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R Kranse

Publications and source records attributed to R Kranse.

At least 19 recordsLinked to original sources

Evaluation of prostate needle biopsies in a population-based screening study: the impact of borderline lesions.

BACKGROUND: The finding of isolated high grade prostatic intraepithelial neoplasia (PIN) or borderline lesions (lesions suspicious for malignancy) in prostate needle biopsies warrants repeat biopsies. The reported frequency of these lesions in prostate needle biopsies varies considerably. The authors evaluated the frequency and clinical impact of high grade PIN and borderline lesions in sextant prostate needle biopsies obtained from screened participants in the European Randomized study of Screening for Prostate Cancer (ERSPC). METHODS: A total of 8763 participants in the Rotterdam section of the ERSPC ages 55-75 years were screened systematically for prostate carcinoma. Systematic sextant prostate needle biopsies were prompted by an abnormal digital rectal examination and/or abnormal transrectal ultrasonography findings at serum prostate specific antigen (PSA) levels > or = 1.0 ng/mL or a PSA level > or = 4.0 ng/mL. Repeat biopsies were obtained within 6 months after initial biopsy. RESULTS: Of 1824 biopsied men, 384 (21.1%) were found to have prostate carcinoma on initial biopsy. Twelve participants (0.7%) had isolated high grade PIN and 43 (2.4%) had borderline lesions. Repeat biopsies yielded no carcinoma in 7 participants with initial high grade PIN and 15 tumors (38.5%) in 39 participants with borderline lesions. CONCLUSIONS: In prostate needle biopsies obtained from a screened population, indications for repeat biopsy such as high grade PIN and borderline lesions do not represent large diagnostic subsets. Borderline lesions comprise the most important indication for a repeat biopsy. The low frequency of equivocal biopsy diagnoses in the current study supports the clinical applicability of sextant needle biopsies in population-based screening for prostate carcinoma.

Adenocarcinoma

Evaluation of the digital rectal examination as a screening test for prostate cancer. Rotterdam section of the European Randomized Study of Screening for Prostate Cancer.

BACKGROUND: The utility of digital rectal examination (DRE) as a screening test for early detection of prostate cancer has not been established. Therefore, we evaluated the usefulness of DRE as a stand-alone screening test and in conjunction with measured serum prostate-specific antigen (PSA) levels of 0-3.9 ng/mL and transrectal ultrasonography (TRUS). METHODS: Our study population consisted of 10,523 men aged 54-76 years who were randomly assigned to the screening arm of the Rotterdam, The Netherlands, section of the European Randomized Study of Screening for Prostate Cancer. The underlying prevalence of detectable prostate cancer was estimated by logistic regression analysis and used for calculating the sensitivity of DRE as a test. Pathologic characteristics of 105 radical prostatectomy specimens were used to determine the aggressiveness of the tumors diagnosed (and missed) by DRE. RESULTS: The overall detection rate for prostate cancer in this population when serum PSA measurement, DRE, and TRUS were used was 4.5%, and the detection rate with DRE alone was 2.5%. The positive predictive value of DRE ranged from 4% to 11% in men with PSA levels of 0-2.9 ng/mL and from 33% to 83% in men with PSA levels of 3.0-9.9 ng/mL or more. Most tumors detected by DRE in men with PSA levels of less than 4.0 ng/mL were small (mean volumes = 0.24-0.83 mL), and most were well differentiated (Gleason scores of 6 or less). Minimal, moderate, and advanced cancers were seen in 42%, 42%, and 16% of men, respectively, with a PSA level of 4.0 ng/mL or less. DRE alone allowed detection of 264 (55.8%) of 473 cancers; 82 (17.3%) of the 473 cancers would have remained undetected by PSA-based screening alone (i.e., no follow-up procedures for PSA values of 0-3.9 ng/mL). CONCLUSIONS: For PSA values of 0-3.9 ng/mL, the positive predictive value and sensitivity of DRE, tumor volume, and tumor grade were strongly dependent on PSA level. DRE has a poor performance in low PSA ranges.

Aged

Comparison of prostate-specific antigen corrected for total prostate volume and transition zone volume in a population-based screening study.

OBJECTIVES: To compare the discriminatory potential between prostate cancer and benign conditions of the prostate in a population-based screening study, of serum prostate-specific antigen levels (PSA) and PSA corrected for both the total prostate volume (PSA-D) and the transition zone volume (PSA-T). METHODS: In a randomized population-based screening study (Rotterdam section of the European Randomized Study of Screening for Prostate Cancer), in which 10,865 men have been screened, the biopsy results of 1202 men with PSA levels of 4 ng/mL or more were evaluated. Planimetric and prolate ellipsoid volumes of the total prostate as well as of the transition zone were measured. The measured volumes were compared with the volumes of 57 radical prostatectomy specimens through Spearman's rank correlation coefficient and agreement tests. A receiver operating characteristic (ROC) curve analysis was done of sensitivity and specificity of biopsy indications through PSA and PSA corrected for the volumes measured with transrectal ultrasound. RESULTS: In the 1202 men studied, 361 cases of prostate cancer were diagnosed. Both PSA-D and PSA-T showed a significantly higher area under the ROC curve (0.77 and 0.79, respectively) than PSA alone (area 0.65). There was no significant difference between PSA-D and PSA-T. The use of a PSA-D threshold value of 0. 10 ng/mL/cc would have avoided 28% of biopsies at the cost of 10% of detectable cancers. A PSA-D threshold of 0.15 ng/mL/cc would have avoided 73.8% of biopsies at the cost of not diagnosing 43.8% of detectable cancers. CONCLUSIONS: The planimetrically obtained prostate volume showed a more favorable agreement with the radical prostatectomy volume than the prolate ellipsoid volume. The discriminatory potential of the corrected PSA value is better at predicting the results of needle biopsy of the prostate when compared with PSA alone. The use of the transition zone volume for this correction results in a higher discriminatory potential when compared to the use of the total prostate volume; however, the observed difference was not statistically significant.

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Microvascular invasion in prostate cancer: prognostic significance in patients treated by radical prostatectomy for clinically localized carcinoma.

OBJECTIVE: To investigate the clinical significance of vascular invasion in prostate cancer patients treated by radical prostatectomy for clinically localized and locally advanced disease. MATERIALS AND METHODS: Vascular invasion was determined during a routine work-up of radical prostatectomy specimens of 273 patients who underwent surgery for prostatic carcinoma. The correlation with other pathological variables was investigated. The prognostic influence for clinical progression, local recurrence, distant metastases, biochemical progression, overall survival and cancer-specific survival was determined. RESULTS: Vascular invasion was present in 33 patients (12%). Vascular invasion correlated significantly with capsular perforation, seminal vesicle invasion, positive margins of resection, perineural invasion, high grade, and pathological stage. Vascular invasion was a significant prognostic factor for clinical progression (p < 0.001), local recurrence (p = 0.007), distant metastases (p < 0.001), biochemical progression (p < 0.001), overall survival (p = 0.02), and cancer-specific survival (p < 0.001). Multivariate analysis, adjusting for capsular perforation, high grade, and positive margins of resection, showed that vascular invasion was associated with a 2.5-fold increased risk for clinical progression. This relative risk was 2.3 for biochemical progression, and 2.7 for cancer-specific survival. CONCLUSION: Vascular invasion is a very important pathological variable for progression and survival, and must be evaluated on a routine basis during the work-up of radical prostatectomy specimens.

Aged

Comparison of pathologic characteristics of T1c and non-T1c cancers detected in a population-based screening study, the European Randomized Study of Screening for Prostate Cancer.

In recent years the introduction of serum prostate-specific antigen (PSA) determination as a screening tool for early detection of prostate cancer in asymptomatic men has led to a markedly increased detection of prostate cancers that are neither palpable nor visible with transrectal ultrasonography (stage T1c). In this preliminary study we assessed pathologic features and aspects that are indicative of clinical significance in T1c tumors and tumors with palpable or visible lesions (non-T1c tumors). Between June 1994 and December 1995, 51 consecutive radical prostatectomies were performed on screened participants in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). After determination of pathologic stage and Gleason score, morphometric analysis was performed to determine tumor volume. Radical prostatectomy specimens were divided into three mutually exclusive subsets: T1c tumors, non-T1c tumors with preoperative PSA levels below 4 ng/ml, and non-T1c tumors with PSA levels equal to or greater than 4 ng/ml. These subsets were compared for differences in the distribution of tumor volume, pathologic stage, and Gleason score. An arbitrarily constructed categorization model was used to assess clinical significance. In all, 17 (33%) of the patients had clinical stage T1c disease. In our categorization mode, 88% of the T1c tumors fit the criteria for clinically significant tumors. T1c tumors, however, were significantly smaller (P < 0.01) and were more likely to be organ-confined (P = 0.01) as compared with non-T1c tumors in patients with an elevated preoperative serum PSA level. In contrast, tumors detected at preoperative PSA levels of < 4 ng/ml had comparably the lowest pathologic stages and tumor volumes in our series. In our categorization model, 42% of these tumors fit the criteria for minimal tumor. This group of radical prostatectomies was therefore most likely to harbor clinically insignificant cancer, a finding that was consistent in two other categorization models derived from earlier reports. T1c tumors comprise a large fraction of the tumors found in population-based screening. As judged by their pathologic characteristics. T1c tumors are clinically significant tumors. The overall low pathologic stage and Gleason score of these tumors make these patients excellent candidates for curative treatment by radical prostatectomy or radiotherapy. In contrast, some concern should be raised on the detection of tumors at low serum PSA levels by means of digital rectal examination and transrectal ultrasound alone, since a substantial proportion of these tumors could be considered clinically insignificant. Long-term follow-up, however, is necessary to substantiate this view.

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Complications of transrectal ultrasound-guided systematic sextant biopsies of the prostate: evaluation of complication rates and risk factors within a population-based screening program.

OBJECTIVES: Screening for prostate cancer to reduce the mortality and morbidity from this disease has become an important issue in recent years. Of all procedures used to diagnose prostate cancer, biopsy of the prostate is the cause of most complications. To evaluate the safety of the screening procedure, we have studied the complications and risk factors for complications within the screened population of the European Randomized Study of Screening for Prostate Cancer (ERSPC), Rotterdam section. METHODS: Between June 1994 and July 1996, 1687 transrectal ultrasound-guided systematic sextant biopsies were performed after screening 6198 men through prostate-specific antigen level, digital rectal examination, and transrectal ultrasonography. RESULTS: From these 1687 biopsies, 302 cases of prostate cancer were diagnosed. Mild complications such as hematuria and hematospermia were reported frequently with rates of 23.6% and 45.3%, respectively. More severe complications were far less frequently seen. Fever, usually of low grade, was seen after 4.2% of biopsies. Seven men (0.4%) were admitted to a hospital after biopsy. Risk factors for complications could not be identified. CONCLUSIONS: Review of the literature concerning transrectal biopsies of the prostate shows that the complication rates within this screened population are comparable to those reported within referred patients. The admittance rate is slightly lower. Transrectal ultrasound-guided systematic sextant biopsy of the prostate is a safe procedure for the diagnosis of prostate cancer within the general population; however, identification of risk factors for complications might further improve the safety of the screening procedure.

Age Factors

Free and total prostate-specific antigen in a screened population.

OBJECTIVES: To determine whether the ratio of free to total (F/T) prostate-specific antigen (PSA) can differentiate between men with prostate carcinoma or benign conditions in a screened population. SUBJECTS AND METHODS: Total and free serum PSA (measured using Delfia PSA assays, Abbott IMx and Hybritech Tandem E methods) were determined retrospectively in 1726 men aged 55-77 years, in whom 67 prostate carcinomas were detected by screening with a digital rectal examination, transrectal ultrasonography, and total serum PSA level. Predictors for a positive biopsy result were estimated as a function of total PSA, free PSA and the combination of both. RESULTS: There was an excellent correlation between the Delfia ProStatus, the Abbott IMx and the Hybritech Tandem E assays. Compared with the total serum PSA level, the F/T ratio improved the specificity significantly only in those men with a total PSA of > or = 7 ng/mL. Using the information given by the total and free PSA values, a maximum sensitivity of 75% at a specificity of 74% was obtained for the whole PSA range from 4 to 10 ng/mL; the maximum sensitivity was 79% with a specificity of 71%. CONCLUSION: The optimal mathematical combination of free and total serum PSA improves the specificity of total serum PSA level in detecting prostate carcinoma more than the does the F/T PSA ratio.

Aged

Tumour control according to pathological variables in patients treated by radical prostatectomy for clinically localized carcinoma of the prostate.

OBJECTIVE: To evaluate the diagnosis, outcome and final pathology of radical prostatectomy for prostate cancer performed by urologists in a clinic where six urologists perform a total of 50 radical prostatectomies a year, using radical prostatectomy specimens processed routinely. PATIENTS AND METHODS: Radical prostatectomy was performed in 273 patients who were followed prospectively. The radical prostatectomy specimens were evaluated for pathological stage, histological grade, capsular perforation, positive and apical margins of resection, seminal vesicle invasion, perineural invasion and vascular invasion; the lymph node status was also determined. The relationship between these variables and clinical progression, local recurrence, distant metastases, biochemical progression, overall survival and cancer-specific survival was assessed. RESULTS: All evaluated variables were significantly predictive for clinical and biochemical progression in the univariate analyses, and all but perineural invasion and lymph node status for cancer-specific survival. Multivariate analysis showed vascular invasion to be the most important prognostic variable, followed by capsular perforation, positive margins of resection and poorly differentiated carcinoma. The overall results for the evaluated variables were comparable to the results from centres with greater experience. CONCLUSIONS: The outcome of treatment in this small clinic was similar to that from larger clinics with more experience. The routine evaluation of the radical prostatectomy specimens identified pathological variables which were important prognostic factors, with vascular invasion, capsular perforation, positive margins of resection and poorly differentiated carcinoma being the most significant. The extent of vascular invasion should be part of the routine evaluation of radical prostatectomy specimens.

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The free-to-total serum prostate specific antigen ratio for staging prostate carcinoma.

PURPOSE: We analyzed the relationship between the free-to-total PSA ratio and prostate cancer tumor stage and grade compared to total serum PSA. MATERIALS AND METHODS: In 123 patients clinical and pathological grade and stage were related to total serum PSA and free-to-total PSA ratio. RESULTS: Total serum PSA paralleled clinical staging of prostate cancer. The distributions of total serum PSA and the free-to-total PSA ratio were significantly different between benign and malignant diseases (any stage), and between any T category and nodal disease. For serum PSA significant differences were noted between the distributions of men with locally confined (stages T1 and T2) and locally extended (stage T3) disease, and between all T categories and systemic metastatic disease. This finding was not noted for the free-to-total PSA ratio. CONCLUSIONS: The free-to-total PSA ratio has no additional value in clinical staging of prostate carcinoma compared to serum PSA. The free-to-total PSA ratio may be considered the result of cell differentiation and not an indicator of tumor load.

Humans

Analytical evaluation of the new Prostatus PSA Free/Total assay for prostate-specific antigen as part of a screening study for prostate cancer.

In this communication a limited analytical study is described on the new Prostatus PSA Free/Total assay. The study is considered as a side study of the European Randomized Study of Screening for Prostate Cancer. The between-day imprecision with 8 control samples for free prostate-specific antigen ranged from 10.3% at 0.17 microg/l to 3.7% at a concentration of 35.5 microg/l, while for total prostate-specific antigen we found 7.3% at 0.69 microg/l and 4.3% at 70.7 microg/l. For total prostate-specific antigen we found excellent agreement between the new assay and well-established assays like Abbott IMx and Hybritech Tandem-E, both for prostate cancer and benign prostate hyperplasia specimens. The age-specific reference ranges proved to be well-comparable with the literature data both for free and total prostate-specific antigen.

Adult

The free-to-total prostate specific antigen ratio improves the specificity of prostate specific antigen in screening for prostate cancer in the general population.

PURPOSE: The ratio between free and total prostate specific antigen (PSA) in serum improves the specificity of total serum PSA for the detection of prostate carcinoma in select populations. The value of the free-to-total PSA ratio for a PSA of 4.0 to 10.0 ng./ml. was analyzed in a screening population. MATERIALS AND METHODS: From 4,800 participants 55 to 76 years old 977 biopsies were obtained because of an abnormal digital rectal examination, suspicious transrectal ultrasonography and total serum PSA 4.0 ng./ml. or more. Of 191 patients with prostate carcinoma detected 101 had a serum PSA of 4.0 to 10.0 ng./ml. and 54 of them underwent radical prostatectomy. A free-to-total PSA ratio of 0.20, age specific PSA reference ranges and a PSA density of 0.12 ng./ml./cc were evaluated for the ability to increase the specificity of total serum PSA in predicting positive prostate biopsy results. RESULTS: Receiver operating characteristics curves for the free-to-total PSA ratio showed a significant increase in specificity compared to PSA. Retrospective application of age specific PSA reference ranges, the free-to-total PSA ratio and the PSA density decreased the number of biopsies significantly by up to 40% in our study, with a decrease in cancer detection rate of 12%. When used in combination with digital rectal examination, the pathological stage of undetected carcinomas appeared favorable. CONCLUSIONS: The free-to-total PSA ratio may be used to decrease biopsies in patients with an intermediate PSA of 4.0 to 10.0 ng./ml.

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European randomized study of screening for prostate cancer--the Rotterdam pilot studies.

Five randomized pilot studies of screening for prostate cancer (PC) have been conducted in the area of Rotterdam from 1991 to 1994. The purpose of these studies was to establish the feasibility of a randomized screening protocol with PC mortality as the major end point in The Netherlands and at a European level. All procedures related to recruitment of participants, to application of the screening tests and to data collection were evaluated. Men (7,200) aged 55-74 years were invited through the Rotterdam Population Registry. The recruitment rate over the 5 pilot studies averaged 38.2% (2,747 men). Recruitment procedures proved to be relevant for establishing higher participation rates (invitation and consent by mail). The screening tests were well accepted and tolerated. The general population-based character of the sample was confirmed by studying symptoms of prostatic disease in participants and in men who refused participation. Data based on one PSA serum determination, rectal examination and transrectal ultrasonography are presented; 204/1,403 men (14.5%) had a positive screening result by either test combination and underwent biopsy. Forty-nine cancers were found in 1,403 men (3.5%); 65% of prostate cancers (17/26) identified in men who eventually underwent radical prostatectomy proved to be locally confined. From the pilot studies, we conclude that a large contribution to a European Randomized Study of Screening for Prostate Cancer (ERSPC) can be made by recruiting about 40,000 men in the area of Rotterdam. The preliminary data suggest that after confirmation of the present data during the first years in the European study, DRE and TRUS can be withheld depending on the PSA result in a large proportion of the screening population.

Age Factors

Some analytical considerations on the measurement of prostate-specific antigen.

In this study, various analytical aspects of the determination of serum prostate-specific antigen are described as applied to the Abbott IMx PSA and the Hybritech Tandem-E PSA assays. We used mainly specimens from a prostate cancer screening study in progress. A very good comparability between the assays proved to exist in our hands. The long-run variation (16 months) was also rated as acceptable, both for the IMx and the Tandem-E method. The method of choice, Tandem-E, showed good reagent stability over this period. We found, however, a difference in accuracy (Tandem-E +/- 8% higher values) that could not be explained by comparison with Tandem-R.

Humans

Estimation of the lag time between detrusor pressure- and flow rate-signals.

In a urodynamic measurement setup there is a considerable spatial separation between the uroflowmeter and the location where the detrusor pressure is measured. Therefore, a "time shift" (or lag time correction) has to be applied to one of these signals in order to align related samples in studies where pressure and flow rate are considered simultaneously (e.g., assessment of bladder contractility or bladder outlet resistance). Currently, a heuristic value for this time shift of 0.8 s is applied. In this article, we present a method to estimate the lag time directly from the measurements. Using this method we have found, amongst others, that the mean lag time in our clinic is 0.6 s for males, 0.4 s for females voiding in sitting position, and 1.1 s for females voiding in standing position using a special receptacle in video urodynamics. Furthermore, we found that sphincter/urethral activity during voiding (which causes a drop in flow rate and an accompanying increase in detrusor pressure) is associated (on average) with shorter lag times than straining (when a positive pressure rise accompanies an increase in flow rate). Additionally strong evidence is provided that lag time correction is not a major source of error in urodynamics.

Female

The value of screening tests in the detection of prostate cancer. Part I: Results of a retrospective evaluation of 1726 men.

OBJECTIVES: The ratio between free and total prostate-specific antigen (PSA) in serum (F/T ratio) was shown to improve the differentiation between prostate carcinoma and benign conditions in selected series of patients. In this study the F/T ratio was analyzed for its ability to improve the specificity of total serum PSA, digital rectal examination (DRE), and transrectal ultrasonography (TRUS) for the detection of prostate cancer in an unselected screening population of men identified in the Rotterdam population. METHODS: In 1726 men between 55 and 76 years old, 67 prostate carcinomas were detected by DRE, TRUS, and total serum PSA (Abbott IMx, Hybritech Tandem E). The DELFIA ProStatus PSA EQM and ProStatus PSA Free/Total assays (Wallac) were applied in retrospect to determine total and free serum PSA. Age, total prostate and inner zone volumes were taken into consideration. RESULTS: Sixty-seven carcinomas were detected, two by TRUS and three by DRE alone. Total serum PSA was the most important single predictor of prostate cancer, followed by DRE. The F/T ratio increased the specificity of total serum PSA in the PSA range between 4.0 and 10.0 ng/mL. However, this improved specificity was not significant, nor for gland volumes restricted to 50 mL or less. CONCLUSIONS: The combination of total serum PSA and DRE remains the standard for detection of prostate carcinoma in a screening population. Their specificity may be improved minimally by the F/T ratio, but not significantly in a sample of 1726 screened men. The threshold of the F/T ratio, and the optimal PSA range for its application, remains to be assessed prospectively.

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