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Abstract：
OBJECTIVE: The goal of this study is to address if detection rates of clinically significant prostate cancer (csPCa) can be increased by additional perilesional biopsies (PB) in magnetic resonance (MR)/ultrasound fusion prostate biopsy in biopsy-naïve men.
METHODS: This prospective, non-randomized, surgeon-blinded study was conducted between February 2020 and July 2022. Patients were included with PSA levels < 20 ng/ml and ≥ one PI-RADS lesion (grades 3-5) per prostate lobe. Prostate biopsy was performed by two urologists. The first performed the MR-fusion biopsy with 3-5 targeted biopsies (TB) and 6 PB in a standardized pattern. The second performed the systematic (12-fold) biopsy (SB) without knowledge of the MR images. Primary outcome of this study is absence or presence of csPCa (≥ ISUP grade 2) comparing TB, PB and SB, using McNemar test.
RESULTS: Analyses were performed for each PI-RADS lesion (n = 218). There was a statistically significant difference in csPC detection rate of TB + SB between PI-RADS 3, 4 and 5 lesions (18.0% vs. 42.5% vs. 82.6%, p < 0.001) and TB + PB (19.7% vs. 29.1% vs. 78.3%). Comparing only maximum ISUP grade per lesion, even SB plus TB plus PB did not detect more csPCa compared to SB plus TB (41.3% vs. 39.9%, p > 0.05).
CONCLUSIONS: We present prospective study data investigating the role of perilesional biopsy in detection of prostate cancer. We detected no statistically significant difference in the detection of csPCa by the addition of PB. Therefore, we recommend continuing 12-fold bilateral SB in addition to TB.
METHODS: This prospective, non-randomized, surgeon-blinded study was conducted between February 2020 and July 2022. Patients were included with PSA levels < 20 ng/ml and ≥ one PI-RADS lesion (grades 3-5) per prostate lobe. Prostate biopsy was performed by two urologists. The first performed the MR-fusion biopsy with 3-5 targeted biopsies (TB) and 6 PB in a standardized pattern. The second performed the systematic (12-fold) biopsy (SB) without knowledge of the MR images. Primary outcome of this study is absence or presence of csPCa (≥ ISUP grade 2) comparing TB, PB and SB, using McNemar test.
RESULTS: Analyses were performed for each PI-RADS lesion (n = 218). There was a statistically significant difference in csPC detection rate of TB + SB between PI-RADS 3, 4 and 5 lesions (18.0% vs. 42.5% vs. 82.6%, p < 0.001) and TB + PB (19.7% vs. 29.1% vs. 78.3%). Comparing only maximum ISUP grade per lesion, even SB plus TB plus PB did not detect more csPCa compared to SB plus TB (41.3% vs. 39.9%, p > 0.05).
CONCLUSIONS: We present prospective study data investigating the role of perilesional biopsy in detection of prostate cancer. We detected no statistically significant difference in the detection of csPCa by the addition of PB. Therefore, we recommend continuing 12-fold bilateral SB in addition to TB.
摘要：
目的：本研究的目的是探讨是否可以通过磁共振（MR）/超声融合前列腺活检中额外的病灶周围活检（PB）来提高临床上有意义的前列腺癌（csPCa）的检出率。
方法：这种前瞻性，非随机化，外科医生致盲研究于2020年2月至2022年7月间进行.患者的PSA水平<20ng/ml，每个前列腺叶≥一个PI-RADS病变（3-5级）。前列腺活检由两名泌尿科医师进行。第一个以标准化模式进行了3-5个靶向活检（TB）和6PB的MR融合活检。第二个人在不了解MR图像的情况下进行了系统（12倍）活检（SB）。本研究的主要结果是缺乏或存在csPCa（≥ISUP2级），比较TB，PB和SB,使用McNemar测试。
结果：对每个PI-RADS病变进行分析（n=218）。PI-RADS3、4和5个病灶中TB+SB的csPC检出率差异有统计学意义(18.0%vs.42.5%vs.82.6%,p<0.001）和TB+PB（19.7%与29.1%vs.78.3%）。仅比较每个病变的最大ISUP等级，与SB加TB相比，即使SB加TB加PB也没有检测到更多的csPCa(41.3%与39.9%,p>0.05)。
结论：我们提供了前瞻性研究数据，调查病灶周围活检在前列腺癌检测中的作用。我们检测到添加PB对csPCa的检测没有统计学上的显著差异。因此,我们建议除结核病外，继续进行12倍的双边SB。
方法：这种前瞻性，非随机化，外科医生致盲研究于2020年2月至2022年7月间进行.患者的PSA水平<20ng/ml，每个前列腺叶≥一个PI-RADS病变（3-5级）。前列腺活检由两名泌尿科医师进行。第一个以标准化模式进行了3-5个靶向活检（TB）和6PB的MR融合活检。第二个人在不了解MR图像的情况下进行了系统（12倍）活检（SB）。本研究的主要结果是缺乏或存在csPCa（≥ISUP2级），比较TB，PB和SB,使用McNemar测试。
结果：对每个PI-RADS病变进行分析（n=218）。PI-RADS3、4和5个病灶中TB+SB的csPC检出率差异有统计学意义(18.0%vs.42.5%vs.82.6%,p<0.001）和TB+PB（19.7%与29.1%vs.78.3%）。仅比较每个病变的最大ISUP等级，与SB加TB相比，即使SB加TB加PB也没有检测到更多的csPCa(41.3%与39.9%,p>0.05)。
结论：我们提供了前瞻性研究数据，调查病灶周围活检在前列腺癌检测中的作用。我们检测到添加PB对csPCa的检测没有统计学上的显著差异。因此,我们建议除结核病外，继续进行12倍的双边SB。
