MRI and Ultrasound Soft Image Fusion Guided Biopsies Compared to Gold Standard Prostate Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cancer detection rate in the two groups
研究概览
简要总结
Background: Prostate biopsies are usually performed due to accidentally discovered elevated prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise documentation concerning the localization of the biopsies are lacking. Therefore, the same locations might be subject to multiple negative biopsies. There is a growing confidence that magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade tumours, and studies have shown value in performing MRI before biopsies. Because image documentation is lacking, it is not possible to know which region actually being biopsied with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a new promising method that will ascertain all regions of the prostate gland to be biopsied, and it is possible to perform accurate targeted biopsies when combined with MRI.
Aims of the study
Compare the biopsy results in the two groups:
- To evaluate the overall rate of positive biopsies.
- To evaluate the rate of re-biopsies.
- To evaluate the detection rate of Gleason grade 4 and 5 tumours.
- To evaluate the rate of positive targeted biopsies.
- To evaluate the rate of positive random biopsies
- To compare targeted and random biopsies between groups.
- To compare patient tolerance, time consumption and cost of the two methods.
- To evaluate the diagnostic accuracy of performing cytological imprints of targeted biopsies.
Material and methods: A prospective randomized study including 300 consecutive patients referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies and image fusion guided biopsy.
All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy will be obtained in case of positive MRI of ultrasound.
详细描述
Biopsy procedures
- Conventional TRUS biopsy procedure (Gold standard). These patients will first undergo 0-6 TRUS targeted biopsies (TRUS TB) (2 targeted biopsies in up to 3 lesions), directed towards lesions suspect of prostate cancer seen on TRUS, or detected by DRE (standard-target). Subsequently, they will undergo a standard random 12 core TRUS guided biopsy procedure. All biopsies will be performed using the Bruel and Kjaer ultrasound unit, type 1846, and transrectal transducer No 8531 (New york, United States). If there for any reason would be desirable to reduce the total number of biopsies, we will omit random biopsies if targeted biopsies already have been taken at that specific site.
Two dedicated urologist, (L. M. E. and G. M.), with special interest and experience in prostate cancer will perform conventional TRUS biopsies according to the protocol, and according to their previous experience. No effort will be done for these two urologists to harmonize their biopsy procedures. 2. 3D image documented biopsy (3D IDB) procedure. These patients will first undergo an MRI examination of the prostate. Possible cancer-suspect areas will be identified and mapped in 3D. MRI findings with high grade of cancer suspicion will be marked as red circles with diameter from 6 to 8 mm. MRI finding compatible with low or intermediate cancer suspicions will be labelled as yellow circles from 6 to 8 mm in the diameter. The circles will be placed in the centre of MRI findings. A few days later the patients will first undergo 0-6 targeted biopsies, directed towards possible lesions detected by MRI, which are transferred (by soft image fusion) to the TRUS images, allowing for TRUS biopsies directed towards lesions detected by MRI, so-called MRI targeted biopsies (MRI TB). These biopsies will be used for additional cytological imprints for evaluation of presence/absence of carcinoma.
Subsequently, they will undergo 12 core random TRUS guided biopsy procedure, using the 3D IDB software and 3D TRUS equipment (3D IDB random). When performing these random biopsies, the MRI findings will not be displayed on the US screen.
One dedicated urologist (E. B.) with substantial experience with the 3D IDB procedure will perform the MRI TB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients without previous biopsies.
- •Men aged < 75 years, in whom it is clinically relevant to decide whether he has prostate cancer.
- •PSA > 3 - 4 ng/ml and < 20 ng/ml.
- •Suspicious findings on DRE or TRUS.
- •Informed consent.
排除标准
- •Patients who refuse to sign the consent form for any reason or do not accept the study premises.
- •Patients who want to withdraw for any reason during the study.
- •Patients with contraindications to MRI (pacemaker, claustrophobia etc.)
- •Patients who have already undergone a high quality MRI examination of the prostate within the last year. In this situation the MRI examination will be evaluated together with the surgeon and radiologist on an individual basis. In case of a low quality examination, we will disregard the findings, and include the patient.
- •An accurate record will be kept of all the excluded patients.
结局指标
主要结局
Cancer detection rate in the two groups
时间窗: Day 1
1. Gold standard TRUS biopsies (random biopsies, targeted and overall) 2. MRI and TRUS fusioned biopsies (random, targeted and overall)
次要结局
- Detection rate of Gleason grade 4 and 5 tumors in the two groups(Day 1)
- Total length of biopsies and cancer involvement for targeted, random and all biopsies in both groups(day 1)
- Patient experience of pain during the biopsy and subjective patients perceptions of durations of the biopsy procedure(day 1)
- Difference in biopsy yield for Urologist 1 and Urologist 2 performing the gold standard biopsies(day 1)
研究者
Erik Rud
Attending radiologist
Oslo University Hospital