Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Adaptive Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Proportion of patients with a successful evaluable biopsy with altered signaling pathways after radioligand therapy (RLT)
研究概览
简要总结
This trial studies image-guided biopsies work in identifying mechanisms of resistance in participants with castration resistant prostate cancer that has spread to other places in the body and who are undergoing radioligand therapy (RLT). Tissue sample collected from a biopsy may help determine why response to RLT varies among patients, and this may help researchers to find better treatments for advanced prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with altered signaling pathways after radioligand therapy assessed by phospho-proteomics of biopsy samples.
SECONDARY OBJECTIVES:
I. Generation of patient derived xenograft (PDX) models to determine if tumor levels of activity for individual adaptive pathways are related to the best prostate specific antigen (PSA) response.
II. Sequencing to identify frequently mutated genes such as TP53 and ATM.
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
- •Enrolled in Lu-PSMA-617 treatment trial (Institutional Review Board [IRB]# 17-000330)
- •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 of 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 altered signaling pathways after radioligand therapy (RLT)
时间窗: Up to 3 years
No statistical power analysis was performed as this is a pilot study. An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy. The study will in subsequent studies use the information obtained here to design a more definitive trial.
次要结局
- Proportion of patients with gene mutation in regulators of replication stress response according to sequencing(Up to 3 years)
- Generation of xenografts(Up to 3 years)