MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,586
- 试验地点
- 4
- 主要终点
- Incidence of Prostate Cancer
研究概览
简要总结
This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy.
详细描述
The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement.
Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA.
Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion.
This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy. The researchers are interested in learning which procedure is more useful in obtaining a diagnosis of prostate cancer which will in turn provide a better diagnosis rate. Each patient will act as their own control.
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
- •All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
- •Age greater than 18 years.
- •No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
- •The ability to understand willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
- •Ability to tolerate sedation and or general anesthesia if required.
- •PSA >1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
- •Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
- •Able to tolerate an ultrasound guided biopsy.
排除标准
- •Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
- •Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
- •Patients with uncorrectable coagulopathies.
结局指标
主要结局
Incidence of Prostate Cancer
时间窗: 1 Month
Incidence of diagnosing subjects with prostate cancer with MR visible lesions
次要结局
- Incidence of adverse events(1 Month)
- Pirads score(1 Month)
- Gleason score(1 Month)
研究者
Ardeshir Rastinehad
Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer
Northwell Health