NCT01530269已完成2 期
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Tissue Biopsy of metastatic site(s)
研究概览
简要总结
Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.
详细描述
OBJECTIVES:
- Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
- Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients will be studied who have prostate cancer:
- •Diagnosed with prostate adenocarcinoma
- •Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
- •Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:
- •Gleason score >= 7 or PSA >= 10
- •Gleason score < 7 or PSA <10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
- •Rising or non-responding PSA
排除标准
- •< 18 years old
- •claustrophobic patients
研究组 & 干预措施
PET/CT imaging with C11-Sodium Acetate
Experimental
干预措施: C11-Sodium Acetate (Drug)
结局指标
主要结局
Tissue Biopsy of metastatic site(s)
时间窗: Assessed within 30 days following AC-PET
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
次要结局
- PSA (prostate specific antigen)(Each 3 - 6 months for 24 months)
研究者
Fabio Almeida MD
Medical Director and Principal Investigator
Phoenix Molecular Imaging
研究点 (1)
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