Department of Urology, Cochin University Hospital, Paris Descartes University, Paris, France; Inserm Unit U1151, Paris Descartes University, Paris, France.
Rangueil University Hospital, Toulouse, France.
J Urol. 2016 Oct;196(4):1069-75. doi: 10.1016/j.juro.2016.04.003. Epub 2016 Apr 12.
In men with suspicion of prostate cancer the standard of cancer detection is transrectal ultrasound guided 10 to 12-core systematic biopsy. The targeted biopsy only strategy using magnetic resonance imaging-transrectal ultrasound image registration is gaining in popularity. We assessed the noninferiority of targeted vs systematic biopsy.
Between June and October 2014 a total of 108 biopsy naïve patients with prostate specific antigen between 4 and 20 ng/ml, normal rectal examination and a single suspicious image on magnetic resonance imaging were included in study at 7 centers. Patients underwent systematic biopsy by a first operator blinded to magnetic resonance imaging, immediately followed by 3 targeted biopsies within the suspicious image by a second operator. The primary end point was the cancer detection rate. The noninferiority margin was set at -5%. The secondary end points were the detection rate of clinically significant prostate cancer (maximum cancer core length 5 mm or greater for Gleason 6 or any Gleason 7 or greater disease) and procedure duration.
Systematic and targeted biopsies detected cancer in 66 (61.1%) and 61 patients (56.5%), respectively. The mean difference was -4.5% with a 95% CI lower bound of -11.8%. A total of 13 patients with protocol violations were excluded from the per protocol analysis, which showed a mean difference of -5.2% with a 95% CI lower bound of -13.1%. Clinically significant prostate cancer was detected in 50 (46.2%) and 52 patients (48.1%) with systematic and targeted biopsies, respectively (p = 0.69). The mean ± SD duration of image fusion plus targeted biopsy was 16.7 ± 7 minutes vs 7.4 ± 3 for systematic biopsy (p <0.001).
Targeted biopsy seemed to be inferior to systematic biopsy for overall cancer detection. Detection of clinically significant prostate cancer did not differ between targeted and systematic biopsies.
在疑似前列腺癌的男性中，癌症检测的标准是经直肠超声引导 10-12 核系统活检。使用磁共振成像-经直肠超声图像配准的靶向活检策略越来越受欢迎。我们评估了靶向与系统活检的非劣效性。
2014 年 6 月至 10 月期间，共有 108 例前列腺特异性抗原在 4-20ng/ml 之间、直肠检查正常且磁共振成像上只有一个可疑图像的活检初治患者，在 7 个中心参与了这项研究。患者由一名对磁共振成像不知情的第一操作者行系统活检，然后由第二操作者在可疑图像内行 3 次靶向活检。主要终点是癌症检出率。非劣效性边界设定为-5%。次要终点是临床显著前列腺癌（最大癌核心长度为 5mm 或更大的 Gleason 6 或任何 Gleason 7 或更高疾病）的检出率和手术时间。
系统活检和靶向活检分别检出癌症 66（61.1%）和 61 例（56.5%）。平均差异为-4.5%，95%置信区间下限为-11.8%。有 13 例违反方案的患者被排除在方案分析之外，其中平均差异为-5.2%，95%置信区间下限为-13.1%。系统活检和靶向活检分别检出临床显著前列腺癌 50（46.2%）和 52 例（48.1%）（p=0.69）。图像融合加靶向活检的平均+SD 时间为 16.7±7 分钟，而系统活检为 7.4±3 分钟（p<0.001）。
靶向活检在总体癌症检出方面似乎劣于系统活检。靶向和系统活检在检出临床显著前列腺癌方面无差异。
