Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer

 描述（由申请人提供）：测试假设，即靶向活检是比传统盲检更好的检测潜在致死性前列腺癌的方法，是一个主要的未满足需求，也是本提案的主题。美国每年进行100万次前列腺活检，估计99%的活检程序采用自20世纪80年代以来几乎没有变化的方法。这种已有30年历史的超声引导活检方法通常不允许肿瘤靶向，因此导致严重的双重问题：过度检测不重要的癌症和检测不足的潜在致命癌症。我们和其他人发现，靶向前列腺活检似乎有助于纠正这两个问题，但迄今为止的所有报告基本上是试点研究或比较，动力不足或缺乏足够的控制。我们的目标是在II期临床试验中测试这一假设，这将允许直接比较传统的超声引导活检与两种形式的靶向活检。疑似前列腺癌（T1 c）的未经活检的男性在活检前将接受多参数MRI（mpMRI）。然后，具有可疑MR发现（PI-RADS >3）的每个患者将作为他自己的对照，进行三种类型的活检：首先是超声引导的系统采样，然后是在放射学指导下的视觉靶向（认知），然后是使用MRI-超声融合靶向（MRI-超声融合靶向）。 阿耳忒弥斯装置主要结果是检测到Gleason评分>7的癌症，以单个活检芯中癌症累及的mm测量。该试验采用基于过去5年在UCLA进行的靶向活检程序的广泛内部数据的功效估计。尚未进行过此类具有充分把握度和受控性的试验。比较两种靶向方法是试验的次要目的，这一点很重要，因为认知活检比器械融合活检更便宜，也更快。然而，认知活检不允许活检部位跟踪，器械融合活检也是如此，并且似乎不太精确。因此，建立两种方法的相对值具有重要的临床和经济意义。限制频谱成像（RSI）的价值，扩散加权成像的分析补充，也将进行研究。RSI已被广泛用于诊断脑肿瘤，最近已被证明可以增加MRI-前列腺切除术相关性中前列腺癌检测的灵敏度和特异性。我们的目标是进一步的早期研究RSI的初步探索这一创新的男性接受前列腺活检。我们预计，靶向活检将显示出比常规活检更高的Gleason >7癌症的检出率。如果这是真的，那么前列腺癌的诊断、治疗和积极监测随访的途径将发生重大变化。前列腺活检将变得比今天更加合理，并且需要更少的程序来做出正确的诊断。如果这一假设得到证实，新方法的价值将获得1级证据，并为确定的III期试验奠定基础。

 DESCRIPTION (provided by applicant): Testing the hypothesis, that targeted biopsy is a better way to detect potentially lethal prostate cancer than conventional blind biopsy, is a major unmet need and the subject of this proposal. One million prostate biopsies are performed annually in the U.S. An estimated 99% of the biopsy procedures employ a method little changed since the 1980s. That 30-year old ultrasound-guided biopsy method does not usually allow tumor- targeting, and thus results in the serious dual problem of over-detection of insignificant cancers and under- detection of potentially lethal cancers. We and others have found that targeted prostate biopsy appears to help rectify both problems, but all reports to date are essentially pilot studies or comparisons which are underpowered or lack adequate controls. We aim to test that hypothesis in a Phase II clinical trial, which would allow direct comparison of conventional ultrasound-guided biopsy with two forms of targeted biopsy. Biopsy naïve men suspected of prostate cancer (T1c) would undergo a multiparametric MRI (mpMRI) prior to biopsy. Each patient with a suspicious MR finding (PI-RADS >3) would then serve as his own control, undergoing three types of biopsy: first an ultrasound- guided systematic sampling, then visual targeting (cognitive) under radiologic direction, then MRI-ultrasound fusion targeting using the Artemis device. Primary outcome is detection of cancers of Gleason Score >7, measured in mm of cancer involvement in individual biopsy cores. The trial employs power estimates based on extensive in-house data from targeted biopsy procedures performed over the past 5 years at UCLA. No such trial, which has been adequately powered and controlled, has yet been performed. Comparing the two methods of targeting, a secondary aim in the trial, is important, since cognitive biopsy is less expensive and somewhat quicker than device-fusion biopsy. However, cognitive biopsy does not permit biopsy site tracking, as does device-fusion biopsy, and appears less precise. Therefore, establishing the relative value of the two methods has great practical importance, both clinically and economically. The value of Restriction Spectrum Imaging (RSI), an analytic supplement to diffusion-weighted imaging, will also be studied. RSI has been used extensively to diagnose brain tumors and has recently been shown to add sensitivity and specificity to prostate cancer detection in MRI-prostatectomy correlations. We aim to further the early studies of RSI with an initial exploration of this innovation in men undergoing prostate biopsy. We anticipate that targeted biopsy will show a higher detection rate of Gleason >7 cancers than conventional biopsy. If true, the basis for a major change in the path to prostate cancer diagnosis, treatment, and active surveillance follow-up could be established. Prostate biopsy would become more rational than it is today, and fewer procedures would be required to reach a correct diagnosis. If the hypothesis is confirmed, the value of the new method would gain Level 1 evidence, and the basis for a definitive Phase III trial would be established.