PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Diagnostic Accuracy of PSMA PET
研究概览
简要总结
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease.
A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.
详细描述
This is a prospective, single arm, phase 2 clinical trial. This patient population will have low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. It will also enroll those who are at high risk of significant prostate cancer (4Kscore >20%, SelectMDx >20%, PSA density >0.15). Patients will be scheduled for magnetic resonance imaging (MRI) as part of routine care for either surgical planning or for further biopsy. Following the informed consent process, patients who enroll in the study will receive a PSMA positron emission tomography (PET) study along with their standard of care (SOC) MRI on an integrated PET-MRI. Registration of PET and MRI will be done using software to generate the PET-MRI images. Patients receiving SOC MRI guided biopsy will receive additional PET guided biopsies as indicated in a single session. The sensitivity and specificity will be evaluated along with the ability of the tracer to inform the treatment planning. Patients receiving surgical removal of the prostate will have a slice-by-slice whole mount analysis to assess the sensitivity and specificity the PSMA PET.
Primary Objectives Define the accuracy of 68Ga-PSMA-11 PET-CT for detecting the clinically significant prostate cancer lesion.
Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.
Exploratory Objectives Generate pilot data for future larger clinical trials
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 do the imaging reads in a blinded fashion.
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
- •≥ 18 years of age
- •Must provide written informed consent
- •Presence of low or intermediate risk prostate cancer or at risk of having intermediate risk cancer
- •a. Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 = 4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii. Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9 cancer lesions if they are in addition to the intermediate risk cancer as described above.)
- •Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.
- •Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.
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 is not allowed).
- •Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
结局指标
主要结局
Diagnostic Accuracy of PSMA PET
时间窗: 60 days
Sensitivity and specificity for EPE using whole-mount analysis or biopsy pathology. EPE is extra-prostatic extension which means the cancer extends beyond the boundary of the prostate into adjacent muscle or fatty tissue.
次要结局
- Impact of PSMA PET-CT on Treatment Plan for Surgery or Biopsy(60 days)
研究者
Clinton Bahler
Assistant Professor of Medicine
Indiana University