A Pilot Study of Use of 11C-Choline PET-CT in the Metastatic Evaluation of Patients With Newly Diagnosed High Risk Adenocarcinoma of the Prostate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
研究概览
简要总结
RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.
PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine the sensitivity and specificity of PET-CT scan using C-11 choline in detecting bone and lymph node metastases in patients with newly diagnosed high-risk adenocarcinoma of the prostate.
Secondary
- To perform semi-quantitative analysis of tracer uptake using standard uptake values and qualitative analysis using pure visual analysis.
- To develop an algorithm that includes the routine use of C-11 choline PET-CT scan for the staging of patients with prostate cancer at high risk of metastatic disease.
- To determine whether the presence of C-11 choline PET-CT scan positivity in these patients is predictive of outcomes, including biochemical relapse-free survival, time to development of clinically apparent metastases, time to local failure, and overall survival.
- To obtain tissue specimens from these patients for correlative studies and further evaluation.
- To obtain information regarding the feasibility and characteristics of C-11 choline PET-CT scan after androgen suppression.
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
- 30 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Prior negative prostate biopsy allowed
- •High-risk disease, as defined by one of the following:
- •PSA ≥ 20 ng/mL
- •Gleason score ≥ 8
- •Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)
- •Creatinine < 2.0 mg/dL
- •Able to tolerate PET scan, CT scan, and bone scan
- •Able to tolerate IV and oral contrast
- •Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan
排除标准
- •Other cancer within the past 5 years (except for nonmelanoma skin cancer)
- •No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed
研究组 & 干预措施
radiolabeled choline tracer scans
PET-CT scans supplemented with Choline 11 tracer
干预措施: needle biopsy (Procedure)
radiolabeled choline tracer scans
PET-CT scans supplemented with Choline 11 tracer
干预措施: PET-CT scans supplemented with 11C-Choline tracer (Drug)
结局指标
主要结局
Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
时间窗: Approximately 1 year
To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.
次要结局
未报告次要终点