Should Medicare provide reimbursement for prostate-specific antigen testing for early detection of prostate cancer? Part I: Framing the debate.
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Adult↗
Biomedical subjects
J E Oesterling
Publications and source records attributed to J E Oesterling.
The correlation between serum prostate-specific antigen and prostate cancer is not influenced by the serum testosterone concentration.
OBJECTIVES: To determine if the serum testosterone (T) concentration influences the ability of prostate-specific antigen (PSA) to predict prostate cancer volume and stage. METHODS: One hundred consecutive patients with clinically localized prostate cancer who underwent radical prostatectomy were examined prospectively. Each patient was evaluated preoperatively with a serum PSA, total T, free T, and percent free T. All surgical specimens were evaluated using the whole mount, step section technique for Gleason score, tumor volume, and extraprostatic disease. RESULTS: Serum total T, free T, and percent free T did not correlate with the serum PSA level (r = .03, .08, and .07, respectively), tumor volume (r = .11, .08, and .11, respectively), prostate weight (r = .00, -.08, and .11, respectively), or Gleason score (r = .11, .08, and .11, respectively). Serum PSA correlated with tumor volume (r = .51, P < 0.0001). Extraprostatic disease was significantly associated with a higher percent free T value (r = .26, P = 0.02) but not with either the total or the free T level. Linear regression analysis showed that neither the total nor the free T concentration was a significant predictor of extraprostatic disease in the presence of PSA (P = 0.30 and 0.24, respectively); percent free T contributed only slightly to PSA in the prediction of extraprostatic disease (P = 0.05). However, neither total T, free T, nor percent free T was a significant predictor of tumor volume; in essence, the association between PSA and tumor volume was independent of the serum T concentration (P = 0.30, 0.24, and 0.60, respectively). CONCLUSIONS: Serum total T, free T, and percent free T values do not enhance the ability of PSA to predict the tumor volume or pathologic stage in patients with clinically localized prostate cancer.
Aged↗
Should Medicare provide reimbursement for prostate-specific antigen testing for early detection of prostate cancer? Part II: Early detection strategies.
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Adult↗
Should Medicare provide reimbursement for prostate-specific antigen testing for early detection of prostate cancer? Part III: Management strategies and outcomes.
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Aged↗
Does the mode of questionnaire administration affect the reporting of urinary symptoms?
OBJECTIVES: To assess the effect of modes of administration (self-administered questionnaires, oral face-to-face interview, and telephone interview) on responses to the American Urological Association Symptom Index (AUASI) in randomly selected community men. METHODS: An age-stratified random sample of 475 white male residents of Olmsted County, Minnesota, aged 40 to 79 years, without prior prostate surgery or prostate cancer were queried about urinary symptom frequency twice at baseline and twice approximately 2 years later using questions with wording similar to the AUASI: At baseline and first follow-up, questionnaires were self-administered initially, followed by a structured interview by a female urology nurse within 2 to 28 weeks. A subset of 200 randomly selected men received a telephone interview by a female research assistant following the self-administered questionnaire given at a second follow-up approximately 4 years after baseline. RESULTS: Mean symptom scores obtained by oral interview were 1 to 2 points lower than those from self-administered questionnaires (P < 0.01). In a random subset (n = 200) interviewed by telephone, mean AUASI scores were as much as 4 points lower than those from self-completed questionnaires. CONCLUSIONS: Values of the AUASI obtained by interviewer administration may be lower than those obtained by self-administered questionnaires. When assessment of change in urinary symptoms over time is of interest, the same standardized method of questionnaire administration should be used at baseline and follow-up evaluations to avoid introducing artifactual differences related to the mode of administration.
Adult↗
Using prostate-specific antigen to eliminate unnecessary diagnostic tests: significant worldwide economic implications.
As the 21st century approaches, it is necessary for urologists worldwide to diagnose and stage malignancies in a cost-effective manner. With the recent advances in the use of prostate-specific antigen (PSA), it is now possible to avoid many time-consuming, expensive, and invasive procedures that have been commonplace in the past. PSA has replaced transrectal ultrasonography (TRUS) as a first-line diagnostic test for evaluating men for early, curable prostate cancer. In older men, the use of age-specific reference ranges for serum PSA can significantly decrease the number of prostate biopsies that are routinely performed. With regard to staging procedures, PSA can now be used successfully to eliminate the bilateral pelvic lymphadenectomy in 30% of men with clinically localized disease and the radionuclide bone scan in 40% of patients with newly diagnosed prostate cancer. In the discussion that follows, the use of serum PSA in the diagnosis and staging of prostate cancer will be discussed. In addition, the economic benefit achieved through proper use of this tumor marker will be reviewed.
Biopsy↗
Should Medicare provide reimbursement for prostate-specific antigen testing for early detection of prostate cancer? Part IV: Estimating the risks and benefits of an early detection program.
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Aged↗
An analytical comparison of the three most commonly used prostate-specific antigen assays: Tandem-R, Tandem-E, and IMx.
OBJECTIVES: To compare the similarity of individual prostate-specific antigen (PSA) results when using the Tandem-R PSA assay, the Tandem-E PSA assay, or the IMx PSA assay; to assess the lot-to-lot variation within (intra-assay interlot) and between (interassay interlot) the Tandem-R, Tandem-E, and IMx PSA assays; and to evaluate the individual and overall potential lot-to-lot bias of the Tandem-R, Tandem-E, and IMx PSA assays. METHODS: Forty-nine serum samples (PSA values from 0 to 85 ng/mL) were each tested by three separate lots (manufacturer's reagent materials) of Tandem-R, Tandem-E, and IMx PSA assays. Therefore, a total of nine different lots were utilized per patient sample in this investigation. Analyses primarily focused on three ranges: 0 to 10 ng/mL (low), 10 to 85 ng/mL (high), and 0 to 85 ng/mL (overall). RESULTS: In the 0 to 10 ng/mL range, 93% of the assay comparisons yielded an actual difference of less than 1 ng/mL. All three assays demonstrated excellent correlation within and between their three respective lots, within all three ranges. The 95% confidence intervals around the percent coefficient of variation (CV) demonstrated similar results for each assay (CV range, 3.2% to 6.0%). All lots demonstrated an average actual PSA bias of less than +/- 1 ng/mL. The average percent PSA bias was also similar between all three assay systems. All lots demonstrated a less than +/- 4% bias. CONCLUSIONS: Overall, the Tandem-R and IMx PSA assays yielded slightly lower results than the Tandem-E PSA assay. However, these differences were not statistically significant. In addition, the overall lot-to-lot variation (intra-assay and interassay) was not statistically significant, and the actual or percent PSA bias was minimal with these three assays. Therefore, a clinician can feel confident that a patient's serum sample should yield a similar and interchangeable result, whether it is determined by the Tandem-R, Tandem-E, or IMx PSA assay system.
Blood Chemical Analysis↗
Serum prostate-specific antigen in a community-based population of healthy Japanese men: lower values than for similarly aged white men.
OBJECTIVE: To determine whether the age-specific reference ranges for serum prostate-specific antigen (PSA) concentration generated for white men are applicable to other races. PATIENTS AND METHODS: Three-hundred and thirty-five healthy Japanese men, aged 40-79 years, residing in the small fishing village of Shimamaki-mura, Japan, agreed to enter this prospective, community-based study. All underwent a detailed clinical evaluation that included a serum PSA determination, a digital rectal examination and a transrectal ultrasound. Two-hundred and eighty-six (85%) completed the prostatic evaluation and had no evidence of prostate cancer by any one of the three diagnostic tests; these men formed the study population on which all analyses were performed. RESULTS: The serum PSA concentration correlated directly with patient age (r = 0.33; P < 0.001) and prostatic volume (r = 0.57; P < 0.001). PSA density (PSAD) also was directly proportional to age (r = 0.30; P < 0.001). Adjusting for age, the serum PSA concentration was lower for Japanese men than for white men (P < 0.001). Thus, the recommended age-specific reference ranges (95th percentile) for serum PSA for Japanese were lower as well: 0.0-2.0 ng/mL for 40-49 years; 0.0-3.0 ng/mL for 50-59 years; 0.0-4.0 ng/mL for 60-69 years; and 0.0-5.0 ng/mL for 70-79 years. Based on transrectal ultrasound-volume determinations, the lower serum PSA concentrations in Japanese men are due in large part to their smaller prostate glands as compared with white men (P < 0.001). CONCLUSIONS: These findings confirm the earlier observations that serum PSA, prostatic volume and PSAD are age-dependent. However, because of physiological differences among the two races, partly due to the size of the prostate gland, the age-specific reference ranges for serum PSA are lower for Japanese men than for white men. Because of these racial differences, it is now crucial to conduct a similar investigation among black men.
Adult↗
Sexual function of men ages 40 to 79 years: the Olmsted County Study of Urinary Symptoms and Health Status Among Men.
OBJECTIVES: Knowledge of male sexual function is somewhat limited because of a lack of current population-based data. This study provides information on sexual function and satisfaction in a population-based sample of men. METHODS: Men aged 40 to 79 years (n = 2115) were selected randomly from the Olmsted County population for the baseline component of a prospective cohort study (the Olmsted County Study of Urinary Symptoms and Health Status Among Men) during 1989-1990. The men completed a self-administered questionnaire that included questions about sexual concerns, performance, satisfaction, drive, and erectile dysfunction. RESULTS: For all five sexual parameters queried, the prevalence of problems and dysfunction increased with age. A comparison of men aged 70 to 79 years with men aged 40 to 49 years suggested that older men were more worried about sexual function (46.6% vs 24.9%), had worsened performance compared with a year ago (30.1% vs 10.4%), expressed extreme dissatisfaction with sexual performance (10.7% vs 1.7%), had absent sexual drive (25.9% vs 0.6%), and reported complete erectile dysfunction when sexually stimulated (27.4% vs 0.3%). Logistic regression analyses suggested that sexual dissatisfaction was significantly associated with erectile dysfunction, decreased libido, and the interaction between erectile dysfunction and libido, but not age. CONCLUSIONS: These population-based cross-sectional data corroborate the previously reported age-related decrease in sexual function. The age-related increase in dissatisfaction could, however, be accounted for primarily by the age-related increase in erectile dysfunction, decreased libido, and the interaction between erectile dysfunction and decreased libido.
Adult↗
Prostate-specific antigen detected prostate cancer: pathological characteristics of ultrasound visible versus ultrasound invisible tumors.
Most studies examining the issue of 'early detection of prostate cancer' advocate the combined use of serum prostate-specific antigen (PSA) and digital rectal examination (DRE). As a result, a significant number of new prostate cancers are diagnosed on the basis of an elevated serum PSA when the DRE is unremarkable. The purpose of this study is to determine if the PSA-detected tumors that are visible on transrectal ultrasound (TRUS) have the same pathological characteristics as PSA-detected tumors that are invisible on TRUS. One hundred and ninety-four patients with an elevated serum PSA concentration and nonpalpable prostate cancer who underwent radical retropubic prostatectomy (RRP) at our institution between March 1988 and December 1991 were reviewed. The patients were divided into two groups: 97 (50%) had no identifiable lesion on TRUS, and 97 (50%) had at least one hypoechoic area consistent with adenocarcinoma of the prostate. The pathological characteristics of the RRP specimens from the two groups were compared. There was no significant difference in the age (p = 0.14) or the preoperative serum PSA values (p = 0.18) between the groups. Also, there was no significant difference between the groups with regard to tumor volume (p = 0.89), focality of the cancer (p = 0.43), Gleason score (p = 0.81), DNA ploidy status (p = 0.96), pathological stage (p = 0.92), surgical margin involvement (p = 0.27), and tumor location (p = 0.64). These findings suggest that the clinical TNM staging system for prostate cancer may be simplified by eliminating the distinction between PSA-detected cancers visible on TRUS and PSA detected cancers not visible on TRUS.(ABSTRACT TRUNCATED AT 250 WORDS)
Adenocarcinoma↗
Age-specific reference ranges for serum prostate-specific antigen.
As more is learned about the biomolecular properties and physiology of the glycoprotein, prostate-specific antigen, its clinical usefulness with regard to the diagnosis and management of prostate cancer also will improve. Recent advances, including the development of the concepts of prostate-specific antigen density and velocity as well as the discovery that prostate-specific antigen exists in the serum in several molecular forms, will further improve the clinical utility of this tumor marker. The even more recent discovery that the serum prostate-specific antigen is dependent upon age also has the potential to enhance the clinical usefulness of this tumor marker with regard to the early detection of prostate cancer.
Journal Article↗
Prostate Cancer Clinical Guidelines Panel Summary report on the management of clinically localized prostate cancer. The American Urological Association.
PURPOSE: The American Urological Association convened the Prostate Cancer Clinical Guidelines Panel to analyze the literature regarding available methods for treating locally confined prostate cancer, and to make practice policy recommendations based on the treatment outcomes data insofar as the data permit. MATERIALS AND METHODS: The panel searched the MEDLINE data base for all articles from 1966 to 1993 on stage T2 (B) prostate cancer and systematically analyzed outcomes data for radical prostatectomy, radiation therapy and surveillance as treatment alternatives. Outcomes considered most important were survival at 5, 10 and 15 years, progression at 5, 10 and 15 years, and treatment complications. RESULTS: The panel found the outcomes data inadequate for valid comparisons of treatments. Differences were too great among treatment series with regard to such significant characteristics as age, tumor grade and pelvic lymph node status. The panel elected to display, in tabular form and graphically, the ranges in outcomes data reported for each treatment alternative. CONCLUSIONS: In making its recommendations, the panel presented treatment alternatives as options, identifying the advantages and disadvantages of each, and recommended as a standard that patients with newly diagnosed, clinically localized prostate cancer should be informed of all commonly accepted treatment options.
Humans↗
The use of age-specific reference ranges for serum prostate specific antigen in men 60 years old or older.
Several investigations have determined that the serum prostate specific antigen (PSA) concentration is dependent upon patient age and, as a result, reference ranges wider than 0.0 to 4.0 ng./ml. have been suggested for men 60 years old or older. To determine the clinical usefulness of the age-specific reference ranges--0.0 to 4.5 ng./ml. for men 60 to 69 years old and 0.0 to 6.5 ng./ml. for men 70 years old or older--the medical records of 2,988 men 60 years old or older who presented to a single urological practice were examined. All patients were evaluated with a serum PSA determination, digital rectal examination and transrectal ultrasound. A total of 1,686 prostate biopsies was performed (biopsy rate 56%) and 608 cancers were diagnosed (cancer detection rate 20%). By using the age-specific reference ranges as compared to the 0.0 to 4.0 ng./ml. reference range, the sensitivity of PSA for detecting early prostate cancer decreased by 9%, while the specificity and positive predictive value increased by 11% and 5%, respectively. If the age-specific reference ranges had been used 92 prostate biopsies (5.5%) performed could have been avoided, while 19 men in the study population (0.6%) would not have had prostate cancer diagnosed. Of the nondetected cancers 13 (67%) occurred in men 70 years old or older and 18 (95%) were small tumors of favorable pathological status unlikely to be of clinical consequence in these older men. These preliminary findings support the clinical usefulness of the wider age-specific reference ranges in men 60 years old or older. A prospective randomized clinical trial is currently underway to confirm the appropriateness of age-specific reference ranges compared to the reference range of 0.0 to 4.0 ng./ml.
Age Factors↗
The role of community-based longitudinal studies in evaluating treatment effects. Example: benign prostatic hyperplasia.
To determine the appropriateness and effectiveness of medical interventions, it is necessary to understand both the natural history of the conditions the interventions are intended to treat or prevent, and the normal reference ranges of tests used in diagnosis and management. The acquisition of this information through clinic-based studies can yield misleading conclusions owing to selection bias. What appears to be intervention-related variation in outcomes may be variation in the magnitude and form of selection bias. To minimize selection bias, population-based studies are required. Results from the Olmsted County Study of Urinary Symptoms and Health Status Among Men were used to show how a population-based longitudinal study of the natural history of benign prostatic hyperplasia (BPH) can complement research programs of the BPH Patient Outcomes Research Team. Population-based studies of disease natural history are a necessary part of medical outcomes research, and deserve greater emphasis in the medical treatment effectiveness research initiative of the Agency for Health Care Policy and Research.
Community Health Planning↗
The role of prostate-specific antigen in the evaluation of benign prostatic hyperplasia.
This article reviews the role of prostate-specific antigen (PSA) in the evaluation of BPH. Efficacy of the PSA test in differentiating patients with BPH from patients with early, potentially curable prostate cancer is discussed. In addition, this complete overview provides a critical analysis of various concepts (PSA density, PSA velocity, age-specific reference ranges, and free versus complexed serum PSA), that are devised to optimize the diagnostic value of the serum PSA concentration in a population in which prostate cancer and BPH are almost equally prevalent. A clinical algorithm, useful to the practicing clinician for the early detection of prostate cancer in the BPH patient, is also proposed.
Diagnosis, Differential↗
Prostatic stents. Current perspectives for the management of benign prostatic hyperplasia.
The urethral stent is a relatively new treatment modality for symptomatic BPH. Our knowledge and experience using various stenting devices for this indication have been enhanced considerably within the last 12 to 18 months as the results from more investigations have become available. These preliminary data indicate that the intraurethral stent is an effective and safe treatment for symptomatic BPH in properly selected patients. Although the majority of clinical data currently available involve the UroLume Endourethral Prosthesis (American Medical Systems), other product designs such as thermosensitive and biodegradable prostheses are being investigated in animal models and human clinical trials. The ultimate urethral endoprosthesis for the treatment of an enlarged prostate gland resulting in symptomatic bladder outlet obstruction has yet to be developed.
Humans↗
Prostatic intraepithelial neoplasia is a risk factor for adenocarcinoma: predictive accuracy in needle biopsies.
PURPOSE: High grade prostatic intraepithelial neoplasia is considered the most likely precursor of prostatic adenocarcinoma. However, the natural history and predictive value of prostatic intraepithelial neoplasia for cancer are unknown. MATERIALS AND METHODS: To examine the predictive value of high grade prostatic intraepithelial neoplasia, we conducted a retrospective clinic based comparative study of 100 patients with high grade prostatic intraepithelial neoplasia and 112 without prostatic intraepithelial neoplasia on needle biopsies matched for digital rectal examination findings, patient age and serum prostate specific antigen level. Only patients who had 1 or more followup biopsies were included. RESULTS: Adenocarcinoma was identified in 35% of subsequent biopsies from patients with prostatic intraepithelial neoplasia, compared with 13% of control biopsies. The likelihood of finding cancer increased as the interval from initial biopsy increased. High grade prostatic intraepithelial neoplasia, patient age and serum prostate specific antigen concentration were jointly highly significant predictors of cancer, with prostatic intraepithelial neoplasia providing the highest risk ratio of 14.93 (95% confidence intervals 5.6 to 39.8). No other candidate predictor was significant, including digital rectal examination findings, transrectal ultrasound results, amount of prostatic intraepithelial neoplasia on biopsy and architectural pattern of prostatic intraepithelial neoplasia. CONCLUSIONS: These results indicate that the presence of high grade prostatic intraepithelial neoplasia on needle biopsy is strongly predictive of carcinoma. Prostatic intraepithelial neoplasia should be reported in needle biopsies and biopsy repeated. These finding support the hypothesis that prostatic intraepithelial neoplasia is a precursor of prostate cancer.
Adenocarcinoma↗