Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
研究概览
简要总结
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.
详细描述
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis.
This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate adenocarcinoma.
- •Planned prostatectomy with lymph node dissection.
- •Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
- •Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
- •Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
- •Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
- •Including focal ablation techniques (HiFu).
- •Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.
研究组 & 干预措施
Ga-68 labeled PSMA-11 PET
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Ga-68 labeled PSMA-11 PET (Drug)
结局指标
主要结局
Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
时间窗: Up to 1 year
Sensitivity is defined as the ratio of the proportion of the patients who have the condition of interest and whose test results are positive over the number who have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis
Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
时间窗: Up to 1 year
Specificity is defined as the number of non-diseased participants correctly classified divided by all non-diseased individuals. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis
Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
时间窗: Up to 1 year
PPV is the proportion of patients with positive test who actually have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis
Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
时间窗: Up to 1 year
NPV is the ratio of participants truly diagnosed as negative to all those who had negative test results. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for obtained up to one year after study scan be used in analysis.
次要结局
- Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases(Up to 1 year)
- Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases(Up to 1 year)
- Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases(Up to 1 year)
- Number of Participants With Grade 3 Treatment-related Adverse Events(Up to 3 days)
- Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases(Up to 1 year)
- Sensitivity of PSMA PET for the Detection of Visceral Metastases(Up to 1 year)
- Specificity of PSMA PET for the Detection of Visceral Metastases(Up to 1 year)
- Positive Predictive Value of PSMA PET Visceral Metastases(Up to 1 year)
- Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases(Up to 1 year)
- Sensitivity of PSMA PET for the Detection of Osseous Metastases(Up to 1 year)
- Specificity of PSMA PET for the Detection of Osseous Metastases(Up to 1 year)
- Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases(Up to 1 year)
- Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases(Up to 1 year)
研究者
Thomas Hope
Assistant Professor of Radiology and Biomedical Imaging
University of California, San Francisco