Abstract

Purpose

Active surveillance (AS) strategies for patients with low- and early intermediate-risk prostate cancer are still not consistently defined. Within a controlled randomized trial, active surveillance was compared to other treatment options for patients with prostate cancer. Aim of this analysis was to report on termination rates of patients treated with AS including different grade groups.

Methods

A randomized trial comparing radical prostatectomy, active surveillance, external beam radiotherapy and brachytherapy was performed from 2013 to 2016 and included 345 patients with low- and early intermediate-risk prostate cancer (ISUP grade groups 1 and 2). The trial was prematurely stopped due to slow accrual. A total of 130 patients were treated with active surveillance. Among them, 42 patients were diagnosed with intermediate-risk PCA. Reference pathology and AS quality control were performed throughout.

Results

After a median follow-up time of 18.8 months, 73 out of the 130 patients (56%) terminated active surveillance. Of these, 56 (77%) patients were histologically reclassified at the time of rebiopsy, including 35% and 60% of the grade group 1 and 2 patients, respectively. No patients who underwent radical prostatectomy at the time of reclassification had radical prostatectomy specimens ≥ grade group 3.

Conclusion

In this prospectively analyzed subcohort of patients with AS and conventional staging within a randomized trial, the 2-year histological reclassification rates were higher than those previously reported. Active surveillance may not be based on conventional staging alone, and patients with grade group 2 cancers may be recommended for active surveillance in carefully controlled trials only.

中文翻译：

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低危和早期中危前列腺癌主动监测患者的终止率和组织学重新分类：PREFERE 试验的结果

摘要

目的

针对低危和早期中危前列腺癌患者的主动监测 (AS) 策略仍未得到一致定义。在一项随机对照试验中，将主动监测与前列腺癌患者的其他治疗方案进行了比较。该分析的目的是报告接受 AS 治疗的患者（包括不同级别组）的终止率。

方法

2013 年至 2016 年进行了一项比较根治性前列腺切除术、主动监测、外照射放疗和近距离放疗的随机试验，纳入了 345 名低危和早期中危前列腺癌患者（ISUP 级别组 1 和 2）。由于累积缓慢，试验提前终止。共有 130 名患者接受了主动监测治疗。其中，42例患者被诊断为中危PCA。自始至终都进行了参考病理学和 AS 质量控制。

结果

在 18.8 个月的中位随访时间后，130 名患者中有 73 名 (56%) 终止了主动监测。其中，56 名 (77%) 患者在再次活检时进行了组织学重新分类，分别包括 1 级和 2 级患者的 35% 和 60%。在重新分类时接受根治性前列腺切除术的患者均无根治性前列腺切除术标本≥ 3 级。

结论

在随机试验中对 AS 和常规分期患者进行前瞻性分析的亚队列中，2 年组织学重新分类率高于先前报告的那些。主动监测可能不仅仅基于传统的分期，仅在仔细对照的试验中，可能会推荐 2 级癌症患者进行主动监测。