PSA密度在PSA 2.5～10.0 ng/mL和10.1～20.0 ng/mL患者前列腺癌诊断价值的多中心研究

目的探讨前列腺特异性抗原密度(PSAD)在前列腺特异性抗原(PSA)值位于2.5~10 ng/m L和10.1~20.0 ng/m L患者前列腺癌诊断的效能。方法回顾性分析广州地区两家医院中PSA在2.5~20.0 ng/m L之间,行经直肠前列腺体积测量并行前列腺穿刺的461名患者临床资料,入选者分为PSA 2.5~10.0 ng/m L和PSA10.1~20.0 ng/m L两组,通过受试者工作特征曲线(ROC)分析法评价PSAD与PSA在预测前列腺癌的诊断效力。结果 PSA 2.5~10.0 ng/m L和PSA 10.1~20.0 ng/ml两组的曲线下面积比较,PSAD均高于PSA。在PSA 2.5~10.0 ng/m L组,PSAD预测前列腺癌的最佳临界点为0.15 ng·m L~(-1)·m L~(-1),敏感性和特异性分别为64.4%和64.6%;在PSA10.1~20.0 ng/m L组,PSAD预测前列腺癌的最佳临界点为0.33 ng·m L~(-1)·m L~(-1),敏感性和特异性分别为60.3%和82.7%。结论对于PSA2.5~10.0 ng/m L和10.1~20.0 ng/m L的中国男性,PSAD是一种更优的前列腺癌预测指标。     

Prostate specific antigen density for discriminating prostate cancer from benign prostatic hyperplasia in the gray zone of prostate-specific antigen.

Serum prostate specific antigen (PSA) is currently the best blood marker for prostate cancer. However, low specificity for detection of prostate cancer, especially in the gray zone of PSA, is a problem. We evaluated the clinical significance of PSA density (PSAD) in gray zone PSA cases with conversion of serum PSA to a Stanford reference value. In a series of histologically confirmed 63 benign prostatic hyperplasia (BPH) patients and 234 prostate cancer patients, 36 BPH patients and 25 prostate cancer patients had gray zone PSA levels. Serum PSA was measured with the Markit-F or Markit-M PA assay. All data were converted to Stanford reference values. We used transabdominal ultrasound to determine prostate volume. PSAD was determined as the serum PSA/prostate volume ratio. The mean PSA values for BPH and prostate cancer were 6.42 +/- 1.80 and 7.80 +/- 2.15 ng/ml (p = 0.0116), respectively, and prostate volume was 33.4 +/- 14.1 ml and 17.1 +/- 8.2 ml, respectively (p < 0.0001). The mean PSAD for prostate cancer was 0.572 +/- 0.363 while that for BPH was 0.218 +/- 0.085 (p = 0.0001). Cut-off values with sensitivity > 90% were 0.218 for PSAD and 30 ml for prostate volume. At these cut-off values, specificity reached 56% for each marker. In discriminating prostate cancer from BPH in the gray zone of PSA, PSAD demonstrated better performance than PSA.     

Relationship between Serum Prostate Specific Antigen and the Pattern of Inflammation in Both Benign and Malignant Prostatic Disease in Middle Eastern Men

To determine the effect of prostatitis on serum prostate specific antigen in the diagnosis of prostate cancer in Middle Eastern men, H&E-stained sections of all consecutive prostate specimens were reviewed for diagnosis (malignant or benign) and pattern of inflammation. Inflammation was categorized into acute, active chronic and chronic inactive and graded semi-quantitatively according to previously published criteria. Results were correlated with serum PSA obtained from patients’ records. Of 513 prostate specimens reviewed; 435 (84.8%) were benign and 78 (15.2%) were malignant. Chronic inactive prostatitis was present in 259 (204 benign, 55 malignant) and active chronic prostatitis in 221 (204 benign, 17 malignant). Acute prostatitis alone was not observed and prostatitis was absent in 33 (27 benign, 6 malignant). There was no significant difference in the prevalence of inactive chronic prostatitis between benign and malignant specimens (p < 0.071), but active chronic prostatitis was more prevalent in benign specimens (p < 0.001). Increasing serum PSA was observed for increasing grades of both inactive and active chronic prostatitis in both benign and malignant disease. Prostate cancer showed higher serum PSA levels than benign, at different cut-off points (4 ng/ml = p < 0.0001; 8 ng/ml = p < 0.0001; 12 ng/ml = p < 0.0001). However, significant numbers of patients with benign prostate biopsies presented with PSA above 12 ng/ml (82/260 = 32%). We conclude that active chronic prostatitis is common in Middle Eastern men with benign prostatic disease and a significant number of these present with very high PSA levels, some over 300 ng/ml.     

Value of the Free to Total Prostate Specific Antigen Ratio and Prostate Specific Antigen Density for Detecting Prostate Cancer in Japanese Patients

Background : This study evaluated the free to total serum prostate specific antigen (f/t PSA) ratio and prostate specific antigen density (PSAD) in detecting prostate cancer in Japanese males with a PSA level between 2.5 and 20.0 ng/mL in a community-based urology practice.
Methods : Twenty-six patients with clinically localized prostate cancer and 44 patients with histologically-proven benign prostatic hyperplasia (BPH) were studied. The serum levels of free PSA (fPSA) and total (t) PSA were determined using a chemiluminescent enzyme immunoassay. The f/t PSA ratio was calculated by dividing the fPSA value by the total PSA value and was compared with the PSA and PSAD via the receiver operating characteristic (ROC) curves.
Results: Patients with prostate cancer had a significantly lower f/t PSA ratio than patients with BPH. The PSAD was a superior diagnostic tool over PSA (P < 0.01) when analyzed by ROC curves. The f/t PSA ratio was also superior to PSA, but lacked significance (P=0.12), and similarly, the PSAD was superior, but not significant, to the f/t PSA ratio. Using a cut-off value of 0.1 9, the PSAD had a sensitivity of 81% and a specificity of 82%. With a cut-off value of 14.0%, the f/t PSA ratio had a sensitivity of 81% and a specificity of 66%.
Conclusion: This study showed that PSAD alone improved cancer detection significantly better than PSA. However, it is still unclear whether the f/t PSA ratio is superior to PSA or PSAD in the discrimination between BPH and prostate cancer in Japanese male patients.     

Cerebrospinal Fluid Prostate Specific Antigen (CSF PSA) in Prostate Cancer Patients with Lower Spine Metastasis

Aim: In this prospective study, our aim was to investigate the CSF PSA levels and CSF/Serum PSA ratios in patients with prostate cancer with lower spine metastasis. Methods: The study involved patients with prostate cancer (n = 15), benign prostatic hyperplasia (n = 17) and non-prostatic disease (n = 9). Serum and CSF were obtained prior to spinal anesthesia for urological surgery. Total PSA levels in the serum and CSF were measured by electrochemiluminescence immunoassay. The results were tested statistically using the Mann–Whitney U test. Results: The mean serum PSA levels were 20.36 ng/ml in the prostate cancer patients, 5.37 ng/ml in the BPH patients and 0.76 ng/ml non-prostatic disease. The mean CSF PSA levels in groups were 0.127, 0.051 and 0.027 ng/ml, respectively. The mean CSF PSA/serum PSA ratios in groups were 0.007, 0.018 and 0.042, respectively. This result is statistically significant (P < 0.001).Conclusions: Although mean serum PSA and CSF PSA levels in the patients with cancer of the prostate and lower spine metastasis are higher than those in the others, the mean CSF PSA/serum PSA ratio is lower. However, clinical usefulness of CSF PSA value and CSF PSA/ Serum PSA ratio can be limited because CSF PSA values are usually very low, and CSF PSA/Serum PSA ratio of 4 prostate cancer patients are as high as 1 BPH patient.     

The Value of PSA,Free-to-total PSA Ratio and PSA Density in the Prediction of Pathologic Stage for Clinically Localized Prostate Cancer

Objective: The ability of prostate-specific antigen (PSA), free/total PSA and PSA density to predict the pathologic stage in prostate cancer has not been clear yet. In this study, we evaluated the value of PSA subgroups in the prediction of pathologic stage after radical prostatectomy. Methods: A total of 42 subjects 55–78-years-old who underwent radical retropubic prostatectomy were included in the study. Preoperative PSA, free/total PSA and PSA density (PSAD) values were compared according to the pathologic stages of radical prostatectomy specimens. Receiver operating characteristics (ROC) curves were measured for each parameter. Results: The clinical stage that was estimated for all patients was between T1N0M0 and T2bN0M0. Pathologic examination revealed organ-confined disease in 18 patients. The area under curve (AUC) for organ confinement was 0.553 for PSA, 0.446 for free/total PSA ratio and 0.706 for PSAD. Cut-off values providing the best sensitivity and specificity in ROC analysis for PSA, free/total PSA and PSAD were 7.1, 0.15, and 0.17, respectively (likelihood ratio: 0.9, 1 and 2). The positive predictive values at these cut-off values were 0.54, 0.56, and 0.70, respectively. Only PSAD cut-off values was found statistically borderline significant for predicting organ-confined disease. Conclusion: While PSAD is more helpful than PSA and free/total PSA ratio for prediction of organ-confined disease, none of these parameters are significant predictor of pathologic stage for clinically localized prostate cancer.     

PSA、PSAD和PSAT对前列腺癌诊断的比较

目的　比较前列腺移行带特异性抗原密度（PSAT）与前列腺特异性抗原（PSA）及前列腺特异性抗原密度（PSAD）在前列腺癌诊断中的意义。方法　对78例PSA4～20ng/ml的患者行前列腺穿刺活检后比较PSA、PSAD和PSAT指标。结果　78例中,病理诊断为前列腺癌(PCa)32例,良性前列腺增生(BPH)46例,二者PSA平均值分别为(14.32±1.46)ng/ml、(13.89±1.52)ng/ml,二者相比差别无显著性意义(P>0.05);PSAD平均值分别为0.43±0.14、0.36±0.17,二者相比差别有显著性意义(P<0.05);PSAT平均值分别为0.75±0.19、0.31±0.06,二者相比差别有非常显著性意义(P<0.01)。结论　PSAD和PSAT对预测PSA<20ng/ml的患者是否患前列腺癌有较大帮助,特别是PSAT更为准确。     

Population Standards of Prostate Specific Antigen Values in Men over 40: Community Based Study in Turkey

Objective: To determine the prostate specific antigen (PSA) population standards of a cluster of Turkish men with no clinical evidence of prostate cancer. Patients and methods: We evaluated PSA values of the men who were living in a well-defined, rural district of Western Anatolia. Two hundred fifty-seven men agreed to participate in this population-based study. They underwent clinical examination, transrectal ultrasonography and serum PSA measurement. The association between serum PSA and age, prostate volume and age, PSA and prostate volume, and PSA density (PSAD) and age were assessed. Distributions of serum PSA levels, prostate volumes (PV), and PSAD values as a function of age were generated. Results: The upper limit of normal PSA concentration were 4.51 ng/ml for men aged 40–49 years, 4.36 ng/ml for 50–59 years, 6.17 ng/ml for 60–69 years, and 10.18 ng/ml for over 70 years. The upper limit of normal (95th percentile) for the serum PSA concentration increased with age. Across the entire age range, no correlation was found between the serum PSA concentrations and age while significant correlation was found between serum PSA concentration and prostate volume. Conclusion: In this present study, the PSA values in different age intervals showed higher than those observed in previous studies. The PSA values are mainly affected by prostate volume rather than age.     

Prostate biopsy in subjects with abnormal transrectal ultrasonography but normal digital examination findings and prostate-specific antigen levels

Aim The aim of the present study was to evaluate the value of transrectal ultrasonography (TRUS) for prostate cancer diagnosis in men with no other indication for biopsy, such as an abnormal digital rectal examination or abnormally high prostate-specific antigen (PSA) levels. Materials and methods The study cohort contained a total of 104 men aged 41–78 years (median 62.5 years) who had suspicious findings on TRUS. The median prostate volume of the patients was 33.0 ml (range 15.0–90.9) and the serum PSA ranged from 0.2 to 4.0 ng/ml (median 2.5 ng/ml). Results Of 104 men, 12 (11.5%) were diagnosed with prostate cancer on initial biopsy. The positive predictive value (PPV) was 3.7% for PSA 0.1–1.0 ng/ml, 4.8% for PSA 1.1–2.0 ng/ml, 16.7% for PSA 2.1–3.0 ng/ml and 18.4% for PSA 3.1–4.0 ng/ml. The PPV for cancer with Gleason score 7 or higher was 0.0%, 0.0%, 16.7% and 7.9%, respectively. No statistically significant differences in patient characteristics and biopsy results were found between patients who received only systemic biopsy and those who received systemic plus lesion-directed biopsies. Conclusion The results of this study do not provide a rationale to recommend the additional use of lesion-directed biopsy in patients with suspicious lesions at TRUS but with no other indication for biopsy. Furthermore, our data raise the question of whether serum PSA levels lower than 4.0 ng/ml should be considered normal in Asian men.     

PSA、PSAD和PSAT在前列腺穿刺活检中的价值

目的 研究血清前列腺特异性抗原(PSA)及其密度(PSAD)和移行带密度(PSAT)在前列腺穿刺活检中的价值.方法 选取本院2014年5月至2015年5月收治的150例患者进行前列腺穿刺活检,分析并比较PSA、PSAD、PSAT在前列腺穿刺活检中的差异及其在确诊疾病方面的价值.结果 在前列腺穿刺活检的150例中发现PSA＜4 ng/mL有8例,4 ng/mL≤PSA≤20 ng/mL有66例,PSA ＞20 ng/mL有76例.其中在PSA＜4 ng/mL的8例中,活检结果良性前列腺增生6例,前列腺小细胞癌1例,前列腺横纹肌肉瘤1例.在4 ng/mL≤PSA≤20 ng/mL的66例中,活检结果诊断为前列腺癌增生患者54例,活检阳性率为81.8％,PSA平均值为(13.98±1.51) ng/mL,PSAD平均值为(0.32±0.18);PSAT平均值为(0.35±0.18);活检前列腺癌12例,活检阳性率为19.2％,PSA平均值为(14.29±1.48) ng/mL,PSAD平均值为(0.42±0.15),PSAT平均值为(0.82±0.15);将其分为良性前列腺增生组和前列腺癌组,两组差异具有统计学意义(P＜0.05).当PSAD ＞0.13或PSAT＞ 0.15时,前列腺癌的敏感性分别为92.86％和96.94％.在PSA＞ 20 ng/mL的76例中,前列腺癌有68例,活检阳性率89.47％.结论 在4 ng/mL≤PSA≤20 ng/mL时,PSAD和PSAT对前列腺增生和前列腺癌的鉴别诊断具有重要意义,其中又以PSAT更为准确;PSA＞ 20ng/mL时,应高度怀疑前列腺癌,及时确诊治疗.     

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。     

Effect of dimensions and volume of the prostate on cancer detection rate of 12 core prostate biopsy

Purpose To evaluate if volume or any of the three dimensions of prostate influences cancer detection rate by 12-core transrectal ultrasound (TRUS) guided prostate biopsy. Materials and methods We have searched our database for patients who underwent 12 core TRUS guided prostate biopsy with PSA values between 4.0 and 9.9 ng/ml, benign digital exam and no suspicious lesions at TRUS. The measurements of three dimensions and volume of the prostate of 99 patients were correlated with cancer detection rates of biopsy. Results There were no statistically significant differences between patients with prostate cancer or with benign histopathologic result for mean age, PSA and % PSA. Patients without cancer had a significantly higher mean prostate volume (58.88 cc) than patients with cancer (48.85 cc) (P = 0.038). A volume of 48.5 cc was determined as a cut-off value above which cancer detection rate decreases. Of the three dimensions, only the difference for the craniocaudal dimension between benign and malignant groups was marginally significant (P = 0.052). Conclusions With 12 core biopsy, cancer detection rate is lower in patients with prostates larger than 48.5 cc. Further studies comparing biopsy results with prostatectomy specimens can clarify whether these results necessitates higher number of cores for such patients.     

Prostate cancer screening: Role of digital rectal examination and prostate-specific antigen

Background: This study was designed to determine the efficacy of digital rectal examination (DRE) and serum prostate-specific antigen (PSA) for early detection of prostate cancer in men ≥50 years of age. Methods: A prospective single-center clinical trial was conducted to screen 644 asymptomatic men, who were elicited by newspaper and radio advertisements, with DRE and PSA. Quadrant biopsy examinations of the prostate were performed if PSA >4 ng/ml or if DRE was suspicious. Results: Thirty-seven percent of the men (n=241) had an abnormality of DRE or elevated PSA. Of the 163 patients who underwent transrectal ultrasound and quadrant biopsies of the prostate, 77% had normal biopsies, 14 (8%) had prostatic intraepithelial neoplasia, and 24 (15%) had carcinoma of the prostate. PSAs ranged from 0.3 to 65.5 ng/ml, with a mean of 2.35 and a median of 1.6. Ninety-five patients had a PSA >4 ng/ml, of whom 17 had a PSA >10 ng/ml. Sensitivity of PSA was 75% and specificity 87%; for DRE the sensitivity was 75% and the specificity 69%. Clinical stage of patients who underwent radical prostatectomy was B1 in 15 and B2 in five. Fifteen of 20 patients (75%) had organ-confined disease; the other five had specimen-confined disease. No patient was found to have nodal involvement. Conclusion: The combination of PSA and DRE seems to improve the stage of diagnosis of patients with prostate cancer. Larger, randomized studies will be necessary to evaluate the effect of screening on overall survival. The results of this study were presented at the 46th annual cancer symposium of the Society of Surgical Oncology, Los Angeles, California, March 18–20, 1993.     

The significance of TPSA, free to total PSA ratio and PSA density in prostate carcinoma diagnostics

Prostate-specific antigen (PSA) is the one of the most valuable tumor markers for the early detection and management of prostate carcinoma, but not an ideal one because of poor specificity in the case of prostatic hypertrophy and other benign conditions. In order to overcome this drawback some other parameters as is free to total ratio (F/T) PSA and PSA density (PSAD) are introduced. It has been investigated in 60 patients, 18 of them are proved to be found prostate cancer and other 42 were identified as benign prostatic hyperplasia. Patients with CaP had TPSA median of 11.4 ng/ml and the others with benign prostatic hyperplasia (BPH) had 6.9 ng/ml. In these two groups there was statistical significant difference (p 0.01). By receiver operating characteristics curve (ROC) estimated cutoff for TPSA was 4.0 ng/ml with 95% sensitivity, 30% specificity and area covered by ROC was in amount of 0.76. Median F/T ratio for patients with prostate cancer was 0.10, and for benign prostatic hyperplasia patients it was 0.25. For these values there is also statistical difference (p). Using ROC cutoff for F/T PSA was determined at the value of 0.18 with sensitivity 95%, specificity 80% and area under the curve (AUC) 0.93. Median for PSAD in the group with CaP was 0.38 and in the BPH group was 0.16. There was statistical significance within those two groups. In conclusion F/T PSA, PSAD and TPSA are valuable tumor markers in distinguishing patients with CaP ant those without with modestly raised TPSA. Also F/T PSA showed up as better marker than TPSA and PSAD in investigated group of patients.     

前列腺特异抗原水平为4～10 μg/L的前列腺癌诊断对策

目的评价现有的前列腺特异抗原(PSA)修正方法对PSA在4~10μg/L的前列腺癌的诊断价值。方法选取经直肠B超引导下前列腺多点穿刺活检血PSA测值在4~10μg/L的86例患者,分析其PSAD、PSATZ、F/T比值及PSA修正方法各域值范围内,对前列腺癌诊断的敏感度及特异度。结果PSAD、PSATZ和F/T比值在各域值范围内,对诊断前列腺癌的敏感度均未超过50%,将PSAD域值设为0.18μg/L/cc时有较高的敏感度,F/T比值设为0.25时有较高的特异度,而PSATZ在各域值范围内对前列腺癌的敏感度及特异度无显著优势。结论PSA修正方法不能有效提高国人血PSA4~10μg/L的前列腺癌检出率;当PSAD超过0.18μg/L应建议患者作前列腺穿刺活检,F/T比值小于0.25则应增加穿刺点。     

The clinical potential of pretreatment serum testosterone level to improve the efficiency of prostate cancer screening

OBJECTIVES: The aim of the present study was to evaluate the clinical value of the pretreatment serum testosterone (T) level as a potential predictor of prostate cancer risk in screening for prostate cancer. MATERIALS AND METHODS: The subjects were 420 patients suspected of having prostate cancer who underwent prostate biopsy, and whose pretreatment T levels were recorded. We checked for association between the presence of prostate cancer and the following clinical factors: pretreatment serum T level, age, pretreatment prostate-specific antigen (PSA) level, digital rectal examination findings, ratio of free to total PSA, prostate volume, and PSA density (PSAD). RESULTS: Overall, there was no significant difference in mean pretreatment T level between patients diagnosed with cancer (3.9+/-2.4 ng/ml) and patients diagnosed with benign prostate disease (BPD; 3.7+/-1.7 ng/ml); diagnosis was based on prostate biopsy. However, among patients with PSA <10 ng/ml, the pretreatment T level was significantly higher in patients diagnosed with prostate cancer (4.2+/-2.6 ng/ml) than in patients diagnosed with BPD (3.6+/-1.4 ng/ml) (p=0.007); a similar trend was observed among patients with PSAD <0.15 ng/ml/cc. Multivariate analysis indicated that pretreatment T level was an independent significant predictor of positive prostate biopsy (p=0.020). Additionally, the serum T level was significantly lower in patients with a Gleason score >or=7 (3.7+/-2.1 ng/ml) versus a score <7 (4.2+/-1.7 ng/ml) (p=0.030). Also, serum T levels were significantly higher in well-differentiated prostate cancer (4.8+/-2.1 ng/ml) versus moderately differentiated (3.8+/-1.3 ng/ml) or poorly differentiated (3.7+/-1.4 ng/ml) (p<0.01). CONCLUSIONS: Among relatively low-risk patients, serum T level was an independent significant predictor of positive prostate biopsy, suggesting that the efficiency of prostate cancer screening can be improved by including measurement of serum T level.     

Evaluation of prostate specific antigen (PSA) adjusted to transition zone in prostatic cancer detection

ObjectiveTo investigate if PSA adjusted to transition zone (PSA-TZ) can be considered as a predictor parameter of cancer with better specificity or not than PSA, PSA density (PSAD) or PSA free/total ratio.Material and methodsData of 706 patients with sextant prostatic biopsies are analyzed in prospective way because of prostatic cancer suspicion. Range of PSA was between 4 to 20 ng/ml. Determination of PSA-TZ was calculated by dividing the PSA value by the volume of the transition zone of the prostate applying the ellipsoid formula and comparison of obtained results in detection of cancer was performed by ROC curves analysis for each one of PSA-related parameters.ResultsOf the total group of patients, in 199 cases (28.2%) prostatic cancer was detected. Analysis by ROC curves demonstrated than PSA-TZ and PSAD were better predictors of cancer than PSA free/total ratio and PSA (p<0.0001). The cutoff value of PSA-TZ of 0.18 ng/ml/cc was considered as the best, obtaining a 95% sensitivity and a 27% specificity. For this sensitivity, PSA, PSAD and PSA free/total ratio only obtained 5, 9 and 16% specificity respectively. Areas under curve (AUC) obtained for PSA, PSA free/total ratio, PSAD and PSA-TZ were 0.539, 0.612, 0.694 and 0.722 respectively.ConclusionsPSA-TZ in the studied population was a parameter with better diagnostic specificity than PSA, PSAD and PSA free/total ratio for the same 95% sensitivity. This would justify its utility in clinical paractice reducing the number of unnecesary biopsies.     

An algorithm for prostate cancer detection in a patient population using prostate-specific antigen and prostate-specific antigen density

Summary Prostate-specific antigen (PSA) is the most accurate serum marker for cancer of the prostate (CaP). However, its sensitivity and specificity are suboptimal, especially at values ranging between 4.1 and 10.0 ng/ml (monoclonal), because benign prostatic hypertrophy and hyperplasia (BPH) and CaP frequently coexist in this range. This study was undertaken to determine the value of incorporating prostate volume measurements with serum PSA levels in a quotient (PSA/volume) entitled PSA density (PSAD). A total of 3140 patients were analyzed and stratified by serum PSA, digital rectal examination (DRE), transrectal prostate ultrasound (TRUS), TRUS volume determination and PSAD. All patients were referred for evaluation and therefore do not represent a screened population. Patients underwent prostate biopsies when abnormalities in TRUS or DRE were detected. Although both PSA and PSAD have statistical significance when the serum PSA value is 4.0 ng/ml, neither has clinical significance in differentiating BPH from CaP. At serum levels ranging between 4.1 and 10.0 ng/ml, PSA has no ability to differentiate BPH from CaP, whereas PSAD does so with statistical and clinical significance. When the PSA value is between 10.1 and 20.0 ng/ml, only PSAD is statistically significant. When PSA exceeds 20 ng/ml, PSAD is redundant. We conclude that all patients with an abnormality on DRE or TRUS should undergo prostate biopsy. If the PSA value is 4.0 ng/ml, TRUS and PSAD are not warranted and routine biopsy is not recommended. For intermediate PSA levels, 4.1–10.0 ng/ml, TRUS, TRUS prostate volume, and PSAD are important. The use of PSAD provides unique information regarding the need for biopsy and the likelihood of CaP. At PSA levels ranging between 10.1 and 20.0 ng/ml, PSAD will identify those patients who are less likely to have CaP, but all should undergo biopsy. If the PSA value is >20 ng/ml, all patients should undergo a biopsy.     

Retrospective evaluation of PSA density for selection of biopsy candidates with prostate specific antigen in the gray zone

PURPOSE: We examined the usefulness of prostate specific antigen density (PSAD) for selection of biopsy candidate with prostate specific antigen levels between 4.1 and 10.0 ng./ml. in prostate cancer screening retrospectively. MATERIALS AND METHODS: The screening was conducted on male candidates in Natori city, aged 55 years or older, for 6 years from 1994 through 1999. We could analyze serum PSA levels and PSA density in 118 men with PSA levels between 4.1 and 10.0 ng./ml. All of 118 men underwent ultrasound guided systematic prostate biopsy regardless of findings of digital rectal examination and transrectal ultrasound. Prostate volume was estimated by transrectal ultrasound measurements using the prolate ellipse formula (pi/6 x length x width x height). PSAD was calculated by dividing serum PSA level by prostate volume. Serum PSA levels were determined by Tandem-R assay. RESULTS: In 118 men, twenty-five men had prostate cancer. There was no significant difference in mean PSA between those with prostate cancer and those without prostate cancer, but the difference was significant in the mean PSA density (mean 0.26 and 0.16, respectively, p < 0.0001). Receiver operating characteristic curves for PSA and PSAD demonstrated superior benefit for PSAD in 118 men. A sensitivity, a specificity, a positive predictive value and a negative predictive value of PSAD cut-off of 0.15 were 88%, 52.7%, 33.3% and 94.2%. PSAD cut-off of 0.18 showed the highest sum of sensitivity and specificity, which gave a sensitivity of 80%, a specificity of 72%, a positive predictive value of 43.5% and a negative predictive value of 93.1%. PSAD cut-off of 0.15 would seem to be preferable to cut-off of 0.18 because of less cancer missing. CONCLUSIONS: Although further studies are needed to determine optimal cut-off value to be used in clinical practice, PASD seems to be useful for the selection of biopsy candidates with PSA levels of 4.1 to 10.0 ng./ml. in the prostate cancer screening.     

Age-specific reference ranges for prostate specific antigen-total and free in patients with prostatitis symptoms and patients at risk

Background Prostate-specific antigen (PSA) is a tumor marker helpful in the diagnosis and follow-up of prostate cancer. However, PSA level may rise due to other causes than prostate cancer such as benign prostatic hyperplasia (BPH), acute prostatitis, chronic bacteria and a bacterial prostatitis. Total serum PSA (TPSA) and free prostate-specific antigen (FPSA) levels of patients with prostatitis symptoms as well as these levels in male population at risk but without clinical prostatic diseases (>40-years-old) with regard to age should be documented in order to increase the sensitivity and specificity of PSA in prostate carcinoma. Methods A comprehensive urological examination was performed on 1150 male patients over the age of 40 with prostatism symptoms from the random-sample community based in with no diagnostic prostate cancer. Men with PSA level 4.1 ng/ml or greater were referred for biopsy and those with positive biopsies or with medical record, cancer registry, or self-reported evidence of prostate cancer were excluded. Data were studied as a function of age to determine the usefulness of measuring TPSA and FPSA as screening tests for risk patient’s cancer. Results Because of the greater variability at older ages, the 95th percentile increased faster than the median, the following age-specific reference ranges of TPSA and FPSA for patients with prostatism symptoms were as follows: 3.1 and 0.7 ng/ml for the age group 40–49 years, 4.4 and 0.89 ng/ml for the age group 50–59 years, 5.6 and 1.3 ng/ml for the age group 60–69 years, and 6.3 and 1.8 ng/ml for age group 70–79 years. There was a continuous increase in TPSA and FPSA means and medians with significant correlation (P < 0.001, P < 0.005) and advancing age group. The aim of this study was to find out age-specific values and ranges of TPSA and FPSA in patients with prostatism symptoms to ensure low false-positive biopsy rates.