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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.

The latest World Health Organization International Classification defines papillary thyroid carcinoma by its “follicular cell differentiation ... as well as characteristic nuclear changes”. However the oxyphilic (Hurthle cell) papillary carcinoma have nuclei which generally resemble the nuclei seen in oxyphilic follicular carcinomas, and such oxyphilic papillary tumors may behave more aggressively than typical papillary cancers. To further characterize these rare tumors, we identified during a 32-year period 22 patients with oxyphilic papillary cancer and compared them with 1,084 patients with typical papillary cancers and 57 patients with oxyphilic follicular cancers treated by the Mayo surgical group during the same time period. Although typical papillary and oxyphilic papillary cancers were comparable with regards to patient age, tumor size and extent, TNM stage, and prognostic score (AGES), there were significant differences. Compared to typical papillary tumors, oxyphilic papillary cancers had fewer neck nodal metastases at primary diagnosis (5% vs 40%,p

Whereas excisional surgery and radiotherapy have resulted in a favorable outcome when non-Hodgkin's lymphoma of the thyroid (NHLT) is confined to the thyroid gland, controversy persists over the potential advantage of aggressive debulking in favor of diagnostic biopsy alone when disease cannot be completely resected. Our aims in this study were to delineate the present role of surgery in NHLT in pre-operative staging, the impact of the extent of resection on achieving complete remission and cause-specific survival, and patterns of failure. All 62 patients who underwent primary surgery for NHLT at the Mayo Clinic between 1965 and 1989 were analyzed. By postoperative staging, 50 patients were stage IE or IIE. Overall survival was 53% and 46% at 5 and 10 years; 80% for stage IE confined to the thyroid, 58% for stage IE-extrathyroid, 50% for stage IIE, and 36% for stages IIIE and IVE. Complete remission was achieved in 88% of patients who underwent diagnostic biopsy plus adjuvant therapy alone compared to 85% for patients in whom debulking plus adjuvant therapy was used. There was no difference in cause-specific survival in these two groups or in cause-specific survival in two subgroups who achieved complete remission. Relapse after complete remission occurred in 12 (26%) of 46 patients, only 2 of whom survived long-term after salvage therapy. The role of surgery in NHLT is diminishing and advances that will increase complete remission and relapse-free survival will not likely involve more aggressive surgical resections.

In this long-term study with a median followup of greater than 10 years 62 patients who underwent bilateral pelvic lymphadenectomy and radical retropubic prostatectomy for stage D1 adenocarcinoma of the prostate were subdivided with respect to nuclear deoxyribonucleic acid ploidy status of the primary cancer and according to whether they received adjuvant early antiandrogen therapy. Patients with diploid cancers who underwent the operation and received adjuvant early endocrine therapy did significantly better than a similar group without early endocrine therapy with respect to disease-free survival (p less than 0.001) and survival from prostate cancer death (p = 0.03). Among patients with nondiploid tumors early endocrine therapy was of some benefit for disease-free survival (p = 0.06) but not for prostate cancer death (p = 0.46).

This study investigated the serum prostate-specific antigen concentration in 100 healthy men (mean age, 26.3 years; range, 20–29 years) with a clinically normal prostate gland. The effect of digital rectal examination and ejaculation on the serum concentration, and the variability of the serum concentration over 1-week and 1-month periods were examined. In the 100 subjects, the serum prostate-specific antigen concentration ranged from less than 0.1–2.6 ng/ml. The mean, median, and mode were 0.68 ng/ml, 0.6 ng/ml, and 0.4 ng/ml, respectively. The 97.5th percentile value was 2.1 ng/ml. The mean and median changes in the serum concentration after digital rectal examination were −0.013 ±0.11 ng/ml and 0.0 ng/ml, respectively (P = 0.59 compared with control group). The mean change after ejaculation was 0.05 ±0.12 ng/ml, and the median change was 0.0 ng/ml (P = 0.14 compared with control group). Diurnal variation showed minimal change in 16 patients over a 1-week period. The mean change (p.m. value - a.m. value) was 0.003 ng/ml (range, −0.2–0.06 ng/ml). In addition, the serum concentration showed minimal intrapatient variability in 20 patients throughout a 1-month period; the average coefficient of variation (standard deviation/mean) in these subjects was 16.5% (range, 6.4–45.2%). These results indicate that the range in the serum concentration of prostate-specific antigen for healthy men with a clinically normal prostate gland is significantly lower (0.0–2.6 ng/ml) than the currently employed range (0.0–4.0 ng/ml; Tandem-R PSA assay); in addition, digital rectal examination and ejaculation have no significant effect on the serum concentration. Finally, the time of day has little effect, and the variability in the serum concentration of prostate-specific antigen over a 1-week and 1-month interval is minimal.

The long-term survival of patients with synchronous bilateral Wilms tumor is not well defined. Retrospective review of 185 patients registered with the National Wilms Tumor Study from January 1974 to July 1986 with stage V tumors suggests that the long-term outcome remains good. Over-all survival is 83%, 73% and 70% at 2, 5 and 10 years, respectively. Unfavorable histology, age at diagnosis and the most advanced stage of the individual tumors remain the most important prognostic variables. No significant difference in survival was noted between patients undergoing initial surgical resection of the tumor and those managed with initial tumor biopsy followed by chemotherapy with or without radiotherapy and subsequent surgical resection. Survival does not appear to be compromised by attempting to conserve native renal function with renal-sparing operations.

The clinical significance of serum prostate specific antigen (PSA) values in hormonally treated prostate cancer patients and the effect of hormonal therapy on the serum PSA concentration, independent of the response observed from its antitumor activity, are not well defined. To elucidate further the influence of antiandrogen therapy on serum PSA expression, 81 randomly selected patients with stage D2 prostate cancer were evaluated with respect to serum PSA concentration. These patients were divided into 2 groups on the basis of previous hormonal therapy. Group 1 consisted of 43 patients 55 to 89 years old (mean age 71 years) who had received no prior therapy for prostate cancer. Group 2 included 38 men 58 to 84 years old (mean age 72 years) who had received only androgen deprivation therapy with either bilateral orchiectomy or diethylstilbestrol. The mean interval between initiation of antiandrogen therapy and evaluation of these patients was 14 months (range 8 to 31 months). At the time of PSA determination both groups were similar in all respects, including tumor grade, disease symptoms and bone scan findings. The median serum PSA concentration was 96.0 ng./ml. in group 1 and 16.5 ng./ml. in group 2 (p less than 0.001), despite both groups having similar symptoms and widespread metastatic disease on radionuclide bone scan. In group 1 only 1 patient (2%) had a serum PSA level less than 4.0 ng./ml., whereas 13 men (34%) in group 2 had a serum PSA concentration below 4.0 ng./ml. (p less than 0.001). Of the patients in group 1, 2% and of the men in group 2, 45% had a serum PSA concentration less than 10 ng./ml. (p less than 0.001). These findings demonstrate that the serum PSA level in prostate cancer patients treated hormonally may have a significantly different meaning than the same serum PSA value in patients without hormonal therapy. In addition, these observations suggest that PSA expression may be under hormonal regulation and that androgen deprivation therapy may have a direct effect on the serum PSA concentration, independent of the response obtained from any antitumor activity. However, the exact mechanism of this androgenic influence on PSA expression awaits further investigation at the cellular level.

We retrospectively analyzed the outcome of all patients who received their primary treatment for follicular thyroid cancer at the Mayo Clinic between 1946 and 1970. The diagnosis was confirmed by reexamination of preserved tissue specimens. The 57 female and 43 male patients (mean age, 53 years) underwent follow-up for a maximum of 32 years (mean, 17.4 years). All patients were treated surgically, and total removal of primary tumor was thought to have been accomplished in all but three. Only 2 of the 88 patients without distant metastatic lesions at the time of initial diagnosis underwent ablation of the thyroid remnant. At the conclusion of the study, 52 patients had died, thyroid cancer being the cause of death in 19. On the basis of univariate survival analysis, age more than 50 years, tumor size that exceeded 3.9 cm, higher tumor grade, presence of marked vascular invasion, adjacent tissue invasion, and distant metastatic involvement at the time of initial diagnosis were associated with increased cancer mortality. Multivariate analysis (by Cox proportional hazards model), however, identified only age greater than 50 years, marked vascular invasion, and metastatic disease at the time of diagnosis to be independent predictors of follicular thyroid cancer-related mortality. Patients with two or more of these predictors were classified as being high risk. These patients had 5- and 20-year survival rates of 47% and 8%, respectively; the corresponding survival data for the low-risk group were 99% at 5 years and 86% at 20 years. The identification of these risk groups may facilitate a more rational approach to treatment of follicular thyroid cancer.

Distinguishing cellular follicular adenomas (FA) from minimally invasive follicular carcinomas (FC) continues to plague even experienced thyroid pathologists. DNA ploidy analysis has been promoted as a means of making this differentiation; however, the finding of DNA aneuploidy in FA has caused concern that they may demonstrate potential for malignant behavior or should even be reclassified as low-grade noninvasive cancers. In histologically-proven FC, nuclear DNA content has been claimed to have predictive power equivalent to that of all other prognostic factors combined. The aims of the present study, therefore, were to define the DNA ploidy characteristics of FA and FC, to assess the diagnostic potential of cell-cycle parameters, and, in FC, to investigate the prognostic role of such measurements. We measured DNA content of 124 tumors (60 FA, 64 FC). DNA pattern was normal (diploid) in 75% of FA and 45% of FC, tetraploid/polyploid (T/P) in 13% of FA and 25% of FC, and aneuploid in 12% of FA and 30% of FC. FC was histologically verified in 39% of DNA normal, 67% of T/P, and 73% of aneuploid tumors. DNA index, S-phase, G2M, and S-phase plus G2M were analyzed and were not helpful in differentiating between FA and FC. No patient with FA developed tumor recurrence. In FC (excluding the Hurthle cell variant), no significant differences were found among the 3 DNA ploidy groups with respect to either cancer death or tumor recurrence; however, combining the Hurthle cell variant of follicular carcinomas with pure follicular carcinomas, the presence of distant metastases, DNA aneuploidy, and patient age were the only independently significant prognostic variables. Based on these data, while not valuable for determining the presence of malignancy, DNA ploidy determination is of major prognostic value in follicular carcinomas (including the Hurthle cell variant).

The National Kidney Foundation has advocated the use of the abbreviated Modification of Diet in Renal Disease (MDRD) equation to estimate glomerular filtration rate (GFR) from serum creatinine measurements in clinical laboratories. However, healthy persons were not included in the development of the MDRD equation.To assess the accuracy of the MDRD equation in patients with chronic kidney disease compared with healthy persons and to develop a new equation that uses both patients with chronic kidney disease and healthy persons.Cross-sectional study.The Mayo Clinic, a tertiary-care medical center.Consecutive patients (n = 320) who had an iothalamate clearance test specifically for chronic kidney disease evaluation and consecutive healthy persons (n = 580) who had an iothalamate clearance test specifically for kidney donor evaluation.Serum creatinine levels, GFR, demographic characteristics, and clinical characteristics were abstracted from the medical record.The MDRD equation underestimated GFR by 6.2% in patients with chronic kidney disease and by 29% in healthy persons. Re-estimated coefficients for serum creatinine and sex were similar to the original MDRD equation in the chronic kidney disease series but not in the healthy series. At the same serum creatinine level, age, and sex, GFR was on average 26% higher in healthy persons than in patients with chronic kidney disease (P0.001). A quadratic GFR equation was developed to estimate logarithmic GFR from the following covariates: 1/SCr, 1/SCr2, age, and sex (where SCr = serum creatinine).The new equation was not developed in a general population sample. Elderly and African-American persons were underrepresented.The MDRD equation systematically underestimates GFR in healthy persons. A new equation developed with patients who have chronic kidney disease and healthy persons may be a step toward accurately estimating GFR when the diagnosis of chronic kidney disease is unknown.

Purpose Despite the increased incidence in organ-confined disease and the decline in regional-distant prostate cancer at initial diagnosis, local or metastatic prostate cancer may still occur at a later time. The purpose of this study was to investigate trends in the community incidence of regional-distant stage prostate cancer over the entire course of illness. Methods All Olmsted County, Minnesota, residents who had prostate cancer initially diagnosed from 1964 through 2000 were identified using the resources of the Rochester Epidemiology Project. Their community medical records were examined for evidence of locally advanced (T3/4 or N+ disease) or metastatic prostate cancer first detected at any time between 1980 and 2000, based on pathology report at radical prostatectomy or pelvic lymphadenectomy at diagnosis (pathologic staging) and on all clinical and radiological findings at diagnosis and during follow-up. Results With priority given to pathologic staging, 407 men were identified with regional-distant disease; the age-adjusted incidence per 100,000 men increased from 47.4 (in 1980–1986) to 65.8 (in 1987–1993), and then declined to 33.3 (in 1994–2000) ( P P = 0.003) and mean number of prostate specific antigen determinations increased (0, 1.4, and 2.4, respectively; P n = 268 men) were lower: 42.3, 41.2, and 18.1 ( P Conclusion The incidence of regional-distant prostate cancer over the entire course of disease has declined in recent years, due in part to increased use of curative treatments and early detection by screening. Estimates based only on stage at initial diagnosis, however, underestimate the true burden of regional-distant disease in the community.

Background A prospective study was conducted to determine if external ionizing radiation could favorably influence the orbital manifestations of Graves ophthalmopathy. Diabetes and untreated systemic hypertension were exclusion criteria. Radiation was directed to the orbits of 42 affected patients using 0.2 rad (20 Gy) delivered in 10 doses of 0.02 rad (2 Gy). Patients were periodically examined during a 3-year interval. Objective To report retinal microvascular abnormalities observed in our study cohort. Methods Fundus findings documented with ophthalmoscopy, stereoscopic color photography, and stereoscopic fluorescein angiography prior to radiation were compared with similarly documented findings approximately 3 years following radiation. Results Prior to orbital radiation, retinal microvascular abnormalities were identified in 2 patients. The abnormalities were present bilaterally in one patient and unilaterally in the other. During the course of the study, microvascular abnormalities developed de novo in the unaffected retina of the latter patient while the retinopathy in the fellow eye progressed. Retinal microvascular abnormalities and their sequelae developed de novo in both eyes in 2 more patients. In addition to the radiation, other confounding factors known to be associated with microvascular retinopathy (uveitis, inadequately controlled systemic hypertension, and borderline blood glucose levels) were identified among the 3 patients whose eyes developed new retinal microvascular abnormalities. Conclusions Whether the retinal microvascular abnormalities observed in these patients were caused or aggravated by external beam irradiation cannot be precisely ascertained. However, the observed progression and de novo development of retinal microvascular abnormalities within 3 years of orbital radiation raise concern that 0.2 rad (20 Gy) delivered to the orbit in 10 doses of 0.02 rad(2 Gy) may aggravate existing retinal microvascular abnormalities or cause radiation retinopathy in some patients with Graves disease. These findings and the failure of external beam radiation with 0.2 rad (2000 c Gy) to favorably affect Graves ophthalmopathy, as demonstrated in a previous study, have led us to discourage further treatment of Graves ophthalmopathy with radiation.

PURPOSE: Men with prostate cancer identified through referral centers tend to be younger on average than those from population-based sources. This could potentially augment the proportion of men with a family history of prostate cancer and therefore bias insights about the role of genetic polymorphisms in case control studies. We sought to examine this hypothesis in the context of an ongoing case control study. METHODS: Cases were identified as the 6,352 consecutive candidates for radical prostatectomy at Mayo Clinic from 1966 to 1995. In 1995, 4,307 of the 5,486 men who were alive (78 percent participation) were queried about family history of prostate cancer and the distance of their home to Rochester, Minnesota was determined on the basis of ZIP code of residence. RESULTS: Among the 4,307 participants, there was a modest shift in age distribution towards younger ages with successively greater distance from Rochester. By contrast, the percentage of men reporting any first degree relatives with prostate cancer shifted very little by distance strata: 30, 30, 27, 27 and 26.5 percent for subjects living 0–100, 101–250, 251–500, 501–1000 and more than 1,000 miles from Rochester, respectively (p for trend = 0.09). The proportion reporting 3 or more first degree relatives differed very little, from 1.2 percent among local subjects to 1.1 percent among those most distant. CONCLUSION: The results from this surgical series provide little evidence of an increased prevalence of family history with increasing referral distance. While they provide some reassurance that referral bias should not overemphasize the contribution of genetic factors in case control studies conducted in referral centers, it would be prudent to investigate this in individual settings.

High-grade prostatic intraepithelial neoplasia (PIN) is the most likely precursor of prostate cancer. The effect of radiation therapy (RT) on the prevalence of PIN is uncertain. We studied 86 patients who underwent salvage radical prostatectomy after irradiation failure at the Mayo Clinic. The prevalence, volume, multicentricity, spatial proximity to cancer, and architectural patterns of PIN were evaluated. High-grade PIN was identified in 53 (62%) of 86 prostatectomy specimens. Multiple architectural patterns were usually observed, including tufting in 87%, micropapillary in 66%, cribriform in 38%, and flat in 17%. The mean volume of PIN was 0.12 cm 3 (range, 0.05-1.20 cm 3 ). PIN was usually multicentric (70%), with a mean number of PIN foci of 2.5 (range, 1-10). Ninety-four percent of PIN foci were located within 2 mm of invasive cancer. There was no correlation between PIN and pathologic stage, surgical margin, tumor size, DNA ploidy, post-RT Gleason score, time interval from RT to biopsy-proven recurrence, postoperative prostate-specific antigen level, distant metastasis-free survival, or cancer-specific survival. Our examination of salvage radical prostatectomy specimens indicated that the prevalence and extent of PIN appeared to be reduced after RT compared to published studies of prostatectomies without prior RT.

We read with interest the recent article by Jacobsen et al 1 on the predictive properties of prostate-specific antigen (PSA) as a screening test for prostate cancer in a population-based setting. This study demonstrates an important point when considering operating characteristics of screening or diagnostic tests when used with different populations. In the urology practice setting, the prevalence of prostate cancer and benign prostate disease (a primary source of false-positive results) is far higher than in the general population. It should be expected that the specificity of the screening test will be greater in the general population, where there are proportionately fewer men with benign disease and more men free of disease. In community-based and primary care settings, the distributions of PSA levels among men with and without prostate cancer are more disparate than in the specialty setting. We want to draw attention to 2 additional points that are crucial

In Reply. —We agree with the comments from Drs Rhoads and Mills regarding the lack of data in our article that demonstrate a reduction in morbidity and mortality from prostate cancer. However, their assertion that the transient increase in incidence of prostate caner will not be short lived is perhaps too globally stated. The duration of the increase is a function of the incidence and prevalence of cancer and it also depends on the degree of penetration of screening programs. In Olmsted County, Minnesota, where the rates of serum PSA testing have reached 50% of the population of men in their 60s, the transient increase will be much shorter lived than in areas where only 10% to 20% of the population is screened each year. Rhoads and Mills are also correct in focusing on mortality as one of the ultimate measures of efficacy of the screening program. We hope that

Objectives. —To define clinically insignificant prostate cancer according to cancer volume, grade, cancer doubling time, and life expectancy; and to determine how many insignificant cancers are removed by radical prostatectomy. Design and Patients. —Clinically insignificant cancer was defined as a tumor that would give rise to no more than 20 cm3 of cancer within the prostate by the time of expected patient death (1990 life tables) and whose Gleason score was less than 4 in 40- to 49-year-olds, 5 in 50- to 59-year-olds, 6 in 60- to 69-year-olds, and 7 in 70- to 79-year-olds. Four definitions were formulated based on assumed cancer volume doubling times of 2, 3, 4, and 6 years. Using these four definitions, we reviewed 337 totally embedded prostates removed at Mayo Clinic between 1991 and 1993 for clinical stage T1c through T3 cancer to determine how many contained clinically insignificant cancer. Main Outcome Measures. —Clinically significant vs clinically insignificant prostate cancer. Results. —For cancer volume doubling time of 2, 3, 4, and 6 years, clinically in significant cancer was identified in one (0.3%), 13 (3.9%), 25 (7.4%), and 49 (14.5%) of 337 prostatectomy specimens, respectively. Conclusions. —Clinically insignificant prostate cancer can be defined by cancer volume, grade, cancer volume doubling time, and life expectancy of the patient. According to our definitions, most men treated with radical prostatectomy have clinically significant cancer. (JAMA. 1996;275:288-294)

Objective. —To estimate the incidence of prostate cancer in Olmsted County, Minnesota, from 1983 through 1992 to describe the secular changes that have occurred since the introduction of serum prostate-specific antigen (PSA) testing to the community medical practice in 1987. Design. —Population-based, descriptive epidemiological study with ecologic and individual level comparisons over time. Study Setting. —Olmsted County, Minnesota, where the Rochester Epidemiology Project provides passive surveillance of the population for health outcomes. Subjects. —All 511 biopsy-proven incident cases of adenocarcinoma of the prostate diagnosed from 1983 through 1992. The community inpatient and outpatient medical records of all incident cases were reviewed to evaluate the presenting characteristics of men at the time of diagnosis. Results. —The age-adjusted incidence of biopsy-proven prostate cancer increased from 64 per 100 000 person-years in 1983 to 215 per 100 000 person-years in 1992. The increase occurred primarily between 1987 and 1988 and was predominately for organ-confined tumors. The age-specific incidence increased dramatically in this same period among men aged 50 years and older. Among men aged 70 years and older, however, prostate carcinoma incidence rates declined after 1990 following the initial increase. This decline among older men contrasted with community-based estimates of PSA utilization rates, which demonstrated consistent increases since 1987 to nearly 50% of the older population in 1992. Conclusion. —These results support the premise that the recent increase in prostate cancer is due in part to the increased utilization of serum PSA testing. Further, the increased incidence appears to be a transient phenomenon due to the depletion of previously undiagnosed cases from the prevalence pool. Finally, these data suggest that, in terms of stage at diagnosis, early detection efforts may be effective in identifying more early stage (smaller) cancers. ( JAMA . 1995;274:1445-1449)

To determine whether a significant percentage of patients with a benign digital rectal examination (DRE) and an elevated serum prostate-specific antigen (PSA) level harbor a prostatic malignancy, 100 consecutive patients underwent transrectal ultrasound (TRUS)-guided biopsy of the prostate. The biopsy results were correlated with the pre-biopsy serum PSA level and ultrasound findings. Overall, the cancer detection rate was 35 percent (S.E. 4.8%). When the biopsy results were analyzed according to the PSA level, the rate of cancer detection increased with advancing PSA levels, irrespective of ultrasound findings. In the 60 patients with ultrasound abnormalities, the cancer detection rate was 47 percent compared with 18 percent for those without ultrasound abnormalities. Comparison of TRUS-negative and TRUS-positive biopsy results revealed a more than two-fold increase in cancer detection for the TRUS-positive group in each PSA range. Cancer detection in the TRUS-positive, PSA 4.1-10, 10.1-20.0, and > 20 ng/mL groups was 40 percent, 56 percent, and 67 percent, respectively; in the TRUS-negative group, cancer detection was 12 percent, 27 percent, and 33 percent, respectively. Twenty (57%) of the patients with prostate cancer underwent radical retropubic prostatectomy. The mean tumor volume was 4.7 cc. Seventy percent had organ-confined disease, 30 percent demonstrated capsular penetration only, and no patients had seminal vesicle or pelvic lymph node invasion. These data indicate that a significant percentage of patients with a benign DRE and an elevated serum PSA value harbor a clinically significant, but potentially curable prostatic malignancy.

Objective. —To assess the need for obtaining radionuclide bone scans in the staging evaluation of patients with newly diagnosed, untreated prostate cancer. This determination was made on the basis of presenting prostate-specific antigen (PSA) levels. Design. —Retrospective review. Participants. —The medical records of 2064 consecutive patients with prostate cancer who were evaluated at the Mayo Clinic in Rochester, Minn, from January 1989 through December 1990 were reviewed. Eight hundred fifty-two patients with newly diagnosed, untreated disease and a serum PSA concentration less than 20.0 μg/L at presentation comprised the study population. Main Outcome Measure. —The rate of false-negative results associated with using the serum PSA concentration to predict bone scan findings. Results. —Five hundred sixty-one patients had a serum PSA concentration of 10.0 μg/L or less; only three had an abnormal bone scan result, and one had an indeterminate scan result. Of the 467 men whose PSA value was 8.0 μg/L or less (two times the upper limit of the reference range), none had bone scan results that were either abnormal or indeterminate. The rate of false-negative results for an abnormal bone scan result was 0% with a serum PSA value of 8.0 μg/L or less and 0.5% with a cutoff level of 10.0 μg/L. The 95% upper confidence limit for the rate of false-negative results for all PSA cutoff levels less than 20.0 μg/L was less than 2%. Conclusions. —For patients with newly diagnosed, untreated prostate cancer, a serum PSA concentration of 10.0 μg/L or less, and no skeletal symptoms, a staging radionuclide bone scan does not appear to be necessary. This clinical situation applies to 39% of all patients presenting with newly diagnosed prostate cancer. Since more than 130 000 new cases are diagnosed each year, approximately 50 000 patients are affected annually. If the $600 staging bone scan were eliminated for these patients, a significant economic savings to the health care system in this country would be effected. ( JAMA . 1993;269:57-60)