Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Rate of safe feasibility (SDR)
研究概览
简要总结
For patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. However, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is given during each session to the prostate or the prostate bed and to confirmed lymph node metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are required, and continuation during radiotherapy and for a further two years are strongly recommended.
详细描述
The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1: Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate.
Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3: Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed.
Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed prostate cancer with Gleason Score
- •risk of lymph node involvement >20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement
- •Karnofsky Index >/= 70%
- •age 18-75 years
- •neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy
- •written informed consent
排除标准
- •stage IV (distant metastases)
- •lymph node metastases outside the pelvis
- •rising prostate-specific antigen (PSA) under antihormonal treatment
- •severe wound complications after laparatomy
- •severe lymph edema of the legs, elephantiasis, postthrombotic syndrome
- •decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy
- •history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin)
- •previous irradiation of the pelvic lymph nodes
- •concurrent participation in a clinical trial that might influence the results of either trial
结局指标
主要结局
Rate of safe feasibility (SDR)
时间窗: 2 years
Proportion of treatments begun as planned without grade 3-4 NCI common toxicity criteria adverse events (CTC AE) or treatment disruption among all patients that fulfill inclusion criteria and have been treated according to trial protocol for at least a week.
次要结局
- Biochemical recurrence free survival(2 years)
- Quality of Life(2 years)
研究者
Klaus Herfarth, MD
Principal Investigator
Heidelberg University