Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate: The Safety and Feasibility of a Novel Method of Prostate Biopsy.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer]
研究概览
简要总结
The purpose of this study is to investigate a novel method of prostate biopsy using a computerized guidance system to accurately target lesions within the prostate. This method of prostate biopsy involves using a computerized technology that permits a lesion detected on MRI to be projected by a computer into 3 dimensions on a patient's CT scan. A CT guided biopsy can then be performed where a needle is advanced into the patient, where the computer has projected the image of the tumor that cannot normally be seen on CT. This is a randomized, cross over designed trial to compare this new method of prostate biopsy to the currently employed standard transrectal ultrasound guided prostate (TRUSP) biopsy technique.
详细描述
This will be a prospective randomized controlled trial using a cross over design. Patients will serve as their own controls and undergo both TRUSP biopsy (standard of care) and mpMRI fused to cone beam CT guided biopsy of the prostate. The procedures and recovery will follow the identical standardized care pathway that is currently used for TRUSP biopsies. A total of 20 patients will be recruited
Patients will be randomized to receive either TRUSP biopsy or cone beam CT guided biopsy first, followed by the alternative procedure. Following the initial biopsy procedure the patients will fill out a short pain score. They will then recover in the radiology suite for a period of one hour. Following a one hour recovery period the patient will subsequently undergo the alternative biopsy procedure. They will then fill out a second pain score with two additional questions asking the patient to compare the two biopsy approaches with respect to comfort and preference using a 7 point Likert scale. Specimens will be sent to pathology separately to detect differences in diagnostic yield between the two biopsy approaches. In order to minimize inter-operator variability in outcomes, Dr. Menard will perform all biopsies regardless of approach.
An interim analysis after 10 patients will be performed. The study will be terminated early if:
-
No TRUSP biopsy detects any form of prostate cancer
-
No cone beam CT guided biopsy detects any form of prostate cancer.
-
Average pain scores between biopsy approaches differ by more than 4 points on the Universal Pain Assessment scale.
-
3 or more patients suffer any of:
-
Immediate procedure related complications
-
30 day return to the emergency room
-
30 day hospital admission
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Participants will be eligible for enrollment if they have both of:
- •Lesion in the prostate on mpMRI that is highly likely to be clinically significant prostate cancer based on the PI-RADS version 2 score (PI-RADS score of 4 or 5).
- •A previous negative TRUSP biopsy or previous TRUSP biopsy showing atypical small acinar proliferation, high grade prostatic intraepithelial neoplasia or low volume Gleason 6 disease (low risk disease) all of which are incongruent with the high PI-RADS score of the mpMRI lesion.
排除标准
- •Uncorrected coagulopathy.
- •Active, untreated urinary tract infection.
- •Inability to access the rectum in order to perform TRUSP biopsy.
结局指标
主要结局
Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer]
时间窗: Day 0
Patients will be considered to have clinically significant prostate cancer based on their PI-RADS score 4 or 5. The ability of TRUSP biopsy and cone beam CT guided biopsy to detect any form of prostate cancer as well as clinically significant prostate cancer (defined as prostate cancer with a Gleason score ≥7) will serve as the primary outcome measures.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).(0 Day and at 30 day)
- Tolerability of CT fusion biopsy(Day 0)
研究者
Dr. Jason Izard, Department of Urology
Assistant Professor
Queen's University