Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT)
研究概览
简要总结
This clinical trial studies mechanisms of resistance to 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy using image-guided biopsies in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Diagnostic procedures, such as image guided biopsies, may help in learning how well 177Lu-PSMA works to kill tumor cells and allow doctors to plan better treatment.
详细描述
PRIMARY OBJECTIVE:
I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with molecular and cellular alterations in tumor, immune and stromal cells after radioligand therapy assessed by histopathology/immunohistochemistry, ribonucleic acid (RNA)-sequencing and proteomic/phospho-proteomic analyses of biopsy samples.
SECONDARY OBJECTIVE:
I. Sequencing to identify frequently mutated genes.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Volunteer patient
- •Histologically confirmed prostate cancer
- •Eligible for 177Lu-PSMA-617 under expanded access protocol (IRB# 21-5010) or as part of an approved trial
- •Based on positron emission tomography (PET)/computed tomography (CT) images: Evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy
- •Platelets > 75,000/ul within 14 days prior to biopsy
- •Prothrombin time (PT) or International normalized ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit normal (ULN) within 14 days prior to biopsy
- •Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)
排除标准
- •Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible
结局指标
主要结局
Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT)
时间窗: At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)
次要结局
- Proportion of patients with gene mutations that might confer resistance to RLT(At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks))