Digital rectal examination, transrectal ultrasonography and prostate specific antigen for diagnosis of prostate cancer in clinical urological practice-detection of impalpable cancer]

OBJECTIVE: The clinical usefulness of multimodality detection for prostate cancer by digital rectal examination (DRE), transrectal ultrasonography (TRUS) and serum PSA determination (PSA) was evaluated in this retrospective study. PATIENTS AND METHODS: A total of 1344 symptomatic male patients who underwent DRE, TRUS and PSA in our outpatient clinic were studied. Prostate biopsies were performed when at least one diagnostic test was positive. RESULTS: Of 1344 patients, 436 (32.4%) had positive test results. Among 403 patients who underwent biopsy, 121 patients (30.0%) were found to have prostate cancer. The overall cancer detection rate was 9.0%. Among the 121 cancer patients, if examination had been carried out using only one or two tests, cancer would have not been detected in 22 patients (18.2%) by DRE alone, 27 patients (22.3%) by TRUS alone, 18 patients (14.9%) by PSA alone, 12 patients (9.9%) by a combination of DRE and TRUS, and 6 patients (5.0%) by a combination of DRE and PSA. Among the 121 patients with cancer, 22 (18.2%) had impalpable cancer. Impalpable cancer was more likely to be localized (77.3%) than palpable cancer (28.3%, p < 0.001) and more likely to be well or moderately differentiated (72.7%) than palpable cancer (41.4%, p = 0.008). CONCLUSION: This study confirmed the need for multimodality detection using DRE, TRUS and PSA as complementary methods in order to minimize decrease in cancer detection. In particular, impalbable cancers not detectable by DRE were detected and were revealed to be more likely to be localized and amenable to curative therapy. These results therefore underscore the importance of multimodality detection for early diagnosis of prostate cancer in urological practice.     

以前列腺特异抗原水平分组筛查与前列腺穿刺阳性率的关系

目的探讨不同血清前列腺特异抗原(PSA)水平前列腺癌检出情况以及直肠指诊(DRE)、经直肠超声检查(TRUS)、PSA密度(PSAD)等指标对筛查前列腺穿刺活检病例的意义。方法回顾性分析在1996年4月至2002年12月间行TRUS引导前列腺6点系统穿刺活检的634例患者的诊断资料,对各PSA组(≤4.0,4.1~,10.1~和>20.0μg/L组)中前列腺癌的检出率,以及PSA、DRE、TRUS、PSAD等对前列腺癌的预测作用进行t检验、χ2检验和多因素Logistic回归分析。结果PSA≤4.0,4.1~,10.1~和>20.0μg/L各组的前列腺癌检出率分别为11.6%(17/146),26.8%(38/142),39.8%(68/171)和68.6%(120/175)。PSA的敏感性最高(93.0%),特异性低(33.0%);DRE、TRUS等诊断效率较低。随血清PSA水平升高,前列腺癌检出率以及DRE、TRUS的阳性预测值逐渐升高;在PSA4.1~20.0μg/L者中,PSAD对前列腺癌有较大的预测价值(OR=687.09±646.96,P=0.000)。以PSAD≥0.13μg.L-1.cm-3为截点筛查前列腺穿刺病例,可在不明显降低敏感性的基础上,减少阴性穿刺。结论各PSA组国人与欧美等国前列腺癌检出率有较大差别;DRE、TRUS的筛查作用与血清PSA水平有关;按PSA水平分组筛查穿刺病例,可提高前列腺穿刺的阳性率。     

Predictors for biopsy outcome in the European Randomized Study of Screening for Prostate Cancer (Rotterdam region).

BACKGROUND: In the European Randomized Study of Screening for Prostate Cancer (ERSPC, Rotterdam region), men aged 55-74 years are screened for prostate cancer by prostate-specific antigen (PSA) sampling, digital rectal examination (DRE), and transrectal ultrasound investigation (TRUS). All men with a PSA > or =4 ng/ml and/or a suspicious DRE and/or a suspicious TRUS are biopsied. METHODS: Logistic regression analysis was applied to derive a predictive index that equals the chance to find prostate cancer in a biopsy given the outcomes of the screening tests. This model was used to assess the number of cancers that could have been detected if all men had been biopsied (extrapolation). Furthermore, the model was used to study the possibilities for improvement of the current screening protocol. RESULTS: PSA was the dominant predictor for prostate cancer in a biopsy, followed by prostate volume, DRE, and TRUS result. It is assessed that 69% (95% CI, 52-86%) of cancers that could be identified if all men were biopsied are currently detected. Application of the same methods to screening data obtained in G?teborg (the Swedish ERSPC partner) yielded almost identical results. It was found that, in the Rotterdam protocol, a considerable number of men were biopsied according to the screening protocol with an assessed lower chance to have prostate cancer than men who were not biopsied according to the protocol. CONCLUSIONS: The chance to detect prostate cancer in a biopsy can be modeled quite accurately as a function of serum PSA, prostate volume, DRE, and TRUS results. Important improvements in the screening protocol can be achieved by the application of the predictive index.     

Early detection of prostate cancer in the ESRD population

BACKGROUND: There are currently no prostate cancer screening guidelines specific to the end-stage renal disease (ESRD) population. With this in mind, we evaluated the clinical usefulness of digital rectal examination (DRE), serum total prostate-specific antigen (PSA), prostate-specific antigen density (PSAD) and transrectal ultrasound (TRUS) in predicting prostate cancer in men with ESRD. METHODS: Fifty male ESRD patients age 40 years and older with no prior history of prostate cancer were enrolled in the study. All patients underwent PSA measurement and a DRE followed by a TRUS. PSAD was calculated as the total PSA divided by the prostate volume. Ultrasound-guided prostate biopsies were performed on any patient with 1 or more of the following abnormal findings: a nodule detected on DRE; an abnormal TRUS; PSA > 4.0 ng/ml, or a PSAD > 0.15 ng/ml/cm3. RESULTS: Abnormal findings were detected in 19 patients. Two (4%) had an abnormal DRE, 3 (6%) had PSA > 4.0 ng/ml, 3 (6%) had PSAD > 0.15 ng/ml/cm3 and 16 (32%) had abnormal findings on TRUS. Three patients had 2 abnormal findings and 1 had 3. Of the 15 prostate biopsies performed, 4 (27%) revealed prostate cancer and 3 (20%) high-grade prostatic intraepithelial neoplasm (HGPIN) comprising 8% and 6%, respectively, of the studied population. Of the 4 patients diagnosed with prostate cancer, none had abnormal DRE, 2 (50%) had PSA > 4.0 ng/ml (sensitivity = 66.7% and PPV = 50% (p = 0.236)), 3 (75%) had PSAD > 0.15 ng/ml/cm3 (sensitivity = 100% and PPV = 75% (p < 0.018)), and 3 (75%) had abnormal findings on TRUS (sensitivity = 30% and PPV = 75% (p = 1.000)). CONCLUSION: Routine screening with PSA and DRE does not seem sensitive enough to predict the presence of the disease. Although TRUS detected abnormalities in 16 patients (32%), sensitivity was very low (30%). In our patients, PSAD increased the sensitivity and positive predictive value (PPV) of detecting prostate cancers compared to PSA alone.     

Serendipity in detecting disease in low prostate-specific antigen ranges

OBJECTIVE: To assess the magnitude of prostate cancer detection by serendipity (the coincidental detection of prostate cancer during the evaluation of an abnormal screening test result) when a digital rectal examination (DRE) and transrectal ultrasonography (TRUS) are used as initial screening tests for prostate cancer in men with low levels of prostate-specific antigen (PSA; 0.0-3.9 ng/mL). PATIENTS AND METHODS: In all, 117 participants of a population-based screening study were diagnosed with prostate cancer after a standard evaluation of an abnormal screening test result; 49 underwent radical prostatectomy. Serendipity was defined as either: (i) the presence of prostate cancer opposite to the side that raised suspicion for cancer on DRE and/or TRUS; (ii) a negative lesion-directed biopsy while cancer was present in one or more of the cores of the sextant biopsy; (iii) a tumour volume of < 0.5 mL on radical prostatectomy. RESULTS: Depending on the definition, 27-63% of prostate cancers detected at low PSA values were detected coincidentally and not as a result of a true-positive test result. The proportion of cancers detected by serendipity was inversely correlated with serum PSA level. CONCLUSION: A relatively high proportion of prostate cancers diagnosed in men with low PSA levels, and in which a biopsy was prompted by a suspicious DRE and/or TRUS, are considered to be detected by chance only. As these cancers are mostly small (< 0.5 mL), with potentially low biological aggressiveness, relying on serendipity seems disadvantageous in prostate-cancer screening. The level of serendipity in prostate cancer detection, the poor performance of the screening test, and high inter-observer variability, casts further doubt on the utility of DRE (and TRUS) as initial screening tests for prostate cancer in population-based screening.     

Predictors of prostate cancer on repeat transrectal ultrasound-guided systematic prostate biopsy

BACKGROUND: We analyzed the outcome of repeated transrectal ultrasound (TRUS)-guided systematic prostate biopsy in Japanese men whose clinical findings were suspected of prostate cancer after previous negative biopsies. METHODS: Between January 1993 and March 2002, 1045 patients underwent TRUS-guided prostate biopsy. Among them, 104 patients underwent repeat biopsy due to indications of persistent elevated serum prostate-specific antigen (PSA), abnormal digital rectal examination (DRE) or TRUS, increased PSA velocity, and/or previous suspicious biopsy findings. Several clinicopathological factors were evaluated for their ability to predict the detection of prostate cancer on repeat biopsy. RESULTS: Prostate cancer was detected in 22 of 104 patients (21.2%) who underwent repeat biopsies. PSA concentration and PSA density at both the initial and repeat biopsies, and PSA velocity in men with positive repeat biopsy were significantly greater than those in men with negative repeat biopsy. The incidence of abnormal findings in DRE and TRUS at initial biopsy in men with positive repeat biopsy was also significantly higher than that in men with negative repeat biopsy. However, neither the presence of prostatic intraepithelial neoplasia nor number of biopsy cores at initial biopsy had a significant association with the results of the repeat biopsy. Furthermore, multivariate analysis revealed that PSA and PSA density at both the initial and repeat biopsies, PSA velocity, and DRE and TRUS findings at initial biopsy were independent predictors of malignant disease on repeat biopsy. CONCLUSION: Despite an initial negative biopsy, repeat TRUS-guided biopsy should be carried out to exclude prostate cancer in cases of suspicious clinical findings, such as elevated PSA or PSA-related parameters, or abnormal findings of DRE or TRUS.     

Evaluation of prostatic specific antigen and digital rectal examination as screening tests for prostate cancer

BACKGROUND: The 11,811 first visits and 46,751 annual follow-up visits performed since 1988 were analyzed in order to assess the efficacy of serum prostatic specific antigen (PSA) and digital rectal examination (DRE) for diagnosis of prostate cancer. METHODS: At first visit, screening included DRE and measurement of PSA using 3.0 ng/ml as upper limit of normal, demonstrated as optimal value in the course of the study. Transrectal echography of the prostate (TRUS) was performed only if PSA and/or DRE was abnormal. For elevated PSA, biopsy was performed only if PSA was above the value predicted from prostatic volume measured by TRUS. At follow-up visits, it was decided during the course of the study to use PSA alone. RESULTS: PSA was above 3.0 ng/ml in 16.6% and 15.6% of men at first and follow-up visits, respectively. Prostate cancer was found in 2.9% of men invited for screening at first visit and in only 0.4% of men at follow-up visits for a 7.1-fold decrease at follow-up visits done up to 11 years. PSA alone allowed to find 90.5% and 90. 0% of cancers at first and follow-up visits, respectively, compared to 41.1% and 25.0% by DRE alone. In the presence of normal PSA, 344 and 1,919 DREs are needed to find one prostate cancer at first and follow-up visits, respectively. A significant improvement in stage of the disease is found at follow-up (215 cancers) compared to first visits (337 cancers). Comparison made between men invited for screening and those who were not invited but screened showed no significant difference in terms of incidence and prevalence of prostate cancer as well as diagnosis of cancer as a function of age or as a function of PSA, DRE, and TRUS data. The cost for finding one case of prostate cancer is estimated at Can $2,420 and Can $7, 105 (first and follow-up visits, respectively, when PSA is used as prescreening). CONCLUSIONS: PSA used as prescreening and followed by DRE and TRUS when PSA is abnormal is highly efficient in detecting prostate cancer at a localized (potentially curable) stage since 99% of the cancers diagnosed were at such a localized stage, thus practically eliminating the diagnosis of metastatic and noncurable prostate cancer. The approach used is highly reliable, sensitive, efficient, and acceptable by the general population. The detection of clinically nonsignificant cancer is an exception.     

Clinical, biochemical and pathological features of initial and repeat transrectal ultrasonography prostate biopsy positive patients

BACKGROUND: Using sextant biopsy, 16-41% of prostate cancers were diagnosed on repeat biopsy. The objective of the present study was to compare the differences in the clinical, biochemical and pathological features between patients with positive results on initial and repeat biopsies, with an aim to identify factors that can be used to improve the detection rate of transrectal ultrasound (TRUS) biopsy of the prostate. METHODS: Between February 2000 and April 2001, 222 patients with a mean age of 64 years (range 38-85) underwent TRUS-guided 10-core prostate biopsy for either abnormal prostate specific antigen (PSA) levels (>4 ng/mL) and/or abnormal digital rectal examination (DRE). Of this number, 165 patients underwent their first biopsy, whereas 45 and 12 patients had had one or two previous biopsies, respectively. RESULTS: Prostate cancer detection rates for the initial biopsy group (n = 165), second biopsy group (n = 45) and third biopsy group (n = 12) were 29.7, 23.0 and 41.7%, respectively. Six patients who had a negative first 10-core biopsy underwent a second 10-core biopsy and one patient (16%) was found to have cancer. Apart from total prostate volume, there were no significant statistical differences between the patient age, mean total PSA, PSA density, PSA-transition zone density, DRE and TRUS findings between the initial and repeat biopsy groups of subjects who had cancer. Those who had cancer detected only on repeat biopsies had larger prostate glands (P = 0.041). CONCLUSION: Patients who had cancer detected only on repeat biopsies had bigger prostate glands, supporting the hypothesis that TRUS sextant biopsy as a technique suffers the error of under-sampling in a bigger prostate.     

Endosonography of the prostate]

The role of transrectal prostate ultrasonography (TRUS) for screening and early detection is controversial due to its low sensitivity and specificity. The digital rectal examination (DRE) in combination with PSA still remains useful in screening for prostate cancer. Less than 4% of patients with normal DRE and normal PSA have prostate cancer found on random biopsies. We recommend TRUS for exact determination of prostate volume, in patients with suspicious DRE findings, in combination with the Biopty gun for ultrasound-guided biopsies, and in staging before radical prostatectomy.     

Diagnostic value of percent free prostate-specific antigen: retrospective analysis of a population-based screening study with emphasis on men with PSA levels less than 3.0 ng/mL

OBJECTIVES: To retrospectively investigate the use of percent free prostate-specific antigen (PSA) compared with total PSA in serum as predictor of prostate cancer in men selected randomly from the general population who underwent biopsy on the basis of abnormal findings on digital rectal examination (DRE) or transrectal ultrasound (TRUS) and/or serum PSA levels greater than 10 ng/mL. METHODS: A single intervention, population-based screening study was undertaken in 1988 and 1989. Of the 2400 men aged 55 to 70 years invited to participate, 1782 men responded and were examined with DRE, TRUS, and PSA testing (Tandem-Hybritech). In 1995, frozen serum samples from 1748 men were analyzed for percent free PSA (Prostatus, Wallac OY). Five-year follow-up data on new cancers in the screened population were obtained from the Swedish Cancer Registry (SCR). RESULTS: Of the 1748 men, 367 underwent TRUS-guided biopsies because of abnormal findings on either DRE or TRUS or serum PSA levels of greater than 10 ng/mL. This resulted in the diagnosis of 64 cases of prostate cancer (3.7%). PSA levels of 3.0 ng/mL or greater were found in 55 (86%) of 64 cancer cases and in 399 (24%) of the 1684 benign cases. Among the 1294 men with PSA less than 3.0 ng/mL, 9 prostate cancers were diagnosed (14% of all prostate cancers). All 9 patients with cancer and with PSA less than 3.0 ng/mL had a percent free PSA of 18% or less. In the group of 1109 patients with PSA less than 3.0 ng/mL and a percent free PSA greater than 18%, 159 biopsies were performed because of abnormal DRE or TRUS. However, no prostate cancer was diagnosed in this category of patients. Five years after the screening intervention, 7 more cases of prostate cancer were clinically diagnosed in the screened population according to the SCR. CONCLUSIONS: The combination of PSA levels less than 3.0 ng/mL and percent free PSA greater than 18% defines a large part of the population at a very low risk of cancer of the prostate both at the time of screening and during the following 5 years. Men in this group may be spared DRE, and longer screening intervals may be considered. However, the risk of having prostate cancer is not negligible in men with PSA less than 3.0 ng/mL and percent free PSA of 18% or less. The results of this study indicate that biopsy should be recommended to men fulfilling these criteria, although these results should be confirmed in larger prospective studies because of the limited number of patients with prostate cancer in the present series.     

Volume-adjusted prostate-specific antigen (PSA) variables in detecting impalpable prostate cancer in men with PSA levels of 2-4 ng/mL: transabdominal measurement makes a significant contribution

OBJECTIVE: To examine whether prostate-specific antigen (PSA) levels adjusted according to prostate volume improve prostate cancer detection using transrected biopsies in men with PSA levels of 2-4 ng/mL, and benign findings on a digital rectal examination (DRE). PATIENTS AND METHODS: Men aged < or = 79 years and with serum PSA levels of 2-4 ng/mL and normal DRE findings were prospectively enrolled. Eligible patients were recommended for transrectal prostate biopsies after measuring prostate volumes with transrectal (TRUS) and transabdominal (TAUS) ultrasonography, and transition zone volumes with TRUS. In addition to PSA levels and the free-to-total PSA ratio, volume-adjusted PSA levels, PSA densities determined by TRUS (PSAD(TRUS)), and TAUS (PSAD(TAUS)), and PSA transition zone densities (PSATzD) were compared using receiver operating characteristic analysis. RESULTS: Prostate cancer was diagnosed in 31 (22%) of the 139 men who had prostate biopsies. The area under the curve (AUC) of PSAD(TRUS) (0.796) and PSATzD (0.792) was similar and significantly greater than that of PSA (AUC 0.588) and the free-to-total PSA ratio (AUC 0.658). PSAD(TAUS) was a significantly better indicator of prostate cancer than PSA levels alone (P = 0.043). CONCLUSION: As predictors of prostate cancer, there were no significant differences between PSAD(TRUS) and PSATzD. Although PSAD(TAUS) was worse than PSA variables adjusted by total and transition zone prostate volumes determined by TRUS, it was a better predictor than the PSA value alone in men with a low PSA level. These results indicate that TAUS is worthwhile where the routine use of TRUS before biopsy is difficult.     

Clinical evaluation of transrectal power Doppler imaging in the detection of prostate cancer

To evaluate the clinical usefulness of power Doppler imaging (PDI), we compared this method to gray-scale transrectal ultrasound (TRUS) in the detection of prostate cancer. A total of 101 men with abnormally high serum prostate specific antigen (PSA) levels and/or abnormal digital rectal examination (DRE) findings were assessed using TRUS and PDI. Random systematic sextant and bilateral far lateral prostate biopsies were performed in all cases. In addition, when TRUS revealed a hypoechoic lesion or PDI revealed a hypervascular lesion (HVL), these lesions were directly biopsied. Of the 101 patients, 48 (47.5%), 42 (41.5%) and 42 (41.5%) were suspicious of having prostate cancer by DRE, TRUS and PDI, respectively. Prostate needle biopsy revealed prostate cancer in 39 patients (38.6%) and benign prostatic diseases in 62 patients (61.4%). If prostate needle biopsy was avoided when PDI was negative, then PDI eliminated the need for biopsy in 59 of the 101 patients (rate of biopsy procedures saved: 58.4%) and missed only 8 (13.6%) prostate cancers. Moreover, in 63 patients with intermediate PSA (3-10 ng/ml), the rate of biopsy procedures saved by DRE, TRUS, and PDI was 60.3%, 65.1%, and 68.3%, respectively, and the rate of cancers missed was 26.3%, 19.5%, and 14.0%, respectively. In a total of 826 specimens of TRUS-guided prostate biopsy, 126 (15.3%) specimens had adenocarcinoma. Site by site based analysis of the present series revealed 34.1% of prostate cancer sites were isoechoic and hypervascular. On a site by site basis, PDI had better sensitivity, specificity, positive predictive value and negative predictive value than TRUS. In 48 patients without abnormal DRE findings, on a site by site basis, the sensitivities of TRUS and PDI were 22.9% and 34.4%, respectively. Gleason score was associated with a positive rate of PDI on both a patient basis and site by site basis. From these results, on a patient basis, we conclude that PDI was helpful in the indication for prostate biopsy for all patients or patients with intermediate PSA level. On a site by site basis, PDI may be able to select prostate cancer sites at biopsy, in particular in patients without abnormal DRE findings.     

常规临床检查与PSA灰区患者前列腺癌检出率的关系

目的:探讨直肠指检(DRE)、影像学(TRUS、MRI)检查、血清游离与总前列腺特异性抗原(PSA)比值(f/t)与PSA在4～10μg/L之间患者前列腺癌检出率的关系。方法:回顾性分析365例PSA处于灰区的患者进行DRE、TRUS、MRI检查、游离PSA测定,并对这些患者行经直肠B超引导下的前列腺穿刺活检。评估其临床资料与前列腺穿刺病理结果的关系。结果:在365例患者中,穿刺病理为前列腺癌的患者共有87例(23.84%)。DRE阳性的患者共有128例,穿刺阳性40例,阳性率为31.25%,TRUS检查的患者共有257例,其中有异常回声结节的69例患者中穿刺阳性26例,阳性率为37.68%,MRI检查的患者共有191例,其中有异常信号结节的107例患者中穿刺阳性59例,阳性率为55.14%。198例患者行fPSA与tPSA比值分析,其中前列腺癌患者的平均f/t PSA明显低于穿刺阴性患者。f/t PSA受试者曲线(ROC)下的面积(0.725)高于患者PSA ROC的面积(0.542)。结论:结合临床DRE、影像学资料及f/t PSA比值可以有效提高前列腺癌检出率,从而减少不必要的穿刺给患者带来的痛苦。     

Prevalence of undiagnosed prostate cancer in men with erectile dysfunction

OBJECTIVE: To explore the prevalence of prostate cancer in men presenting with erectile dysfunction (ED). PATIENTS AND METHODS: In a prospective study, 127 men with ED of at least 6 months duration underwent screening for prostate cancer using prostate specific antigen (PSA) and a digital rectal examination (DRE). Men with a high PSA level (> 4 ng/mL) had sextant biopsies taken under sedoanalgesia. The serum testosterone level was measured in all the men. RESULTS: Twenty-six men were aged < 50 years and all had a normal PSA level; of 101 men aged > 50 years, 20 had an abnormal PSA. The detection rate for prostate cancer using PSA and DRE was 5%, which was not significantly higher than in the general population. All the detected cancers were clinically significant (> T2a, Gleason grade > 4). Two of the five men diagnosed with prostate cancer were Afro-Caribbean. Of the 127 men, 31% had a low serum testosterone level, but there was no association between testosterone and PSA levels. CONCLUSIONS: Prostate cancer is no more common in men with ED than in the normal male population. Therefore, routine screening for prostate cancer in men with ED is not indicated.     

Screening for prostate cancer without digital rectal examination and transrectal ultrasound: results after four years in the European Randomized Study of Screening for Prostate Cancer (ERSPC), Rotterdam

BACKGROUND: Omission of DRE/TRUS as biopsy indication results in fewer unnecessary biopsies, but may increase the risk of missing potentially aggressive prostate cancers (PCs). In 1997, the biopsy indication within the ERSPC was changed from a PSA cut-off of 4.0 ng/ml and/or abnormal DRE/TRUS (group-1) to solely a PSA cut-off of 3.0 ng/ml (group-2). We estimated the effect of omitting DRE/TRUS by comparing the results of a re-screening 4 years after initial screening to the original policy. METHODS: We compared rate and characteristics of detected PCs in the second round in men initially screened in group-1 (N=5,957) or group-2 (N=8,044). Additionally, we compared the rate of interval cancers (ICs) after screening with and without DRE/TRUS. RESULTS: There was no significant difference in second round cancer-detection-rates (group-1, 3.0%; group-2, 2.7%), positive-predictive-values (group-1, 23.9%; group-2, 26.3%), and number of poorly-differentiated tumors (group-1, 2.6%; group-2, 3.8%). Most PCs were clinically confined to the prostate. Eleven ICs were detected in each group (0.18 and 0.14%). CONCLUSIONS: Omitting DRE/TRUS did not result in an increased IC- or PC-detection. However, considering the natural history of PC, the 4-year follow-up may be too short to draw a definitive conclusion.     

Frequency and clinical significance of transition zone cancer in prostate cancer screening

Approximately 20% of prostate cancers originate in the transition zone (TZ). Although transrectal ultrasound (TRUS) and systematic biopsies have improved peripheral zone (PZ) cancer diagnosis, additional biopsies directed into the TZ may further improve cancer detection. To evaluate the frequency and clinical significance of TZ cancers, we added two TZ biopsies to the routinely performed sextant biopsies. Three hundred forty patients (aged 45–75) from our prostate-specific antigen (PSA) screening study (21,078 volunteers) with negative rectal examination findings underwent systematic and TZ biopsies with three-dimensional ultrasound equipment. All patients had elevated PSA levels according to age-specific reference ranges. Ninety-eight of 340 men (28.5%) had biopsies positive for cancer. Of these 98 cancers, 28 (28%) originated in the TZ only and 5 (5%) were located in the TZ as well as the PZ. Eight men showed TZ abnormalities on ultrasound images, of whom four had biopsies positive for TZ cancer. The TZ cancers detected were pathologically significant in 96% (27 of 28). Seventy-one percent (20 of 28) of pathologically staged cancers were found to be organ confined and all combined TZ and PZ cancers were advanced tumors. We conclude that TZ biopsies enhance the cancer detection rate in prostate cancer screening and should therefore be added to the routinely done sextant biopsies in men with PSA elevation and normal digital rectal examination findings. Prostate 30:130–135, 1997. © 1997 Wiley-Liss, Inc.     

Examination for indication of systematic biopsy for diagnosis of prostate cancer]

BACKGROUND: Systematic biopsy has been commonly used for detection of prostate cancer. Nevertheless, as this examination occasionally gives patients severe complications it is necessary to give careful consideration for application of this examination. Thus, we analyzed retrospectively 145 cases who underwent transrectal ultrasonography (TRUS) guided systematic biopsy to evaluate the application of systematic biopsy, correlating with the findings of digital rectal examination (DRE), prostate specific antigen (PSA), the findings of transrectal ultrasonography (TRUS) and the results of biopsies. METHODS: Between May, 1995 and May, 1997, 143 patients who were suspected to have prostate cancer with either of PSA and DRE, and 2 patients who received visual laser ablation of prostate (VLAP), underwent TRUS guided systematic biopsy of prostate. We evaluated diagnostic efficacy of PSA, DRE, TRUS, prostate-volume-specific PSA, and PSA density (PSAD). RESULTS: Sensitivity, specificity and positive predictive value (P.P.V.) are 78.4%, 62.8% and 53.5% for DRE, 100.0%, 4.4% and 41.8% for PSA, 88.2%, 60.0% and 52.9% for TRUS, 87.8%, 72.1% and 64.2% for prostate-volume-specific PSA, 100.0%, 30.6% and 45.4% for PSAD, respectively. Ten of 69 patients (14.5%) whose PSA levels were 4.0 to 10.0 ng/ml were diagnosed as cancer, and positive for both or either of DRE and TRUS. Twenty-seven who were negative for both of DRE and TRUS were not diagnosed as prostate cancer. Using the combination of prostate-volume-specific PSA, DRE and TRUS, we could eliminate 29 non-cancer men (21.5%) whose PSA level was greater than 4.0 ng/ml from systematic biopsy. CONCLUSION: On the diagnosis of prostate cancer, the combination of prostate-volume-specific PSA, DRE and TRUS is very useful to exclude unnecessary systematic biopsy, if an urologist could be used to and trained for DRE and TRUS.     

Community‐based prostate cancer screening in Japan: Predicting factors for positive repeat biopsy

Objectives: To assess possible predictors in determining criteria for repeat biopsy in a prostate cancer screening population. Methods: A total of 50 207 men over 55 years‐of‐age have participated in a prostate cancer screening program in Otokuni, Kyoto, Japan for 12 years. Transperineal systematic biopsy was carried out in case of positive digital rectal examination (DRE) or positive transrectal ultrasonography (TRUS) or a prostate‐specific antigen (PSA) value greater than 10.0 ng/mL. For those with a PSA level from 4.1 to 10.0 ng/mL, and negative DRE and TRUS findings, biopsy was indicated only when PSA density (PSAD) was greater than 0.15. The same indication was applied for the repeat biopsy. Results: A repeat biopsy after an interval of more than 2 years was carried out in 140 patients and was positive in 50 (36%) patients. The PSA value at the diagnosis of cancer declined from the initial value in six (12%) patients. On multivariate logistic regression analysis, PSA velocity (PSAV) as well as PSAD and DRE findings at latest screening were independent predictors for positive repeat‐biopsy outcome. The odds ratio (95% confidence intervals) of PSAV >0.48, latest PSAD >0.33 and positive latest DRE were 4.17 (1.05–18.5), 4.15 (1.31–14.0), and 3.62 (1.06–13.2), respectively. A combination of three variables defined as positive if any of these were positive, reduced 31% of unnecessary biopsies while missing 8% of low volume, low grade cancers. Conclusions: A combination of latest PSAD, PSAV and positive DRE at latest screening might help to reduce unnecessary repeat biopsies in high‐risk patients with an initial negative biopsy.     

Early detection program for prostate cancer: results and identification of high-risk patient population.

Three hundred sixty-two men underwent transrectal ultrasound of the prostate (TRUS), digital rectal examination (DRE), and serum prostate-specific antigen (PSA) determination as part of an early detection program for prostate cancer. Thirty-seven (10%) cancers were detected. DRE had the highest sensitivity and specificity, 89 percent and 84 percent, respectively. TRUS and PSA had comparable sensitivities (84% and 81%) and specificities (82% and 82%). The positive predictive values of DRE, TRUS, and PSA determination were 39 percent, 35 percent, and 33 percent, respectively. We found a cancer detection rate of 16 percent among patients with symptoms of bladder outlet obstruction and 5 percent in patients without these symptoms. The detection rate was 36 percent for physician-referred patients and 3 percent for self-referred patients. This suggests to us that at the present time the best utilization of medical resources to increase prostate cancer detection is to educate men to have annual medical evaluations by primary-care physicians who are encouraged to incorporate risk assessment and screening DRE as part of their routine practice. Any man with either abnormal findings on examination or increased risk should be referred to a urologist for further evaluation.     

Follow-up of men with elevated prostate-specific antigen and one set of benign biopsies at prostate cancer screening

OBJECTIVE: To study the follow-up of men with elevated prostate-specific antigen (PSA) (>3 ng/ml) after one benign set of sextant biopsies. From the G?teborg branch of the European Randomised Study of Screening for Prostate Cancer (ERSPC). METHOD: 456 men with one set of benign sextant biopsies were followed every second year for 4 years with PSA determinations. In cases of elevated PSA, transrectal ultrasound (TRUS) guided sextant biopsies were suggested. Digital rectal examination (DRE), prostate volume, PSA, PSA density (PSAD) and the ratio between free and total PSA (PSA F/T) were recorded. RESULTS: Complete data were available for 322 men. 3 groups were identified. In 84/322 (26%) men cancer was found ("cancer" group). 182/322 (56%) had benign biopsies ("benign" group) and 56/322 (17%) had normalised PSA ("normalised PSA" group). Median prostate volumes were 36, 46, and 33 cc respectively in the three groups. DRE and/or TRUS were abnormal in only 30% of the men in all groups. Cancer was not found in any prostate >70 cc volume. In prostates of <20 cc either cancer was found or PSA was normalised. The "normalised PSA" group had initial PSA, PSAD and PSA F/T similar to cancer, normalising during follow-up. CONCLUSIONS: Patients with one negative sextant biopsy still have a high likelihood of cancer, especially men with persistently elevated PSA and small prostates (<20 cc) while the majority of men with large prostates (>70 cc) have PSA elevation due to benign prostate hyperplasia (BPH) and not to cancer.