PubMed Health⌕ Search

Biomedical subjects

J E Oesterling

Publications and source records attributed to J E Oesterling.

At least 109 records · Page 6Linked to original sources
PubMed1995

The volume of prostate cancer in the biopsy specimen cannot reliably predict the quantity of cancer in the radical prostatectomy specimen on an individual basis.

Previous studies suggest that prostate cancer with a volume of 0.5 ml. or less and a Gleason score of less than 7 may be clinically insignificant and may be managed with watchful waiting. A proposed method of determining the volume of cancer in the prostate gland has been the grade and volume of cancer present in the transrectal needle biopsy specimen. Volume of cancer in the biopsy specimen as a predictor of volume of cancer in the prostate gland was studied in 130 men who underwent radical retropubic prostatectomy for adenocarcinoma. Of the men 46 (35%) had clinical stage T1c (nonpalpable) disease, while 84 (65%) had clinical stage T2 (palpable) disease. Each radical prostatectomy specimen was whole-mounted and step-sectioned for accurate cancer volume determination. Three parameters for measuring volume of cancer in the biopsy specimen (percentage of biopsy cores involved, millimeters of cancer per biopsy core and percentage of cancer in the biopsy specimen) were determined and compared by Spearman rank correlation analysis. The percentage of cancer in the biopsy specimen was marginally better than the percentage of cores involved and the millimeters of cancer per biopsy core as a predictor of cancer volume in the radical prostatectomy specimen. While regression analysis revealed a direct correlation between the volume of cancer in the biopsy and radical prostatectomy specimens (r = 0.51), there was significant variability in prostate cancer volume for a given percentage of cancer in the biopsy specimen since the standard error of the estimate was 6.1 ml. Of the 13 patients with 5% or less cancer volume and a Gleason score of less than 7 in the biopsy specimen 1 (8%) had a cancer smaller than 0.5 ml. in volume in the radical prostatectomy specimen. Therefore, the risk of removing clinically insignificant prostate cancer, even when the biopsy parameter indicates low volume disease, is less than 10%. Overall, only 3 study patients (2.3%) had a prostate cancer volume of less than 0.5 ml. With 97.7% of the men having a clinically significant cancer by a volume criterion, it is apparent that the majority of clinically insignificant prostate cancers remained undetected and untreated. Currently, transrectal needle biopsy does not provide adequate information for differentiating between clinically insignificant and life threatening prostate cancer on an individual basis.

Adenocarcinoma↗
PubMed1994

Cigarette smoking and prostatism: a biphasic association?

OBJECTIVE: To evaluate the association between cigarette smoking and prostatism in a community-based setting using standardized urinary symptom scores, peak urinary flow rates, and prostatic volume as indicators of disease. METHODS: A population-based cohort of 2,115 Caucasian men aged forty to seventy-nine years from Olmsted County, Minnesota, was administered a previously validated questionnaire that elicited information on frequency of urinary symptoms (approximating the American Urological Association's symptom index), and a detailed history on cigarette smoking, including both amount and pack-years of smoking. Peak urinary flow rates were measured by a standard uroflowmeter (Dantec 1000). The prostatic volume was measured for a subsample of 471 men by transrectal ultrasound. RESULTS: Compared to never-smokers, smokers were less likely to have moderate to severe urinary symptoms (age-adjusted odds ratio 0.82; 95% confidence interval [CI] 0.61 to 1.08). This varied by smoking intensity, however; in men who smoked less than 1 pack a day the age-adjusted odds ratio was 0.53 (95% CI 0.33 to 0.83) and among men smoking 1 to 1.4 packs a day, the odds ratio was 0.87 (95% CI 0.56 to 1.36). For men who smoked 1.5 packs or more a day, the odds ratio was elevated at 1.32 (95% CI 0.84 to 2.07). Smokers were less likely to have peak flow rates less than 15 mL/sec compared with never-smokers (age- and voided volume-adjusted odds ratio 0.48; 95% CI 0.35 to 0.66), or prostatic volume greater than 40 mL (odds ratio 0.54; 95% CI 0.19 to 1.55). CONCLUSIONS: These data from a community-based sample suggest that light or moderate smokers are less likely to have moderate to severe prostatism, whereas heavy smokers are at least as likely to have moderate to severe prostatism compared with never-smokers.

Adult↗
PubMed1994

Homologous blood transfusion in patients with prostate cancer: no effect on tumor progression or survival.

OBJECTIVE: To determine the effect of perioperative blood transfusions in patients with prostate cancer who underwent radical prostatectomy, we analyzed 1,785 patients with a follow-up of five years or more who were treated during a twenty-one-year period (1966 to 1987). METHODS: Patients were divided into three groups according to the number of units transfused during the perioperative period: group 1, 0 units (n = 440), group 2, 1 to 2 units (n = 746), and group 3, 3 or more units (n = 599). RESULTS: With univariate analysis, no statistically significant differences were found among the three groups in overall survival rate (71%, 75%, and 71% at ten years; p = 0.48), cause-specific survival rate (89%, 88%, and 86% at ten years; p = 0.36), or progression-free survival rate (61%, 68%, and 68% at ten years; p = 0.83). Adjusting for tumor grade, pathologic stage, and hormonal therapy using the Cox statistical model, we found no significant association between the blood-use group and overall survival rate (p = 0.45), cause-specific survival rate (p = 0.17), or progression-free survival rate (p = 0.34). The estimated relative risk and 95 percent confidence interval associated with blood transfusion (three or more units versus none) were as follows: 1.03 and 0.76 to 1.38 for total mortality, 1.56 and 0.95 to 2.56 for cause-specific death, and 1.20 and 0.91 to 1.57 for disease progression, respectively. CONCLUSIONS: According to these findings, withholding homologous blood transfusion, except for infectious precautions, should not be based on the suspicion that it can accelerate death from cancer in patients who undergo radical prostatectomy for prostate cancer.

Adult↗
PubMed1994

Natural history of prostatism: worry and embarrassment from urinary symptoms and health care-seeking behavior.

OBJECTIVE: To assess the interrelationships among psychosocial symptoms of worry and embarrassment about urinary function, prevalent urinary symptoms, psychological well-being, and health care-seeking behavior in a population-based cohort of men. METHODS: A cohort of 2,119 men aged forty to seventy-nine years, randomly selected from the Olmsted County, Minnesota population between December 1989 and March 1991, were administered a previously validated questionnaire that elicited information about the frequency of urinary symptoms, the degree to which they were perceived as a bother, and if the participant had seen a doctor in the previous twelve months for evaluation of any of these urinary symptoms. Psychological well-being was assessed by a subset of the Psychological General Well-Being Index, and sociodemographic information was also sought. RESULTS: Urinary symptom indices (measured by American Urological Association frequency and bother scores and psychological general well-being subscales) were significantly associated with worry and embarrassment about urinary symptoms in bivariate analyses. Multiple logistic regression analyses demonstrated that men with moderate or severe urinary symptoms or impaired psychological well-being were more likely to be worried or embarrassed about their urinary symptoms than men with mild symptoms. Furthermore, men who were worried about their urinary function were more likely to have sought medical care for their symptoms than men who were not worried. The association between health care-seeking behavior and embarrassment was especially strong among men with little bother associated with their urinary symptoms. CONCLUSIONS: Worry and embarrassment about urinary symptoms reflect quality-of-life issues that appear important in the health care-seeking behavior of men with prostatism. The results underscore findings that prevalent urinary symptoms alone do not determine a man's health care-seeking behavior, and treatment for psychosocial symptoms may be beneficial in some men with symptoms of prostatism.

Adult↗
PubMed1994

Endocrine therapies for symptomatic benign prostatic hyperplasia.

OBJECTIVE: To provide a comprehensive overview of the various endocrine therapies being developed and investigated for the treatment of symptomatic benign prostatic hyperplasia (BPH). METHODS: Peer-reviewed reports in the medical and urologic literature were examined for pertinent information relating to the role of luteinizing hormone-releasing hormone (LHRH) agonists, antiandrogens, 5 alpha-reductase inhibitors, and aromatase inhibitors in the management of BPH. Special attention was given to the scientific rationale and clinical results for each therapy. RESULTS: LHRH agonists, antiandrogens, and 5 alpha-reductase inhibitors all reduce the androgenic stimulation to the prostate gland. In doing so, they decrease prostate size by 25 percent, but cause a modest improvement in symptom score (3-4 points) and peak urinary flow rate (approximately 2.5 mL/sec). All of these therapies cause a significant decrease in the serum prostate-specific antigen (PSA) concentration, and an effect is maintained as long as the treatment is continued. Side effects are most pronounced for the LHRH agonists, in which impotency and decreased libido are universal phenomena, and least significant for the 5 alpha-reductase inhibitors. Aromatase inhibitors eliminate the estrogenic stimulation to the prostate gland. Although substantial evidence exists to support the role of estrogens in the development and maintenance of BPH, no data from large-scale randomized clinical trials are available to document the clinical usefulness of aromatase inhibitors in the treatment of symptomatic BPH. CONCLUSIONS: Medications that produce a state of androgen deprivation can reduce the static component of BPH. Of these agents, the 5 alpha-reductase inhibitors have the greatest promise because of their low toxicity profile. The role of the aromatase inhibitors in the treatment of BPH remains to be determined.

Androgen Antagonists↗
PubMed1994

Effect of several recruitment strategies on response rates at baseline in a prospective cohort investigation. The Olmsted County Study of Urinary Symptoms and Health Status among Men.

Epidemiologic survey response rates were studied in relation to maneuvers introduced to improve acceptance: (a) variation in invitation letters, (b) the use of a brochure with the recruitment mailing, and (c) options for interview location. The baseline population-based survey of a prospective cohort investigation of the natural history of benign prostatic hyperplasia was used. Invitations to participate were mailed to eligible, randomly selected men aged 40 to 79 years from the Olmsted County, Minnesota, population during 1989 to 1991. Of the 3874 men identified, 2119 (55%) participated. Overall, there was no difference in response rate according to invitation characteristics (chi 2(5) = 8.02, P = 0.16). Nevertheless, response rates varied with age (chi 2(7) = 30.9, P < 0.001) and home location (rural versus Rochester city; chi 2(1) = 76.9, P < 0.001). This suggests the innovations used to bolster acceptance did not materially improve response rates. Further, since response rates were highest for men aged 60 to 74 years, men with more symptoms and free time may have joined the cohort more often than others.

Adult↗
PubMed1994

Long-term (15 years) results after radical prostatectomy for clinically localized (stage T2c or lower) prostate cancer.

To provide information about long-term outcome after radical prostatectomy for clinically localized prostatic cancer (stage T2c or lower), we undertook a retrospective analysis of 3,170 consecutive patients (mean age 65.3 +/- 6.4 years, range 31 to 81) with a mean followup of 5 years. Complication rates for patients who underwent prostatectomy before 1988 were compared with those who underwent radical prostatectomy more recently. Of the patients 49 (1.5%), 178 (5.6%), 897 (28%) and 2,047 (65%) had clinical stages T1a, T1b, T2a and T2b,c disease, respectively. The Gleason score was 3 or less in 292 patients (9%) and 7 or greater in 782 (25%). Overall, 438 patients (14%) died, 159 (5%) of cancer. The crude 10 and 15-year survival rates for all patients were 75% and 60%, respectively, which is comparable to the expected survival of a control group (67% and 46%). The cause specific survival rates were 90% and 82%, respectively, metastasis-free survival rates 82% and 76%, local recurrence-free survival rates 83% and 75%, overall recurrence-free rates 72% and 61%, and overall recurrence plus prostate specific antigen progression-free (greater than 0.2 ng./ml.) rates 52% and 40%, respectively. Clinical stage did not significantly affect survival but tumor grade was associated: 10 and 15-year cause specific survival rates were 95% and 93%, respectively, for a Gleason score of 3 or less, 90% and 82%, respectively, for a score of 4 to 6, and 82% and 71%, respectively, for a score of 7 or more. Of all patients 26% received adjuvant treatment (hormonal and/or radiation) within 3 months postoperatively because of advanced local pathological stage (pT3 or higher) or margin positive disease. The 30-day mortality rate was 0.3% (0% for 1,728 patients who underwent surgery in 1988 or later). Only 1 patient in the 70 year or older age group died during hospitalization. Complications decreased with time. In a contemporary group the complications were rectal injury in 0.6% of the patients, colostomy in 0.06%, myocardial infarction in 0.4%, deep venous thrombosis in 1.1%, pulmonary embolism in 0.7% and total urinary incontinence (3 or more pads per day) in 0.8%. Recent intraoperative blood loss was a median of 600 ml., and the incidence of recent need for any transfusion was 31% and it is presently less than 5%. In this series patients undergoing radical prostatectomy for clinically localized prostate cancer were usually healthy and, thus, had low co-morbidity. Survival rates at 10 and 15 years compare favorably with those of an age-matched control group.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1994

The clinical usefulness of prostate specific antigen: update 1994.

In conclusion, PSA is the first prostate specific serum marker of clinical usefulness in urology. It represents a valuable clinical tool that has improved our ability to detect early prostate cancer and to monitor response to therapy. While large PSA screening studies have demonstrated an appreciable increase in the detection of organ confined, potentially curable prostate cancers, no study to date has yet demonstrated that the increased detection rate will decrease the prostate cancer-specific mortality rate. Yet more importantly, no study to date has demonstrated that early diagnosis using PSA will not decrease the prostate cancer specific mortality rate and until such data exist, PSA should be used to aid in early diagnosis and treatment planning for men with prostate cancer. PSA, when combined with other variables such as Gleason score and clinical stage, improves the prediction of pathological stage for prostate cancer. The introduction of PSA velocity and age specific reference ranges should further enhance the clinical usefulness of PSA. New advances in PSA research hold great promise for further improvements in PSA, and truly make it the most important and useful tumor marker for adenocarcinoma of the prostate.

Adenocarcinoma↗
PubMed1994

Measurement of serum prostate specific antigen using IMx prostate specific antigen assay.

The analytical characteristics of singlet determinations of the IMx prostate specific antigen (PSA) assay are similar to the mean of duplicates using the Tandem-R not equal to PSA assay. The 2 assays are standardized equally and provide test results that correlate well (r = 0.9997). The IMx PSA assay is more automated, requires less technologist time and provides faster test results. This assay has a minimal detection limit of 0.02 to 0.04 ng./ml. and functional sensitivity at a 20% coefficient of variation of 0.06 to 0.13 ng./ml. With a sensitive lot of IMx PSA reagents, only 38% of post-radical prostatectomy patients had nondetectable values compared to 60% with the Tandem-R PSA assay. The within-person, biological standard deviation of PSA concentrations in post-radical prostatectomy patients was 0.01 ng./ml. Therefore, with a sensitive assay these low concentration measurements should be reliable for monitoring. However, the clinical use of these low concentrations for early detection of tumor recurrence must await further studies.

Analysis of Variance↗
PubMed1994

Prostate specific antigen cannot distinguish stage T1a (A1) prostate cancer from benign prostatic hyperplasia.

To determine if serum prostate specific antigen (PSA) has decreased the prevalence of stages T1a (A1) and T1b (A2) prostate cancer, and to compare the PSA values for patients with stages T1a and T1b prostate cancer and men with symptomatic benign prostatic hyperplasia, 966 patients undergoing transurethral resection of the prostate were evaluated retrospectively. Included in the study population were 499 consecutive patients who underwent transurethral resection of the prostate for obstructive urinary symptoms in 1986 (no PSA group), and 467 consecutive patients who underwent resection in 1989 and 1990 who were evaluated with serum PSA preoperatively (PSA group). The mean age for the no PSA group was 71 years compared to 70 years for the PSA group (p = 0.36). The overall prevalence of stages T1a and T1b prostate cancer in the no PSA group was 8.6% compared to 10.3% in the PSA group (p = 0.37). The prevalence of stages T1a and T1b prostate cancer in the no PSA group was 3.6% and 5.0%, respectively, compared to 7.3% and 3.0%, respectively, for the PSA group (p = 0.01). In the PSA group the median PSA value for patients with stages T1a and T1b prostate cancer was 3.8 ng/ml compared to 3.4 ng/ml for the patients without cancer (p = 0.59). The median PSA level for the stage T1a cancer patients was 2.4 ng/ml, which was not statistically different from that in patients without cancer (p = 0.31), and the median PSA level for the stage T1b cancer patients was 5.9 ng/ml, which was statistically different than that in patients without cancer (p = 0.01). These findings suggest that the routine use of serum PSA does not decrease the prevalence of stage T1a prostate cancer and that PSA may decrease the prevalence of stage T1b tumors but a larger study would be necessary to document this finding.

Adult↗
PubMed1994

Eliminating the need for bilateral pelvic lymphadenectomy in select patients with prostate cancer.

To determine if the preoperative variables of serum prostate specific antigen (PSA), primary Gleason grade from the biopsy specimen and local clinical stage as determined from digital rectal examination can accurately predict the pelvic lymph node status in patients with clinically localized prostate cancer, we reviewed the medical records of 1,632 patients who underwent bilateral pelvic lymphadenectomy at our institution between January 1988 and December 1991. Using logistic regression analysis, serum PSA was found to be the best predictor of pelvic lymph node metastases (p < 0.0001). The predictive power of serum PSA could be enhanced considerably by taking into account the Gleason grade (p < 0.001) and local clinical stage (p < 0.001). A statistical model using all 3 variables was developed that allows the practicing urologist to estimate on an individual basis the probability of pelvic lymph node involvement. Using a conservative cutoff point of less than 3% as an acceptable false-negative rate, 61% of the patients with clinical stages T1a to T2b (A1 to B1) disease and 29% of those with clinical stages T1a to T2c (A1 to B2) prostate cancer may be spared an open or laparoscopic staging bilateral pelvic lymphadenectomy. As a result, patient morbidity can be decreased and a significant economic savings to the health care system can be realized. This observation has particular importance for prostate cancer patients being managed with radical perineal prostatectomy or definitive radiation therapy.

Adult↗
PubMed1994

Combining prostate specific antigen with cancer and gland volume to predict more reliably pathological stage: the influence of prostate specific antigen cancer density.

The serum prostate specific antigen (PSA) level was determined in 311 men with documented prostate cancer (stages T1cN0, T2N0 and T3N0) before bilateral pelvic lymphadenectomy and radical retropubic prostatectomy. The prostates were whole mounted, serially sectioned, and examined for cancer volume, capsular perforation, seminal vesicle invasion, lymph node involvement, Gleason grade, nuclear grade and nuclear deoxyribonucleic acid content. Median serum PSA level was significantly different between cancers that were organ confined, those that had capsular perforation or seminal vesicle invasion and those with positive lymph nodes (p < 0.001). Median serum PSA level was also significantly different between tumors with Gleason scores of less than 6 and those with higher Gleason scores (p < 0.001), and between tumors with greater than 30% of poorly differentiated cancer (Gleason primary grades 4 and 5) and those with 30% or less poorly differentiated cancer (p < 0.001). Bivariate analysis revealed that the strongest correlations of serum PSA level were with cancer volume (r = 0.56), per cent of poorly differentiated cancer (r = 0.42), positive surgical margins (r = 0.39) and pathological stage (r = 0.38), for all p < 0.001. Multivariate analysis showed that cancer volume was the major contributor to serum PSA level. The derivative, PSA-cancer density (serum PSA times cancer volume divided by prostate volume), accounted for the effects of prostate volume and cancer volume on serum PSA. PSA-cancer density showed a significant correlation with pathological stage (r = 0.56), Gleason score (r = 0.53) and per cent of poorly differentiated cancer (r = 0.49, for all p < 0.001), and these correlations were significantly stronger than serum PSA level alone or PSA density (serum PSA divided by prostate volume; volume determined from tissue specimens) for all variables. These results indicate that preoperative serum PSA level has significant predictive value in determining tumor burden and pathological stage, and this predictive value is increased by accounting for cancer and gland volume with PSA-cancer density.

Adenocarcinoma↗
PubMed1994

Prostate-specific antigen: critical issues for the practicing physician.

BACKGROUND: Serum prostate-specific antigen (PSA), when used in combination with existing detection methods, improves the clinician's ability to detect early and potentially curable prostate cancer. FINDINGS: This report describes clinically important issues about use of the serum PSA concentration for detecting early prostate cancer. Other PSA-related factors--PSA density, PSA velocity, and age-specific reference ranges--seem to enhance the ability of clinicians to distinguish benign prostatic conditions from early prostate cancer. Because digital rectal examination only minimally affects the serum PSA concentration, delaying a determination after this examination is unnecessary. Finasteride therapy for benign prostatic hyperplasia should be initiated only after the prostate has been evaluated for cancer because this 5 alpha-reductase inhibitor lowers the serum PSA value by approximately 50%; however, reassessment of the prostate for cancer is necessary if the PSA level fails to decrease as expected or increases to more than 2 ng/mL during finasteride treatment. CONCLUSION: Currently, PSA is the most important, accurate, and clinically useful tumor marker for prostate cancer.

Adult↗
PubMed1994

Prostate-specific antigen: concepts for staging prostate cancer and monitoring response to therapy.

FINDINGS: The prostate-specific antigen (PSA) level alone does not facilitate precise pathologic staging on an individual basis, although advanced stage tends to correlate with an increased PSA level. The staging accuracy of PSA, however, can be enhanced by considering the variables of tumor grade and clinical stage. Staging radionuclide bone scans in asymptomatic, untreated patients with clinically localized prostate cancer and a PSA value of less than 10.0 ng/mL are unnecessary. After radical prostatectomy, the serum PSA level is exquisitely sensitive to recurrent or residual disease. Ultrasensitive PSA assays can increase the sensitivity of PSA as a tumor marker after surgical removal of the prostate. Currently, however, the clinical usefulness of PSA concentrations detected in the ultrasensitive range after radical prostatectomy is unknown. Serum PSA values aid in monitoring patients who have received definitive radiation therapy for prostate cancer. Patients in whom the serum PSA level decreases to the reference range have a favorable prognosis. An increasing serum PSA concentration after radiation therapy heralds progressive prostate cancer. The serum PSA level after androgen deprivation therapy (ADT) also has prognostic importance in that a decrease to the normal range predicts a prolonged remission in most patients. Because expression of PSA is under direct hormonal influence, however, ADT can decrease the serum PSA value independent of antitumorigenic activity. Patients who have received ADT must be closely monitored for signs of clinical progression because, in some patients, a serum PSA concentration within the reference range may underestimate actual tumor burden and activity. CONCLUSION: PSA is the most useful and accurate tumor marker for staging and monitoring prostate cancer after therapy.

Biomarkers, Tumor↗
PubMed1994

Development of a highly sensitive immunochemiluminometric assay for prostate-specific antigen.

OBJECTIVES: An assay is described for measuring very low concentrations of prostate-specific antigen (PSA) which could be used to reliably monitor patients with radical prostatectomies potentially to detect early recurrence of prostate cancer. METHODS: A combination of immobilized and acridinium ester-labeled monoclonal antibodies was used to develop a two-step, 90-minute chemiluminometric assay. The reference standards for the serum assays were prepared by adding patient sera with a high concentration of PSA to base pools of female sera, which were selected because of low background counts and good recovery of added PSA. The assay was standardized to match the Abbott IMx PSA Assay. RESULTS: The serum-based analytic detection limit (calculated as response 2.5 standard deviations [SD] above the zero standard) is 0.004 ng/mL, whereas the "biologic detection limit" (calculated as 2.0 SD above the analytic detection limit) is 0.008 ng/mL. The assay is highly reproducible with interassay coefficients of variation (CV) under 12% down to 0.02 ng/mL, qualifying this as a "second generation" assay (eg, CV < 20% at 0.05 ng/mL). CONCLUSION: This assay can measure very low concentrations of PSA in plasma and a wide range of PSA concentrations in urine. This assay will provide a valuable analytic tool for the future evaluation of the clinical utility of "ultrasensitive" PSA measurements for the management of prostate cancer.

Analysis of Variance↗
PubMed1994

Comparability of the Tandem-R and IMx assays for the measurement of serum prostate-specific antigen.

OBJECTIVES: To assess the comparability of the Tandem-R and IMx serum prostate-specific antigen (PSA) assays across levels of the ratio of free-to-total serum PSA found in a community-based population of healthy men. METHODS: Banked serum samples from the baseline component of the Olmsted County Study of Urinary Symptoms and Health Status Among Men were thawed and analyzed using the Tandem-R and IMx PSA assays. Serum levels also were determined for the free, noncomplexed form of PSA, PSA complexed to alpha-1 antichymotrypsin, and total PSA with a research-based immunofluorometric assay. RESULTS: The results of the Tandem-R and IMx assays were strongly correlated at all levels of the ratio of free-to-total serum PSA. The Spearman correlation coefficients ranged from 0.87 to 0.98 (all p < 0.001). The relationship between the Tandem-R and IMx assays, however, differed at low levels of free-to-total serum PSA compared with high levels. In the lowest 10th percentile of the ratio of free-to-total serum PSA (0.04 to 0.18), the IMx assay read lower than the Tandem-R (slope +/- standard error = 0.92 +/- 0.04, intercept +/- standard error = 0.21 +/- 0.14); whereas in the upper 10th percentile of free-to-total ratio (0.46 to 0.65) the IMx assay yielded values higher than the Tandem-R assay (slope = 1.21 +/- 0.07, intercept = 0.14 +/- 0.05). In the middle 90%, the slope did not statistically differ from 1.0. CONCLUSIONS: For the majority of men, results of the Tandem-R and IMx PSA assays were virtually identical. The small differences found would not be of clinical significance for most men but should be considered when comparing results of different assays in sequential determinations for a specific man.

Adult↗
PubMed1994

The North American experience with the UroLume endoprosthesis as a treatment for benign prostatic hyperplasia: long-term results. The North American UroLume Study Group.

OBJECTIVES: To determine the efficacy and safety of the UroLume endoprosthesis as a treatment for obstructive benign prostatic hyperplasia in healthy men. METHODS: One hundred twenty-six men were enrolled prospectively in a multicenter North American Clinical Trial. Ninety-five men (mean age 68 +/- 7 years) had moderate or severe prostatism, whereas 31 participants (mean age 76 +/- 8 years) were in urinary retention. Voiding function for all patients was assessed prior to stent placement and in follow-up at 1, 3, 6, 12, and 24 months with the Madsen-Iversen symptom questionnaire, peak urinary flow rate, postvoid residual urine volume, and cystoscopic examination. RESULTS: For the nonretention cohort at 24-month follow-up, the results were as follows: (1) total symptom score decreased from 14.3 +/- 0.5 preinsertion to 5.4 +/- 0.5 (p < 0.001); (2) peak urinary flow rate increased from 9.1 +/- 0.5 mL/s preinsertion to 13.1 +/- 0.7 mL/s (p < 0.001); and (3) postvoid residual urine volume decreased from 85 +/- 9 mL to 47 +/- 8 mL (p = 0.02). For the retention group, the total symptom score, peak urinary flow rate, and postvoid residual urine volume at 24 months were 4.1 +/- 0.5, 11.4 +/- 1.0 mL/s and 46 +/- 7 mL, respectively. By 12-month follow-up, most endoprostheses were completely covered with urothelium. Although significant long-term complications were minimal, 17 endoprostheses have been explanted for an overall removal rate of 13%. All devices were removed transurethrally without subsequent sequelae to the external urinary sphincter or urethra. CONCLUSIONS: The long-term results from this North American Clinical Trial suggest that the UroLume endoprosthesis can be an effective and safe treatment for properly selected healthy men with obstructive benign prostatic hyperplasia. Randomized clinical trials comparing this minimally invasive procedure with transurethral resection of the prostate are now underway to document further its efficacy and safety.

Aged↗