前列腺癌预测新模型的建立及其评估

目的:联合应用血清总前列腺特异性抗原(tPSA),游离前列腺特异性抗原(fPSA)及结合前列腺特异性抗原(cPSA),构建出新的前列腺癌(PCa)预测模型:tPSA/fPSA×cPSA1/2,即前列腺癌预测因子(PCP),进而评估PCP诊断PCa的临床应用价值。方法:从我院2011年12月1日~2014年12月1日期间的病例中,筛选出拥有明确病理报告且术前血清前列腺特异性抗原(PSA)检查结果满足2≤tPSA10ng/ml的PCa患者54例,BPH患者579例;满足10≤tPSA20ng/ml的PCa患者48例,BPH患者147例。应用Logestic regression及ROC曲线对比分析tPSA、fPSA、fPSA与tPSA的比值(f/tPSA)、cPSA及PCP诊断PCa的价值,应用列线图分析PCP预测PCa的能力。结果:在PCa及BPH两组间,tPSA、f/tPSA、cPSA与PCP的中位数(9.2,5.5;0.13,0.19;8.0,4.4;22.1,11.0)均存在明显差异(P0.000)。当2≤tPSA10ng/ml时:PCP的ROC曲线下面积(AUC)为0.680,明显高于tPSA的0.588、fPSA的0.571、f/tPSA的0.675、cPSA的0.613;在诊断PCa的敏感性均为90.7%左右的前提下,PCP诊断PCa的特异性为22.8%,明显高于tPSA的11.1%、fPSA的11.2%、f/tPSA的17.4%、cPSA的15.5%。当10≤tPSA20ng/ml时:PCP的ROC曲线下面积为0.686,明显高于tPSA的0.603、fPSA的0.643、f/tPSA的0.679、cPSA的0.647;在诊断PCa的敏感性均为91%左右的前提下,PCP诊断PCa的特异性为29.3%,明显高于tPSA的10.9%、fPSA的10.2%、f/tPSA的23.1%、cPSA的18.4%。结论:当2≤tPSA10ng/ml或10≤tPSA20ng/ml时,PCP明显较PSA、fPSA、f/tPSA、cPSA对PCa更具预测价值。     

ROC曲线分析比较tPSA、fPSA／tPSA和PSAD在PSA灰区前列腺癌诊断中的价值

目的 ROC曲线分析探讨前列腺特异性抗原密度(PSAD)、总PSA(tPSA)和游离PSA/总PSA(fPSA/tPSA)3者在PSA灰区前列腺癌(PCa)中的临床诊断价值.方法 同顾性分析tPSA在4～10ng/ml之间的前列腺增生(BPH)患者75例和前列腺癌患者31例.化学发光法测定血清tPSA和fPSA,经直肠超声(TRUS)测定前列腺体积,计算fPSA/tPSA和PSAD.比较BPH组和PCa组间tPSA、PSAD和fPSA/tPSA各指标的差异,分析各指标在ROC曲线卜的面积、各指标的诊断特异性及敏感性.结果 PCa组与BPH组tPSA差异无统计学意义(P＞0.05),PCa组fPSA/tPSA比值较BPH组降低(P＜0.01),PSAD值较BPH组升高(P＜0.05).ROC曲线下的面积从大到小为fPSA/tPSA＞PSAD＞tPSA.在诊断敏感性相同的情况下,fPSA/tPSA比值诊断特异性高于PSAD的诊断特异性.当fPSA/tPSA临界值取0.16时,诊断前列腺癌的灵敏度和特异性为67.7%和79.7%,PSAD临界值取0.12时,其灵敏度和特异性为61.3%和62.7%.结论 当tPSA在诊断灰区时,PSAD和fPSA/tPSA可以提高前列腺癌的诊断特异性和敏感性,fPSA/tPSA较PSAD有更高的诊断价值.     

f/tPSA比值对tPSA值为2.6～4.0ng/ml前列腺癌的诊断意义

目的探讨利用血清游离前列腺特异性抗原(fPSA)和总前列腺特异性抗原(tPSA)的比值(f/tPSA),提高tPSA2.6～4.0ng/ml前列腺癌的诊断率的价值。方法对117例tPSA在2.6～4ng/ml可疑前列腺癌患者行直肠B超引导下前列腺穿刺活检,对患者血清tPSA,fPSA及f/t PSA值及其他临床病理资料进行统计学分析。结果经病理诊断良性前列腺增生(BPH)82例和前列腺癌35例,35例癌中Gleason score≤4分共6例(17%),Gleason score5-7分和8-10分别为22例(63%)和7例(20%)。前列腺癌的f/tPSA明显高于BPH(P＜0.01),以f/tPSA0.22为界值,诊断癌的特异性为83%,敏感性为71%,阳性预测值为68%。结论f/t PSA作为一项辅助检查可提高tPSA 2.6～4.0ng/ml前列腺癌的诊断率。     

前列腺特异抗原对前列腺癌诊断和疗效监测的价值探讨

目的 探讨前列腺特异抗原(tPSA)、游离PSA(fPSA)以及fPSA/tPSA在前列腺癌(PCa)诊断和疗效监测中的临床价值。方法 采用全自动化学发光免疫分析仪测定36例正常人、42例前列腺增生(BPH)和44例前列腺癌患者tPSA、fPSA,并计算fPSA/tPSA比值。同时,对29例前列腺癌患者术后tPSA、fPSA进行动态监测。结果 fPSA/tPSA对PCa诊断的特异性为88.1％,诊断指数为0.79,显著高于单独tPSA(P<0.05)。结论 fPSA/tPSA的引入提高了对PCa诊断的特异性,动态监测是提示肿瘤是否转移与复发最理想的指标。     

血清结合PSA对前列腺疾病诊断价值的探讨

目的 :探讨血清中结合前列腺特异性抗原 (cPSA)在前列腺癌 (PCa)诊断中的临床价值。　方法 :用磁微粒子免疫化学发光法测定 110例良性前列腺增生 (BPH)病人和 78例PCa病人cPSA、tPSA ,并计算cPSA/tPSA比值。　结果 :cPSA及cPSA/tPSA比值可有效地区分BPH和PCa(P <0 .0 0 5 ) ,尤其是在诊断灰值区 (tPSA为 4～10 μg/L)时效果更显著。在以tPSA≤10 .0 μg/L和cPSA/tPSA≥0 .78为筛选界值联合对PCa进行筛选时 ,临床概率敏感度为 97.8%,特异性为 95 .8%,阴性预示值为 81.9%,阳性预示值为 96 .5 %。　结论 :cPSA的引入及cPSA/tPSA比值的应用 ,对PCa的诊断具有重要临床意义 ,尤其是在tPSA的诊断灰值区。     

前列腺特异性抗原与前列腺结节增生病理类型的关系

目的 探讨前列腺特异性抗原（PSA）与前列腺结节增生病理类型的关系。方法 对210例经临床和病理确诊为良性前列腺增生（BPH）的患者资料作回顾性研究。结果 本组间质结节18例（9％）、腺肌性结节59例（28％）、纤维腺瘤性结节12例（6％）、腺性结节39例（19％）、混合结节82例（39％）。5组间总PSA（tPSA）、游离PSA（fPSA）差异均有统计学意义（P〈0．05），而％fPSA差异无统计学意义（P〉0．05）。若按腺体增生为主和间质增生为主两类比较，tPSA和fPSA差异有统计学意义（P〈0．05），％fPSA差异无统计学意义（P〉0．05）。多元线性回归分析发现，tPSA是5种病理结节类型最相关的指标，通过ROC曲线（受试者工作曲线）确定敏感指标的界值tPSA≥2．5ng／ml，敏感性为96％，特异性为20％，ROC曲线下面积为0．61，如果组合fPSA≥0．5ng／ml和tPSA≥2．5ng／ml，敏感性为100％，特异性为67％，ROC曲线下面积为0．91（P〈0．001）。结论 组合tPSA与fPSA可提示前列腺结节增生病理类型，对临床药物选择具有指导意义。     

血清PSA、游离PSA与良性前列腺增生临床的相关性研究

目的分析血清前列腺特异性抗原(PSA)及游离前列腺特异性抗原(fPSA)与良性前列腺增生(BPH)临床的相关性。方法应用化学发光微粒子免疫分析法(CMIA)对BPH患者血清PSA、fPSA进行检测。结果入选的40例患者病理均为BPH。PSA>4ng/ml者,术后随访1～3个月,平均2.5个月,PSA值均降至0.02ng/ml以下,可除外前列腺癌(PCa)病例。PSA<4ng/ml者16例(40%),4～10ng/ml者14例(35%),>10ng/ml者10例(25%);fPSA>0.934ng/ml者22例(55%)。血清PSA、fPSA水平与前列腺总体积(PV)、前列腺移行区体积(TZV)、年龄及国际前列腺症状评分(IPSS)呈正相关。结论本组血清fPSA与PV、TZV、年龄、IPSS评分有更强相关性。BPH患者血清PSA、fPSA水平升高的相关因素与前列腺总体积及移行区增大、高龄及高IPSS评分有关。     

游离前列腺特异性抗原密度对前列腺穿刺活检结果的预测价值

目的:探讨血清游离前列腺特异性抗原密度(fPSAD)预测前列腺穿刺活检结果的价值。方法:回顾性分析2017年1月—2020年1月我院行经直肠前列腺穿刺活检术患者的临床资料,收集患者一般情况和入院时血清总前列腺特异性抗原(tPSA)及游离前列腺特异性抗原(fPSA)的水平,超声或MRI测量患者前列腺三横径的大小。利用Excel软件计算出fPSA/tPSA、前列腺体积、PSAD和fPSAD,再采用IBM SPSS Statistics 22软件绘制游离PSA密度诊断前列腺癌的ROC曲线,通过曲线确定游离PSA密度诊断前列腺癌的最佳临界值,再使用卡方检验,从敏感度、特异度、约登指数、诊断符合率及Kappa值等方面比较tPSA、fPSA/tPSA、PSAD及fPSAD诊断前列腺癌的能力,评价fPSAD的水平对前列腺穿刺活检患者结果的预测价值。结果:本研究共纳入符合标准的患者394例,其中前列腺癌144例(36.5%),前列腺增生250例(63.5%)。fPSAD诊断前列腺癌的ROC曲线下面积为0.848,最佳临界值为fPSAD=0.06,此临界值的灵敏度为(75.7%)、特异度为(89.6%)、约登指数(0.653)和诊断符合率为(84.5%)。tPSA、fPSA/tPSA、PSAD及fPSAD诊断前列腺癌的Kappa值分别为0.034、0.207、0.231和0.662。当PSA≤4 ng/mL、4 ng/mLPSA≤10 ng/mL及PSA10 ng/mL时前列腺癌的发生率分别为11.8%、12.5%和47.3%,fPSAD预测前列腺活检结果的诊断符合率分别为82.4%、87.5%和83.5%。结论:当临界值为0.06时,fPSAD预测前列腺穿刺活检结果的准确性优于tPSA、fPSA/tPSA和PSAD,是前列腺癌诊断和预测穿刺结果的最佳工具。     

良性前列腺增生病人血清不同类别PSA的检测与分析

目的 :分析前列腺增生 (BPH)病人血清中不同前列腺特异抗原 (PSA)的稳定性 ,探讨其在前列腺疾病诊断中的应用价值。　方法 :将病理诊断证实的 1 0 5例BPH病人按总PSA(tPSA)水平分为 3组 :A组 (tPSA <4μg/L)67例 ,B组 (tPSA值 4～ 1 0 μg/L) 2 6例 ,C组 (tPSA >1 0 μg/L) 1 2例。按年龄分为 3组 :a组 (≤ 55岁 ) 1 8例 ,b组 (56～ 69岁 ) 33例 ,c组 (≥ 70岁 ) 54例。采用Bayer磁微粒化学发光免疫方法 ,测定各组BPH病人血清中的复合PSA(cPSA)、tPSA、游离PSA(fPSA) ,并计算cPSA/tPSA、fPSA/tPSA、fPSA/cPSA比值 ,比较它们在不同年龄和tPSA水平组间的稳定性。　结果 :无论在不同的tPSA水平组 ,还是在不同的年龄组 ,cPSA/tPSA比值和fPSA/tPSA、fP SA/cPSA比值比其它各种PSA更稳定。　结论 :cPSA/tPSA比值和fPSA/tPSA、fPSA/cPSA比值在前列腺疾病的诊断中可能更具有应用价值     

游离PSA与总PSA比值在前列腺癌鉴别诊断中的意义

目的　探讨游离前列腺特异性抗原 (fPSA)与总前列腺特异性抗原 (tPSA)比值 (f tPSA)在tPSA为 4～ 10ng ml时对前列腺癌和良性前列腺增生 (BPH)鉴别的意义及其局限性。方法　对1998年 10月至 2 0 0 2年 10月接受诊治的 180例血清tPSA为 4～ 10ng ml的前列腺癌和BPH患者进行回顾性分析。经组织学证实 ,36例 (2 0 % )是前列腺癌 ,14 4例 (80 % )是BPH。血清中tPSA和fPSA通过酶免微粒子捕捉法测定。前列腺体积通过经腹壁超声测定。前列腺癌与BPH组间比较用t检验。采用Pearson相关系数分析前列腺体积与f tPSA之间的相关性。结果　前列腺癌患者的tPSA、f tPSA平均值分别是 6 75ng ml与 0 17;BPH患者则是 6 4 8ng ml和 0 2 5。两组患者的tPSA差异无显著意义 (P >0 0 5 ) ,而前列腺癌患者的f tPSA值显著低于BPH患者 (P <0 0 1)。此外 ,两组患者的前列腺体积与f tPSA均呈显著正相关 (前列腺癌组相关系数r=0 5 0 ,P <0 0 1;BPH组r=0 2 4 ,P <0 0 1)。在前列腺体积小于 4 0cm3,两组患者的f tPSA差异有显著意义 (P <0 0 5 ) ,当体积超过 4 0cm3,则差异无显著意义 (P >0 0 5 )。结论　f tPSA对tPSA在 4～ 10ng ml之间的前列腺癌和BPH的鉴别诊断有重要意义 ,但由于受前列腺体积的影响 ,只有在     

f/t PSA比值、PSA密度、PSA移行带密度在tPSA灰区前列腺偶发癌诊断中的意义

【摘要】 目的： 探讨血清f/t PSA比值、PSA密度、PSA移行带密度在tPSA位于灰区时前列腺癌诊断中的意义。方法： tPSA位于4～10ng/ml的前列腺增生患者112例,术前经前列腺穿刺活检均证实为前列腺增生,行TURP术后病理证实21例为前列腺偶发癌患者。回顾性分析该21例前列腺偶发癌患者和其余前列腺增生患者间的血清f/t PSA比值、PSA密度、PSA移行带密度,并进行统计学分析,以了解其在tPSA灰区前列腺偶发癌诊断中的意义。结果：前列腺偶发癌组和BPH组血清f/t PSA比值分别为0.13±0.03、0.21±0.04;PSAD分别为0.20±0.05 ng/ml2 、0.12±0.04 ng/ml2;PSATZ分别为0.38±0.06 ng/ml2 、 0.21±0.05 ng/ml2;两组在以上三个检测指标上差异具有显著性(P<0.05)。以0.15 ng/ml2为截断点则PSAD 灵敏性为76.115%,特异性为69.146%;以0.35 ng/ml2为截断点则PSATZ 灵敏性为60.642%,特异性为93.943%。结论：f/t PSA比值、PSAD、PSATZ对前列腺偶发癌的诊断具有重要价值,其中尤以PSATZ更具预测价值。     

Comparisons of the various combinations of free, complexed, and total prostate-specific antigen for the detection of prostate cancer

OBJECTIVES: We compared the ability of three prostate-specific antigen (PSA) ratios - free-to- total PSA ratio (fPSA/tPSA), free-to-complexed PSA ratio (fPSA/cPSA), and complexed-to-total PSA ratio (cPSA/tPSA) - to distinguish prostate cancer from benign prostatic hyperplasia (BPH). METHODS: We tested 258 consecutive patients who underwent transrectal ultrasound-guided prostate needle biopsy because of an abnormal digital rectal examination or a Tandem-R PSA of >4.1 ng/ml. Free PSA (fPSA) and total PSA (tPSA) were measured by Tandem-R assay. alpha(1)-Antichymotrypsin-complexed PSA (cPSA) was measured by Markit-M PSA-ACT assay. RESULTS: Of the 258 patients, 204 had BPH, and 54 had prostate cancer. The specificity at 96% sensitivity for fPSA/tPSA, fPSA/cPSA, and cPSA/tPSA was 23, 25, and 33%, respectively. Of 162 patients with tPSA between 4.1 and 10.0 ng/ml, 132 had BPH and 30 had prostate cancer. The specificity at 96% sensitivity for f/tPSA, f/cPSA and c/tPSA was 32, 44, and 41%, respectively. There was no significant difference in the area under the receiver-operating characteristic curves among fPSA/tPSA, fPSA/cPSA, and cPSA/tPSA in the overall PSA range or in tPSA between 4.1 and 10.0 ng/ml. CONCLUSION: fPSA/tPSA, fPSA/cPSA, and cPSA/tPSA did not differ in their ability to distinguish prostate cancer from BPH.     

fPSA/tPSA比值在前列腺癌和前列腺增生鉴别中的意义

目的 探讨fPSA/tPSA比值在前列腺癌和前列腺增生鉴别中的意义。方法 回顾分析了2000年9月-2001年8月期间在我院住院治疗的72例前列腺癌和前列腺增生患者的tPSA和fPSA/tPSA比值。结果 72例患者中,前列腺增生48例,前列腺癌24例。tPSA为4.0～10.0ng/ml之间时,前列腺癌患者3例,其fPSA/tPSA平均值为0.12,而前列腺增生患者有16例,其fPSA/tPSA平均值为0.21,两者差异明显。tPSA为4.0～10.0ng/ml,fPSA/tPSA比值为0.20,诊断前列腺癌的特异性为61％,而敏感性为100％。结论 当tP-SA为4.0～10.0ng/ml时,fPSA/tPSA比值作为一种参考标准可以用于临床筛选潜在的前列腺癌患者。     

Complexed prostate-specific antigen for the diagnosis of biochemical recurrence after radical prostatectomy

OBJECTIVES: To determine the validity of using complexed prostate-specific antigen (cPSA) levels for diagnosing biochemical recurrence after radical prostatectomy (RP). PATIENTS AND METHODS: With linear regression modelling, we determined threshold cPSA levels for biochemical recurrence in patients after RP for clinically localized prostate cancer. We calculated sensitivity, specificity, predictive values, and likelihood ratio tests of each threshold for diagnosing biochemical recurrence using total PSA (tPSA) as the reference standard. RESULTS: In the regression models, tPSA and cPSA were highly correlated (r = 0.99). For the diagnosis of biochemical recurrence, tPSA thresholds of 0.20 and 0.40 ng/mL corresponded to cPSA thresholds of 0.12 ng/mL (95% confidence interval 0.08-0.17) and 0.29 (0.22-0.28) ng/mL, respectively. For the detection of biochemical recurrence, a cPSA threshold of 0.12 ng/mL had a sensitivity of 96%, specificity of 88%, positive predictive value of 89%, negative predictive value of 88%, positive likelihood ratio of 8, and negative likelihood ratio of 0.05; the respective values for a cPSA threshold of 0.29 ng/mL were 96%, 96%, 96%, 96%, 24 and 0.04. CONCLUSIONS: cPSA has high validity for the diagnosis of biochemical recurrence after RP. Pending external validation, cPSA might be useful for biochemical surveillance after RP.     

Effect of NIH-IV prostatitis on free and free-to-total PSA

OBJECTIVE: To examine the effect of asymptomatic prostatic inflammation (NIH category IV prostatitis) on total PSA (tPSA), free serum PSA (fPSA) and the ratio of free-to-total prostate specific antigen (%fPSA). The role of free and %fPSA as a diagnostic tool for distinguishing between cancer and non-malignant diseases of the prostate was also investigated. MATERIAL AND METHODS: In a retrospective study 1090 prostate biopsies performed between January 2000 and September 2003 were evaluated and the levels of serum total and free PSA as well as the f/tPSA ratio were determined in samples obtained immediately before biopsy. 404 patients with full clinical and histological records were included in the study. All patients underwent 6 or 8 core primary prostate needle biopsies. RESULTS: A total of 404 patients were included in the analysis. 100 prostate cancer (PCa) (24.8%), 137 NIH-IV prostatitis (33.9%) and 143 patients with benign prostatic hyperplasias (BPH) (35.4%) were identified. 24 (5.9%) patients presented with both PCa and prostatitis on histology and were excluded from further analysis. The mean (median) levels of tPSA, fPSA and %fPSA were 11.94 ng/ml (8.0), 1.31 ng/ml (1.07) and 0.15 (0.14) for NIH-IV prostatitis; 11.94 ng/ml (8.35), 1.54 ng/ml and 0.13 (0.11) for prostate cancer; and 8.19 ng/ml (7.0), 1.48 ng/ml (1.03) and 0.18 (0.15) for BPH. No significant difference was found in tPSA levels between PCa and prostatitis (p = 0.32), while the difference in tPSA levels between PCa and BPH was significant (p = 0.007). Free PSA alone had no diagnostic power in distinguishing PCa from prostatitis (p = 0. 37) and BPH (p = 0. 61). By contrast, the f/tPSA ratio showed significant between-group differences (PCa versus prostatitis (p = 0. 011), PCa versus BPH (p = 0.0001). CONCLUSIONS: Chronic asymptomatic prostatitis NIH category IV has similar effects on total PSA and free PSA levels in serum as PCa. fPSA alone cannot distinguish prostate cancer from non-malignant inflammatory disease of the prostate. The ratio of free-to-total PSA is significantly different in PCa and NIH category IV prostatitis.     

游离PSA/总PSA比值诊断前列腺癌的临床意义

目的　探讨血清游离前列腺特异抗原（ｆＰＳＡ）／ 总前列腺特异抗原（ｔＰＳＡ）比值对前列腺癌的诊断价值。方法　用酶联双抗夹心法检测２２ 例前列腺癌,４８ 例前列腺增生（ＢＰＨ） 和２０ 例正常对照组的血清ｆＰＳＡ、ｔＰＳＡ,并计算ｆＰＳＡ／ｔＰＳＡ 比值,评价其对前列腺癌的诊断价值。结果　以ｆＰＳＡ／ｔＰＳＡ０．１５ 为判断上限时,其诊断敏感性为９０ ．９％ ,特异性为８７．５％ ,诊断准确性为８８ ．６ ％ ,明显优于ｔＰＳＡ和ｆＰＳＡ 单独测定结果。结论　ｆＰＳＡ／ｔＰＳＡ可更有效地诊断前列腺癌。     

Complexed prostate specific antigen (PSA) reduces unnecessary prostate biopsies in the 2.6-4.0 ng/mL range of total PSA

OBJECTIVE: To compare the performance of complexed prostate-specific antigen (cPSA) to total PSA (tPSA) and percentage free PSA (f/tPSA) in the diagnosis of prostate cancer for the tPSA range 2.6-4.0 ng/mL. PATIENTS AND METHODS: Consecutive men scheduled for prostate biopsy were enrolled prospectively at 14 different sites in two multicentre studies in Europe and the USA. Serum obtained before biopsy was tested with the ACS:180 and Immuno 1 tPSA and cPSA assays (Bayer Diagnostics, Tarrytown, NY, USA) and the Access fPSA and tPSA assays (Beckman, Inc., San Diego, CA, USA). Receiver operating characteristics (ROC) curves were generated to compare the diagnostic performance of tPSA, cPSA and f/tPSA. RESULTS: Of 316 men with a tPSA of 2.6-4.0 ng/mL, 82 (26%) were diagnosed with prostate cancer on biopsy. ROC analysis of all 316 men showed an area under the curve (AUC) for cPSA of 0.63, significantly greater than the AUC for tPSA of 0.56 (P = 0.008). At a sensitivity of 95%, threshold values of 2.3 ng/mL for cPSA and 2.73 ng/mL for tPSA provided specificities of 20.1% and 9.8%, respectively. f/tPSA was only available for 205 of the 316 (65%) men and the AUC for cPSA was 0.63, and did not significantly differ from the f/tPSA AUC of 0.64 (P = 0.58). CONCLUSIONS: As a single test, cPSA provides improved specificity over tPSA and comparable specificity to f/tPSA for detecting prostate cancer, and may reduce the number of unnecessary prostate biopsies in the 2.6-4.0 ng/mL tPSA range.     

Use of prostate-specific antigen (PSA) isoforms for the detection of prostate cancer in men with a PSA level of 2-10 ng/ml: systematic review and meta-analysis

OBJECTIVE: Measurement of serum prostate-specific antigen (PSA) for the detection of prostate cancer has poor specificity in men with PSA levels between 2 and 10 ng/ml. It has been suggested that measurement of the ratio of free to total PSA (f/tPSA) or complexed PSA (cPSA) might offer an improvement. We performed a systematic review and meta-analysis to evaluate the diagnostic performance of these tests among men with PSA levels between 2 and 10 ng/ml. METHODS: Data on sensitivity and specificity were extracted from 66 eligible studies. Likelihood ratios and summary receiver operating characteristic curves were estimated and possible sources of heterogeneity between studies examined. RESULTS: Use of the f/tPSA or the cPSA test improved diagnostic performance among men with a total PSA (tPSA) of 2-4 or 4-10 ng/ml compared to tPSA alone. The diagnostic performance of the f/tPSA test was significantly higher in the tPSA range of 4-10 ng/ml compared to a tPSA range of 2-4 ng/ml (p < 0.01); at a sensitivity of 95%, the specificity was 18% in the 4-10 ng/ml tPSA range and 6% in the 2-4 ng/ml tPSA range. Among studies that measured both isoforms, the diagnostic performance of the f/tPSA test and the cPSA was equivalent in both PSA ranges. CONCLUSIONS: The use of the f/tPSA or cPSA test among men with PSA levels between 2 and 10 ng/ml can reduce the number of unnecessary biopsies whilst maintaining a high cancer detection rate.