A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Localizing Tumors
研究概览
简要总结
The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery.
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
- •Age ≥18 years
- •Biopsy proven adenocarcinoma of the prostate
- •Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included
- •Planned radical prostatectomy at MSKCC
- •Multiparametric MRI of the pelvis (performed or planned) as routine care
排除标准
- •Patients meeting any of the following exclusion criteria will not be eligible for study entry:
- •Hematologic
- •Platelets <75K/mcL
- •ANC <1.0 K/mcL
- •Hepatic laboratory values
- •Bilirubin >2.0 x ULN (institutional upper limits of normal)
- •AST/ALT >2.5 x ULN
- •Renal laboratory values
- •o Creatinine > 2.0 x ULN
- •Claustrophobia interfering with MRI and PET/CT imaging
- •Prior pelvic radiation
- •Prior androgen deprivation therapy
- •Patients deemed not surgical candidates due to prohibitive co-morbidities
结局指标
主要结局
Localizing Tumors
时间窗: within two weeks prior to the planned prostatectomy
Localization will be defined using a total of 12 regions within the prostate: right and left base, midgland and apex in both peripheral and transition zones. The uptake on each region will be assessed by a radiologist blinded to standard of care imaging and clinical characteristics. Histopathological confirmation will be used as the gold standard.
次要结局
未报告次要终点