The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Specificity of PSMA-PET and MRI
研究概览
简要总结
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).
Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).
Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.
Assess quality of life changes from preoperative baseline.
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
盲法说明
Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.
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
- •Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy
- •Prostate pathology results consistent with:
- •> 3 cores of Gleason 3+4 or
- •NCCN unfavorable intermediate risk or
- •NCCN high-risk or
- •NCCN very-high risk
- •Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).
- •Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
排除标准
- •Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- •Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).
- •Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
结局指标
主要结局
Specificity of PSMA-PET and MRI
时间窗: Pre-surgery prediction.
Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
时间窗: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
次要结局
- 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET(60 Days)
研究者
Clinton Bahler
Principal Investigator
Indiana University