PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI
研究概览
简要总结
This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.
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 treatment-naïve prostate adenocarcinoma with pelvic metastases known to suspected on standard-of-care staging imaging
- •Eligibility and plan to undergo definitive radiation therapy for prostate cancer per established standard-of-care radiation oncology clinical guidelines
- •Be at least 18 years of age
排除标准
- •Inability to tolerate or undergo PET/MRI or PET/CT
- •Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
- •Recurrent prostate adenocarcinoma
- •Known distant metastatic disease
- •Current or prior treatment for prostate cancer
- •Known allergy to glucagon
- •Previous diagnosis of insulinoma or pheochromocytoma
研究组 & 干预措施
Metastatic Prostate Cancer Arm
[68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer
干预措施: [68Ga]PSMA-PET/MRI or PET/CT (Drug)
结局指标
主要结局
The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI
时间窗: 1 scan
次要结局
- Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities(18 months)
- The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI(1 scan)
- Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered(1 simulation scan)
- The Total Number of Pelvic Nodal Metastases Detected on MRI(1 scan)
研究者
Samuel Joseph Galgano
Program Director, Abdominal Imaging Fellowship Assistant Professor, Abdominal Imaging Section and Division of Molecular Imaging and Therapeutics
University of Alabama at Birmingham