Stephan Carsten, Stroebel Greta, Heinau Marc, Lenz Andre, Roemer Andreas, Lein Michael, Schnorr Dietmar, Loening Stefan A, Jung Klaus
Department of Urology, University Hospital Charité Berlin, Berlin, Germany.
Cancer. 2005 Sep 1;104(5):993-1003. doi: 10.1002/cncr.21267.
The objective of this study was to evaluate the prostate specific antigen (PSA) density (PSAD) (the quotient of PSA and prostate volume) compared with the percent free PSA (%fPSA) in different total PSA (tPSA) ranges from 2 ng/mL to 20 ng/mL. Possible cut-off levels depending on the tPSA should be established.
In total, 1809 men with no pretreatment of the prostate were enrolled between 1996 and 2004. Total and free PSA were measured with the IMMULITE PSA and Free PSA kits (Diagnostic Products, Los Angeles, CA). Prostate volume was determined by transrectal ultrasound. The diagnostic validity of tPSA, %fPSA, and PSAD was evaluated by receiver operation characteristic (ROC) curve analysis.
The PSAD differed significantly (P < 0.0001) between patients with prostate carcinoma and patients with benign prostatic hyperplasia in all analyzed ranges of tPSA and prostate volume. At the 90% and 95% sensitivity levels and regarding the area under the ROC curve (AUC) within the tPSA range of 2-4 ng/mL, The PSAD was significantly better than tPSA and %fPSA. Within the tPSA range of 4-10 ng/mL, the PSAD did not perform better than %fPSA.
PSAD showed a better performance than %fPSA at tPSA concentrations < 4 ng/mL for detecting prostate carcinoma, with a significantly larger AUC for PSAD (0.739) compared with %fPSA (0.667). PSAD did not perform better than %fPSA when the tPSA range of 4-10 ng/mL was analyzed. Different PSAD cut-off values of 0.05 at tPSA 2-4 ng/mL, 0.1 at tPSA 4-10 ng/mL, and 0.19 at 10-20 ng/mL were necessary to reach 95% sensitivity.
本研究的目的是评估在总前列腺特异性抗原（tPSA）范围为2 ng/mL至20 ng/mL时，前列腺特异性抗原密度（PSAD）（PSA与前列腺体积的商）与游离PSA百分比（%fPSA）相比的情况。应根据tPSA确定可能的临界值水平。
1996年至2004年期间，共纳入1809例未经前列腺预处理的男性。使用IMMULITE PSA和游离PSA检测试剂盒（Diagnostic Products，洛杉矶，加利福尼亚州）测量总PSA和游离PSA。通过经直肠超声测定前列腺体积。通过受试者操作特征（ROC）曲线分析评估tPSA、%fPSA和PSAD的诊断有效性。
在所有分析的tPSA和前列腺体积范围内，前列腺癌患者和良性前列腺增生患者的PSAD差异显著（P < 0.0001）。在90%和95%的灵敏度水平以及tPSA范围为2 - 4 ng/mL时的ROC曲线下面积（AUC）方面，PSAD显著优于tPSA和%fPSA。在tPSA范围为4 - 10 ng/mL时，PSAD的表现并不优于%fPSA。
在tPSA浓度< 4 ng/mL时，PSAD在检测前列腺癌方面的表现优于%fPSA，PSAD的AUC（0.739）显著大于%fPSA（0.667）。在分析tPSA范围为4 - 10 ng/mL时，PSAD的表现并不优于%fPSA。要达到95%的灵敏度，在tPSA为2 - 4 ng/mL时，PSAD的临界值为0.05；在tPSA为4 - 10 ng/mL时，临界值为0.1；在tPSA为10 - 20 ng/mL时，临界值为0.19。
