NCT07132671尚未招募不适用
MRI-guided Brachytherapy + Salvage SBRT Program for Patients With Prostate Bed Relapses After Radical Prostatectomy
Clinica Universidad de Navarra, Universidad de Navarra0 个研究点目标入组 29 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 29
- 主要终点
- Biochemical control
研究概览
简要总结
Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy
详细描述
The goal of this clinical trial is to learn if the use of brachytherapy followed by MRI-guided irradiation increases the rates of tumor control and decreases the rates of adverse events in patients with tumor bed relapses after radical prostatectomy
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
- •Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and RMN+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.
- •Pathological confirmation is advised in all cases but it is not mandatory .
- •Patients with any of the following were not considered eligible:
- •Distance < 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter)
- •Distant Metastases
- •Isolated nodal relapses
- •Prior Irradiation to the IPBR area
- •Multicentric IPBRs
- •Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
- •No prior radiation therapy to the target areas;
- •Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
- •WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.
- •Ability to undergo MRI scanning.
排除标准
- 未提供
研究组 & 干预措施
MRI-guided Brachytherapy and Salvage SBRT Program
Experimental
Brachytherapy and MR-guided SBRT
干预措施: Brachytherapy and MR-Guided SBRT (Radiation)
结局指标
主要结局
Biochemical control
时间窗: 5-year
To achieve 5-year biochemical control rate in 85% of the patients.
Adverse Events
时间窗: 5-year
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
次要结局
- QOL(From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter)
研究者
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