Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Acute gastrointestinal toxicity
研究概览
简要总结
This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.
Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 80 years;
- •Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
- •Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA <0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
- •No distant metastases (M0) diagnosed with PSMA-PET-CT;
- •Informed consent to trial's participation and personal data treatment.
排除标准
- •Age <18 years old;
- •Adjuvant radiotherapy;
- •Previous radiation in the same anatomical site.
结局指标
主要结局
Acute gastrointestinal toxicity
时间窗: 90 days from the RT treatment
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.
次要结局
- Time to biochemical failure(24 months)
- Local in-field relapse(24 months)
- QLQ-C30(At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months)
- Biochemical failure(24 months)
- Acute genitourinary toxicity(90 days from the RT treatment.)
- Late toxicity(From 90 days after the RT treatment until 24 months)
- Metastases-free survival(24 months)