Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)
研究概览
简要总结
Primary Objective:
- To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.
Secondary Objectives:
- To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS)
- To determine whether baseline SUVmax correlate with rPFS
- To compare number of lesions detected with standard imaging at baseline and at the time of progression
详细描述
Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.
PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.
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
- •Histologically confirmed diagnosis of prostate cancer
- •Age ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- •Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3
- •Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease
- •Ability to understand and willingness to sign a written informed consent document
- •Wiling to comply with clinical trial instructions and requirements
排除标准
- •History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
- •Presence of prostate brachytherapy implants
- •Administration of another radioisotope within five physical half-lives of trial enrollment
- •Radiation or chemotherapy within 2 weeks prior to trial enrollment
- •Serum creatinine > 3 times the upper limit of normal
- •Serum total bilirubin > 3 times the upper limit of normal
- •Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal
- •Inadequate venous access
研究组 & 干预措施
PyL-PET
Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive [F-18] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.
干预措施: [F-18] DCFPyL (Drug)
PyL-PET
Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive [F-18] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.
干预措施: PET/CT imaging (Procedure)
结局指标
主要结局
Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)
时间窗: Baseline, Post-treatment (approximately 6 weeks)
To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.
次要结局
- Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS)(Baseline, Post-treatment (approximately 6 weeks))
- Prevalence of baseline SUVmax correlating with rPFS(Baseline, Post-treatment (approximately 6 weeks))
- Change in number of lesions detected with standard imaging at baseline and at the time of progression(Baseline, up to 1 year)
研究者
Matthew Dallos
Assistant Professor of Medicine
Columbia University