Shoji Sunao, Kaya Takatoshi, Tanaka Yumiko, Uemura Kohei, Kusaka Taku, Takahashi Kumpei, Yuzuriha Soichiro, Kano Tatsuo, Hanada Izumi, Umemoto Tatsuya, Ogawa Takahiro, Nakano Mayura, Kawakami Masayoshi, Nitta Masahiro, Hasegawa Masanori, Hashida Kazunobu, Hasebe Terumitsu, Kaneko Tomonori, Okada Jun, Asai Satomi, Miyajima Akira
Department of Urology, Tokai University School of Medicine, Kanagawa, Japan.
Precision Medicine Business Unit, Healthcare Business Headquarters, Konica Minolta, Inc., Tokyo, Japan.
J Urol. 2023 Jan;209(1):187-197. doi: 10.1097/JU.0000000000002958. Epub 2022 Sep 6.
This study aimed to evaluate the usefulness of the LDN-PSA (LacdiNAc-glycosylated-prostate specific antigen) in detecting clinically significant prostate cancer in patients suspected of having clinically significant prostate cancer on multiparametric magnetic resonance imaging.
Patients with prostate specific antigen levels ranging between 3.0 ng/mL and 20 ng/mL and suspicious lesions with PI-RADS (Prostate Imaging-Reporting and Data System) category ≥3 were included prospectively. The LDN-PSA was measured using an automated 2-step Wisteria floribunda agglutinin lectin-anti-prostate specific antigen antibody sandwich immunoassay.
Two hundred four patients were included. Clinically significant prostate cancer was detected in 105 patients. On multivariable logistic regression analysis, prostate specific antigen density (OR 1.61, 010), LDN-PSAD (OR 1.04, 012), highest PI-RADS category (3 vs 4, 5; OR 14.5, 0001), and location of the lesion with highest PI-RADS category (transition zone vs peripheral zone) (OR 0.34, 009) were significant risk factors for detecting clinically significant prostate cancer. Among the patients with the highest PI-RADS category 3 (n=113), clinically significant prostate cancer was detected in 28 patients. On multivariable logistic regression analysis to predict the detection of clinically significant prostate cancer in patients with the highest PI-RADS category 3, age (OR 1.10, 026) and LDN-PSAD (OR 1.07, 0001) were risk factors for detecting clinically significant prostate cancer.
LDN-PSAD would be a biomarker for detecting clinically significant prostate cancer in patients with prostate specific antigen levels ≤20 ng/mL and suspicious lesions with PI-RADS category ≥3. The use of LDN-PSAD as an adjunct to the use of prostate specific antigen levels would avoid unnecessary biopsies in patients with the highest PI-RADS category 3. Multi-institutional studies with large population are recommended.
本研究旨在评估LDN-PSA（乳糖胺糖基化前列腺特异性抗原）在多参数磁共振成像怀疑患有临床显著性前列腺癌的患者中检测临床显著性前列腺癌的效用。
前瞻性纳入前列腺特异性抗原水平在3.0 ng/mL至20 ng/mL之间且PI-RADS（前列腺影像报告和数据系统）类别≥3的可疑病变患者。使用自动化两步紫藤凝集素-抗前列腺特异性抗原抗体夹心免疫测定法测量LDN-PSA。
纳入204例患者。105例患者检测出临床显著性前列腺癌。多变量逻辑回归分析显示，前列腺特异性抗原密度（OR 1.61，0.10）、LDN-PSAD（OR 1.04，0.12）、最高PI-RADS类别（3对比4、5；OR 14.5，0.0001）以及最高PI-RADS类别病变的位置（移行带对比外周带）（OR 0.34，0.009）是检测临床显著性前列腺癌的显著危险因素。在最高PI-RADS类别为3的患者（n = 113）中，28例患者检测出临床显著性前列腺癌。在对最高PI-RADS类别为3的患者预测临床显著性前列腺癌检测的多变量逻辑回归分析中，年龄（OR 1.10，0.026）和LDN-PSAD（OR 1.07，0.0001）是检测临床显著性前列腺癌的危险因素。
LDN-PSAD将成为前列腺特异性抗原水平≤20 ng/mL且PI-RADS类别≥3的可疑病变患者中检测临床显著性前列腺癌的生物标志物。将LDN-PSAD用作前列腺特异性抗原水平的辅助手段可避免最高PI-RADS类别为3的患者进行不必要的活检。建议开展大规模人群的多机构研究。
