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临床试验 NCT07208240 针对High Risk Prostate Cancer目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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拉宾医疗中心Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial. I期, II期 20 创新疗法
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临床试验NCT07208240旨在研究治疗，主要针对High Risk Prostate Cancer。这是一项I期 II期 干预性研究试验，目前试验状态为招募中。试验始于2025年8月12日，计划招募20名患者。该研究由拉宾医疗中心主导，预计于2028年8月12日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年10月6日。
简要概括
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 ...显示更多
官方标题
Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.
疾病
High Risk Prostate Cancer其他研究标识符
- RMC 833-23
NCT编号
实际开始日期
2025-08-12
最近更新发布
2025-10-06
预计完成日期
2028-08-12
计划入组人数
20
研究类型
干预性研究
试验分期 (阶段)
I期
II期
II期
试验状态
招募中
关键词
High risk Prostate cancer
Radical Prostatectomy
PSMA
Theranostics
radionuclide therapy
Radical Prostatectomy
PSMA
Theranostics
radionuclide therapy
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | Tb-PSMA-I&T (Tb-PSMA) Terbium-161 produce beta emission with the addition of Auger electrons which have higher linear energy transfer and a very short range. By that it has the potential to improve local and distal (micro-metastatic disease) efficacy with a similar safety profile. It will be given to patients with high risk locally advanced prostate cancer prior to Radical prostatectomy |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009) | 1 year | |
Surgical and clinical safety | 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. | 1 year |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response | Secondary outcomes include the immediate response to treatment in terms of biochemical response. A post-surgical prostate specific antigen above 0.1 ng/ml is considered biochemical failure. | 3 months |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
男性
- 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.
- 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
拉宾医疗中心研究责任方
golan shay, 主要研究者, Pro Shay Golan , Chair of Urology at Rabin Medical Cener, Rabin Medical Center
研究中心联系人
联系人: Shay Golan, MD, +972507447573, [email protected]
联系人: Hana Burnstein, MD, +972544400822, [email protected]
1 位于 1 个国家/地区的研究中心