Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer

 描述(申请人提供)：验证这样一个假设，即靶向活检是检测潜在致命前列腺癌的一种比传统盲检更好的方法，这是一个主要的未得到满足的需求，也是这项提案的主题。在美国，每年有100万例前列腺活检。据估计，99%的活检程序使用的方法自上世纪80年代以来几乎没有变化。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，因此导致了对微不足道的癌症的过度检测和对潜在致命癌症的检测不足的严重双重问题。我们和其他人发现，定向前列腺活检似乎有助于纠正这两个问题，但到目前为止的所有报告基本上都是试验性研究或比较，动力不足或缺乏足够的控制。我们的目标是在第二阶段临床试验中验证这一假设，这将允许传统的超声引导活检与两种形式的靶向活检进行直接比较。疑似前列腺癌(T1c)的幼稚男性在活检前将接受多参数磁共振成像(MpMRI)。然后，每个MR发现可疑(PI-RADS&GT；3)的患者将作为自己的对照，接受三种类型的活检：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定位(认知)，然后是使用 阿耳特弥斯装置。主要结果是发现Gleason Score&gt；7级的癌症，以个体活检核心中肿瘤受累的毫米为单位。这项试验使用了基于加州大学洛杉矶分校过去5年进行的靶向活检程序的大量内部数据的功率估计。还没有进行过这样的试验，这种试验已经得到了足够的动力和控制。比较两种靶向方法是试验中的次要目标，因为认知活组织检查比设备融合活组织检查成本更低，速度也更快。然而，认知活检不允许像设备融合活检一样跟踪活检部位，而且看起来不那么精确。因此，确定两种方法的相对值具有重要的临床意义和经济意义。此外，还将研究限制谱成像(RSI)的价值，它是扩散加权成像的分析性补充。RSI已被广泛用于诊断脑肿瘤，最近被证明在MRI-前列腺切除术的相关性中增加了前列腺癌检测的敏感性和特异性。我们的目标是通过在接受前列腺活检的男性中初步探索这一创新来进一步开展RSI的早期研究。我们预计，与常规活检相比，靶向活检将显示出更高的Gleason&GT；7癌症的检测率。如果是真的，前列腺癌诊断、治疗和积极监测随访的道路上的重大变化的基础可以建立起来。前列腺活检将变得比今天更合理，需要更少的程序就可以得出正确的诊断。如果这一假设得到证实，新方法的价值将获得1级证据，并为最终的第三阶段试验奠定基础。

 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.