Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Grade ≥2 Toxicity for GU
研究概览
简要总结
This is a Phase II prospective single-arm trial that is recruiting 80 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men older than 18 years old.
- •Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
- •Previous radical prostatectomy.
- •Biochemical relapse with local or regional recurrence proven on PSMA PET.
- •Five or less positive nodes on the PSMA PET.
排除标准
- •Presence of para-aortic lymph nodes or distant metastasis.
- •Chronic pelvic inflammatory disease.
- •Contraindication for radiation treatment.
- •Previous radiation treatment within the pelvis
研究组 & 干预措施
Molecular Imaging Informed Radiation Dose Escalation and De-escalation
Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.
干预措施: Image-guided Radiotherapy (Radiation)
结局指标
主要结局
Grade ≥2 Toxicity for GU
时间窗: Baseline to 5-year follow-up
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
- Biochemical Failure Free Survival(Baseline to 5-year follow-up)
- Patient-reported quality-of-life assessed by EPIC-26(Baseline to 5-year follow-up)