Improved Detection and Localization Accuracy of Early Aggressive Prostate Adenocarcinoma Using Novel MR-directed Ultrasound-guided (MRdUSg) Prostate Biopsy Technique
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate investigational fusion software.
研究概览
简要总结
The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Able to give informed consent
- •Male - age > 18
- •mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa)
- •Scheduled for TRUS biopsy for prostate lesion or mass
排除标准
- •Age under 18 years of age.
- •Pre-existing blood dyscrasias
- •Inability to perform TRUS due to anal sphincter closure/surgery
- •Patients needing general anesthesia
- •Patients allergic to lidocaine
- •Patients allergic or unable to take antibiotics
结局指标
主要结局
Evaluate investigational fusion software.
时间窗: Through study completion, planned 5 year duration.
To evaluate the sensitivity of the investigational software to aid in targeted biopsy of prostate lesions seen on pre-biopsy mpMRI.
次要结局
- Assess sensitivity of software.(Through study completion, planned 5 year duration.)
- Correlation of imaging with biomarkers.(Through study completion, planned 5 year duration.)
- Assess accuracy of mpMRI.(Through study completion, planned 5 year duration.)