Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Response rate differences
研究概览
简要总结
This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.
详细描述
The investigators propose to evaluate the feasibility of using a novel small molecule PET radiotracer, DCFPyL to target prostate cancer prostate-specific membrane antigen (PSMA). PSMA is a well studied cell surface marker of prostate cancer with increased expression associated with higher tumor grade and advanced metastatic tumors. More specifically it is associated with a higher Gleason score and there is evidence it can serve as a potential marker for prostate tumor carcinogenesis, progression and as a AR signaling surrogate marker of ADT response. This small molecule PET radiotracer specifically targeting an important prostate specific marker of AR signaling dynamics following ADT, tumor progression and metastatic potential warrants validation as an in-vivo non-invasive imaging biomarker for PSMA expression and prostate cancer detection.
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
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.
- •Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)
- •Newly diagnosed prostate cancer pathologically proven by prostate biopsy
- •Prostate biopsy histology grade ≥ Gleason 8-10
- •Patients considered as candidates for and medically fit to undergo radiation and ADT
- •At least 10 days after most recent prostate biopsy
排除标准
- •Prior pelvic external beam radiation therapy or brachytherapy
- •Chemotherapy for prostate cancer
- •Hormone deprivation therapy
- •Investigational therapy for prostate cancer
- •Hemorrhagic cystitis or active prostatitis
研究组 & 干预措施
DCFPyL PET-MRI fusion or PET/MRI
- Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT
- Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months
干预措施: Pelvic DCFPyL PET-MRI fusion or PET/MRI (Drug)
结局指标
主要结局
Response rate differences
时间窗: baseline and after 2-3 months
To compare the detection , sextant localization and response of DCFPyL PET-MRI fusion or PET/MRI before and after 2-3 months of ADT in men with biopsy-positive high-risk localized or locally advanced prostate cancer.
次要结局
- Biomarker changes(Baseline and at 2=3 months)
- Nodal metastatic disease changes(Baseline and then at 2-3 months)
- All cause DCFPyL PET-MRI fusion or PET/MRI toxicity(Baseline and then at 2-3 months)
- Metabolic tumor uptake changes(baseline and then at 2-3 months)
- Gene expression changes(Baseline and then at 2-3 months)