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Interexaminer variability of digital rectal examination in detecting prostate cancer.

OBJECTIVES: Digital rectal examination (DRE) is an important method of prostate cancer detection used by primary care physicians and medical specialists to identify patients in whom a prostatic biopsy is warranted. However, there is little empirical evidence assessing the degree of interexaminer variability in the use of DRE for the detection of prostate cancer. We addressed this issue within the framework of a prostate cancer screening study. METHODS: We performed DRE examinations in 116 consecutive volunteers twice on the same day, with different urologists performing the examinations. The urologists were blinded to the results of the other examination and to the subject's serum prostate-specific antigen (PSA) level. DRE results were coded as being benign or sufficiently suspicious for cancer to warrant a prostatic biopsy. RESULTS: Examiners independently agreed on the DRE findings in 98 of the 116 (84%) subjects. However, when adjusted for chance agreement, the interexaminer agreement among urologists was only fair (ie, kappa = 0.22, P = 0.009). Interexaminer variability was greater between faculty and resident examiners than among faculty examiners. CONCLUSIONS: Our results suggest that the reproducibility of DRE for detecting prostate cancer is only fair among urologists. Further studies are indicated to evaluate interexaminer variability between primary care physicians and urologists.

Aged↗

Is there a role for digital rectal examination in the followup of patients after radical prostatectomy?

PURPOSE: We determine the role of digital rectal examination in the followup of patients after radical prostatectomy. MATERIALS AND METHODS: We retrospectively analyzed data on 501 consecutive patients who underwent radical retropubic prostatectomy between 1992 and 1998, and were followed at the University of Miami. Patients were evaluated at 3 to 6-month intervals after surgery with serum prostate specific antigen (PSA) and digital rectal examination. Biochemical recurrence was defined as PSA greater than 0.2 ng./ml. and increasing on at least 2 consecutive measurements. Local recurrence, detected by an abnormal digital rectal examination, was defined as an induration or nodularity in the prostatic fossa. RESULTS: Mean followup plus or minus standard deviation was 25.4+/-20.8 months. Disease recurred in 72 patients (14.4%) and was biochemical in all. An abnormal digital rectal examination was noted in 4 patients, none of whom had an undetectable PSA at the time of a palpable abnormality. CONCLUSIONS: Our results suggest that an abnormal digital rectal examination after radical prostatectomy is always associated with a detectable PSA, which implies that performing a digital rectal examination in the absence of a detectable PSA may not be necessary.

Adenocarcinoma↗

High concordance of gene methylation in post-digital rectal examination and post-biopsy urine samples for prostate cancer detection.

PURPOSE: We evaluated the concordance between post-digital rectal examination and post-prostate biopsy urine samples using conventional methylation specific polymerase chain reaction analysis of 3 gene promoters in patients with suspected or confirmed prostate cancer. MATERIALS AND METHODS: Voided urine specimens were collected from 17 men after 15-second digital rectal examination and again after transrectal ultrasound guided biopsy of the prostate for suspected malignancy or for followup biopsy as part of an expectant management protocol. Urine sediment DNA was isolated and subjected to bisulfite modification. Methylation of GSTP1, EDNRB and APC promoters was determined by conventional methylation specific polymerase chain reaction analysis in post-digital rectal examination and post-biopsy samples, and correlated with clinical information. RESULTS: Prostate cancer was detected on prostate biopsy in 12 of 17 patients (71%). Promoter methylation was detected in post-digital rectal examination urine specimens for GSTP1 (24%), APC (12%) and EDNRB (66%). Promoter methylation was detected in post-biopsy urine specimens for GSTP1 (18%), APC (18%) and EDNRB (77%). The concordance between post-digital rectal examination and post-biopsy urine samples was 94% for GSTP1 and APC, and 82% for EDNRB. Overall 100% of patients with biopsy proven prostate cancer had at least 1 gene methylated in urine vs 60% of those without evidence of prostate cancer on biopsy. CONCLUSIONS: Gene analysis using conventional methylation specific polymerase chain reaction is a reliable method for detecting abnormal DNA methylation in voided urine samples obtained following digital rectal examination or prostate needle biopsy. The concordance between post-digital rectal examination and post-biopsy urinary samples for promoter methylation is high (82% to 94%), suggesting that urine collected after digital rectal examination may be used for genetic analysis with results similar to those in post-biopsy urine samples.

Adenomatous Polyposis Coli Protein↗

Preoperative prediction of tumor heterogeneity and recurrence after radical prostatectomy for localized prostatic carcinoma with digital rectal, examination prostate specific antigen and the results of 6 systematic biopsies.

PURPOSE: Digital rectal examination, preoperative serum prostate specific antigen (PSA) concentration and results of 6 ultrasound guided systematic sextant biopsies in 257 consecutive patients with clinical stages T2 and T1c prostatic carcinoma were evaluated for their use in predicting pathological stage and tumor recurrence. MATERIALS AND METHODS: Each of the 257 consecutive specimens was examined using the 3 mm. step section technique. Results of preoperative digital rectal examination, PSA and 6 systematic sextant biopsies were correlated with pathological stage, margin status and postoperative PSA during a mean followup of 2 years. Patients were considered to have disease progression based on elevated PSA level by a supersensitive assay. RESULTS: Digital rectal examination could not predict pathological stage and tumor recurrence. Preoperative PSA concentration, number of positive biopsies and tumor grade in the biopsy specimens correlated well with pathological stage. The best predictor of tumor recurrence was the biopsy result. However, a precise prediction of outcome (87% probability of being PSA negative versus 0%) was possible only in a third of the patients if the biopsy results were used. Use of preoperative PSA concentration did not improve this probability. CONCLUSIONS: Preoperative PSA concentration and/or biopsy results correlate significantly with pathological stage and margin status. Precise prediction of tumor recurrence is possible in only approximately a third of the patients with clinical stage T2 prostatic carcinoma.

Aged↗

Comparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men.

To compare the efficacy of digital rectal examination and serum prostate specific antigen (PSA) in the early detection of prostate cancer, we conducted a prospective clinical trial at 6 university centers of 6,630 male volunteers 50 years old or older who underwent PSA determination (Hybritech Tandem-E or Tandem-R assays) and digital rectal examination. Quadrant biopsies were performed if the PSA level was greater than 4 micrograms/l or digital rectal examination was suspicious, even if transrectal ultrasonography revealed no areas suspicious for cancer. The results showed that 15% of the men had a PSA level of greater than 4 micrograms/l, 15% had a suspicious digital rectal examination and 26% had suspicious findings on either or both tests. Of 1,167 biopsies performed cancer was detected in 264. PSA detected significantly more tumors (82%, 216 of 264 cancers) than digital rectal examination (55%, 146 of 264, p = 0.001). The cancer detection rate was 3.2% for digital rectal examination, 4.6% for PSA and 5.8% for the 2 methods combined. Positive predictive value was 32% for PSA and 21% for digital rectal examination. Of 160 patients who underwent radical prostatectomy and pathological staging 114 (71%) had organ confined cancer: PSA detected 85 (75%) and digital rectal examination detected 64 (56%, p = 0.003). Use of the 2 methods in combination increased detection of organ confined disease by 78% (50 of 64 cases) over digital rectal examination alone. If the performance of a biopsy would have required suspicious transrectal ultrasonography findings, nearly 40% of the tumors would have been missed. We conclude that the use of PSA in conjunction with digital rectal examination enhances early prostate cancer detection. Prostatic biopsy should be considered if either the PSA level is greater than 4 micrograms/l or digital rectal examination is suspicious for cancer, even in the absence of abnormal transrectal ultrasonography findings.

Aged↗

Diagnosis of prostatic carcinoma: the yield of serum prostate specific antigen, digital rectal examination and transrectal ultrasonography.

Three tests are commonly used to diagnose prostate carcinoma to date: serum prostate specific antigen (PSA), digital rectal examination and transrectal ultrasonography. We evaluated these 3 tests in 1,001, 6-sector prostate needle biopsies to rule out prostate carcinoma. Of the biopsies 253 (25.3%) revealed prostate cancer. As a single test, PSA was superior to digital rectal examination or transrectal ultrasonography in predicting cancer in this patient population using difference of proportions tests. Receiver operating characteristic analysis also showed PSA to be the superior test. The combinations of PSA plus transrectal ultrasonography and PSA plus digital rectal examination were superior to digital rectal examination plus transrectal ultrasonography. We found cancer in 35 of 188 patients (18.6%) with intermediate PSA levels of 4.1 to 10.0 ng./ml. and normal or asymmetric nonindurated rectal examinations. Only 5 of 79 patients (6.3%) with a normal digital rectal examination and PSA level of less than 4.0 ng./ml. demonstrated carcinoma on biopsy. Of the 5 patients 4 had annual increases in PSA of 40% or greater. While hypoechoic sectors were more than twice as likely as isoechoic sectors of the prostate to contain malignancy on biopsy, nearly 37.6% of the cancers were found in isoechoic sectors. A strategy of performing biopsy of only hypoechoic sectors would have misdiagnosed 24.6% of the patients with prostate cancer. We conclude that serum PSA is the most accurate of the 3 diagnostic tests evaluated. We also recommend a systematic sextant biopsy technique.

Aged↗

[Effects of digital rectal examination on serum prostate specific antigen].

OBJECTIVE: Prostate specific antigen (PSA) level is determined under precise conditions for the detection and follow-up of cancer of the prostate. The question is raised as to whether digital rectal examination has an effect on serum levels and whether an interval of time is required before PSA assay can give reliable results. METHODS: A prospective protocol was conducted for 6 months. PSA was assayed in 56 patients hospitalized in an internal medicine ward whose clinical status justified digital rectal examination. Blood samples were taken 2 to 3 hours before the digital rectal examination, performed by the same physician in all cases, then 21 to 22 hours after the examination. RESULTS: After digital rectal examination, there was a nearly significant increase in PSA level (p = 0.06), an increase which was clinically unimportant (0.25 ng/ml). The levels before and after rectal examination were perfectly correlated and reproducible. These data confirmed those reported in the literature showing marginally significant increases of little or no clinical importance, usually within 2 hours of the examination. CONCLUSION: The interval of time between the two assays in our study indicates that in everyday clinical practice, for both inpatients and outpatients, digital rectal examination has no effect on prostate specific antigen and that subsequently there is no need to delay assay.

Adult↗

Screening by prostate-specific antigen and digital rectal examination in relation to prostate cancer mortality: a case-control study.

BACKGROUND: The potential role of prostate cancer screening in reducing mortality is uncertain. To examine whether screening with the prostate-specific antigen (PSA) test or digital rectal examination is associated with reduced prostate cancer mortality, we conducted a population-based case-control study in 4 health maintenance organizations. METHODS: Cases were 769 health plan members who died because of prostate adenocarcinoma during the years 1997-2001. We randomly selected 929 controls from the health plan membership and matched them to cases on health plan, age, race, and membership history. Medical records were used to document all screening tests in the 10 years before and including the date on which prostate cancer was first suspected. RESULTS: Among white participants, 62% of cases and 69% of controls had a least 1 screening PSA test or digital rectal examination (odds ratio = 0.73; 95% confidence interval = 0.55-0.97). The corresponding proportions for blacks were 59% and 61% (1.0; 0.59-1.4). Most screening tests were digital rectal examinations; therefore, in the subgroup with no history of PSA screening, the association between digital rectal screening and prostate cancer mortality was similar to the overall association (0.65 [0.48-0.88] among whites; 0.86 [0.53-1.4] among blacks). Very few men received screening PSA without screening digital rectal examination (6% of cases and 7% of controls among whites). CONCLUSIONS: Digital rectal screening was associated with a reduced risk of death due to prostate cancer in our population. Because of several data limitations, this study could not accurately estimate the effect of PSA screening separate from digital rectal examination.

Adenocarcinoma↗

The relationship between digital rectal examination and abdominal radiographs in elderly patients.

The relationship between digital rectal examination and the findings of faecal loading on abdominal radiograph was studied in elderly patients admitted to hospital. No significant association was found but there was a relationship between faecal loading of the recto-sigmoid, colonic and caecal areas of the radiograph. Soft faeces in the rectum were commoner in older patients and were associated with faecal loading in the caecal area. The digital rectal examination is useful for identifying anal and rectal lesions and faecal impaction but abdominal radiograph is required to assess faecal loading of the large bowel.

Aged↗

Digital rectal examination for detecting prostate cancer at prostate specific antigen levels of 4 ng./ml. or less.

PURPOSE: We evaluated the detection rate of prostate cancer in men with suspicious digital rectal examination findings and serum prostate specific antigen (PSA) 4 ng./ml. or less. We also evaluated the stage and grade of cancers detected. MATERIALS AND METHODS: We screened 22,513 community volunteers by PSA testing and digital rectal examination at 6-month intervals. Biopsy was recommended when either test was suspicious for cancer. In the subset of 2,703 white and black men in whom PSA was 4 ng./ml. or less and digital rectal examination was suspicious for prostate cancer we compared compliance with biopsy recommendations, cancer detection rates, and stage and grade of cancers detected. We then correlated these results with patient age, race and serum PSA concentration. We performed multivariate logistic regression analysis to predict cancer based on clinical characteristics, and evaluated the positive predictive value of digital rectal examination for detecting cancer as stratified by race and PSA. RESULTS: Of the men 70% underwent biopsy with no difference in compliance according to age, race or PSA level. The 13% cancer detection rate correlated with age, race and PSA (p <0.003). The positive predictive value of a suspicious digital rectal examination was 5, 14 and 30% in men with PSA 0 to 1.0, 1.1 to 2.5 and 2.6 to 4.0 ng./ml., respectively. All cancers were clinically localized. Of the 72% of cases that were surgically staged 82% were organ confined and 78% were moderately differentiated. CONCLUSIONS: The positive predictive value of suspicious digital rectal examination was appreciable in men with low serum PSA. The majority of cancer cases detected by digital rectal examination had features of clinically important and potentially curable disease.

Aged↗

Patients with abnormal ultrasound of the prostate but normal digital rectal examination should be classified as having clinical stage T2 tumors.

PURPOSE: The current TNM staging system classifies prostate tumors with abnormal transrectal ultrasound but normal digital rectal examination as clinical stage T2. However, most urologists consider these tumors as clinical stage T1c due to the perceived inaccuracy of transrectal ultrasound in clinical staging. To determine the role of transrectal ultrasound in the clinical staging of prostate cancer we evaluated the pathological stage and disease-free survival of patients undergoing radical prostatectomy who had tumor detected by needle biopsy because of elevated serum prostate specific antigen with or without transrectal ultrasound abnormalities. MATERIALS AND METHODS: Between 1991 and 1996, 738 patients underwent radical retropubic prostatectomy as monotherapy for clinically localized prostate cancer. Patients were classified into group 1-normal digital rectal examination and transrectal ultrasound (138), group 2-normal digital rectal examination but abnormal transrectal ultrasound (366) and group 3 -abnormal digital rectal examination (234). We compared pathological parameters and disease-free-survival among the 3 groups. RESULTS: Tumors were organ confined in 61%, 42% and 41% of patients in groups 1, 2 and 3, respectively (p = 0.0001). Overall disease-free survival was 80% with a mean followup of 68 months. Disease recurred in 8%, 22% and 25% of patients in groups 1, 2 and 3, respectively (p = 0.007). Group 1 had better disease-free survival compared to groups 2 and 3 (p = 0.003 and p = 0.002, respectively), and there was no difference in disease-free survival between groups 2 and 3 (p = 0.39). CONCLUSIONS: We provide evidence to support the use of transrectal ultrasound findings in the clinical staging system for prostate cancer. Patients with normal digital rectal examination, elevated serum prostate specific antigen and abnormal transrectal ultrasound should be considered as having clinical stage T2 disease.

Adult↗

Role of digital rectal examination and prostate specific antigen in detecting carcinoma prostate.

OBJECTIVE: To investigate the ability of digital rectal examination (DRE) and prostate specific antigen (PSA) in detecting carcinoma prostate. DESIGN: Descriptive cross-sectional study. PLACE AND DURATION OF STUDY: The study was conducted in the Department of Urology and Renal Transplantation from December 1996 to December 1999. PATIENTS AND METHODS: Two hundred patients entered the protocol. They presented with complaint of prostatism or retention of urine. The patients were evaluated with estimation of serum prostate specific antigen and digital rectal examination was performed. Prostatic tissue biopsy was also done. RESULTS: Digital rectal examination has shown sensitivity of 63% and specificity of 73.22%. The sensitivity of PSA was 87% and specificity was 70.8%. The positive predictive value for DRE and PSA was 57.5% and 78.04% respectively. Negative predictive value was 73.22% and 85.22% respectively. P value was statistically significant <0.037. In the second part of study a baseline serum PSA level in age-matched 200 patients without history of prostatism was estimated. CONCLUSION: It was concluded that PSA represent an important adjunct to DRE for detection of prostate carcinoma.

Aged↗

Transrectal ultrasound versus digital rectal examination for the staging of carcinoma of the prostate: results of a prospective, multi-institutional trial.

PURPOSE: We determined the accuracy of transrectal ultrasonography versus digital rectal examination in staging the local extent of biopsy proved carcinoma of the prostate. MATERIALS AND METHODS: A National Institutes of Health funded network was developed to perform prospective, multi-institutional trials. A total of 386 patients judged by the investigators to be candidates for radical prostatectomy underwent transrectal ultrasonography with recording of data according to a numerical analog for construction of receiver operating characteristic curves. The results of digital rectal examination were similarly recorded. After radical prostatectomy whole mount histology was performed on all surgical specimens, and pathological findings were correlated with preoperative transrectal ultrasound and digital rectal examination results. RESULTS: The calculated area under the curve for transrectal ultrasound in predicting extracapsular tumor extension was 0.69 compared to 0.72 for digital rectal examination (p = 0.64), while that for predicting seminal vesicle invasion was 0.74 and 0.69, respectively (p = 0.36). There was a nonstatistically significant trend for improved accuracy of both examinations as tumor volume increased. Transrectal ultrasound was more accurate for staging posterior cancers than for those in the anterior portion of the prostate. CONCLUSIONS: Neither transrectal ultrasound nor digital rectal examination proved to be superior to each other for staging the local extent of prostate cancer. No imaging modality or examination that depends on gross architectural changes is likely to have a high degree of accuracy in detecting microscopic extension of extracapsular tumor frequently observed in radical prostatectomy specimens.

Adenocarcinoma↗

Correlation of digital rectal examination, prostate specific antigen, and transrectal ultrasound in prostate carcinoma in African Americans.

Since there is general agreement that screening for prostate cancer should be carried out, at least for high-risk individuals, there should be little debate that African-American men should be screened. Current screening guidelines include the two most cost-effective methods of early detection, digital rectal examination and prostate specific antigen. The use of transrectal ultrasound and guided biopsy improves the yield. This article reports on the findings of 50 African-American patients with prostatic carcinoma diagnosed by sonographically guided biopsy in a single, community urology practice. Overall, prostate specific antigen was elevated in 94%, digital rectal examination was positive in 60%, and transrectal ultrasound was positive in 78%. A focal hypoechoic lesion was demonstrated in 58%. When the site of tumor, as specified in the pathology report, was correlated with the findings on digital rectal examination and transrectal ultrasound, both digital rectal examination and transrectal ultrasound were positive in 45%. Transrectal ultrasound was positive when digital rectal examination was negative in 30%. Digital rectal examination was positive when ultrasound was not in 14%. Random biopsy revealed areas of carcinoma that were not detected by digital rectal examination nor ultrasound in 40%. We conclude that even though random biopsy significantly improves the detection of prostate carcinoma, sonographic guidance is beneficial to systematically biopsy the gland and to avoid omission of characteristic lesions during random samplings.

Aged↗

Digital rectal examination and the primary care physicians: a lost art?

Digital rectal examination (DRE) in children is crucial to differentiate between simple (habitual) and complicated constipation. Previous experience suggests that primary care physicians (PCPs) avoid DRE in children with constipation before referral. We evaluated the rate of DRE performance by West Virginian PCPs in patients referred to our gastroenterology clinic. Data were collected from the physicians' referral letters and parental reports. We found that the vast majority (85%) of WV-PCPs do not perform DRE before referring their patients, resulting in missed diagnoses and treatment. We concluded that the lack of DRE in children with constipation may result in unnecessary referral to the specialist. To improve standard of care for children with constipation, an educational campaign for PCPs is clearly warranted.

Child↗

Comparison of digital rectal examination and prostate specific antigen in early detection of prostate cancer.

This study compares the value of digital rectal examination (DRE) and prostate specific antigen (PSA) determination in the detection of prostate cancer. 1,000 men aged > or = 50 from the Osijek surroundings were examined. The subjects with prostatitis were excluded from the study. The subjects with elevated concentration of total prostate specific antigen and/or digital rectal examination suspect of carcinoma underwent prostate biopsy. The rate of prostate cancer detection showed to be 3.3% for PSA > 4 ng/ml, 2% for abnormal finding of DRE, and 3.7% for combination of the two methods. Out of 35 patients with prostate cancer detected, 19 had suspect DRE finding and 32 had PSA exceeding 4 ng/ml. Thus, PSA pointed to the diagnosis of prostate cancer in 91.4%, and abnormal finding of DRE in 54.2% of cases, the difference being statistically significant. The positive predictive value was 48.7% for abnormal finding of DRE, 47% for PSA > 4 ng/ml, and 80.0% for the combination of both. Although PSA determination detected a considerable proportion of tumors missed on DRE, the former alone was found to be insufficient as a screening method because of its inadequate sensitivity. When combined with digital rectal examination, the probability of prostate cancer detection increased considerably.

Humans↗

Prostate specific antigen as a predictor of an abnormal digital rectal examination.

OBJECTIVE: To assess the ability of serum prostate specific antigen (PSA) to predict and differentiate patients with normal and abnormal digital rectal findings. SUBJECTS AND METHODS: A prospective analysis of 1374 participants in a prostate cancer screening programme was performed. After completion of a questionnaire including age and voiding symptoms as well as phlebotomy for PSA analysis, digital rectal examination was performed and the findings were categorized with respect to size, consistency, symmetry and nodularity. RESULTS: In men less than 50 years of age the mean serum PSA level failed to discriminate any of the digital rectal examination categories. In men over 50 there was a statistically significant difference in mean PSA levels between symmetrical, normal sized prostates and symmetrically enlarged glands as well as between symmetrical, normal sized and abnormal prostates (P < 0.05). No statistically significant difference was found in mean serum PSA levels between symmetrically enlarged prostate glands and those with palpable nodules. PSA levels < or = 2.5 ng/ml (normal range for the Yang polyclonal assay) and < 7.4 ng/ml (corresponding to the normal range of < 4.0 ng/ml for the Hybritech monoclonal assay) demonstrated a probability of an abnormal digital rectal examination of 11% and 14% respectively. PSA levels > 18.4 ng/ml (corresponding to monoclonal levels of > 10 ng/ml) had a 67% probability of an abnormal digital rectal examination. However, moderate elevations in PSA could not be used to predict digital examination abnormalities due to the high incidence of moderate PSA elevations associated with symmetrical enlargement of the prostate. CONCLUSIONS: Serial annual PSA measurements may provide an alternative means of screening men over 50 years of age. Contamination of results with PSA elevation due to benign prostatic hyperplasia remains, however, a problem.

Adult↗