Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Thomas Hope
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
研究概览
简要总结
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.
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 HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become available for clinical imaging in prostate cancer patients.
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 HBED-CC PSMA to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.
This study focuses on three patients populations that are imaged. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. In the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. In the castrate resistant prostate cancer population the primary objective is to determine if PSMA PET detects more metastatic lesions than conventional imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:
- •Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15 ng/mL and/or Gleason score ≥ 4+
- •Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months.
- •i. These patients may have received androgen deprivation therapy prior to imaging.
- •Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).
- •i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment
- •Karnofsky performance status of > 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 exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- •Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- •Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
研究组 & 干预措施
High-risk prostate cancer pre-prostatectomy (preRP) population
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Ga-68 labeled HBED-CC PSMA (Drug)
High-risk prostate cancer pre-prostatectomy (preRP) population
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT) (Device)
High-risk prostate cancer pre-prostatectomy (preRP) population
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) (Device)
Biochemical Recurrence (BCR)
Patients with prostate cancer with biochemical recurrence
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Ga-68 labeled HBED-CC PSMA (Drug)
Biochemical Recurrence (BCR)
Patients with prostate cancer with biochemical recurrence
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT) (Device)
Biochemical Recurrence (BCR)
Patients with prostate cancer with biochemical recurrence
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) (Device)
Castrate Resistant Prostate cancer (CRCP) population
Patients with castrate resistant prostate cancer.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Ga-68 labeled HBED-CC PSMA (Drug)
Castrate Resistant Prostate cancer (CRCP) population
Patients with castrate resistant prostate cancer.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT) (Device)
Castrate Resistant Prostate cancer (CRCP) population
Patients with castrate resistant prostate cancer.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) (Device)
结局指标
主要结局
Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
时间窗: 1 day
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. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases
时间窗: 1 day
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. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.
Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
时间窗: 1 day
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. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
时间窗: one month
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. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
次要结局
- Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group(Up to 1 year)
- Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management(Up to 1 year)
研究者
Thomas Hope
Principal Investigator
University of California, San Francisco