Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Positive predictive value of 68Ga-PSMA-11 (gallium Ga 68-labeled PSMA-11) positron emission tomography (PET)
研究概览
简要总结
This phase II trial studies how well gallium-68 PSMA-11 PET/CT or PET/MRI works in finding prostate cancer cells that have come back (recurrent) in patients with prostate cancer. Gallium-68 PSMA-11 is a type of radioactive compound, called a radiotracer, which is injected in the vein and can accumulate in tumor cells to generate a signal detected by PET/CT or PET/MRI imaging. This may help researchers in finding recurrent prostate cancer cells in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To assess the positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA11) positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MRI) on a patient level using histopathology or confirmatory imaging as a standard of truth (SoT).
SECONDARY OBJECTIVES:
I. To assess the PPV per-patient for 68Ga-PSMA-11 PET/CT and PET/MRI detection of tumor location confirmed by histopathology/biopsy alone.
II. Demonstrate the safety of 68Ga-PSMA-11 PET/CT or PET/MRI imaging in participants with prostate cancer.
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
- •Pathologically proven prostate cancer
- •Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
- •Karnofsky performance status (KPS) >= 50 (Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] 0, 1, or 2)
- •Ability to understand and willingness to provide informed consent
- •Participants with known metastatic prostate cancer planned to undergo active systemic treatment
排除标准
- •Unable to lie flat, still, or tolerate a PET or MRI scan
- •Contraindication to optional furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction - (defined as either Ga-68 specific prompt gamma correction or multiple scatter model) is available for the used PET device
研究组 & 干预措施
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
干预措施: Computed Tomography (Procedure)
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
干预措施: Gallium Ga 68-labeled PSMA-11 (Drug)
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Positive predictive value of 68Ga-PSMA-11 (gallium Ga 68-labeled PSMA-11) positron emission tomography (PET)
时间窗: Up to 36 months
Positive predictive value will be defined as true positive/(true positive + false positive). Positive predictive value on a per-participant and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up will be calculated and reported along with the corresponding two-sided 95% confidence intervals.
次要结局
未报告次要终点