Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
研究概览
简要总结
This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with higher daily doses and shorter total treatment time compared to standard fractionation) of the prostate bed with or without the pelvic lymph nodes.
详细描述
While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.
A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance wil be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •resected prostate carcinoma with histological grading (Gleason Score)
- •status post prostatectomy for a pT3 carcinoma and/or R1/2 resection or PSA recurrence after prostatectomy (2 consecutive PSA rises)
- •PSA recurrence ≥ 1 ng/ml: CT/PET/MRI imaging excluding pathological lymph nodes
- •Karnofksy performance score ≥ 70 %
- •age 18 - 80 years
- •only arm 2: antihormonal therapy for 2 months prior to radiotherapy and continuation of hormonal suppression after radiotherapy recommended
- •written informed consent
排除标准
- •patient's refusal
- •patient's inabillity to give informed consent
- •stage IV (distant metastases)
- •lymph node involvement outside the pelvis
- •severe wound complications after laparatomy
- •only arm 2: severe lymphoedema of the legs, elephantiasis, postthrombotic syndrome
- •decompensated pulmonary, cardiovascular, metabolic, hematopoetic, coagulatory or renal comorbidities
- •known other malignant disease with distant metastases
- •prior pelvic irradiation
- •participation in another clinical trial that might compromise the results of the PRIAMOS trial or the other trial
研究组 & 干预措施
prostate bed
irradiation of the prostatic bed only (no higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy)
This arm has already finished recruitment
干预措施: hypofractionated helical IMRT (Radiation)
prostate bed & lymph nodes
irradiation of the prostatic bed and the pelvic lymphatic drainage (in patients with higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
干预措施: hypofractionated helical IMRT (Radiation)
结局指标
主要结局
proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
时间窗: 2 years
Proportion SDR of patients with no NCI CTC AE grade 3-4 toxicity and no discontinuation of treatment during the full set of 18 fractions by any reasons in the intent-to-treat (ITT) population
次要结局
- biochemical recurrence free survival (BFS)(2 years)
- Quality of Life(2 years)
- overall survival(2 years)
研究者
Klaus Herfarth, MD
Principal Inverstigator
Heidelberg University