-proven prostate cancer with Gleason Score and PSA-value;
- •indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
- •Karnofsky-Index ≥ 70%
- •age ≥ 18 years
排除标准
- •androgen deprivation therapy
- •lymphatic spread
- •macroscopic tumor/ R2
- •stage IV (M1)
- •previous irradiation
研究组 & 干预措施
70.0/ 2.0 Gray (RBE)
Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)
干预措施: Normofractionated radiotherapy with photons (Radiation)
57.0/ 3.0 Gray (RBE)
Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)
干预措施: Hypofractionated radiotherapy with photons (Radiation)
57.0/ 3.0 (RBE)
Hypofractionated radiotherapy with protons (57.0/ 3.0 Gray relative biological effectiveness [RBE]).
干预措施: Hypofractionated radiotherapy with protons (Radiation)
结局指标
主要结局
Quality of life (prostate-associated, 12 weeks vs baseline)
时间窗: 12 weeks
The primary objective of the present trial is to show a Change in the bowel symptoms according to scores on the EORTC QLQ-PR25 questionaire after proton therapy compared to photon irradiation (week 12 vs. baseline).
次要结局
- biochemical progression-free survival (bPFS)(5 years after baseline)
- overall survival (OS)(5 years after baseline)
- Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years(2 and 5 years after baseline)
- Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)(2 and 5 years after baseline)
研究者
Juergen Debus
Principal Investigator
University Hospital Heidelberg
