Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Maximum standardized uptake value (SUVmax)
研究概览
简要总结
Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).
详细描述
PRIMARY OBJECTIVE:
I. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest during prostatic arterial and intravenous 68Ga-PSMA-11 infusions.
SECONDARY OBJECTIVES:
I. To compare the tumoral time-activity curves for selective prostatic arterial and intravenous 68Ga-PSMA-11 infusions.
II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion of 68Ga-PSMA-11 (obtained only from arterial time activity curves [TACs] ipsilateral to the side of infusion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years and less than or equal to 80 years.
- •Children are excluded from this study because the disease does not occur in children
- •Individuals from age 76 to age 80 must have a prior CT of the abdomen and pelvis within 5 years of first PSMA scan demonstrating non-occlusive pelvic atherosclerosis, regardless of smoking status
- •Individuals over the age of 80 are excluded from this study to improve the likelihood of a catheterizable prostatic artery, given the higher rates of occlusive atherosclerosis with advanced age
- •Ability to provide informed consent
- •Biopsy-proven unilateral or bilateral prostate adenocarcinoma, any stage (any N or any M)
- •Large tumor burden, characterized by either
- •A discrete lesion with maximal tumor diameter >= 2.0cm on at least one affected side, documented on prostate magnetic resonance imaging (MRI) or Transrectal ultrasound (TRUS) within 4 months of first scan.
- •Infiltrative disease with primary pattern Gleason 4 adenocarcinoma in at least 4 of 6 sextant core biopsy locations on at least one affected side, documented in a surgical pathology report within 4 months of first scan.
- •Gleason score >= 4+4
- •Cancer of the Prostate Risk Assessment (CAPRA) score >= 6
排除标准
- •Body mass index (BMI) > 35 kg/m^2
- •Prior treatment for prostate cancer, or any use of anti-androgen therapy within 3 months of first scan
- •History of any pelvic radiotherapy
- •Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.
- •Stage IV or V chronic kidney disease by estimated glomerular filtration rate (eGFR) within 45 days of first scan
- •Platelet count < 50 x 10^9/L and/or international normalized ratio > 1.5
- •Severe allergy to iodinated contrast
- •Active urinary tract infection or recent episode of prostatitis within 1 month of first scan
- •Inability to tolerate prolonged supine positioning
研究组 & 干预措施
Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization
Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. One to 14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.
干预措施: Angiogram (Procedure)
Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization
Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. One to 14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.
干预措施: Catheterization (Procedure)
Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization
Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. One to 14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.
干预措施: Gallium Ga-labeled PSMA-11 (Drug)
Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization
Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. One to 14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Maximum standardized uptake value (SUVmax)
时间窗: Day 1 and from Day 2 up to Day 15 (2 days total)
A two-sided paired t-test will determine whether the ipsilateral SUVmax values obtained during selective arterial 68Ga-PSMA-11 infusions are greater than those obtained during venous infusions. A similar paired analysis will be made during arterial infusions to compare tumoral regions of interest (ROIs) ipsilateral and contralateral to the side of the infusion. Means/medians, ranges/standard deviations will be calculated for each endpoint.
次要结局
- Comparison of Rate of 68Ga-PSMA-11 uptake(Day 1 and from Day 2 up to Day 15 (2 days total))
- Comparison of Mean SUV during 15-minute washout (SUVwashout)(1 day)
- Comparison of Mean SUV (SUVmean)(Day 1 and from Day 2 up to Day 15 (2 days total))
- Comparison of Time to early saturation effects(1 day)
- Comparison of Time to SUVmax (TSUV)(Day 1 and from Day 2 up to Day 15 (2 days total))
- Comparison of Area under the curve (AUC)(Day 1 and from Day 2 up to Day 15 (2 days total))
- Comparison of Mass dose at saturation(Day 1 and from Day 2 up to Day 15 (2 days total))
研究者
Ryan Kohlbrenner, MD
Principal Investigator
University of California, San Francisco