Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany,
Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.
Urol Int. 2021;105(5-6):446-452. doi: 10.1159/000513075. Epub 2021 Jan 26.
The risk of occult prostate carcinoma (PCa) after negative multiparametric MRI (mpMRI)-transrectal fusion biopsy (F-Bx) is unknown. To determine the false-negative predictive value, we examined PCa detection after prior negative F-Bx.
Between December 2012 and November 2016, 491 patients with suspected PCa and suspicious mpMRI findings underwent transrectal F-Bx. Patients with benign pathology (n = 191) were eligible for our follow-up (FU) survey. Patient characteristics and clinical parameters were correlated to subsequent findings of newly detected PCa.
Complete FU with a median of 31 (interquartile range: 17-39) months was available for 176/191 (92.2%) patients. Of those, 54 men had either surgical interventions on the prostate or re-Bxs. Newly detected PCa was evident in 14/176 (7.95%) patients stratified to ISUP ≤2 in 10 and ≥3 in 4 cases. The comparison of patients with newly detected PCa to those without cancerous findings in FU showed significant differences in prostate-specific antigen (PSA) density (0.16 vs. 0.13 ng/mL2) and prostate volume (45 vs. 67 mL, both p < 0.05). Both factors are significant predictors for newly detected cancer after initial negative F-Bx.
Only PSA density (>0.13 ng/mL2) and small prostate volume are significant predictors for newly detected PCa after initial negative F-Bx. Despite negative mpMRI/TRUS F-Bx results, patients should be further monitored due to a risk of developing PCa over time. Notwithstanding the limitation of our study that not all patients underwent another Bx, we assume that the false-negative rate is low but existing. Our data represent a real-world scenario.
经多参数磁共振成像（mpMRI）-经直肠融合活检（F-Bx）检查为阴性后的隐匿性前列腺癌（PCa）风险尚不清楚。为了确定假阴性预测值，我们检查了先前阴性 F-Bx 后 PCa 的检出情况。
2012 年 12 月至 2016 年 11 月，491 例疑似前列腺癌且 mpMRI 结果可疑的患者接受了经直肠 F-Bx 检查。良性病理患者（n=191）符合我们的随访（FU）调查。将患者特征和临床参数与随后新检出的 PCa 结果相关联。
191 例患者中，176 例（92.2%）完成了中位时间为 31（四分位间距：17-39）个月的完整 FU。其中，54 例男性接受了前列腺手术或再次 Bx。14/176（7.95%）例患者新检出 PCa，10 例为 ISUP ≤2 级，4 例为 ISUP ≥3 级。与 FU 中无癌症发现的患者相比，新检出 PCa 的患者在前列腺特异性抗原（PSA）密度（0.16 比 0.13 ng/mL2）和前列腺体积（45 比 67 mL，均 p<0.05）方面存在显著差异。这两个因素都是初始阴性 F-Bx 后新发癌症的显著预测因子。
仅 PSA 密度（>0.13 ng/mL2）和小前列腺体积是初始阴性 F-Bx 后新检出 PCa 的显著预测因子。尽管 mpMRI/TRUS F-Bx 结果为阴性，但由于随时间推移发生 PCa 的风险，患者仍应进一步监测。尽管我们的研究存在并非所有患者都接受了另一次 Bx 的局限性，但我们假设假阴性率较低但确实存在。我们的数据代表了实际情况。
