Izadpanahi Mohammad-Hossein, Elahian Amirreza, Gholipour Farshad, Khorrami Mohammad-Hatef, Zargham Mahtab, Mohammadi Sichani Mehrdad, Alizadeh Farshid, Khorrami Farbod
Department of Urology, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Urology, Iran University of Medical Sciences, Tehran, Iran.
Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1103-1109. doi: 10.1038/s41391-021-00366-9. Epub 2021 Apr 27.
The combination of MRI-guided targeted biopsy (MRGB) with systematic biopsy (SB) provides the highest accuracy in detecting prostate cancer. There is a controversy over the superiority of fusion targeted biopsy (fus-MRGB) over cognitive targeted biopsy (cog-MRGB). The present head-to-head randomized controlled trial was performed to compare diagnostic yield of fus-MRGB in combination with SB with cog-MRGB in combination with SB.
Biopsy-naive patients with a prostate-specific antigen level between 2 and 10 ng/dL who were candidates for prostate biopsy were included in the study. Multiparametric MRI was performed on all patients and patients with suspicious lesions with Prostate Imaging Reporting and Data System score of 3 or more were randomized into two groups. In the cog-MRGB group, a targeted cognitive biopsy was performed followed by a 12-core SB. Similarly, in the fus-MRGB group, first targeted fusion biopsy and then SBs were performed. The overall and clinically significant prostate cancer detection rates between the two study groups were compared by the Pearson χ test. McNemar test was used to compare detection rates yielded by SB and targeted biopsy in each study group.
One-hundred men in the cog-MRGB group and 99 men in the fus-MRGB group were compared. The baseline characteristics of patients including age, PSA level, prostate volume, PSA density, and clinical stage were similar in the two groups (p > 0.05). Both the overall and clinically significant prostate cancer detection rates in the fus-MRGB group (44.4% and 33.3%, respectively) were significantly higher than cog-MRGB group (31.0% and 19.0%, respectively) (p = 0.035 and p = 0.016, respectively).
The accuracy of identifying overall and clinically significant prostate cancer by fus-MRGB in biopsy-naive patients with PSA levels between 2 and 10 ng/dL is significantly higher than cog-MRGB and if available, we recommend using fus-MRGB over cog-MRGB in these patients.
磁共振成像引导下的靶向活检（MRGB）与系统活检（SB）相结合，在检测前列腺癌方面具有最高的准确性。融合靶向活检（fus-MRGB）与认知靶向活检（cog-MRGB）谁更具优势存在争议。本项头对头随机对照试验旨在比较fus-MRGB联合SB与cog-MRGB联合SB的诊断率。
本研究纳入了前列腺特异性抗原水平在2至10 ng/dL之间、符合前列腺活检条件且未接受过活检的患者。所有患者均接受多参数磁共振成像检查，前列腺影像报告和数据系统（PI-RADS）评分为3分及以上的可疑病变患者被随机分为两组。在cog-MRGB组中，先进行靶向认知活检，然后进行12针系统活检。同样，在fus-MRGB组中，先进行靶向融合活检，然后进行系统活检。采用Pearson χ²检验比较两组的总体及临床显著前列腺癌检出率。采用McNemar检验比较各研究组中系统活检和靶向活检的检出率。
比较了cog-MRGB组的100名男性和fus-MRGB组的99名男性。两组患者的年龄、前列腺特异性抗原水平、前列腺体积、前列腺特异性抗原密度和临床分期等基线特征相似（p > 0.05）。fus-MRGB组的总体及临床显著前列腺癌检出率（分别为44.4%和33.3%）均显著高于cog-MRGB组（分别为31.0%和19.0%）（p分别为0.035和0.016）。
对于前列腺特异性抗原水平在2至10 ng/dL之间、未接受过活检的患者，fus-MRGB识别总体及临床显著前列腺癌的准确性显著高于cog-MRGB。如果条件允许，我们建议在这些患者中使用fus-MRGB而非cog-MRGB。
