177Lu-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Prior to Radical Prostatectomy: Feasibility Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Surgical safety
研究概览
简要总结
Despite surgical advances, up to 50% of patients with high-risk locally advanced prostate cancer will die from their disease. Drug therapy before surgery has the potential to improve treatment success by lowering tumor volume in the prostate and treating small metastases. PET PSMA is an advanced imaging technique that allows the identification of areas involved by the tumor in the prostate or in the pelvis. This technique is based on the protein PSMA (prostate-specific membrane antigen) which is located on the tumor cells. The presence of PSMA on tumor cells has been recently used for treatment purposes. A chemical element (Lutetium) that binds to PSMA and emits local radiation can destroy tumors cells. This treatment has been used in patients with advanced metastatic disease and showed promising results. The investigators hypothesized that using these particles can improve long term results in patients who undergo surgery for prostate cancer which has not extensively spread. The investigators will assess both the immediate and long-term impact of this novel 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
- •Male aged 18 years and older.
- •Patients were diagnosed with high risk localized prostate cancer (cT3/4 and/or Gleason score ≥8 and/or prostate biopsy or PSA ≥ 20 ng/dl) or loco-regional prostate cancer (pelvic lymphadenopathy of ≥2 cm on axial imaging).
- •High PSMA expression was confirmed. PET PSMA with tracer uptake greater than normal liver (maximal standardized uptake value ≥1.5 of liver). In addition, no PET FDG positive sites without high PSMA expression.
- •Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score5 of 1 or lower and life expectancy of > 10 years.
排除标准
- •Clinically significant impaired bone marrow defined by platelet count lower than 150×103/µl, white blood cells count lower than 4×103/µl, hemoglobin concentration lower than 12mg/dl.
- •Impaired liver function defined by albumin concentration lower than 3.5 gr/dl.
- •Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min.
- •Recent radiotherapy (within two months)
- •Concomitant usage of nephrotoxic drugs
- •Evidence of distant metastatic disease (distal lymphadenopathy, visceral or bone metastases).
结局指标
主要结局
Surgical safety
时间窗: 2 years
Surgical safety will be assessed according to the rate of intra- and post operative complications graded according to the clavien dindo classification.
Early oncological outcomes
时间窗: 2 years
Early oncological outcomes will be assessed according to the final surgical histology (e.g. stage , grade) and postoperative PSA
次要结局
未报告次要终点
研究者
golan shay
Director of urologic-oncology service, Principal Investigator, Clinical senior lecturer
Rabin Medical Center