Background

Many patients who are on active surveillance (AS) for prostate cancer will have surveillance prostate needle biopsies (PNBs) without any cancer evident.

Objective

To define the association between negative surveillance PNBs and risk of reclassification on AS.

Design, setting, and participants

All men were enrolled in the Canary Prostate Active Surveillance Study (PASS) between 2008 and 2016. Men were included if they had Gleason ≤3 + 4 prostate cancer and <34% core involvement ratio at diagnosis. Men were prescribed surveillance PNBs at 12 and 24 mo after diagnosis and then every 24 mo.

Outcome measurements and statistical analysis

Reclassification was defined as an increase in Gleason grade and/or an increase in the ratio of biopsy cores to cancer to ≥34%. PNB outcomes were defined as follows: (1) no cancer on biopsy, (2) cancer without reclassification, or (3) reclassification. Kaplan–Meier and Cox proportional hazard models were performed to assess the risk of reclassification.

Results and limitations

A total of 657 men met inclusion criteria. On first surveillance PNB, 214 (32%) had no cancer, 282 (43%) had cancer but no reclassification, and 161 (25%) reclassified. Among those who did not reclassify, 313 had a second PNB. On second PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no reclassification, and 54 (17%) reclassified. In a multivariable analysis, significant predictors of decreased future reclassification after the first PNB were no cancer on PNB (hazard ratio [HR] = 0.50, p = 0.008), lower serum prostate-specific antigen, larger prostate size, and lower body mass index. A finding of no cancer on the second PNB was also associated with significantly decreased future reclassification in a multivariable analysis (HR = 0.15, p = 0.003), regardless of the first PNB result. The major limitation of this study is a relatively small number of patients with long-term follow-up.

Conclusions

Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These findings have implications for tailoring AS protocols.

Patient summary

Men on active surveillance for prostate cancer who have a biopsy showing no cancer are at a decreased risk of having worse disease in the future. This may have an impact on how frequently biopsies are required to be performed in the future.

中文翻译：

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无癌症监测活检作为重新分类的预后标志物的作用：金丝雀前列腺主动监测研究的结果

背景

许多接受前列腺癌主动监测 (AS) 的患者将接受前列腺穿刺活检 (PNB) 监测，但没有发现任何癌症迹象。

客观的

定义阴性监测 PNB 与 AS 重新分类风险之间的关联。

设计、设置和参与者

所有男性均在 2008 年至 2016 年期间参加了金丝雀前列腺主动监测研究 (PASS)。如果男性在诊断时患有 Gleason ≤3 + 4 前列腺癌且核心受累率 <34%，则被纳入。男性在诊断后 12 个月和 24 个月接受 PNB 监测，然后每 24 个月接受一次 PNB。

结果测量和统计分析

重新分类被定义为 Gleason 等级增加和/或活检核心与癌症的比率增加至≥34%。PNB 结果定义如下：(1) 活检无癌症，(2) 癌症未重新分类，或 (3) 重新分类。执行 Kaplan–Meier 和 Cox 比例风险模型以评估重新分类的风险。

结果和局限性

共有 657 名男性符合纳入标准。在第一次 PNB 监测中，214 人（32%）没有癌症，282 人（43%）有癌症但没有重新分类，161 人（25%）重新分类。在那些没有重新分类的人中，313 人有第二次 PNB。在第二次 PNB 中，120 人 (38%) 没有癌症，139 人 (44%) 有癌症但没有重新分类，54 人 (17%) 重新分类。在多变量分析中，第一次 PNB 后未来重新分类减少的重要预测因素是 PNB 无癌症（风险比 [HR] = 0.50，p  = 0.008）、较低的血清前列腺特异性抗原、较大的前列腺大小和较低的体重指数. 在多变量分析中，第二次 PNB 未发现癌症也与未来重新分类显着减少有关（HR = 0.15，p = 0.003)，无论第一个 PNB 结果如何。本研究的主要局限性在于长期随访的患者数量相对较少。

结论

接受 PNB 监测但没有癌症证据的男性在 PASS 队列中重新分类为 AS 的可能性要小得多。这些发现对定制 AS 协议有影响。

患者总结

接受前列腺癌主动监测且活检未显示癌症的男性未来患上更严重疾病的风险降低。这可能会影响将来需要进行活检的频率。