Novel Biparametric MRI and Targeted Biopsy Improves Risk Stratification in Men With a Clinical Suspicion of Prostate Cancer (IMPROD Trial)
Novel Biparametric MRI and Targeted Biopsy Improves Risk Stratification in Men With a Clinical Suspicion of Prostate Cancer (IMPROD Trial)
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DOI：
10.1002/jmri.25641
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发表时间：
2017-10-01
影响因子：
4.4
通讯作者：
Aronen, Hannu J.
中科院分区：
文献类型：
--
作者：
Jambor, Ivan;Bostrom, Peter J.;Aronen, Hannu J.
目的：评估3 T双参数磁共振成像（bpMRI）、T-2加权成像和三种单独的弥散加权成像采集结合靶向活检（TB）在改善前列腺特异性抗原（PSA）升高男性风险分层中的作用。材料和方法：在2013年3月至2015年2月期间，对175名临床疑似前列腺癌（PCa）的男性进行了bpMRI检查（NCT 01864135）基于怀疑PCa（两次重复PSA测量值范围为2.5- 20.0 ng/ml和/或直肠指检异常）。可疑到高度怀疑PCa的男性使用认知超声引导有两个TB的主要病变，然后进行系统活检（SB）。低至极低怀疑的男性仅患有SB。总共有161例（161/175，92%）前瞻性入组男性完成了试验，并纳入最终分析。试验的主要终点是TB和SB的癌症检出率（CDR），临床显著癌症（SPCa）定义为Gleason评分>= 3+ 4。Gleason评分3+3的CDR较低（8%，15/161 vs. 16%，30/161; P < 0.05）。将活检限制在bpMRI结果不明确到高度可疑的男性中，将导致接受活检的男性数量减少24%（38/161），而SPCa则缺失4例（2%）。所有匿名的数据集，包括bpMRI报告和后续信息，是免费提供的试验server.Conclusion：活检前bpMRI和结核病的男性临床怀疑PCa改善风险分层。
Purpose: To evaluate the role of a 3T biparametric magnetic resonance imaging (bpMRI), T-2-weighted imaging, and three separate diffusion-weighted imaging acquisitions combined with targeted biopsy (TB) for improving risk stratification of men with elevated prostate-specific antigen (PSA).Materials and Methods: Between March 2013 and February 2015, 175 men with a clinical suspicion of prostate cancer (PCa) were offered bpMRI (NCT01864135) based on a suspicion of PCa (two repeated PSA measurements in the range 2.5-20.0ng/ml and/or abnormal digital rectal examination). Men with an equivocal to high suspicion of PCa had two TBs of the dominant lesion using cognitive ultrasound guidance, followed by systematic biopsy (SB). Men with a low to very low suspicion had only SB. In total, 161 (161/175, 92%) prospectively enrolled men completed the trial and were included in the final analyses. The primary endpoint of the trial was the cancer detection rate (CDR) of TB and SB. Clinically significant cancer (SPCa) was defined as Gleason score >= 3+4.Results: TB compared with SB had higher CDR for SPCa (45%, 72/161 vs. 39%, 63/161, respectively; P > 0.05) and a lower CDR for Gleason score 3+3 (8%, 15/161 vs. 16%, 30/161; P < 0.05). Restricting biopsy to men with equivocal to highly suspicious bpMRI findings would have resulted in a 24% (38/161) reduction in the number of men undergoing biopsy, while missing 4 (2%) with SPCa. All anonymized datasets, including bpMRI reports and follow up information, are freely available on the trial server.Conclusion: Prebiopsy bpMRI and TB in men with a clinical suspicion of PCa improved risk stratification.