Background

Multiparametric magnetic resonance imaging (mpMRI) of the prostate has excellent sensitivity in detecting clinically significant prostate cancer (csPCa). Nevertheless, the clinical utility of negative mpMRI (nMRI) is less clear.

Objective

To assess outcomes of men with nMRI and clinical follow-up after 7 yr of activity at a reference center.

Design, setting, and participants

All mpMRI performed from January 2010 to May 2015 were reviewed. We selected all patients with nMRI and divided them in group A (naïve patients) and group B (previous negative biopsy). All patients without a diagnosis of PCa had a minimum follow-up of 2 yr and at least two consecutive nMRI. Patients with positive mpMRI were also identified to assess their biopsy outcomes.

Outcome measurements and statistical analysis

A Kaplan-Meier analysis was performed to assess both any-grade PCa and csPCa diagnosis-free survival probabilities. Univariable and multivariable Cox regression models were fitted to identify predictors of csPCa diagnosis.

Results and limitations

We identified 1545 men with nMRI, and 1255 of them satisfied the inclusion criteria; 659 belonged to group A and 596 to group B. Any-grade PCa and csPCa diagnosis-free survival probabilities after 2 yr of follow-up were 94% and 95%, respectively, in group A; in group B, they were 96%. After 48 mo of follow-up, any-grade PCa diagnosis-free survival probability was 84% in group A and 96% in group B (log rank p < 0.001). Diagnosis-free survival probability for csPCa was unchanged after 48 mo of follow-up. On multivariable Cox regression analysis, increasing age (p = 0.005) was an independent predictor of lower csPCa diagnosis probability, while increasing prostate-specific antigen (PSA) and PSA density (<0.001) independently predicted higher csPCa diagnosis probability. The prevalence of and positive predictive value for csPCa were 31.6% and 45.5%, respectively. Limitations include limited follow-up and the inability to calculate true csPCa prevalence in the study population.

Conclusions

mpMRI is highly reliable to exclude csPCa. Nevertheless, systematic biopsy should be recommended even after nMRI, especially in younger patients with high or raising PSA levels.

Patient summary

It is a matter of debate whether patients with negative multiparametric magnetic resonance imaging (mpMRI) of the prostate could obviate the need to perform a systematic biopsy. In this report, we looked at the outcomes of patients with negative mpMRI and midterm clinical follow-up at a reference center. We found mpMRI to be highly reliable to exclude significant prostate cancer; nonetheless, systematic biopsy must still be recommended after negative mpMRI in patients with high clinical suspicion of prostate cancer.

中文翻译：

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前列腺癌的负多参数磁共振成像：下一步是什么？

背景

前列腺的多参数磁共振成像（mpMRI）在检测具有临床意义的前列腺癌（csPCa）方面具有出色的灵敏度。但是，阴性mpMRI（nMRI）的临床应用尚不清楚。

客观的

评估在参考中心进行了7年活动的nMRI男性患者的临床结局和临床随访情况。

设计，设置和参与者

回顾了从2010年1月至2015年5月进行的所有mpMRI。我们选择了所有nMRI患者，并将其分为A组（初次患者）和B组（先前的阴性活检）。所有未诊断为PCa的患者均至少接受了2年的随访，并至少进行了两次连续的nMRI检查。还确定了mpMRI阳性的患者，以评估其活检结果。

成果测量和统计分析

进行了Kaplan-Meier分析以评估任何等级的PCa和csPCa的无诊断生存率。拟合单变量和多变量Cox回归模型以识别csPCa诊断的预测因子。

结果与局限性

我们鉴定了1545名nMRI男性，其中1255名符合纳入标准。A组为659，A组为596。随访2年后，任何等级的PCa和csPCa的无诊断生存率分别为94％和95％。在B组中，他们占96％。随访48个月后，A组的任何等级PCa的无诊断生存率分别为84％和B组的96％（对数等级p  <0.001）。随访48 mo后，csPCa的无诊断生存率没有变化。在多变量Cox回归分析中，年龄增长（p = 0.005）是较低csPCa诊断可能性的独立预测因子，而增加前列腺特异性抗原（PSA）和PSA密度（<0.001）独立预测较高csPCa诊断可能性。csPCa的患病率和阳性预测值分别为31.6％和45.5％。局限性包括有限的随访以及无法计算研究人群中真正的csPCa患病率。

结论

mpMRI高度可靠地排除了csPCa。但是，即使在进行nMRI检查后，也应建议进行系统活检，尤其是在PSA水平较高或升高的年轻患者中。

病人总结

前列腺多参数磁共振成像（mpMRI）阴性的患者是否可以消除进行系统活检的需要，这是一个有争议的问题。在本报告中，我们在参考中心研究了mpMRI阴性和中期临床随访患者的结局。我们发现mpMRI可以高度可靠地排除重大前列腺癌。然而，对于高度怀疑前列腺癌的患者，在mpMRI阴性后仍必须建议进行系统活检。