Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dosimetry Parameters
研究概览
简要总结
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.
详细描述
Patients who received previous adjuvant or salvage radiotherapy to the prostate bed >
Isolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible >
Baseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning >
Two fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) >
Follow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)
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
- •Patients who received previous RT to the prostate bed +/- pelvic nodal regions
- •Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
- •At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
- •With or without ADT PSA doubling time from nadir greater than 6 months
- •Age greater than 18 years
排除标准
- •Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
- •History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
- •Any contraindications to MR and/or brachytherapy
研究组 & 干预措施
2xHDR Brachytherapy
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy.
干预措施: High Dose Rate Brachytherapy (Radiation)
结局指标
主要结局
Dosimetry Parameters
时间窗: 5 Years
As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
时间窗: 5 Years
Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3
次要结局
- Local Disease Control(2 Years)
- Changes in Quality of Life(5 years)
- Biochemical Control assessed by PSA(5 Years)