Background and objective

The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis.

Methods

We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0–10) for biopsy-related pain and discomfort during and 7-d after biopsy.

Key findings and limitations

A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference –1.4%; 95% confidence interval [CI] –3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI –6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0–10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d.

Conclusions and clinical implications

Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making.

Patient summary

In this multicenter randomized trial, we compare prostate biopsy infectious complications for the transperineal versus transrectal approach. The absence of infectious complications with transperineal biopsy without the use of preventative antibiotics is noteworthy, but not significantly different from transrectal biopsy with targeted antibiotic prophylaxis.

中文翻译：

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经会阴与经直肠磁共振成像——有针对性的系统性前列腺活检预防感染性并发症：预防随机试验

背景和目标

经直肠活检方法传统上用于检测前列腺癌。历史上，另一种经会阴方法是在全身麻醉下进行，但最近的进展使得经会阴活检可以在局部麻醉下进行。我们试图比较不使用抗生素预防的经会阴活检与使用靶向预防的经直肠活检的感染并发症。

方法

通过一项多中心、随机试验，我们将未接受过活检的参与者分配到接受不使用抗生素预防的经会阴活检，与使用有针对性预防的经直肠活检（直肠培养筛查氟喹诺酮类耐药细菌以及针对培养和敏感性结果的抗生素）。主要结果是通过前瞻性医学审查和 7 天调查的患者报告捕获的活检后感染。次要结局包括癌症检测、非感染性并发症以及活检期间和活检后 7 天与活检相关的疼痛和不适的数字评分量表 (0-10)。

主要发现和局限性

共有 658 名参与者被随机分组​​，其中 0 例经会阴活检感染与 4 例 (1.4%) 经直肠活检感染（差异 –1.4%；95% 置信区间 [CI] –3.2%, 0.3%；p  = 0.059）。其他并发症的发生率非常低且相似。重要的是，临床上显着癌症的检测相似（53% 经会阴 vs 50% 经直肠，调整后差异 2.0%；95% CI –6.0, 10）。经会阴组的参与者经历了更严重的围手术期疼痛（0.6 调整后差异 [0-10 量表]，95% CI 0.2，0.9），但影响很小，并在 7 天后消失。

结论和临床意义

办公室经会阴活检是可以忍受的，不会影响癌症检测，也不会导致感染并发症。具有针对性预防的经直肠活检取得了相似的感染率，但需要直肠培养并仔细注意抗生素的选择和给药。对这些因素和抗生素管理的考虑应指导临床决策。

患者总结

在这项多中心随机试验中，我们比较了经会阴与经直肠方法的前列腺活检感染并发症。值得注意的是，不使用预防性抗生素的经会阴活检没有感染并发症，但与有针对性的抗生素预防的经直肠活检没有显着差异。