Heo Ji Eun, Han Hyun Ho, Jang Won Sik, Ham Won Sik, Han Woong Kyu, Choi Young Deuk, Lee Jongsoo
Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.
Prostate Int. 2025 Jun;13(2):112-115. doi: 10.1016/j.prnil.2024.12.001. Epub 2024 Dec 27.
The necessity of prostate biopsy in patients with a Prostate Imaging-Reporting and Data System (PI-RADS) score below 3 and prostate-specific antigen (PSA) levels of 4-10 ng/ml remains controversial. We tested the diagnostic performance of the free PSA ratio (%fPSA) in detecting clinically significant cancer (CSC) in patients with PI-RADS <3 and PSA ≤10 ng/ml.
We analyzed 1435 prostate biopsies performed by a single operator between April 2018 and January 2023 at a single institution. PSA and free PSA results on the day of biopsy or within 1 month were used, and all biopsies were performed after prostate magnetic resonance imaging (MRI). CSC was defined as Gleason grade group ≥2.
Among 208 men with PI-RADS <3 and PSA ≤10 ng/ml, CSC was detected in 37 (17.8%) patients. The median age was 65 years (interquartile range [IQR] 61-71), with a median PSA level of 5.06 ng/ml (IQR 3.98-7.08) and a median %fPSA of 18.2% (IQR 13.7-22.0). The area under the curve was 0.757 (95% confidence interval, 0.674-0.841), with a %fPSA cutoff of 17.6%, sensitivity of 86.5%, specificity of 63.7%, positive likelihood ratio (LR) of 2.38, and negative LR of 0.21. CSC was diagnosed in 5 out of 114 patients (4%) with %fPSA >17.6%, compared to 32 out of 94 patients (34%) with %fPSA <17.6%.
In patients with PI-RADS <3 and PSA ≤10 ng/ml, %fPSA values < 17.6% may facilitate early prostate cancer diagnosis in those who might not undergo biopsy based on MRI results alone. Additionally, unnecessary biopsies could be avoided in patients with elevated PSA levels when %fPSA exceeds 17.6%.
对于前列腺影像报告和数据系统（PI-RADS）评分低于3且前列腺特异性抗原（PSA）水平为4-10 ng/ml的患者，前列腺活检的必要性仍存在争议。我们测试了游离PSA比值（%fPSA）在检测PI-RADS<3且PSA≤10 ng/ml患者的临床显著癌（CSC）中的诊断性能。
我们分析了2018年4月至2023年1月期间在单一机构由一名操作者进行的1435例前列腺活检。使用活检当天或1个月内的PSA和游离PSA结果，所有活检均在前列腺磁共振成像（MRI）后进行。CSC定义为Gleason分级组≥2。
在208例PI-RADS<3且PSA≤10 ng/ml的男性中，37例（17.8%）患者检测到CSC。中位年龄为65岁（四分位间距[IQR]61-71），中位PSA水平为5.06 ng/ml（IQR 3.98-7.08），中位%fPSA为18.2%（IQR 13.7-22.0）。曲线下面积为0.757（95%置信区间，0.674-0.841），%fPSA临界值为17.6%，敏感性为86.5%，特异性为63.7%，阳性似然比（LR）为2.38，阴性LR为0.21。在114例%fPSA>17.6%的患者中，5例（4%）诊断为CSC，相比之下，在94例%fPSA<17.6%的患者中，32例（34%）诊断为CSC。
在PI-RADS<3且PSA≤10 ng/ml的患者中，%fPSA值<17.6%可能有助于对那些可能仅根据MRI结果不进行活检的患者进行早期前列腺癌诊断。此外，当%fPSA超过17.6%时，PSA水平升高的患者可避免不必要的活检。
