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临床试验/NCT02138760
NCT02138760Unknown不适用

Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior Negative Prostate Biopsy

Kaiser Permanente4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
4
主要终点
Prostate cancer detection rate

研究概览

简要总结

Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy have a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance imaging (mpMRI) is an imaging test that may improve prostate cancer detection rates in this population of men. In this prospective randomized trial multicenter trial the investigators will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared with the addition of either a computer targeted system (UroNav - InVivo corp) to sample suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of these areas and systematic biopsy alone.

详细描述

Prostate cancer (PC) is the second most common cancer in men in the United States, affecting approximately 250,000 men per year. With the advent of the prostate specific antigen (PSA) blood test, PC has undergone downward stage migration resulting in earlier cancer detection. In the pre-PSA era, tumors presented with advanced stage which were often visible on transrectal ultrasound. In the modern era, tumors more often are microscopic and not apparent on ultrasound imaging which creates a diagnostic challenge in which biopsy is essentially blind. As a result, many tumors are missed resulting in subsequent biopsies, tumor progression, and decreased cancer-specific survival due to delayed diagnosis.

Multiparametric magnetic resonance imaging (mpMRI) of the prostate has now become the preferred imaging modality to visualize prostate tumors radiographically. mpMRI has become increasing utilized for targeting tumor suspicious areas in the prostate in men with prior negative conventional systematic biopsy. Numerous studies have shown MRI targeted biopsy results in detection of cancer in this subset of men in approximately 30-60% of patients (refs). In addition, MRI detects a higher number of aggressive prostate cancers which would require treatment.

Several methods of incorporating MRI into biopsy targeting have been tested: 1) in gantry/in bore MRI biopsy 2) Robotic biopsy (Artemis) 3) UroNav ultrasound-MR fusion biopsy. The first two techniques are cumbersome and difficult to use in clinical practice. The latter technology is the most widely utilized, user and patient friendly technique. UroNav utilizes a work-station which imports the MRI and then co-registers (fuses) it with real time ultrasound; the ultrasound transducer communicates with an electromagnetic received above the patient to allow the work-station/computer to target suspicious MRI lesions to guide the users needle to the appropriate 3-dimensional location. Data has shown this to be more effective than either systematic biopsy or free-MRI guided biopsy.

The goal of the present study is to compare head-to-head systematic biopsy + freehand MRI targeted biopsy vs systematic biopsy + UroNav targeted in men with elevated PSA and prior negative systematic biopsy.

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

年龄范围
30 Years 至 79 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • PSA > 2.5 ng/ml (ages 30-50) or PSA > 4.0 ages (50-79)
  • Patients with prior negative prostate biopsy
  • Written informed consent
  • Age > 30

排除标准

  • Prior diagnosis of prostate cancer
  • No contraindication to MRI or prostate biopsy (e.g. coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies, anatomical contraindications)
  • Active urinary tract infection or indwelling catheter
  • Prior pelvic irradiation
  • Prior androgen deprivation hormonal therapy
  • Prostate surgery (e.g. prostate biopsy, transurethral prostate procedure) within 8 weeks prior to mpMRI.
  • Contraindication to MRI (extreme claustrophobia, metallic implants incompatible with MRI)

结局指标

主要结局

Prostate cancer detection rate

时间窗: 1 week after biopsy

Prostate cancer detection rate between MRI guided free hand biopsy and UroNav targeted biopsy

次要结局

  • Clinically significant prostate cancer detection rate(1 week after biopsy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David S Finley, MD

Director of Robotic Surgery

Kaiser Permanente

研究点 (4)

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