Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of patients with true diagnosis based on biopsy pathology
研究概览
简要总结
MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.
详细描述
The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are:
- To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
- To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
- To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
- To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.
Secondary Objectives:
- To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer.
- To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
- To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer
- •Inclusion criteria for sub-group follow-up scans:
- •1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)
排除标准
- •Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
- •The presence of an implanted pacemaker or implanted defibrillator device.
- •Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
- •Implanted medical device not described above that is not MRI-compatible;
- •Known history of severe claustrophobia;
- •For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) < 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed;
- •Minors will be excluded.
- •Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.
结局指标
主要结局
Number of patients with true diagnosis based on biopsy pathology
时间窗: Up to two weeks after MRI
1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
Number of patients with the most likely diagnosis based on the five-point scale - PIRADS
时间窗: Up to two weeks after MRI
Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
次要结局
- biopsy and MRI based diagnosis match in at least 8/10 patients(Up to two weeks after MRI)
- Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy(Up to two weeks after MRI)