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临床试验/NCT04083937
NCT04083937招募中不适用

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 897 人开始时间: 2018年9月12日最近更新:
适应症
干预措施

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

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)

Active Comparator

Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)

干预措施: Normofractionated radiotherapy with photons (Radiation)

57.0/ 3.0 Gray (RBE)

Experimental

Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)

干预措施: Hypofractionated radiotherapy with photons (Radiation)

57.0/ 3.0 (RBE)

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juergen Debus

Principal Investigator

University Hospital Heidelberg

研究点 (1)

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