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[Effect of digital rectal examination on PSA].

A prospective randomized study on 100 patients was conducted to determine the effect of the rectal digital examination on prostate specific antigen (PSA) serum concentration. The control group consisted of 50 patient, all with two PSA determinations with no urological manipulation between them. The study group had 50 patient, who underwent digital examination 24 hours before the second PSA determination. Mean difference in PSA concentration in the study group is 0.84 ng/ml, compared to 0.0048 ng/ml in the control group (p << 0.05). Only 7 patients with initial PSA within the normal range (0.0-0.4 ng/ml) had a second PSA higher than 4.0 ng/ml. Only a patient with initial PSA lower than 4.1 ng/ml, had a second PSA higher than 10.1 ng/ml. This minimal change is independent of the initial concentration and the diagnosis (benign prostate hyperplasia, prostate adenocarcinoma or chronic prostatitis). Though changes are statistically significant they are not clinically so because the 0.84 increase is irrelevant. Based on these data we believe rectal digital examination has no effect on PSA serum levels.

Aged↗

Diagnostic utility of the digital rectal examination as part of the routine pelvic examination.

The digital rectal examination (DRE) is an uncomfortable procedure that adds time to the routine pelvic examination. Patients may postpone or defer their pelvic examination because of this discomfort. Although commonly recommended and performed, there is little evidence that this screening test provides unique or useful information. The goal of this project was to determine the diagnostic yield of routine DRE in otherwise healthy female patients who were younger than 40 years of age at the time of the examination. A total of 272 DREs were documented. Case findings were recorded in 8 (3%) of the patients. One notation reflected a previous diagnosis of ulcerative colitis; the rest of the findings were incidental. None of these findings were categorized as diagnostic, producing a diagnostic yield of 0 (95% confidence interval, 0 to 1.35). The results of this study do not support the continued use of the DRE as part of the routine pelvic examination in women younger than 40 years old.

Adult↗

[Analysis of biologic changes in PSA blood concentration and free PSA percentage in patients with normal rectal digital examination].

OBJECTIVE: To study intra-individual variations in serum PSA and percent free PSA in patients with normal digital rectal examination. MATERIAL AND METHODS: Analysis of changes in serum PSA levels and percent free PSA in two blood measurements conducted in 107 non-consecutive patients prior to prostate biopsy, over a period of time ranging from 23 to 60 days. Both total and free PSA were measured with two dual monoclonal antibody assays, Tandem-E and Tandem-R, Hybritech. Diagnosis was benign hyperplasia in 63 patients and cancer in 44. RESULTS: PSA variations ranged between -6.8 and +3.2 ng/ml in BPH patients, and between -2.8 and +9.0 when cancer was detected. The median coefficient of variation was 15.4 and 15.7, respectively. Variations in percent free PSA ranged between -30.7 and +40.9 in the BPH group and between -17.9 and +15.8 in the cancer group. The median coefficient of variation was 32.2 and 32.3%, respectively. Should prostate biopsy had been indicated when percent free PSA was equal to or lower than 25 in the 4 to 10 ng/ml PSA range, 15% patients would have exhibited discrepancies. Sensitivity would have ranged between 100 and 94.4%, with a reduction rate in negative biopsies between 16.6 and 19.4%. CONCLUSIONS: Intra-individual variations in serum PSA levels and percent free PSA may condition the decision of whether to perform a prostate biopsy.

Aged↗

Efficacy of digital rectal examination after radiotherapy for prostate cancer.

PURPOSE: Digital rectal examination is widely performed for following patients with localized prostate cancer after definitive therapy. This examination has marginal efficacy for detecting initial prostate cancer and postoperative recurrence. To determine the efficacy of digital rectal examination in terms of new information provided after radiotherapy we analyzed the results of digital rectal examination in the followup of patients with prostate cancer after radiotherapy. MATERIALS AND METHODS: We performed a nonrandomized study in 235 consecutive patients with prostate cancer followed at a large tertiary care military hospital between January 1, 1995 and December 31, 1999. All patients had been treated with prostate radiotherapy and had no evidence of metastatic disease at the first visit within that interval. Digital rectal examination was done at followup and the main outcome measure was new information provided by that examination. RESULTS: A total of 1,544 digital rectal examinations were performed in 1,627 visits. New information was provided by digital rectal examination in only 30% of 286 abnormal examinations, of which more than three-quarters were related to bleeding and would otherwise have been noted on routine examination by the primary care provider. All 8 persistent recurrent prostate nodules were noted in the context of increasing prostate specific antigen. CONCLUSIONS: Routine digital rectal examination in patients with prostate cancer after radiotherapy may be omitted from followup protocols.

Combined Modality Therapy↗

Is deleting the digital rectal examination a good idea?

Many groups have taken the position that the digital rectal examination should be discontinued as part of the annual screening physical examination. We examined the effects of not doing a digital rectal examination on the early diagnosis of prostate cancer. The average time since a previous rectal examination increased as the stage of cancer increased. The digital rectal examination proved to be a relatively insensitive test, with 40% of stage D cancers being detected initially within 12 months of the most recent examination. Nevertheless, an annual digital rectal examination did detect a greater percentage of lower stage (and thus more localized and potentially curable) cancers when repeated within 12 months. When the last rectal examination was more than 24 months previous, cancers detected were more likely to be advanced. Without a digital rectal examination, patients would have their disease detected only by the presence of symptoms. When it was done because of symptoms, 81% of our patients had stage D cancers compared with 32% of stage B and 38% of stage C patients. Without the routine use of this examination, patients with prostate cancer would be more likely to have higher stage and less potentially curable lesions at the time of diagnosis. We conclude that the digital rectal examination remains an important part of routine annual physical examinations.

Aged↗

American Cancer Society--National Prostate Cancer Detection Project. Results from multiple examinations using transrectal ultrasound, digital rectal examination, and prostate specific antigen.

BACKGROUND: The American Cancer Society-National Prostate Cancer Detection Project is a prospective study of the feasibility of early prostate cancer detection by digital rectal examination (DRE), transrectal ultrasound (TRUS), and prostate specific antigen (PSA). Two thousand nine hundred ninety-nine men not previously suspected of having prostate cancer have been entered on study in ten participating clinical centers. METHODS: The study protocol requires these men to undergo testing with the three detection methods under investigation on an annual basis for up to 5 years. Data currently are available on 1972 men who have completed protocol requirements for two sequential series of examinations. RESULTS: At the first visit, it was recommended that 16.5% of subjects undergo biopsy based on the TRUS and/or DRE findings. Seventy-three (3.7%) men were found to have cancer after the first series of examinations. When the 1899 men who did not have cancer were reexamined, in 11.4%, a biopsy was recommended, and an additional 33 (1.7%) cancers were detected. Cancer detection rates were higher in older men, and the sensitivity of TRUS was higher than that of DRE at both examinations. The positive predictive values (PPV) of TRUS and DRE varied significantly depending on the PSA level; PPV decreased at the second examination. Positive findings during the second examination were associated with elevated PSA levels during the earlier visit and rising PSA levels between examinations. Analyses of the 106 cancers detected currently showed a preponderance of early-stage cancer and low Gleason scores. CONCLUSIONS: It may be possible to increase the early detection of prostate cancer by periodic examination by a combination of detection modalities.

Aged↗

Early prostate cancer: diagnostic costs of screening transrectal US and digital rectal examination.

A screening study with transrectal ultrasound (US) and digital rectal examination to diagnose early prostate cancer was performed to calculate diagnostic costs. The total costs of screening 784 men were $130,400 with transrectal US and $41,080 with digital rectal examination. Per diagnosed cancer, the costs were $6,520 for transrectal US and $4,108 for digital rectal examination, a difference of 37%. The costs per early diagnosed cancer (stage A or B) were $7,671 and $5,869 for transrectal US and digital rectal examination, respectively--a difference of 23%. The costs per early cancer that would have been advanced if diagnosed without screening were $22,177 for transrectal US and $28,528 for digital rectal examination--a difference of 22% in favor of transrectal US. Equations for these relative costs were generated for transrectal US and digital rectal examination. Costs are related to changes in prevalences and to changes in the stages of prostate cancer when diagnosed without screening.

Cost-Benefit Analysis↗

Comparison of digital rectal examination and biopsy results with the radical prostatectomy specimen.

PURPOSE: Digital rectal examination is integral to staging prostate cancer. Ultrasound guided biopsy establishes the diagnosis, and it may provide useful information regarding disease grade and extent. Treatment decisions are largely based on information gained from digital rectal examination and biopsy but this information is only useful if it correlates with the radical prostatectomy specimen and prognosis. We correlated digital rectal examination and transrectal ultrasound guided biopsy results with a detailed analysis of the radical prostatectomy specimen. MATERIALS AND METHODS: The accuracy of an abnormal digital rectal examination for predicting the location and extent of cancer was assessed in 89 patients thought to have clinical stage T2 disease. We evaluated 155 patients with clinical stages T1c and T2 disease to correlate the location of positive biopsies with the tumor site in the prostate. Radical prostatectomy specimens were completely sectioned at 2 mm. intervals, and tumor extent and location were recorded. RESULTS: In 85 patients a unilateral lesion was suspicious on digital rectal examination, that is stage cT2. The final pathological review revealed cancer on the suspicious side in 82 cases (96%) with tumor confined to the same lobe in only 23 (27%), bilateral disease in 59 (69%) and tumor confined to the contralateral lobe in 3 (4%). In 4 patients with a palpable bilateral abnormality a bilateral lesion was confirmed on final pathological evaluation. Digital rectal examination demonstrated a 36 and 31% incidence of extracapsular tumor extension and positive surgical margins, respectively, on the clinically benign side. In 100 patients only unilateral biopsy was positive. The final pathological evaluation revealed cancer in the biopsy positive side in 95 cases (95%) with tumor confined to the ipsilateral lobe in only 26 (26%), bilateral disease in 69 (69%) and tumor confined to the contralateral lobe in 5 (5%). In 46 of the 55 patients (84%) with bilateral positive biopsies tumor involved both sides but the pathologist did not identify cancer in both lobes in 9 (16%). While 100 patients had a unilateral negative biopsy, analysis of the prostatectomy specimen revealed carcinoma in the benign lobe in 74 (74%). Moreover, extracapsular tumor extension and a positive surgical margin were observed on the biopsy negative side in 31% of the patients. The degree to which digital rectal examination and biopsy results confirmed the final pathological evaluation was assessed using the kappa statistic, which revealed only slight agreement with each factor. The correlation of digital rectal examination and biopsy results with the location of extracapsular extension and positive margins was evaluated by the Spearman coefficient of correlation, which indicated poor agreement. When patients with unilateral versus bilateral positive biopsy were compared with respect to prognostic parameters, the difference was statistically significant for initial serum prostate specific antigen, the percentage of surface involved by tumor, biopsy and final Gleason scores, and the incidence of extracapsular extension of tumor. CONCLUSIONS: Digital rectal examination and the interpretation of prostate biopsy are not accurate clinical tools for defining the location and extent of prostatic carcinoma. Bilateral positive biopsy may be useful as an adjunct to the current clinical staging system.

Biopsy, Needle↗

Digital rectal examination for trauma: does every patient need one?

The digital rectal examination is widely accepted as an essential component in the initial assessment of trauma. However, no data have been published that justify its routine use in all seriously injured patients. The objective of this study was to determine what if any impact on subsequent treatment and management decisions the initial digital rectal examination had on injured patients arriving at our emergency department (ED). We conducted a prospective observational study of all injured patients arriving at a Level II trauma center over a period of 6 months. A digital rectal examination was performed on all patients during the secondary survey phase of their initial evaluation shortly after arrival to the ED. The results of the rectal examination were noted for each patient with particular attention placed on the presence or absence of gross blood, Hemoccult result, prostatic examination, rectal vault integrity, and rectal sphincter tone. In addition the patient's hemodynamic parameters while in the ED and the injuries that were sustained were noted, as was their final disposition. Four hundred twenty-three patients were admitted to the ED after sustaining serious injuries. The mean Injury Severity Score was 9.96. The prostatic examination was normal in more than 99 per cent of patients; no high-riding or nonpalpable prostate glands were noted. Twenty-two patients (5.2%) were Hemoccult positive, but in none of these cases did the presence of occult blood in the stool lead to a change in the initial management or diagnostic approach. Three patients (0.7%) with penetrating injuries to the perineal/pelvic area had gross blood on digital rectal examination that prompted operative exploration to rule out a lower gastrointestinal injury. All three had rectal injuries confirmed at surgery. Rectal sphincter tone was normal in 406 (96%) patients, weak in 17 (4%), and absent in none. The only patient in whom the sphincter tone influenced management was an individual complaining of complete paralysis after a blunt mechanism of injury. He had normal rectal sphincter tone and admitted to malingering shortly thereafter. Overall the rectal examination influenced therapeutic decision making in five cases (1.2%). The digital rectal examination is unlikely to affect initial management when applied indiscriminately to all seriously injured patients during the secondary survey. Patients in whom the rectal examination may have a higher probability of influencing management are those with penetrating injuries in proximity to the lower gastrointestinal tract, questionable spinal cord damage, and severe pelvic fractures with potential urethral disruption or open fractures in continuity with the rectal vault. The Hemoccult test does not add useful information and should be discontinued as part of the secondary survey of injured patients.

Adult↗

Frequency of digital rectal examination in children with chronic constipation.

OBJECTIVES: To determine the frequency of performance of digital rectal examination by primary care practitioners on children with chronic constipation and to assess its effect on therapy. PATIENTS AND METHODS: One hundred twenty-eight children referred for chronic constipation to the Division of Pediatric Gastroenterology at Schneider Children's Hospital, New Hyde Park, NY, as well as their parents were questioned as to whether a digital rectal examination was ever performed prior to referral. All children underwent subsequent digital rectal examination by a pediatric gastroenterologist and recommended treatment regimens were compared with pretreatment regimens. The patients evaluated were a mix of private-insurance and Medicaid patients referred by pediatricians in the general community. RESULTS: Ninety-eight (77%) of the children referred for chronic constipation were found to have never had a digital rectal examination performed prior to referral. Fifty-three (54%) of these children were found to have fecal impaction. Only 19 (21%) were found to have minimal to no stool retention on digital examination. Enema therapy had been infrequently used to "clean out" the colon in referred children. Seventy percent were treated with multiple enema therapy following digital rectal examination. Organic causes of constipation were identified in 3 patients. CONCLUSIONS: Digital rectal examination is often not performed in the examination of the child with chronic constipation. The digital examination can help differentiate functional constipation from an organic process and may alter the course of therapy.

Adolescent↗

[Physical diagnosis--digital rectal examination].

For a wide range of complaints, there is an indication for digital rectal examination. The position patients should adopt depends on their physical condition and the indication concerned. The reach of the palpating index finger is fairly short. The severity of micturition complaints has little or no relation to the size of the prostate. The sensitivity of digital rectal examination for detecting prostate carcinoma ranges from about 50 to 80%. Therefore, a prostate carcinoma cannot be excluded on the basis of digital rectal examination. The positive predictive value of digital rectal examination for detecting prostate carcinoma increases as the serum PSA level increases. Digital rectal examination can make an important contribution to the diagnosis of anorectal disorders, including rectal carcinoma. In total, 5-10% of consultations with general practitioners are related to anorectal or urogenital complaints and 50% of the elderly have micturition problems; therefore digital rectal examination is one of the physician's basic skills.

Diagnosis, Differential↗

Correlation between prostate size estimated by digital rectal examination and measured by transrectal ultrasound.

OBJECTIVES: To correlate prostate size estimates performed by single or multiple examiners through digital rectal examination (DRE) with volume measured by transrectal ultrasound (TRUS) and to propose measures for predicting prostate volume using DRE estimates in clinical settings. METHODS: Data from four sources were analyzed: (1) the Olmsted County community study of 397 patients examined by a single urology nurse, with TRUS measurements done by multiple examiners; (2) a community study in Stirling, Scotland, involving 480 patients with DRE and TRUS performed by one urologist; (3) baseline data from the Veterans Affairs Cooperative Study No. 359 in 1222 patients with DRE and TRUS measurements by multiple personnel at 31 centers; and (4) a clinical series of 100 men with DRE and TRUS by a single urologist. RESULTS: DRE estimates and TRUS volumes were significantly correlated (r = 0.4 to 0.9), but prostate size was underestimated by 25% to 55% for men with a prostate volume over 40 mL, depending on the study, with greater variability for studies involving multiple examiners. In one study that assessed prostate dimensions by DRE, posterior surface area (SA) correlated with overall TRUS volume (r = 0.4). According to receiver operating characteristic curves, SA showed a 70% and 76% chance of correctly identifying men with prostate volume greater than 30 or 40 mL, respectively; those with larger prostates were best distinguished by SA greater than 7 cm2 (sensitivity greater than 0.74, specificity greater than 0.50). CONCLUSIONS: DRE underestimates prostate size, particularly if TRUS volume is greater than 30 mL. However, DRE estimates may help identify prostates likely to be larger than certain cutpoints by TRUS. Posterior SA may be useful as a preliminary assessment when prostate size is an important predictor of therapeutic response.

Aged↗

PSA testing and digital rectal examination in New Zealand.

OBJECTIVE: To investigate the use of digital rectal examination and prostate specific antigen (PSA) testing in a population-based sample of men in New Zealand. METHODS: A random selection of men aged 40-74 years, weighted by age, was chosen from the general electoral roll of New Zealand. Only men with a telephone who had been married at some time were eligible. Telephone interviews were conducted using a standard questionnaire. Crude and age-adjusted proportions were calculated. Logistic regression was used to explore associations between sociodemographic factors and digital rectal examination or PSA testing. RESULTS: Interviews were completed for 85% of the 1,486 eligible men and analyses were confined to the 1,225 European men. Many more men reported having a digital rectal examination (41%; 95% CI 33.8-48.2) than a PSA test (9%; 95% CI 4.2-14.2). Men in the lowest social class were significantly less likely to have had a digital rectal examination (OR 0.30; 95% CI 0.18-0.50) or PSA test (OR 0.25; 95% CI 0.11-0.60) compared with those in the highest social class. Men with vocational training or no post-school qualifications were approximately half as likely to report a digital rectal examination or a PSA test compared with men with degrees or diplomas. CONCLUSIONS: Although current New Zealand recommendations are that population screening for prostate cancer should not be introduced, many men are still having digital rectal examinations and PSA tests in the absence of symptoms. The frequency of PSA testing is considerably lower than in Australia and appears to be largely influenced by a man's social class.

Adult↗

The effect of digital rectal examination on the serum prostate specific antigen concentration: results of a randomized study.

To determine the effect of digital rectal examination on the serum prostate specific antigen (PSA) concentration a prospective, randomized, controlled trial involving 143 patients was conducted. Of the patients 86 (60%) had benign prostatic hyperplasia (BPH), 47 (33%) had prostate cancer and 10 (7%) had chronic prostatitis. The study group consisted of 71 men, all of whom had a serum PSA determination followed by a digital rectal examination and then a second serum PSA determination. The control cohort consisted of 72 men, all of whom had 2 serum PSA determinations without an intervening digital rectal examination. The median change in the serum PSA level for the study group was 0.4 ng./ml. compared to -0.1 ng./ml. for the control cohort (p less than 0.0001). For 76% of the study patients the second serum PSA level was greater than the initial value; only 32% of the control patients exhibited a higher second serum PSA level than the initial level (p less than 0.0001). However, only 4 patients with an initial PSA value in the reference range (0.0 to 4.0 ng./ml.) had a post-digital rectal examination value greater than 4.0 ng./ml. and only 1 patient whose presenting serum value was less than 10.0 ng./ml. had a serum PSA level greater than this cutoff point after digital rectal examination. This minimal change in serum PSA after digital rectal examination was independent of the diagnosis (BPH, cancer or chronic prostatitis), initial serum PSA concentration and examiner. Thus, although digital rectal examination had a statistically significant effect on the serum PSA concentration, the clinical significance of a 0.4 ng./ml. median increase appears inconsequential. Based on these findings, physicians should be confident that the serum PSA concentration in the immediate post-digital rectal examination period is accurate and does not compromise clinical use of the tumor marker.

Adult↗

Accuracy of digital rectal examination and transrectal ultrasonography in localizing prostate cancer.

Not all prostate cancers are sonographically hypoechoic or palpable on digital rectal examination, and suspicious areas on transrectal prostatic ultrasonography or digital rectal examination often are not cancer. We present quadrant biopsy results from a multicenter prostate cancer screening study in which men were evaluated with prostate specific antigen (PSA) and digital rectal examination. If the PSA level was elevated (greater than 4.0 ng./ml., Hybritech Tandem assay) or digital rectal examination was suspicious quadrant biopsies were performed. Biopsy specimens were labeled separately, and histological findings were correlated by quadrant with the findings on ultrasonography and digital rectal examination. Of the 6,630 subjects enrolled into the study 16% were biopsied. Of 1,002 quadrants that were suspicious on digital rectal examination 110 (11%) had cancer, while 308 of 418 quadrants containing cancer (74%) were not suspicious on digital rectal examination. Of 855 quadrants that were sonographically suspicious 153 (18%) had cancer, while 282 of 435 quadrants containing cancer (65%) were not sonographically suspicious. Of 225 patients with cancer 137 (61%) would have been missed if only the exact site of the palpable induration had been biopsied. Of 251 patients with cancer 131 (52%) would have been missed if only the exact site of the hypoechoic lesion had been biopsied. We conclude that digital rectal examination and transrectal ultrasonography have limited accuracy in identifying and localizing prostate cancer. Our study emphasizes the importance of obtaining systematic biopsies if the PSA level is elevated, even in the absence of digital rectal examination or ultrasound anomalies.

Aged↗

Digital rectal examination in the early detection of prostate cancer.

Screening using digital rectal examination improves the clinical stage distribution of prostate cancer and prolongs survival. Unfortunately, digital rectal examination may not be sensitive enough to detect the small-volume tumors that are most amenable to cure. In several studies, approximately 50 per cent of cancers detected through screening had already spread beyond the prostate. Regardless, the key to demonstrating overall benefit from screening is a diminished disease-specific mortality rate. To date, this has not been shown. Lower mortality rates from prostate cancer can be demonstrated only through a randomized study comparing screened and unscreened populations. Such a study, which has recently been approved and funded by the National Institutes of Health, will require 10 to 15 years to complete. Until that time, the value of screening for prostate cancer by digital rectal examination or any other method will be unknown. Beyond a lack of proved benefit, screening for prostate cancer may be harmful because of the variable natural history of the disease and the morbidity and mortality rates associated with treatment. There exists a large population of patients with pathologically detectable prostate cancer who will never have clinical disease. The detection of some of these tumors may expose those patients to the risks of unnecessary treatment. Large-scale prostate cancer screening studies may ultimately be shown to be advantageous. The sooner this occurs, the earlier aggressive screening can be advocated, similar to screening for breast cancer. However, the temptation to embark on such screening programs without first demonstrating clear benefit should be resisted.

Humans↗

Prostate cancer: comparison of digital rectal examination and transrectal ultrasound for screening.

A prostate cancer screening study of 315 asymptomatic men comparing digital rectal examination and transrectal ultrasound identified 23 cancers, for a detection rate of 7.3%. Of the cancers 17 (5.4%) were diagnosed by digital rectal examination. Contrary to the experience of others, this was a higher rate than achieved by transrectal ultrasound (14 cases or 4.4%). Systematic multiple needle biopsies of both lobes with ultrasound guidance were routinely performed. As a result of this technique 7 of 23 cancers (30%) were fortuitously diagnosed. In addition, only unilateral disease was suspected in 4 of 7 patients with bilateral disease on biopsy. Digital rectal examination and transrectal ultrasound identified the same number of patients with small (less than 1.5 cm.) cancers, contrary to other reports that found transrectal ultrasound to be superior. Digital rectal examination is considered an effective screening examination, equivalent to transrectal ultrasound and preferable because of lower cost. An algorithm for screening is outlined with digital rectal examination and prostate specific antigen determinations.

Aged↗