Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Surgical and clinical safety
研究概览
简要总结
This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.
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
- •Male aged 18 years and older.
- •Patients with high-risk localized prostate cancer (cT3/4 and/or Gleason score ≥ eight and/or prostate biopsy or PSA ≥ 20 ng/dl)
- •High PSMA expression was confirmed according to PROMISE V2 8
- •Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or lower and a life expectancy of > 10 years.
排除标准
- •Platelet count lower than 150×103/µl
- •white blood cell count lower than 4×103/µl,
- •haemoglobin concentration lower than 12mg/dl.
- •albumin concentration lower than 3.5 g/dl.
- •glomerular filtration rate (GFR) lower than 40 mL/min.
- •usage of nephrotoxic drugs
- •distant metastatic disease
研究组 & 干预措施
Patients receiving Tb-PSMA before RAdical prostatectomy
Patients with high-risk locally advanced prostate cancer will receive 3 Tb-161-PSMA treatments followed by radical prostatectomy.
干预措施: Tb-PSMA-I&T (Tb-PSMA) (Drug)
结局指标
主要结局
Surgical and clinical safety
时间窗: 1 year
The primary outcome is the safety of administering Tb-PSMA before radical prostatectomy, its impact on intra- and post-operative clinical course according to the Clavien-Dindo Classification.
Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009)
时间窗: 1 year
次要结局
- Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response(3 months)
研究者
golan shay
Pro Shay Golan , Chair of Urology at Rabin Medical Cener
Rabin Medical Center