BACKGROUND The initial report from the ASIST trial showed little benefit from targeted biopsy for men on active surveillance (AS) for prostate cancer. Data after 2-yr follow-up are now available for analysis. OBJECTIVE To determine if there was a difference in the AS failure rate in a 2-yr follow-up period among men undergoing magnetic resonance imaging (MRI) before initial confirmatory biopsy (CBx) compared to those who did not. DESIGN, SETTING, AND PARTICIPANTS This is the 2-yr post-CBx follow-up for the ASIST trial, a prospective, randomized, multicenter, open-label study for men with Gleason grade group (GG) 1 cancer eligible for AS. Patients were randomized to CBx with 12-core systematic sampling or MRI with systematic and targeted sampling. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Patients with GG ≤ 1 on CBx were followed for 2 yr and had MRI and biopsy at that time point. Patients failed AS if they were no longer under AS because of grade progression, clinical progression, subject choice, clinical judgment, treatment, or lost to follow-up. Clinically significant cancer (CSC) was defined as GG ≥ 2. RESULTS AND LIMITATIONS In total, 259 men underwent CBx, 132 in the non-MRI and 127 in the MRI arm. After biopsy, 101 men in the non-MRI arm (76%) and 98 in the MRI arm (77%) continued AS. There were fewer men with AS failures in the MRI (19/98, 19%) compared to the non-MRI group (35/101, 35%; p =  0.017). At 2-yr biopsy there were fewer men with CSC in the MRI arm (9.9%, 8/81) than in the non-MRI arm (23%, 17/75; p =  0.048). Significant differences in AS failure rates were detected across the three centers in the MRI arm only (4.2% [2/48] vs 17% [4/24] vs 27% [7/26]; p =  0.019). CONCLUSIONS Baseline MRI before CBx during AS results in 50% fewer AS failures and less grade progression over 2 yr. The center where MRI and targeted biopsy is performed may influence AS failure rates. PATIENT SUMMARY The ASIST trial randomized 273 men on active surveillance with low-grade prostate cancer diagnosed within the last year to systematic biopsy or magnetic resonance imaging (MRI) with systematic and targeted biopsy. The initial report showed little benefit from targeted biopsy. However, after 2 yr of follow-up we found that baseline MRI before confirmatory biopsy resulted in 50% fewer failures of surveillance and less progression to higher-grade cancer. This confirms the value of MRI in men on surveillance. This study is registered at ClinicalTrials.gov (NCT01354171).

中文翻译：

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男性活检的系统活检与磁共振成像以及有针对性的全身活检（ASIST）的随机研究：活检后2年随访。

背景技术ASIST试验的最初报告显示，对男性进行前列腺癌主动监测（AS）的靶向活检几乎无济于事。两年随访后的数据现在可用于分析。目的确定在进行首次确诊活检（CBx）之前接受磁共振成像（MRI）的男性与未接受核磁共振成像（MRI）的男性相比，在2年的随访期内AS失败率是否存在差异。设计，地点和参与者这是ASIST试验的CBx随访两年，这是一项针对符合AS资格的Gleason分级组（GG）1男性患者的前瞻性，随机，多中心，开放标签研究。将患者随机分为12核心系统抽样的CBx或具有系统和针对性样本的MRI。结果测量和统计分析随访CBx GG≤1的患者2年，并在该时间点进行MRI和活检。如果患者由于年级进展，临床进展，受试者选择，临床判断，治疗或失去随访而不再接受AS，则AS失败。临床上显着的癌症（CSC）被定义为GG≥2。结果与局限性共有259名男性接受了CBx，非MRI接受了132例，而MRI接受了127例。活检后，非MRI组101例男性（76％）和MRI组98例男性（77％）继续AS。与非MRI组（35 / 101，35％； p = 0.017）相比，MRI中AS失败的男性人数更少（19 / 98，19％）。在第2年活检时，MRI组（9.9％，8/81）的CSC男性少于非MRI组（23％，17/75; p = 0.048）。仅在MRI臂的三个中心之间发现AS失败率有显着差异（4.2％[2/48]对17％[4/24]对27％[7/26]； p = 0.019）。结论AS期间在CBx之前进行基线MRI可以在2年内将AS失败减少50％，并降低等级进展。进行MRI和靶向活检的中心可能会影响AS失败率。患者总结ASIST试验将273名接受了去年诊断为低度前列腺癌的积极监测的男性患者随机分为系统活检或有针对性活检的磁共振成像（MRI）。初步报告显示靶向活检几乎无益处。但是，在随访2年后，我们发现在进行活检确诊之前进行基线MRI检查，可以使监测失败的次数减少50％，并且进展为更高级别的癌症的机会也更少。这证实了MRI对男性进行监视的价值。该研究已在ClinicalTrials.gov（NCT01354171）上注册。