Histological diagnosis of prostate cancer in Korean men aged 70-79 years

BACKGROUND: The objective of this study was to evaluate the value of the prostate-specific antigen (PSA) in the diagnosis of prostate cancer in elderly Korean men, aged 70-79 years. METHODS: Patients with an abnormal digital rectal examination (DRE) and/or a serum PSA level greater than 2.0 ng/ml underwent a biopsy. A total of 344 men (median age 73 years) constituted the study cohort. RESULTS: Of 344 men, 163 (47.4%) were diagnosed with prostate cancer upon initial biopsy. The positive predictive value (PPV) for cancer was 48.4% for a PSA cutoff of 4 ng/ml, 65.3% for a cutoff of 10 ng/ml, and 87.0% for a cutoff of 20 ng/ml. When combined with an abnormal DRE, the predictive values for these PSA cutoffs increased to 79.3, 87.3 and 100%, respectively. When 10 ng/ml was chosen as a PSA cutoff level, about 50% of patients were found to have a Gleason score of 7 or higher. When 4 ng/ml was chosen as a PSA cutoff level, more than 50% of patients with an abnormal DRE were found to have a Gleason score of 7 or higher. CONCLUSIONS: In elderly men, more than 50% of patients are found to have cancers with a Gleason score of 7 or higher when their PSA level is greater than 10 ng/ml. This threshold may be lowered to 4 ng/ml in the presence of an abnormal DRE. Our findings provide a rationale for recommending a prostate biopsy in elderly patients with an abnormal DRE and/or an elevated serum PSA level. However, at present, it is not clear whether elderly men have better outcomes when they undergo cancer screening.     

Population-based screening for prostate cancer by measuring free and total serum prostate-specific antigen in Iran.

PURPOSE: To evaluate the natural background of prostate cancer in Iran a large population-based study of screening using total prostate-specific antigen (tPSA) and per cent free PSA (fPSA) as the initial test was performed. MATERIALS AND METHODS: For 9 years (1996 to 2004) in Tehran, Iran, 3670 Iranian men older than 40 years were mass checked by PSA-based screening. They were invited to have a digital rectal examination (DRE), serum PSA assay and transrectal ultrasonography (TRUS)-guided sextant prostate biopsy to see if the DRE was clinically suspicious of malignancy, the serum PSA was > or =2.1 ng/ml or free-to-total PSA (f/tPSA) ratio < or=15%. RESULTS: In 433 (11.8%) of screened males, tPSA levels exceeded the cut-off value of > or =2.1 ng/ml and 128 prostate cancers were diagnosed [positive predictive value (PPV) 29.6%] corresponding to an overall detection rate of 3.5%. Altogether 138 cancers were detected (detection rate 3.8%); none were stage M(1), three were stage N(+) and 4 stage T(3). A threshold tPSA of > or =2.1 ng/ml would have detected 128 cancers in 447 biopsied men (PPV 29%). There were 109 of 138 (79%) men with cancer who had an f/tPSA of < or =15%, while 152 of 305 (49.8%) with benign biopsies had a f/tPSA of < or =15%, which corresponds to a PPV of 30.8%. CONCLUSION: PSA-based screening with low PSA cut-off values increase the detection rate of clinically significant, organ confined and potentially curable prostate cancer. Further studies are warranted in order to determine the incidence and prevalence of prostate cancer in different ethnic groups.     

Detection of prostate cancer at low and intermediate serum prostate-specific antigen levels in a country with a low incidence of prostate cancer

BACKGROUND: The objective of this study was to evaluate the cancer detection rate and the pathologic findings of biopsy in men at low and intermediate prostate-specific antigen (PSA) levels in an Asian population. METHODS: Patients between 40 and 79 years were entered into a study and 755 patients with serum PSA level of 2.0-10.0 ng/ml underwent trus-guided systematic biopsy. Patients were divided to low (PSA 2.0-4.0 ng/ml, n = 144) and intermediate (PSA 4.1-10.0 ng/ml, n = 611) PSA groups. RESULTS: Patients in the low PSA group had significantly smaller prostates (P = 0.003) and lower PSA density (P < 0.001). The rate of cancer detection was 16.7% (24 of 144) in the low PSA group and 23.7% (145 of 611) in the intermediate PSA group (P = 0.067). In men with normal digital rectal examination (DRE), prostate cancer was diagnosed in 14 (13.3%) of the 105 men in the low PSA group and 99 (19.5%) of the 508 men in the intermediate PSA group (P = 0.139). In all patients and patients with normal DRE, no statistically significant differences were found in the pathologic findings of biopsy between the two groups. CONCLUSIONS: Our findings provide a rationale to recommend prostate biopsy at lower PSA threshold in this population. At present, however, it is not clear that men who are treated when their cancers are detected at lower PSA levels have better outcomes than those who are treated when the PSA is higher than 4.0 ng/ml.     

Prostate-specific antigen testing of older men.

BACKGROUND: Elevated serum prostate-specific antigen (PSA) levels are predictive of a future diagnosis of prostate cancer. To test the hypothesis that older men with low PSA levels may require less intensive PSA testing because of a reduced prostate cancer detection rate, we evaluated the association between age, baseline PSA level, and prostate cancer detection. METHODS: We conducted a prospective cohort study among participants in a study of aging who had serial PSA measurements taken from age 60 or 65 years until they either were diagnosed with prostate cancer (cancer case subjects) or reached the age of 75 years (subjects without prostate cancer). The time of cancer detection among cancer case subjects was defined as the measurement date on which a PSA level above 4.0 ng/mL was detected (i.e., PSA conversion). Cancer case subjects and subjects without prostate cancer were analyzed according to baseline PSA level and age. RESULTS: All cancer case subjects in the 60-year-old cohort had baseline PSA levels above 0.5 ng/mL, and 14 of 15 cancer cases that would have been detected by a PSA conversion among the 65-year-old cohort were associated with baseline PSA levels of 1.1 ng/mL or more. If PSA testing were discontinued in men aged 65 years with PSA levels of 0.5 ng/mL or less, 100% (95% confidence interval [CI] = 78%-100%) of the cancers would still be detected by age 75 years; if PSA testing were discontinued in men aged 65 years who had PSA levels of 1.0 ng/mL or less, 94% (95% CI = 70%-100%) of the cancers would still be detected by age 75 years. CONCLUSIONS: These data suggest that a decrease in the intensity of screening among older men with low PSA values may not lead to an increase in undetected prostate cancer.     

Baseline prostate-specific antigen level and risk of prostate cancer and prostate-specific mortality: diagnosis is dependent on the intensity of investigation

BACKGROUND: When considering prostate biopsy, men and their physicians must balance the potential benefits of early diagnosis of localized cancer with the implications of overdiagnosis of clinically insignificant cancers. We investigated the risk of prostate cancer and prostate cancer-specific and all-cause mortality by baseline prostate-specific antigen (PSA) level in a population-based cohort study in Northern Ireland, where PSA screening is not recommended and where low to moderately raised (<10.0 ng/mL) PSA levels were not routinely investigated. METHODS: From a regional electronic database of PSA results, men who had their initial PSA between January 1, 1994 and December 31, 1998 were identified and followed for diagnosis of prostate cancer and prostate cancer-specific and all-cause mortality until December 31, 2003. RESULTS: 68,354 men (mean age, 65.2 years) were included, with 50,676 (74.1%) having a baseline PSA of <4.0 ng/mL; 402 (0.8%) of these were subsequently diagnosed with prostate cancer. PSA level was positively associated with risk of prostate cancer and prostate-specific mortality. In men with baseline PSA <4.0 ng/mL, the rate of prostate cancer and high-grade cancer diagnosis was <2 and <1 cases per 1,000 person-years, respectively, whereas prostate-specific mortality was very low (0.18 cases per 1,000 person-years) compared with overall mortality (28.71 cases per 1,000 person-years). CONCLUSION: Following a PSA result, men need to be aware not only of the risk of prostate cancer but also of having cancer that may cause them harm during their lifetime or, more importantly, kill them. These data should inform and reassure men of their risk of clinically significant prostate cancer.     

European randomized study of prostate cancer screening: first-year results of the Finnish trial

Approximately 20000 men 55-67 years of age from two areas in Finland were identified from the Population Registry and randomized either to the screening arm (1/3) or the control arm (2/3) of a prostate cancer screening trial. In the first round, the participation rate in the screening arm was 69%. Of the 5053 screened participants, 428 (8.5%) had a serum prostate-specific antigen (PSA) concentration of 4.0 ng/ml or higher, and diagnostic examinations were performed on 399 of them. A total of 106 cancers were detected among them corresponding to a positive predictive value of 27%, which is comparable with mammography screening for breast cancer. The prostate cancer detection rate based on a serum PSA concentration of 4.0 ng ml(-1) or higher was 2.1%. Approximately nine out of ten screen-detected prostate cancers were localized (85% clinical stage T1-T2) and well or moderately differentiated (42% World Health Organization (WHO) grade I and 50% grade II), which suggests a higher proportion of curable cancers compared with cases detected by other means.     

Risk assessment for biochemical recurrence prior to radical prostatectomy: significant enhancement contributed by human glandular kallikrein 2 (hK2) and free prostate specific antigen (PSA) in men with moderate PSA-elevation in serum

Most models to predict biochemical recurrence (BCR) of prostate cancer use pretreatment serum prostate-specific antigen (PSA), clinical stage and prostate biopsy Gleason grade. We investigated whether human glandular kallikrein 2 (hK2) and free prostate-specific antigen (fPSA) measured in pretreatment serum enhance prediction. We retrospectively measured total PSA (tPSA), fPSA and hK2 in preoperative serum samples from 461 men with localized prostate cancer treated with radical prostatectomy between 1999 and 2001. We developed a regression model to predict BCR using preoperative tPSA, clinical stage and biopsy Gleason grade. We then compared the predictive accuracy of this "base" model with a model with fPSA and hK2 as additional predictors. BCR was observed in 90 patients (20%), including 48 patients with a pretreatment tPSA < or = 14 ng/ml (13%), and 28 patients (10%) with a pretreatment tPSA < or = 10 ng/ml. Overall, the predictive accuracy of the base model (bootstrap-corrected concordance index of 0.813) was not improved after the addition of fPSA or hK2 (0.818). However, for men with moderate tPSA-elevation (tPSA < or = 10 ng/ml), addition of fPSA and hK2 data increased predictive accuracy (from a base model concordance index of 0.756-0.815, p = 0.005). The improvement in accuracy was not sensitive to the threshold for "moderately elevated" PSA. For patients with a moderate tPSA-elevation (tPSA < or = 10 ng/ml), which closely corresponds to concurrent disease demographics, BCR-prediction was enhanced when fPSA and hK2 were added to the conventional model. Measurements of fPSA and hK2 improve on our ability to counsel patients prior to treatment as to their risk of BCR.     

A new Model Consists of Intravesical Prostatic Protrusion,Prostate Volume and Serum Prostatic-Specific Antigen in the Evaluation of Prostate Cancer

The Prostate-specific antigen (PSA) level is largely used to diagnose prostate cancer (PCa) in last decades. However, its specificity is low in patients with a PSA level ranging from 4.0 to 10.0 ng/ml. This study aims to define the correlation between intravesical prostatic protrusion (IPP) and PSA and to establish a new model to predict PCa. A total of 339 patients order than 45 years examined between October 2010 and June 2012 were enrolled. Eligible patients were recommended for transrectal ultrasonography (TRUS)-guided prostate biopsies after measuring total prostate volume (TPV), tranzisional zone volume (TZV) and IPP. The levels of total PSA (tPSA), free PSA (fPSA) were analyzed by using Hybritech calibrated Access tPSA and fPSA assays. A new mathematical model, named IPP removed PCa predicting score (IRPPS), consists of tPSA, TZV and IPP was established. The predictive accuracy of IRPPS, PSA density (PSAD), %PSA and tPSA were compared using receiver-operator characteristic (ROC) analysis. Eighty-six patients had PSA levels of 4.0–10.0 ng/ml. Twenty of them were diagnosed as PCa. Using ROC curves, the areas under the curve for IRPPS, PSAD and %PSA and tPSA were 0.786, 0.768 and 0.664 and 0.585, respectively. We suggested IPP grade had a significant relationship with serum tPSA levels. The predictive accuracy of IRPPS was higher than the other 3 indictors.     

应用前列腺特异抗原筛查诊断前列腺癌的临床意义

目的 探讨应用前列腺特异抗原(PSA)筛查诊断前列腺癌的临床意义.方法 对年龄≥50岁的8562例男性体检者进行PSA筛查,对血清PSA≥4.0 ng/ml者建议进行经直肠前列腺系统活检,活检病理确诊为前列腺癌的患者人选筛查组,记录其临床病理特点,并与同时期临床诊治的82例前列腺癌患者(临床组)进行比较.结果 在8562例进行血清PSA筛查的男性中,有719例血清PSA水平≥4.0 ng/ml,其中295例接受经直肠前列腺系统活检,共检出前列腺癌58例,活检率和活检阳性率分别为41.0%和19.7%.虽然两组患者的年龄分布差异无统计学意义(P=0.176),但筛查组中有41.4%(24/58)的患者年龄＞75岁,明显高于临床组(25.6%,P=0.0491).筛查组中血清PSA水平≥20.0 ng/ml的患者所占的比例为44.8%,明显低于临床组(75.6%,P＜0.0001).筛查组中活检Gleason评分＜7分的患者所占的比例为60.3%,明显高于临床组(34.1%,P=0.0020).筛查组中临床分期为T1和T2期(局限期)患者所占的比例为87.9%,明显高于临床组(26.8%,P＜0.0001).筛查组中接受根治性前列腺切除术的患者所占的比例为50.0%,明显高于临床组(18.3%,P＜0.0001).在年龄≤75岁的患者中,筛查组患者诊断时的血清PSA水平、活检Gleason评分和临床分期均显著低于临床组(均P＜0.05);在年龄＞75岁的患者中,筛查组患者的临床分期也明显低于临床组(P=0.0002),但两组诊断时血清PSA水平和活检Gleason评分的差异并无统计学意义(均P＞0.05).结论 应用血清PSA在我国50岁以上男性中进行前列腺筛查是有效的.筛查出的前列腺癌患者在血清PSA水平、活检Gleason评分、临床分期以及根治性切除的机会等方面均较临床组有明显优势.     

Serum insulin-like growth factor I/free prostate specific antigen (IGF-I/fPSA) ratio enhances prostate cancer detection in men with total PSA 4.0-10.0 ng/ml

BACKGROUND: Recent studies have suggested that IGF-I and IGFBP-3, in combination with PSA, may enhance PCa detection. This study was to investigate the use of serum IGF-I and IGFBP-3, and their combinations with prostate volume and fPSA in enhancing the discriminatory diagnosis of PCa in men with tPSA of 4.0-10.0 ng/ml. METHODS: Serum IGF-I and IGFBP-3 were determined by ELISA from 586 men with tPSA between 4.0 and 10.0 ng/ml. Of them, 281 were diagnosed with PCa and 305 without. ROC, univariate and multivariate logistic regression analyses were performed to evaluate the predictive performance of those parameters. RESULTS: IGF-I, IGFD, IGF-I/fPSA, and IGFBP-3/fPSA were significantly higher in PCa cases than benign controls, whereas the differences of IGFBP-3 and IGFBPD were statistically insignificant between the two groups, respectively. The AUC values indicated enhanced performance of IGF-I/fPSA ratio (AUC = 0.753) in PCa detection compared with the currently used f/tPSA (AUC = 0.689). Multivariate logistic regression confirmed the observed relationships and identified IGF-I/fPSA as independent factor in PCa presence. CONCLUSION: Our data show that IGF-I/fPSA as a promising marker can enhance PCa detection in ambiguous cases often found in the tPSA between 4.0 and 10.0 ng/ml.     

Combined use of prostate-specific antigen derivatives decreases the number of unnecessary biopsies to detect prostate cancer.

The authors evaluated the prostate cancer detection rate in Turkish patients with prostate-specific antigen (PSA) levels of 4 ng/ml to 10 ng/ml and who had normal digital rectal examination (DRE) findings. They also aimed to evaluate the value of PSA density and percent free PSA in minimizing unnecessary prostate biopsies for these PSA ranges. This prospective study included 134 consecutive men referred for early prostate cancer detection or lower urinary tract symptoms. All men underwent transrectal ultrasound with systematic sextant needle biopsies. The ability of PSA density and percent free PSA to improve the power of PSA in the detection of prostate cancer was evaluated with statistical analyses as well as receiver operating characteristics curves. Among the 134 men, 124 (92.5%) had a benign histology and 10 (7.5%) had cancer diagnosed on the initial biopsies. Despite the disappointing results in regard to the sensitivity and specificity of PSA derivatives alone, the combination of PSA density and percent free PSA significantly increased the area under the curve compared with the use of each test alone. To increase the specificity of PSA in this patient population, the authors recommend combining two PSA derivatives in deciding whether to perform a biopsy. In a PSA range of 4 ng/ml to 10 ng/ml and with normal DRE, a percent free PSA < 21% and a PSA density > 0.18 yields highest specificity with 90% sensitivity.     

Clinical and pathological characteristics of screen-detected versus clinically diagnosed prostate cancer in Nanjing, China

Previous studies have suggested that implementation of PSA screening in China is of crucial importance. This study compared clinical and pathological characteristics of screen-detected and clinically diagnosed prostate cancers and evaluated the effectiveness of PSA screening for early detection of prostate cancer in Nanjing. Between July 2004 and December 2005, 8,562 men aged ≥50 years were included for PSA screening. Participants with serum PSA ≥4.0 ng/ml were recommended for transrectal ultrasonography (TRUS)-guided prostate needle biopsy (TRNB). During the same period, 82 consecutive clinically diagnosed prostate cancers were included as controls. The clinical and pathological features of the screened versus clinically diagnosed cancers were evaluated. A total of 719 (8.4%) of screened men had PSA levels ≥4.0 ng/ml. Biopsy was performed in 295 men, and 58 prostate cancers were detected. The biopsy rate, positive predictive value (PPV), and detection rate were 41.0, 19.7, and 0.68%, respectively. More screened patients were found with PSA levels <20 ng/ml (55.2 vs. 22.4%, P < 0.001), Gleason scores <7 (60.3 vs. 34.1%, P = 0.002), organ-confined tumors (87.9 vs. 26.8%, P < 0.001), and opportunities for radical prostatectomy (50.0 vs. 18.3%, P < 0.001) than that in clinically diagnosed patients. PSA screening is effective for early detection of prostate cancer in Chinese elderly men. Favorable PSA levels, Gleason scores, clinical stages, and chances for radical prostatectomy are associated with PSA screening. Further studies are needed to evaluate the effect of screening on treatment outcomes and mortality of prostate cancer in Chinese.     

Prostate-specific Antigen Velocity (PSAV) and PSAV per Initial Volume (PSAVD) for Early Detection of Prostate Cancer in Chinese Men

Aim: To investigate the utility of prostate-specific antigen velocity (PSAV) and PSAV per initial volume(PSAVD) for early detection of prostate cancer (PCa) in Chinese men. Methods: Between January 2009 andJune 2012, a total of 193 men (aged 49–84 years, median 67 years) with at least 2 transrectal ultrasonography(TRUS) procedures and concurrent serum PSA measurements underwent prostate biopsy because of suspicionof PCa. The total group were classified into PCa and non-PCa groups, and the variables of the two groups werecompared. Univariate and multivariate analyses were used to investigate which variables were predictove. Thediagnostic values of PSAV, PSAVD and prostate-specific antigen density (PSAD) were compared using receiveroperating characteristic (ROC) analysis. Results: Prostate cancer was diagnosed in 44 (22.8%) of the 193 men.There were significant differences between the groups in last and initial prostate volumes determined by TRUS,initial age, last serum PSA levels, PSAV, PSAD and PSAVD. After adjusting for confounding factors, the oddsratios of PCa across the quartile of PSAVD were 1, 4.06, 10.6, and 18.9 (P for trend <0.001).The area under theROC curves (AUCs) of PSAD (0.779) and PSAVD (0.776) were similar and both significantly greater than thatof PSA (AUC 0.667). PSAVD was a significantly better indicator of PCa than PSAV (AUC 0.736). There was nostatistical significant difference between the AUC of PSAV and that of last serum PSA level. The sensitivity andspecificity of PSAVD at a cutoff of 0.023ng in participants with last serum PSA levels of 4.0ng/mL-10.0ng was73.7% and 70.7%, respectively. Conclusions: The results of this study demonstrated PSAVD may be a usefultool in PCa detection, especially in those undergoing previous TRUS examination.     

Prostate cancer screening: current trends and future implications.

Screening for prostate cancer represents a clinical dilemma with no clear evidence to suggest decreased mortality from any diagnostic test. We now possess new knowledge regarding optimal combinations of DRE, TRUS, and PSA. While DRE and TRUS may be too subjective and PSA too nonspecific, their combined predictive values identify not only men at high risk but also those for whom continued frequent screening may not be cost effective. A monoclonal PSA decision level of no more than 4.0 ng/ml should be used, since 40 percent of cancers detected from 4.0 to 10.0 ng/ml already have extracapsular extension. Assuming that DRE is performed by experienced examiners, the combination of PSA and DRE should produce cost-effective early detection and minimize missed cancers below 4.0 ng/ml. TRUS should be reserved for those patients with either PSA elevations and/or DRE abnormalities. The use of TRUS gland volume data to further modify PSA decision levels, such as the "predicted" PSA concept, may also improve TRUS biopsy criteria and predictive values. Prostate cancer detection can then be objectively limited to a small percentage of the population and better selected for earlier, more localized disease. The ultimate decrease in mortality from screening remains to be demonstrated in randomized trials or observed only after decades of increased public awareness about prompt early detection combined with effective, definitive therapy.     

Free-to-total prostate-specific antigen (PSA) ratio contributes to an increased rate of prostate cancer detection in a Japanese population screened using a PSA level of 2.1–10.0 ng/ml as a criterion

BACKGROUND: Although the free-to-total prostate-specific antigen (PSA) ratio (f/t ratio) is low in prostate cancer, its usefulness in mass screening remains unclear. We examined the clinical usefulness of the f/t ratio for screening in a Japanese population. METHODS: Since 2000, we have performed PSA screening in Japanese men aged 55-69 years. From 2000 to 2002, patients with total PSA (tPSA) levels over 2.1 ng/ml were referred to the urological clinic for secondary screening, regardless of the f/t ratio. We analyzed both the tPSA level and the f/t ratio in prostate cancer patients, and since 2003, subjects with tPSA levels ranging from 2.1-10.0 ng/ml and f/t ratios higher than 0.22 have not been referred for secondary screening. Here, we report the results of tPSA screening, comparing findings in the two periods (2000-2002 and 2003-2005). RESULTS: Between 2000 and 2005, we performed the tPSA screening test in 27 730 men, and detected 214 cases of prostate cancer. Sixty patients (28.0%) showed tPSA levels between 2.1 and 4.0 g/ml. There were no differences in cancer detection rates between the two periods in the populations referred for an initial screening. However, the percentage of individuals referred for secondary screening decreased from 17.0% to 13.0% during the later period (P < 0.001). The cancer detection rate in all patients with biopsies rose from 13.5% in the earlier period to 22.7% in the later period for the group with tPSA between 2.1 and 10.0 ng/ml (P < 0.001). CONCLUSION: The f/t ratio may be a useful additional screening parameter for patients showing tPSA levels between 2.1 and 10.0 ng/ml on their initial screening examination.     

Prostate-specific antigen velocity and the detection of gleason score 7 to 10 prostate cancer

BACKGROUND: An increasing prostate-specific antigen (PSA) velocity is associated with a shorter survival after local therapy for prostate cancer. In this study, the authors evaluated whether PSA velocity was associated with prostate cancer detection and grade at diagnosis after adjusting for established predictors. METHODS: Between January 1989 and December 2003, 914 men who had PSA levels >/=4 ng/mL were identified by using the Center for Prostate Disease Research (CPDR) multicenter national database, including 541 men who were diagnosed with prostate cancer. Multivariable logistic regression analyses were performed that included continuous variables (PSA velocity and level, number of prior negative biopsies, and age) along with categorical variables (ethnicity and family history) were used to identify the factors associated with prostate cancer detection and grade. RESULTS: An increasing PSA velocity was associated with Gleason scores from 7 to 10 versus Gleason scores form 2 to 6 or no cancer (adjusted odds ratio [OR], 1.04 ng/mL per year; 95% confidence interval [95% CI], 1.003-1.085 ng/mL per year; P = .035). This finding was not evident in patients who had prostate cancers with Gleason scores between 2 and 6 or for any prostate cancer. PSA level was associated with the detection of any prostate cancer (OR, 1.06 ng/mL; 95% CI, 1.03-1.10 ng/mL; P = .004) and Gleason score 4 ng/mL. These findings, in conjunction with life expectancy, may be used when deciding which men should not be recommended for prostate biopsy despite a PSA level >4 ng/mL.     

The relationship of prostate-specific antigen to digital rectal examination and transrectal ultrasonography. Findings of the American Cancer Society National Prostate Cancer Detection Project.

The participating institutions of the American Cancer Society National Prostate Cancer Detection Project did 520 biopsies on 2425 men over a 3.5-year period. A total of 88 cancers were confirmed pathologically, 93% of which clinically were organ confined. In 324 men (62.3%), a recommendation for biopsy was made based solely on the results of transrectal ultrasonography (TRUS); in 69 patients (13.3%), solely on the digital rectal examination (DRE); in 116 patients (22.3%), on abnormal DRE and TRUS examinations; and in 11 patients (2.1%), in whom DRE and TRUS were normal, on elevated prostate-specific antigen (PSA) levels. The TRUS was abnormal in 80.6% of men found to have cancer, and the PSA level and DRE were abnormal for 67% and 50% of cancers, respectively. The influence of PSA level on cancer detection increased as the serum level increased above 4 ng/ml. The positive predictive values of both the DRE and TRUS were influenced significantly by the presence of an elevated PSA level (P = 0.044 and P less than 0.001, respectively). The results of this ongoing multicenter study support the following statements: (1) the prostate cancer detection rate is influenced by this diagnostic triad and (2) the detection rate of organ-confined disease can be improved substantially by early detection programs.     

Prostate-specific antigen, digital rectal examination, and transrectal ultrasound in predicting the probability of cancer.

Over a 4 1/2 year period, 1,940 asymptomatic men were entered in a prostate cancer detection program consisting of digital rectal examination (DRE), prostate-specific antigen (PSA), and transrectal prostate ultrasound (TRUS). Four hundred and sixteen biopsies were performed resulting in the diagnosis of 79 cancers; 82% had clinically organ confined tumors. A recommendation for biopsy was made in 260 (62%) based on the TRUS alone, 55 (13%) by DRE alone, 92 (22%) when the DRE and TRUS were both abnormal, and in 9 (2.2%) cases when only PSA levels were elevated. The DRE, PSA, and TRUS were abnormal in 1,261 (65%), 989 (51%), and 1,552 (80%) of the patients with cancer, respectively. Prostate cancer detection increased as the serum PSA level increased above 4 ng/ml. The positive predictive value of both DRE and TRUS were significantly influenced by an elevated PSA, (P = .042 and P less than .00005, respectively). The results of this study support the idea that, although the prostate cancer detection rate is influenced by these three modalities and the detection rate of localized disease can be improved by early detection programs, its effect on mortality rates remains undefined at this time.     

Cumulative probability of PSA increase above 4.0 NG/ML in population-based screening for prostate cancer

Routine screening for prostate cancer remains controversial. However, it is very important to show how the optimal rescreening interval should be set for men who want to be screened after informed consent. To solve this issue, the risk of prostate-specific antigen (PSA) increase above 4.0 ng/ml relative to baseline PSA levels and age was investigated. Between 1988 and 2000, 7,757 subjects screened twice or more and also with baseline PSA levels of 4.0 ng/ml or lower were enrolled in our study. All serum PSA levels were measured by E-test Tosoh II PA assay at one center. Interval PSA levels for men undergoing screening with a greater than 1 year interval were calculated on the assumption that PSA levels changed over time in a simple exponential fashion. Then, the cumulative rate of freedom from PSA increase above 4.0 ng/ml was estimated using the Kaplan-Meier technique stratified by baseline PSA ranges of 0.0 to 1.0, 1.1 to 2.0, 2.1 to 3.0 and 3.1 to 4.0 ng/ml and every 10 years of age ranges. Of the 7,757 subjects, 559 (7.2%) were expected to have had PSA levels increase above 4.0 ng/ml within 5 years after the baseline PSA measurements. The cumulative rate of freedom from the PSA increase above 4.0 ng/ml at 5 years was 98.7%, 92.9%, 70.3% and 38.5% in cases of baseline PSA levels of 1.0 ng/ml or lower, 1.1 to 2.0 ng/ml, 2.1 to 3.0 ng/ml and 3.1 to 4.0 ng/ml, respectively. The cumulative rates of freedom from the PSA increase were significantly decreased with the baseline PSA ranges being higher regardless of age range. Re-screening interval should be set stratified by baseline PSA levels, regardless of age and race. Rescreening interval should be set at 1, 1 to 2 and 3 to 5 years for men with baseline PSA ranges of 2.1 to 4.0 ng/ml, 1.1 to 2.0 ng/ml and 0.0 to 1.0 ng/ml, respectively, in individual-based screening. In mass screening system using PSA alone, rescreening interval should be set in the same manner as in individual-based screening, except for men with baseline PSA levels of 1.1 to 2.0 ng/ml, which should be set at 1 year to avoid developing incurable prostate cancer.     

The clinical utility of measuring total PSA, PSA density, gamma-seminoprotein and gamma-seminoprotein/total PSA in prostate cancer prediction

BACKGROUND: To evaluate whether serum total prostate-specific antigen (PSA), PSA density (serum total PSA level divided by prostate volume), gamma-seminoprotein and gamma-seminoprotein/total PSA ratio could predict prostate cancer (PCa) prior to biopsy. METHODS: A total of 316 consecutive patients who had undergone transrectal prostate biopsy and/or transurethral resection were examined. The prostate volume was determined by transrectal ultrasonography (TRUS) and the ability of the above-mentioned four variables to distinguish PCa from benign prostatic hyperplasia (BPH) was evaluated. RESULTS: PCa was detected in 61 cases. Receiver-operating characteristic (ROC) analysis revealed that both the PSA density and serum total PSA were the most useful predictors of PCa among the four variables. For the patients with a serum total PSA level of 4.1-10.0 ng/ml, PSA density was significantly more accurate than total PSA (p < 0.005). An optimum PSA density value of 0.18 was chosen as a cutoff because it showed the highest sum of sensitivity and specificity, 92 and 54%, respectively. Using this PSA density cutoff, the number of biopsies could have been reduced to 57 from 63% when compared with a PSA density of 0.15. CONCLUSIONS: PSA density was significantly more accurate than other variables in predicting PCa. To avoid unnecessary biopsies, the PSA density cutoff value of 0.18 would be recommendable for determining a prostate biopsy for Japanese males with a serum total PSA level of 4.1-10.0 ng/ml.