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Take Home Message Intervention-related deaths were rare in the ERSPC trial, but relatively large differences in the number of intervention-related deaths were observed among centers. Standardized cause-of-death reviews are important in identifying intervention-related deaths and should be used in screening trials., Background Identification of intervention-related deaths is important for an accurate assessment of the ratio of benefit to harm in screening trials. Objective To investigate intervention-related deaths by study arm in the European Randomized Study of Prostate Cancer Screening (ERSPC). Design, setting, and participants ERSPC is a multicenter trial initiated in the 1990s to investigate whether screening on the basis of prostate-specific antigen (PSA) can decrease prostate cancer mortality. The present study included men in the core age group (55–69 yr: screening group n = 112 553, control group n = 128 681) with 16-yr follow-up. Outcome measurements and statistical analysis Causes of death among men with prostate cancer in ERSPC were predominantly evaluated by independent national committees via review of medical records according to a predefined algorithm. Intervention-related deaths were defined as deaths caused by complications during the screening procedure, treatment, or follow-up. Descriptive statistics were used for the results. Results and limitations In total, 34 deaths were determined to be intervention-related, of which 21 were in the screening arm and 13 in the control arm. The overall risk of intervention-related death was 1.41 (95% confidence interval 0.99–1.99) per 10 000 randomized men for both arms combined and varied among centers from 0 to 7.0 per 10 000 randomized men. A limitation of this study is that differences in procedures among centers decreased the comparability of the results. Conclusions Intervention-related deaths were rare in ERSPC. Monitoring of intervention-related deaths in screening trials is important for assessment of harms. Patient summary We investigated deaths due to screening or treatment to assess harm in a trial of prostate cancer screening. Few such deaths were identified.

Resumen Objetivos Estimar la efectividad de la ecografía en consultas externas de alta resolución de urología. Como objetivos secundarios, se evaluó el impacto de otros factores como la edad, sexo, prioridad y procedencia de la consulta. Métodos Se analizó retrospectivamente a pacientes que acudieron a una primera visita a la consulta de urología del hospital entre los años 2008-2018.Se recogieron las variables edad, sexo, procedencia, prioridad de la consulta y realización de ecografía.Realizamos un análisis descriptivo de aquellos pacientes que resultaron ser alta resolución y de aquellos en los que se había realizado una ecografía. Posteriormente realizamos un análisis univariado mediante el test de chi-cuadrado y multivariado mediante la regresión logística. Resultados Se incluyeron 32980 primeras visitas, con una edad media en la primera visita de 48,2 años (mediana 48,2) y tratándose en la mayoría de hombres (74,4%).La proporción de pacientes que pudieron ser dados de alta tras una primera visita, fue del 16% y gracias a la realización de una ecografía llegó al 16,7%.En el análisis univariado, tanto la procedencia, la prioridad, la ecografía realizada, el sexo y la edad, se asociaron a que la consulta realizada fuera de alta resolución. En el análisis multivariado, se confirmó la asociación de todas las variables (exceptuando la prioridad, p = 0,37), aumentando el riesgo de modo discreto (entre 0,3-0,9 veces). Conclusiones La ecografía resultó ser una buena herramienta en las consultas de alta resolución, llegándose a realizar hasta casi en un 20% de los casos. Sin embargo, aunque tanto la ecografía como la edad, sexo y procedencia son factores relacionados con la alta resolución, esa relación no es relevante desde un punto de vista clínico.

INTRODUCTION AND OBJECTIVE:With a median follow–up of 16 years the European Randomized Study of Screening for Prostate Cancer (ERSPC) shows a relative reduction of prostate cancer (PCa) specific mo...

Background: The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality. Objective: To determine whether PSA screening decreases PCa mortality for up to 16 yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended. Design, setting, and participants: This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182 160 men, followed up until 2014 (maximum of 16 yr), with a predefined core age group of 162 389 men (55-69 yr), selected from population registry. Outcome measurements and statistical analysis: The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended. Results and limitations: The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p 20 ng/ml (9.9% compared with 4.1% in the second round, p

Background The European Randomized Study of Screening for Prostate Cancer (ERSPC) demonstrated that prostate-specific antigen (PSA) screening significantly reduced prostate cancer mortality (rate ratio, 0.79; 95% confidence interval, 0.69-0.91). The US Prostate, Lung, Colorectal, and Ovarian (PLCO) trial indicated no such reduction but had a wide 95% CI (rate ratio for prostate cancer mortality, 1.09; 95% CI, 0.87-1.36). Standard meta-analyses are unable to account for key differences between the trials that can impact the estimated effects of screening and the trials' point estimates. Methods The authors calibrated 2 microsimulation models to individual-level incidence and mortality data from 238,936 men participating in the ERSPC and PLCO trials. A cure parameter for the underlying efficacy of screening was estimated by the models separately for each trial. The authors changed step-by-step major known differences in trial settings, including enrollment and attendance patterns, screening intervals, PSA thresholds, biopsy receipt, control arm contamination, and primary treatment, to reflect a more ideal protocol situation and differences between the trials. Results Using the cure parameter estimated for the ERSPC, the models projected 19% to 21% and 6% to 8%, respectively, prostate cancer mortality reductions in the ERSPC and PLCO settings. Using this cure parameter, the models projected a reduction of 37% to 43% under annual screening with 100% attendance and biopsy compliance and no contamination. The cure parameter estimated for the PLCO trial was 0. Conclusions The observed cancer mortality reduction in screening trials appears to be highly sensitive to trial protocol and practice settings. Accounting for these differences, the efficacy of PSA screening in the PLCO setting is not necessarily inconsistent with ERSPC results. Cancer 2018;124:1197-206. © 2017 American Cancer Society.

Objectives Recently, the European Randomized Study of Screening for Prostate Cancer achieved a reduction in prostate cancer mortality by measuring serum prostate-specific antigen (PSA) levels. These results were not reproduced in the Spanish arm of European Randomized Study of Screening for Prostate Cancer. PSA contamination (opportunistic measurements outside the study) could decrease the study's contrasting power if performed in the control arm. We have calculated the long-term rate of PSA contamination and its effect on performing prostate biopsy and detecting cancer. Material and methods A total of 4276 men were randomized (2415 to the screening arm, 1861 to the control arm) in the Spanish section of the European Randomized Study of Screening for Prostate Cancer. PSA measurements were not scheduled in the control arm. Sextant prostate biopsy was indicated if PSA levels were ≥3 ng/ml. All PSA readings performed outside the study were labeled as “PSA contamination”. We calculated the rates of PSA contamination, biopsy implementation and cancer detection. Results The median age and follow-up time were 57 and 15.1 years, respectively. A total of 2511 men underwent at least one PSA reading outside the study. PSA contamination at 5, 10 and 15 years was 22.0%, 47.1% and 66.3% in the screening arm, respectively, and 20.8%, 43.2% and 58.6% in the control arm, respectively ( p p p = 0.0006). Conclusions Although the cumulative PSA contamination was pronounced in the 2 study arms, the rate of prostate biopsies was low in the control arm. We therefore believe that the effect of PSA contamination on the study's statistical power should be limited.

Objetivos: Recientemente, el Estudio Aleatorizado Europeo de Screening del Cáncer de Próstata consiguió una reducción de la mortalidad por cáncer de próstata mediante la determinación sérica de antígeno específico-prostático (PSA). Estos resultados no fueron reproducidos en la rama española del Estudio Aleatorizado Europeo de Screening del Cáncer de Próstata. La contaminación de PSA (determinación oportunista fuera del estudio) podría disminuir el poder de contraste del estudio si se lleva a cabo en el brazo control. Hemos calculado la tasa de contaminación de PSA a largo plazo, y su efecto en la realización de biopsia prostática y en la detección de cáncer. Material y métodos: Se aleatorizaron 4.276 varones (2.415 brazo screening, 1.861 brazo control) en la sección española del Estudio Aleatorizado Europeo de Screening del Cáncer de Próstata. No se programó la determinación de PSA en el brazo control. Se indicó biopsia prostática sextante si PSA ≥ 3 ng/ml. Toda determinación de PSA realizada fuera del estudio fue etiquetada como «contaminación de PSA». Se calcularon las tasas de contaminación de PSA, realización de biopsia y detección de cáncer. Resultados: Las medianas de edad y tiempo de seguimiento fueron de 57 y 15,1 años respectivamente. Un total de 2.511 varones se realizó al menos una determinación de PSA fuera del estudio. La contaminación de PSA a los 5, 10 y 15 años fue del 22; 47,1 y 66,3% en el brazo screening, y del 20,8; 43,2 y 58,6 en el brazo control, respectivamente (p < 0,0001). La tasa de biopsia a los 5, 10 y 15 años fue del 19,3; 22,6 y 24,1% (screening) y del 1; 3,6 y 7,1% (control), respectivamente (p < 0,0001). La detección de cáncer de próstata fue del 6,7% (screening) y del 4,3% (control, p = 0,0006). Conclusiones: Aunque la contaminación acumulada de PSA fue notable en los 2 brazos del estudio, la realización de biopsia prostática fue escasa en el brazo control. Por ello, creemos que el impacto de la contaminación de PSA sobre el poder estadístico del estudio debe ser limitado. Objectives: Recently, the European Randomized Study of Screening for Prostate Cancer achieved a reduction in prostate cancer mortality by measuring serum prostate-specific antigen (PSA) levels. These results were not reproduced in the Spanish arm of European Randomized Study of Screening for Prostate Cancer. PSA contamination (opportunistic measurements outside the study) could decrease the study's contrasting power if performed in the control arm. We have calculated the long-term rate of PSA contamination and its effect on performing prostate biopsy and detecting cancer. Material and methods: A total of 4,276 men were randomised (2,415 to the screening arm, 1,861 to the control arm) in the Spanish section of the European Randomized Study of Screening for Prostate Cancer. PSA measurements were not scheduled in the control arm. Sextant prostate biopsy was indicated if PSA levels were ≥ 3 ng/mL. All PSA readings performed outside the study were labelled as “PSA contamination”. We calculated the rates of PSA contamination, biopsy implementation and cancer detection. Results: The median age and follow-up time were 57 and 15.1 years, respectively. A total of 2,511 men underwent at least one PSA reading outside the study. PSA contamination at 5, 10 and 15 years was 22.0%, 47.1% and 66.3% in the screening arm, respectively, and 20.8%, 43.2% and 58.6% in the control arm, respectively (P < .0001). The biopsy rate at 5, 10 and 15 years was 19.3%, 22.6% and 24.1% (screening), respectively, and 1.0%, 3.6% and 7.1% (control), respectively (P < .0001). The PC detection rate was 6.7% (screening) and 4.3% (control; P = .0006). Conclusions: Although the cumulative PSA contamination was pronounced in the 2 study arms, the rate of prostate biopsies was low in the control arm. We therefore believe that the effect of PSA contamination on the study's statistical power should be limited. Sin financiación 1.181 JCR (2016) Q4, 60/77 Urology & Nephrology UEM

Purpose: The balance of benefits and harms in prostate cancer screening has not been sufficiently characterized. We related indicators of mortality reduction and overdetection by center within the European Randomized Study of Prostate Cancer Screening (ERSPC). Experimental Design: We analyzed the absolute mortality reduction expressed as number needed to invite (NNI = 1/absolute risk reduction; indicating how many men had to be randomized to screening arm to avert a prostate cancer death) for screening and the absolute excess of prostate cancer detection as number needed for overdetection (NNO = 1/absolute excess incidence; indicating the number of men invited per additional prostate cancer case), and compared their relationship across the seven ERSPC centers. Results: Both absolute mortality reduction (NNI) and absolute overdetection (NNO) varied widely between the centers: NNI, 200–7,000 and NNO, 16–69. Extent of overdiagnosis and mortality reduction was closely associated [correlation coefficient, r = 0.76; weighted linear regression coefficient, β = 33; 95% confidence interval (CI), 5–62; R2 = 0.72]. For an averted prostate cancer death at 13 years of follow-up, 12 to 36 excess cases had to be detected in various centers. Conclusions: The differences between the ERSPC centers likely reflect variations in prostate cancer incidence and mortality, as well as in screening protocol and performance. The strong interrelation between the benefits and harms suggests that efforts to maximize the mortality effect are bound to increase overdiagnosis and might be improved by focusing on high-risk populations. The optimal balance between screening intensity and risk of overdiagnosis remains unclear. Clin Cancer Res; 22(1); 243–9. ©2015 AACR.

Introduction We researched the usefulness of optimizing prostate cancer (PC) screening in our community using baseline PSA readings in men between 40 and 49 years of age. Material and method A retrospective study was performed that analyzed baseline PSA in the fifth decade of life and its ability to predict the development of PC in a population of Madrid (Spain). An ROC curve was created and a cutoff was proposed. We compared the evolution of PSA from baseline in patients with consecutive readings using the Friedman test. We established baseline PSA ranges with different risks of developing cancer and assessed the diagnostic utility of the annual PSA velocity (PSAV) in this population. Results 4304 men aged 40–49 years underwent opportunistic screening over the course of 17 years, with at least one serum PSA reading (6001 readings) and a mean follow-up of 57.1 ± 36.8 months. Of these, 768 underwent biopsy of some organ, and 104 underwent prostate biopsy. Fourteen patients (0.33%) were diagnosed with prostate cancer. The median baseline PSA was 0.74 (0.01–58.5) ng/ml for patients without PC and 4.21 (0.76–47.4) ng/ml for those with PC. The median time from the reading to diagnosis was 26.8 (1.5–143.8) months. The optimal cutoff for detecting PC was 1.9 ng/ml (sensitivity, 92.86%; specificity, 92.54%; PPV, 3.9%; NPV, 99.97%), and the area under the curve was 92.8%. In terms of the repeated reading, the evolution of the PSA showed no statistically significant differences between the patients without cancer ( p = 0.56) and those with cancer ( p = 0.64). However, a PSAV value >0.3 ng/ml/year revealed high specificity for detecting cancer in this population. Conclusions A baseline PSA level ≥1.9 ng/ml in Spanish men aged 40–49 years predicted the development of PC. This value could therefore be of use for opportunistic screening at an early age. An appropriate follow-up adapted to the risk of this population needs to be defined, but an annual PSAV ≥ 0.3 ng/ml/year appears of use for reaching an early diagnosis.

Objetivo: En la actualidad el papel del screening del cáncer de próstata (CaP) está cuestionado. El estudio aleatorizado europeo de screening del cáncer de próstata (ERSPC) tiene como objetivo demostrar si el screening del CaP reduce la mortalidad por esta enfermedad. Se muestran los resultados en la rama española de este estudio: mortalidad global y cáncer-específica, características de los tumores detectados, de los tratamientos primarios y de la progresión a enfermedad avanzada. Material y métodos: Se invitó a participar a 18.612 varones entre los 45 y 70 años de edad, excluyendo aquellos con una expectativa de vida inferior a 10 años. Se llevó a cabo aleatorización a brazo screening (determinación de PSA sérico) y brazo control (no pruebas diagnósticas). Se indicó biopsia prostática aleatorizada sextante dirigida por ecografía transrectal en los varones del brazo screening con PSA ≥ 3 ng/ml. Se identificaron los CaP detectados (estadio y tratamiento primarios), así como los fallecimientos producidos (fecha y causa de la muerte). Resultados: El estudio se llevó a cabo con 4.276 varones (2.415 brazo screening, 1.861 brazo control). Las medianas de edad y PSA sérico fueron de 57 años y 0,90 ng/ml respectivamente. El tiempo de seguimiento (mediana) fue de 15,8 años. Se diagnosticaron 242 CaP, 162 (6,7%) en el brazo screening y 80 (4,3%) en el control (p < 0,001). De ellos 214 (88,4%) comenzaron con estadio clínico organoconfinado (91,4% brazo screening vs 82,5% control, p = 0,024). Un total de 112 pacientes (46,3%) fue sometido a prostatectomía radical, 53 (21,9%) a radioterapia prostática, 24 (9,9%) a tratamiento hormonal y 47 (19,4%) a observación. Un total de 18 CaP evolucionaron a enfermedad avanzada (M+ o PSA > 100 ng/ml), sin diferencia entre los brazos del estudio (p = 0,938). Un total de 618 (14,5%) fallecieron a lo largo del seguimiento: 340 (14,1%) en el brazo screening y 278 (14,9%) en el control, sin diferencias entre brazos en términos de mortalidad cáncer-específica (p = 0,907) ni por todas las causas (p = 0,399). Las principales causas de muerte encontradas fueron neoplasia (54,0%), cardiovascular (17,6%), respiratoria (8,7%) y digestiva (4,0%), sin diferencia entre brazos. De los 334 pacientes fallecidos por neoplasia tan solo 12 (3,6%) murieron por CaP. Conclusiones: El screening del CaP produce una migración del diagnóstico hacia estadios más precoces. No obstante, no hemos demostrado un beneficio en términos de supervivencia global ni cáncer-específica tras más de 15 años de seguimiento. La baja mortalidad por esta enfermedad en nuestro entorno podría ser uno de los principales factores para explicar estos resultados. Objective: The role of prostate cancer (PC) screening is currently being questioned. The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) was to demonstrate whether PC screening reduced mortality from this disease. The results from the Spanish branch of this study are presented: all-cause and cancer-specific mortality, the characteristics of the detected tumors, primary treatments and progression to advanced disease. Material and methods: A total of 18,612 men, between the ages of 45 and 70, were invited to participate in the study, excluding those with a life expectancy of less than 10 years. The men were randomized to the screening arm (serum prostate-specific antigen [PSA] reading) or the control arm (no diagnostic tests). Randomized transrectal ultrasound-guided sextant prostate biopsies were indicated for the men in the screening arm with PSA levels ≥ 3 ng/ml. The detected PCs were identified (stage and primary treatment), as well as the deaths that occurred (date and cause of death). Results: The study was performed with 4276 men (2415 in the screening arm and 1861 in the control arm). The median age and serum PSA level were 57 years and 0.90 ng/mL, respectively. The median follow-up time was 15.8 years. A total of 242 PCs were diagnosed, 162 (6.7%) in the screening arm and 80 (4.3%) in the control arm (P < .001). Of these, 214 (88.4%) had an organ-confined clinical stage at onset (91.4% in the screening arm vs. 82.5% in the control arm; P = .024). A total of 112 patients (46.3%) underwent radical prostatectomy, 53 (21.9%) underwent prostate radiation therapy, 24 (9.9%) underwent hormone therapy and 47 (19.4%) were kept under observation. A total of 18 PCs progressed to advanced disease (M+ or PSA levels > 100 ng/mL), with no differences between the study arms (P = .938). A total of 618 (14.5%) patients died during follow-up: 340 (14.1%) in the screening arm and 278 (14.9%) in the control arm, with no differences between the arms in terms of cancer-specific (P = .907) or all-cause (P = .399) mortality. The main causes of death were neoplasia (54.0%), cardiovascular (17.6%), respiratory (8.7%) and gastrointestinal (4.0%), with no difference between study arms. Of the 334 patients who died from neoplasia, only 12 (3.6%) died from PC. Conclusions: PC screening results in a shifting of the diagnosis towards earlier stages. Nevertheless, we have not demonstrated a benefit in terms of overall or cancer-specific survival after more than 15 years of follow-up. The low mortality from this disease in our community could be one of the main factors that explain these results. Sin financiación 0.964 JCR (2015) Q4, 63/77 Urology & Nephrology UEM

Objective The role of prostate cancer (PC) screening is currently being questioned. The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) was to demonstrate whether PC screening reduced mortality from this disease. The results from the Spanish branch of this study are presented: all-cause and cancer-specific mortality, the characteristics of the detected tumors, primary treatments and progression to advanced disease. Materials and methods A total of 18,612 men, between the ages of 45 and 70, were invited to participate in the study, excluding those with a life expectancy of less than 10 years. The men were randomized to the screening arm (serum prostate-specific antigen [PSA] reading) or the control arm (no diagnostic tests). Randomized transrectal ultrasound-guided sextant prostate biopsies were indicated for the men in the screening arm with PSA levels ≥3 ng/ml. The detected PCs were identified (stage and primary treatment), as well as the deaths that occurred (date and cause of death). Results The study was performed with 4276 men (2415 in the screening arm and 1861 in the control arm). The median age and serum PSA level were 57 years and 0.90 ng/mL, respectively. The median follow-up time was 15.8 years. A total of 242 PCs were diagnosed, 162 (6.7%) in the screening arm and 80 (4.3%) in the control arm ( p p = .024). A total of 112 patients (46.3%) underwent radical prostatectomy, 53 (21.9%) underwent prostate radiation therapy, 24 (9.9%) underwent hormone therapy and 47 (19.4%) were kept under observation. A total of 18 PCs progressed to advanced disease (M+ or PSA levels >100 ng/mL), with no differences between the study arms ( p = .938). A total of 618 (14.5%) patients died during follow-up: 340 (14.1%) in the screening arm and 278 (14.9%) in the control arm, with no differences between the arms in terms of cancer-specific ( p = .907) or all-cause ( p = .399) mortality. The main causes of death were neoplasia (54.0%), cardiovascular (17.6%), respiratory (8.7%) and gastrointestinal (4.0%), with no difference between study arms. Of the 334 patients who died from neoplasia, only 12 (3.6%) died from PC. Conclusions PC screening results in a shifting of the diagnosis toward earlier stages. Nevertheless, we have not demonstrated a benefit in terms of overall or cancer-specific survival after more than 15 years of follow-up. The low mortality from this disease in our community could be one of the main factors that explain these results.

The ERSPC (European Randomized Study of Screening for Prostate Cancer) found that screening reduced prostate cancer mortality, but the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) found no reduction.To evaluate whether effects of screening on prostate cancer mortality relative to no screening differed between the ERSPC and PLCO.Cox regression of prostate cancer death in each trial group, adjusted for age and trial. Extended analyses accounted for increased incidence due to screening and diagnostic work-up in each group via mean lead times (MLTs), which were estimated empirically and using analytic or microsimulation models.Randomized controlled trials in Europe and the United States.Men aged 55 to 69 (ERSPC) or 55 to 74 (PLCO) years at randomization.Prostate cancer screening.Prostate cancer incidence and survival from randomization; prostate cancer incidence in the United States before screening began.Estimated MLTs were similar in the ERSPC and PLCO intervention groups but were longer in the PLCO control group than the ERSPC control group. Extended analyses found no evidence that effects of screening differed between trials (P = 0.37 to 0.47 [range across MLT estimation approaches]) but strong evidence that benefit increased with MLT (P = 0.0027 to 0.0032). Screening was estimated to confer a 7% to 9% reduction in the risk for prostate cancer death per year of MLT. This translated into estimates of 25% to 31% and 27% to 32% lower risk for prostate cancer death with screening as performed in the ERSPC and PLCO intervention groups, respectively, compared with no screening.The MLT is a simple metric of screening and diagnostic work-up.After differences in implementation and settings are accounted for, the ERSPC and PLCO provide compatible evidence that screening reduces prostate cancer mortality.National Cancer Institute.

Objetivo Estudiar si el screening del cancer de prostata (CaP) reduce la mortalidad por esta enfermedad en la poblacion asintomatica, dentro del ambito de la rama espanola del European Randomized Study of Screening for Prostate Cancer (ERSPC). Material y metodos Entre 1996 y 1999 fueron reclutados 4.278 varones con edades comprendidas entre los 45 y los 70 anos. Fueron aleatorizados a brazo screening (PSA cada 4 anos, con biopsia prostatica si PSA?3ng/ml) y brazo control (no tests). De modo anual se registraron fechas y causas de mortalidad. Se realizo un analisis Kaplan-Meier para calcular la supervivencia global y cancer-especifica. Resultados Se reclutaron 2.416 sujetos en el brazo screening y 1.862 en el control. La edad media fue de 57,8 anos y la mediana del tiempo de seguimiento de 13,3 anos. Al finalizar el seguimiento se registraron 427 fallecimientos (9 por CaP). El analisis de supervivencia no mostro diferencia entre los brazos del estudio con respecto a la mortalidad global ni cancer-especifica (p=0,939 y p=0,544 respectivamente). Las causas principales de muerte fueron los tumores malignos (52,9%), las enfermedades cardiovasculares (17,3%) y respiratorias (8,9%). Solo un 2,1% de las muertes (0,2% de todos los reclutados) fueron causadas por CaP (2,5% screening, 1,6% control). Conclusiones La rama espanola del ERSPC no ha reproducido los resultados a largo plazo del estudio principal, no observandose diferencias en la mortalidad (global o cancer-especifica) despues de 15 anos de seguimiento. La mortalidad por CaP fue muy limitada (inferior al 1%). Estos resultados apoyan el escaso rendimiento del screening del CaP en nuestro entorno.

Objective To address if prostate cancer (PCa) screening decreases PCa mortality in the asymptomatic population, within the setting of the Spanish arm of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Material and methods From 1996 to 1999, 4278 men aged 45–70 years were recruited and randomized to the screening arm (PSA every 4 years, prostate biopsy when PSA ≥ 3 ng/ml) and control arm (no tests). Dates and causes of death were collected on an annual basis. A Kaplan–Meier analysis was used to calculate overall and cancer-specific survival. Results A total of 2416 men were recruited in the screening arm and 1862 in the control arm. Mean age was 57.8 years, and median follow-up was 13.3 years. At the end of the follow-up period, 427 deaths (9 from PCa) were observed. Survival analysis did not show any difference between the study arms with respect to overall and cancer-specific survival ( p = 0.939 and p = 0.544 respectively). Most relevant causes of death were malignant tumors (52.9%), cardiovascular disease (17.3%) and respiratory (8.9%). Only 2.1% of deaths (0.2% of all recruited men) were due to PCa (2.5% screening, 1.6% control). Conclusions The Spanish arm of ERSPC failed to reproduce the long-term results shown in the whole study. No differences in mortality (overall or cancer-specific) were observed after 15 years of follow-up. PCa mortality was infrequent (less than 1%). These results suggest limited yield of PCa screening in our setting.

Background: The European Randomized Study of Screening for Prostate Cancer (ERSPC) has shown a 21% reduction in prostate cancer (PCa) mortality and a 1.6-fold increase in PCa incidence with prostate-specific antigen (PSA)-based screening (at 13 yr of follow-up). We evaluated PCa incidence by risk category at diagnosis across the study arms to assess the potential impact on PCa mortality. Design, setting, and participants: Information on arm, centre, T and M stage, Gleason score, serum PSA at diagnosis, age at randomisation, follow-up time, and vital status were extracted from the ERSPC database. Four risk categories at diagnosis were defined: 1, low; 2, intermediate; 3, high; 4, metastatic disease. PSA ( 100 ng/ml) was used as the indicator of metastasis. Outcome measurements and statistical analysis: Incidence rate ratios (IRRs) for screening versus control arm by risk category at diagnosis and follow-up time were calculated using Poisson regression analysis for seven centres. Follow-up was truncated at 13 yr. Missing data were imputed using chained equations. The analyses were carried out on an intention-to-treat basis. Results and limitations: In the screening arm, 7408 PCa cases were diagnosed and 6107 in the control arm. The proportion of missing stage, Gleason score, or PSA value was comparable in the two arms (8% vs 10%), but differed among centres. The IRRs were elevated in the screening arm for the low-risk (IRR: 2.14; 95% CI, 2.03-2.25) and intermediate-risk (IRR: 1.24; 95% CI, 1.16-1.34) categories at diagnosis, equal to unity for the high-risk category at diagnosis (IRR: 1.00; 95% CI, 0.89-1.13), and reduced for metastatic disease at diagnosis (IRR: 0.60; 95% CI, 0.52-0.70). The IRR of metastatic disease had temporal pattern similar to mortality, shifted forwards an average of almost 3 yr, although the mortality reduction was smaller. Conclusions: The results confirm a reduction in metastatic disease at diagnosis in the screening arm, preceding mortality reduction by almost 3 yr. Patient summary: The findings of this study indicate that the decrease in metastatic disease at diagnosis is the major determinant of the prostate cancer mortality reduction in the European Randomized study of Screening for Prostate Cancer. (C) 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

To evaluate the clinical utility of using the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) to quantify prostate-specific antigen (PSA) mRNA in peripheral blood samples from patients with prostate cancer as a predictor of extraprostatic extension of the disease and to assess any correlations with known predictive markers of this condition.Immediately before radical prostatectomy, peripheral blood samples were taken from 42 men with clinically localized prostate cancer and analysed for PSA and 18S ribosomal (endogenous control) genes using real-time RT-PCR (with gene expression assays and the comparative CT-cycle threshold-method for quantifying). A total of 30 healthy male blood donors aged50 y was taken as a control group. The relationships between PSA mRNA values, pathological and clinical features were analysed. PSA mRNA value, PSA level and biopsy Gleason score were then compared as predictors of extraprostatic extension.PSA gene expression was 3.73 times significantly higher in patients with clinically localized prostate cancer than in healthy men (P0.05). There was no relationship between PSA real-time RT-PCR values and pathological stage pT2 or pT3 (P=0.5), and no association between PSA mRNA value and serum PSA level (P=0.9) or the Gleason score of the preoperative biopsy (P=0.9).There was no significant advantage in using the real-time RT-PCR assay of PSA mRNA before surgery to stage prostate cancer and to discriminate between organ-confined and extraprostatic extension.

OBJECTIVE To validate the spontaneous hypertensive rat (SHR) model for basic research into benign prostate hyperplasia (BPH), and to assess doxazosin-induced changes in prostatic structure and apoptotic status. MATERIALS AND METHODS Four groups of rats were assessed: group 1, 15 SHRs treated with doxazosin; group 2, 14 SHRs with unilateral excision of the major pelvic ganglion; group 3, 14 untreated SHRs; and group 4, 16 intact Wistar-Kyoto (WKY) rats. The doxazosin mesylate (0.03 mg daily) was given compacted in rat food for 3 months. The prostatic ventral lobe (VL) was excised and weighed. Stereological light microscopy, multiplex reverse transcription-polymerase chain reaction of prostate caspases, and caspase-3 activity (cellular enzymatic assay) were assessed. RESULTS There was more development of the glandular epithelium (P

Introducción: Investigamos en nuestro entorno la utilidad de optimizar el cribado de cáncer de próstata (CaP) mediante determinación de PSA basal en varones entre 40-49 años. Material y método: Estudio retrospectivo que analiza el PSA basal en la quinta década y su capacidad para predecir desarrollo de CaP en una población de Madrid (España). Se realiza curva ROC y se propone un punto de corte. Se compara la evolución del PSA desde basal en pacientes con determinaciones consecutivas mediante el test de Friedman. Se establecen rangos de PSA basal con diferente riesgo de desarrollo de cáncer y se evalúa la utilidad diagnóstica de la velocidad de PSA (VPSA) anual en esta población. Resultados: Un total de 4.304 varones de 40-49 años fueron sometidos a cribado oportunista a lo largo de 17 años, con al menos una determinación sérica de PSA (6.001 determinaciones) y con seguimiento medio de 57,1 ± 36,8 meses. A 768 se les practicó biopsia de algún órgano y a 104 biopsia prostática. Catorce pacientes (0,33%) fueron diagnosticados de cáncer de próstata. La mediana de PSA basal fue 0,74 ng/ml (0,01-58,5) para pacientes sin CaP y 4,21 ng/ml (0,76-47,4) con CaP. La mediana de tiempo desde la determinación hasta el diagnóstico fue 26,8 meses (1,5-143,8). El punto de corte óptimo para detectar CaP fue 1,9 ng/ml (sensibilidad 92,86%, especificidad 92,54%, VPP 3,9%, VPN 99,97%) y el área bajo la curva 92,8%. Respecto a las determinaciones repetidas, la evolución del PSA no mostró diferencias estadísticamente significativas entre pacientes sin cáncer (p = 0,56) o con cáncer (p = 0,64); pero un valor de VPSA > 0,3 ng/ml/año revela elevada especificidad para detectar cáncer en esta población. Conclusiones: Un PSA basal ≥ 1,9 ng/ml en varones españoles de 40-49 años predice el desarrollo de CaP, por lo que podría resultar de utilidad para el cribado oportunista en edad temprana. Se necesita definir un seguimiento apropiado adaptado al riesgo en esta población, pero una VPSA anual ≥ 0,3 ng/ml/año parece de utilidad para conseguir un diagnóstico temprano. INTRODUCTION: We researched the usefulness of optimizing prostate cancer (PC) screening in our community using baseline PSA readings in men between 40-49 years of age. MATERIAL AND METHOD: A retrospective study was performed that analyzed baseline PSA in the fifth decade of life and its ability to predict the development of PC in a population of Madrid (Spain). An ROC curve was created and a cutoff was proposed. We compared the evolution of PSA from baseline in patients with consecutive readings using the Friedman test. We established baseline PSA ranges with different risks of developing cancer and assessed the diagnostic utility of the annual PSA velocity (PSAV) in this population. RESULTS: Some 4,304 men aged 40-49 years underwent opportunistic screening over the course of 17 years, with at least one serum PSA reading (6,001 readings) and a mean follow-up of 57.1±36.8 months. Of these, 768 underwent biopsy of some organ, and 104 underwent prostate biopsy. Fourteen patients (.33%) were diagnosed with prostate cancer. The median baseline PSA was .74 (.01-58.5) ng/mL for patients without PC and 4.21 (.76-47.4) ng/mL for those with PC. The median time from the reading to diagnosis was 26.8 (1.5-143.8) months. The optimal cutoff for detecting PC was 1.9ng/mL (sensitivity, 92.86%; specificity, 92.54%; PPV, 3.9%; NPV, 99.97%), and the area under the curve was 92.8%. In terms of the repeated reading, the evolution of the PSA showed no statistically significant differences between the patients without cancer (p=.56) and those with cancer (P=.64). However, a PSAV value >.3ng/mL/year revealed high specificity for detecting cancer in this population. CONCLUSIONS: A baseline PSA level ≥1.9ng/mL in Spanish men aged 40-49 years predicted the development of PC. This value could therefore be of use for opportunistic screening at an early age. An appropriate follow-up adapted to the risk of this population needs to be defined, but an annual PSAV ≥.3ng/mL/year appears of use for reaching an early diagnosis. Sin financiación 0.964 JCR (2015) Q4, 63/77 Urology & Nephrology UEM

OBJECTIVE To assess the effect of five polyphenol constituents of red wine (quercetin, morin, rutin, gallic acid and tannic acid) on the proliferation of LNCaP cells, and to quantify the extent of apoptosis with each polyphenol. MATERIALS AND METHODS LNCaP cells (500) were cultured in microtitre plates and treated with gallic acid, tannic acid, quercetin (1, 5 and 10 micromol/L), rutin and morin (25, 50 and 75 micromol/L). A colorimetric immunoassay was then used to determine the extent of proliferation at 24, 48, 72 and 96 h, and a cell-death detection assay to assess apoptosis at 24, 48 and 72 h. RESULTS Gallic and tannic acid (5 and 10 micromol/L), morin (50 and 75 micromol/L), quercetin (5 and 10 micromol/L) and rutin (50 and 75 micromol/L) all significantly inhibited (P

Objective To evaluate the clinical utility of using the reverse transcriptase-polymerase chain reaction (RT-PCR) to detect prostate-specific antigen (PSA) mRNA in peripheral blood samples from patients with prostate cancer, as a predictor of extraprostatic disease, and to assess any correlations with known predictive markers of this condition. Patients and methods Immediately before radical prostatectomy, peripheral blood samples were taken from 25 men with clinically localized prostate cancer and analysed for PSA mRNA using RT-PCR (in ‘hot-start’ conditions and confirmed using ClaI restriction enzyme). The relationships between PSA mRNA positivity, pathological and clinical features were analysed; PSA mRNA positivity, PSA level and biopsy Gleason score were then compared as predictors of extraprostatic disease. Results There was no relationship between PSA mRNA positivity and pathological stage (pT2 or pT3), and no association between PSA mRNA positivity and serum PSA level, PSA density, the findings on a digital rectal examination or transrectal ultrasonography, and perineural invasion in the prostatic biopsy. However, there was a significant correlation between the Gleason score of the preoperative biopsy and PSA mRNA positivity. The best predictors of extraprostatic disease were the biopsy Gleason score and the PSA level. Conclusion There was no significant advantage in using the RT-PCR assay of PSA mRNA before surgery to stage prostate cancer and to discriminate between organ-confined and extraprostatic neoplasms.

To present the long-term results of a prostate cancer (PC) screening trial conducted in a Mediterranean setting.A total of 4276 men aged 45-70 years were randomized to screening arm (PSA test performed) and control arm (no tests). Transrectal ultrasonography-guided sextant prostate biopsy was conducted when PSAor = 3 ng ml(-1). Date and cause of death were retrieved from death certificates. PC incidence, and disease-specific and overall mortality curves were plotted and comparison between arms was made. Analysis of causes of death was also performed.Median age at randomization was 57.0 years. Median follow-up time was 15.2 years. A total of 241 men were diagnosed with PC, 161 (6.7%) in the screening arm and 80 (4.3%) in the control arm (P0.01). Eventually, 554 men (13%) died. No difference in all-cause mortality was found between arms (P=0.34). Only 10 men (10/4276, 0.23%) died from PC, no differences between arms (P=0.67). Overall, the main causes of death were malignancy (54.2%), cardiovascular (17.9%) and respiratory (9.2%) diseases. Main cancer causes of death were lung and bronchus cancer (37.2%), colorectum (15.0%) and stomach (9.0%) cancer. PC only accounted for 3.0% of all malignant causes of death (ranked 10th).Our study failed to demonstrate benefits of PC screening in terms of all-cause and PC-specific mortality after a median follow-up of 15 years. The limited sample size and the low long-term PC mortality observed in our setting were probably the most important factors to explain these results.

To create an innovative process to care for urological outpatient surgery patients in an outpatient clinic basis conducted by nursing staff.Our centre covers a population of 153,266 inhabitants. A differentiated process for urological outpatient surgery patients has been implemented, conducted by nursing staff trained for the attendance of urologic patients ("phimosis","short penile frenulum",and "vasectomy request" sent from Primary Care units). Planning and implementation phases have been carried out. In the control phase, a questionnaire was given after surgical procedures with 9 different items, in order to assess different issues of the process.A total of 224 patients were attended during the study period, and 175 valid questionnaires were collected (78.1%). The procedures performed were circumcision (11.7%), frenuloplasty (14.6%), and vasectomy (73.7%), with a median patient age of 36 years. Satisfaction level was high for all items of the questionnaire, with 98.2% of patients" very satisfied" or "rather satisfied" when asked for the overall quality of attention of the whole process. The lowest scores were obtained in items that assessed delay from the appointment to attendance date (5.1% of patients "little satisfaction or not satisfied"), and the perception of information supplied (2.3% "little satisfaction or not satisfied"). A lower satisfaction score was observed (in the delay from appointment to attendance) in younger patients (p=0.001) and in patients who underwent circumcision (p=0.004). No complaints with regard to this process were collected. No incorrect indications for interventions were observed.The attendance of urological outpatient surgery patients can be safely and effectively performed by nursing staff trained for the care of urologic patients, without observing a decrease of the level of user satisfaction. Focusing on a process strategy allows the identification of areas for improvement and makes possible total quality management.

Objetivos: Determinar la incidencia real de los episodios de cólico renal (CR) en nuestro ámbito, así como su relación con varios factores epidemiológicos, estacionales y climáticos. Material y métodos: Hemos analizado los registros de 156.687 atenciones en el Servicio de Urgencias del Hospital Infanta Cristina (Parla, Madrid, España), desde su apertura el 7 de abril de 2008 hasta la fecha del análisis (28 de marzo de 2010). Se registraron la fecha de nacimiento, el sexo, la historia de episodios previos de CR, el motivo de consulta y la fecha de la atención. Se obtuvieron también los valores diarios de algunos parámetros climáticos (temperatura máxima y humedad relativa). Resultados: Se registraron un total de 1.866 episodios de CR (1,19% de todas las atenciones). La edad osciló entre los 15 y los 94 años, con una mediana de 39. Los episodios de CR fueron más prevalentes en la población masculina (58,4% vs. 41,6% en la femenina, respectivamente, p

Objetivos: Determinar la incidencia real de los episodios de cólico renal (CR) en nuestro ámbito, así como su relación con varios factores epidemiológicos, estacionales y climáticos. Material y métodos: Hemos analizado los registros de 156.687 atenciones en el Servicio de Urgencias del Hospital Infanta Cristina (Parla, Madrid, España), desde su apertura el 7 de abril de 2008 hasta la fecha del análisis (28 de marzo de 2010). Se registraron la fecha de nacimiento, el sexo, la historia de episodios previos de CR, el motivo de consulta y la fecha de la atención. Se obtuvieron también los valores diarios de algunos parámetros climáticos (temperatura máxima y humedad relativa). Resultados: Se registraron un total de 1.866 episodios de CR (1,19% de todas las atenciones). La edad osciló entre los 15 y los 94 años, con una mediana de 39. Los episodios de CR fueron más prevalentes en la población masculina (58,4% vs. 41,6% en la femenina, respectivamente, p

Objetivo: Establecer un protocolo de seguimiento adecuado basado en el tiempo necesario para conseguir la azoospermia tras la realización de vasectomía, y revisar la frecuencia de complicaciones en nuestro entorno. Métodos: Análisis retrospectivo de 391 vasectomías. Seguimiento mediante seminograma postvasectomía a los 6 meses de la intervención, y posteriormente con periodicidad trimestral hasta conseguir la azoospermia. Registro de las frecuentaciones en el Servicio de Urgencia de nuestro centro dentro de los 30 días del postoperatorio. Resultados: Durante el seguimiento se han llevado a cabo 567 seminogramas. De las 391 vasectomías realizadas, 275 presentaron al menos una muestra válida para su procesamiento. Al finalizar los 6 meses tras la cirugía un 41,1% presentaron espermatozoides aislados inmóviles en el seminograma, 9,7% tras los 9 meses, y 4,7% al finalizar los 12 meses. El retrasar el primer seminograma de los 6 a los 9 meses tras la intervención supondría un ahorro de 6153,23 Euros anuales en nuestro entorno, con la desventaja de diferir el alta de casi el 60% de los pacientes intervenidos. La tasa de complicaciones se situó en el 3,1% (sólo un paciente requirió reintervención e ingreso). No existió diferencia significativa en cuanto al tiempo operatorio en los pacientes con o sin complicación urológica. Conclusiones: La proporción de pacientes que no alcanzan la azoospermia tras los 6 meses postcirugía es notable. La práctica de la vasectomía parece fiable y relativamente segura en nuestro entorno, con una contenida tasa de complicaciones.

Prostate cancer (PC) mortality is the most valid end-point in screening trials, but could be influenced by the choice of initial treatment if treatment has an effect on mortality. In this study, PC treatment was compared between the screening and control arms in a screening trial. Data were collected from the European Randomized Study of Screening for Prostate Cancer (ERSPC). The characteristics and initial treatment of PC cases detected in the screening and the control arm were compared. Polytomous logistic regression analysis was used to assess the influence of study arm on treatment, adjusting for potential confounders and with statistical imputation of missing values. A total of 8,389 PC cases were detected, 5,422 in the screening arm and 3,145 in the control arm. Polytomous regression showed that trial arm was associated with treatment choice after correction for missing values, especially in men with high-risk PC. A control subject with high-risk PC was more likely than a screen subject to receive radiotherapy (OR: 1.43, 95% CI: 1.01-2.05, p = 0.047), expectant management (OR: 2.92, 95% CI: 1.33-6.42, p = 0.007) or hormonal treatment (OR: 1.77, 95% CI: 1.07-2.94, p = 0.026) instead of radical prostatectomy. However, trial arm had only a minor role in treatment choice compared to other variables. In conclusion, a small effect of trial arm on treatment choice was seen, particularly in men with high-risk PC. Therefore, differences in treatment between arms are unlikely to play a major role in the interpretation of the results of the ERSPC.

Background: Prostate-specific antigen (PSA) based screening for prostate cancer (PCa) has been shown to reduce prostate specific mortality by 20% in an intention to screen (ITS) analysis in a randomised trial (European Randomised Study of Screening for Prostate Cancer [ERSPC]). This effect may be diluted by nonattendance in men randomised to the screening arm and contamination in men randomised to the control arm. Objective: To assess the magnitude of the PCa-specific mortality reduction after adjustment for nonattendance and contamination. Design, setting, and participants: We analysed the occurrence of PCa deaths during an average follow-up of 9 yr in 162 243 men 55-69 yr of age randomised in seven participating centres of the ERSPC. Centres were also grouped according to the type of randomisation (ie, before or after informed written consent). Intervention: Nonattendance was defined as nonattending the initial screening round in ERSPC. The estimate of contamination was based on PSA use in controls in ERSPC Rotterdam. Measurements: Relative risks (RRs) with 95% confidence intervals (CIs) were compared between an ITS analysis and analyses adjusting for nonattendance and contamination using a statistical method developed for this purpose. Results and limitations: In the ITS analysis, the RR of PCa death in men allocated to the intervention arm relative to the control arm was 0.80 (95% CI, 0.68-0.96). Adjustment for nonattendance resulted in a RR of 0.73 (95% CI, 0.58-0.93), and additional adjustment for contamination using two different estimates led to estimated reductions of 0.69 (95% CI, 0.51-0.92) to 0.71 (95% CI, 0.55-0.93), respectively. Contamination data were obtained through extrapolation of single-centre data. No heterogeneity was found between the groups of centres. Conclusions: PSA screening reduces the risk of dying of PCa by up to 31% in men actually screened. This benefit should be weighed against a degree of over diagnosis and overtreatment inherent in PCa screening. (C) 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Data from the participation of our department in the ERSPC study in terms of detection and PSA diagnostic yield, staging, therapeutic management and mortality in the context of a multicentric randomized screening study for prostate cancer.Patients were recruited between February 1996 and June 1999, randomized in screening and control arms, with several rounds for screening patients with four-year intervals, with PSA analysis and sextant prostate biopsy (t PSA4 ng/ml before May 1998, tPSA2.99 ng/ml after May 1998). These tests were not done in the control group. All deaths were studied (date and cause)A total of 4278 patients were included, 24 16 in the screening arm (56.4%) and 1862 in the control arm (43.5%), with an age between 45 and 70 years (mean age 57.8 years, 95 CI 57.6-58.0). Median follow-up was 8.77 years. 142 prostate cancers were found, 113 in the screening arm (accumulated detection rate 4.7%) and 29 in the control arm (1.6%). Detection rates were 1.7%, 2.2% and 0% in the first, second and third round respectively. Organ confined cancers (T1 and T2) were 102 in the screening arm (90.3%) and 24 in the control arm (82.8%), p = 0.254 . Metastatic disease was found in six patients (4.2% out of 142), 3 in the screening arm ( 2.7%) and three in the control arm (10.3%), p = 0.187. Radical prostatectomy was the most frequently performed treatment: 47 cases in the screening arm (41.6%), 10 in the control arm (34.5%). 151 patients have died, 82 in the screening arm and 69 in the control arm. Only 3 of this deaths were secondary to prostate cancer, all of them in the screening arm (p = 0.308).We observed a non significant tendency to lower clinical stages in patients undergoing screening. Radical surgery was the treatment of choice in patients with prostate cancer. Even with the current follow-up in the series (close to 9 years), no differences have been observed in terms of prostate cancer mortality between both study arms.

The performance of tests outside prostate cancer screening trials (PSA contamination) may affect their statistical power. The present study addressed the extent of PSA contamination in the Spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) and its impact on biopsy performance and prostate cancer detection.Data linkage was performed to address screening-related interventions outside the study. Four databases were used: (1) Spanish ERSPC database (n=4278), (2) laboratory database with all PSA determinations (n=31,140), (3) database of 1608 prostate biopsies, and (4) records of all prostate cancers (n=819) diagnosed at our centre. PSA contamination, biopsy performance, and cancer detection rates were calculated.Median follow-up time was 6.6 yr. A total of 2201 PSA determinations were performed for 1253 men. Cumulative PSA contamination was 29.3% (17% in the control arm during the first 4 yr). A higher proportion of men undergoing biopsies was found in the screening arm (21.3% vs. 2.9% in the control arm, p0.0001). Similarly, higher cancer detection rates were found in the screening (4.7% vs. 1.2% in the control arm, p0.0001).In our experience, the PSA contamination rate has increased during the last years, but its impact on biopsy performance and cancer detection in the control arm of the trial is limited and not likely to compromise the statistical power of the ERSPC trial.

Objectives: Rectal involvement due to local spread from prostate cancer is an uncommon finding. When this condition occurs, prognosis is ominous. Our objective is to report our experience in the use of self-expanding endorectal stents in the management of rectal invasion from prostate cancer. Two cases are presented and a review of the literature is carried out. Methods and Results: In both cases, self-expanding Wallstent® devices were placed (under fluoroscopic control), in order to solve their episodes of bowel obstruction. It was successfully performed in both patients. Therefore, an open surgery procedure was avoided. Conclusions: When facing the evidence ofa tumor that invades the rectal wall, it is important to rule out the existence of prostate cancer (the surgical option in these patients carries an ominous prognosis). Therefore, we propose this new procedure whose results could be very satisfactory in certain settings.

Purposes: To address prostate cancer (PCa) detection with respect to the number of biopsy sessions performed, to identify risk factors for detection after a negative biopsy, and to analyze the clinical characteristics of the detected tumors. Scope: Only biopsied men (sextant) were included. A total of 1011 biopsy sessions were carried out in 770 men; 172 underwent a second prostate biopsy and 51 a third biopsy. During the first biopsy round, 111 cancers were found (14.4%), 27 in the second (15.7%), and five during the third round (9.8%), P=0.156. Only high-grade PIN or atypia were identified as independent predictors or PCa detection in subsequent biopsies (P=0.008). A nonsignificant increase of clinically localized tumors, and a decrease of metastatic and poorly differentiated cases were found when more biopsy sessions were needed for detection. Conclusions: A nonsignificant trend to lower cancer detection rates and less clinical relevance of the tumors detected can be observed when more biopsy rounds are needed for detection.

To address detection rates and clinical features of the cancers detected with low prostate specific antigen (PSA) levels.In the context of a prostate cancer (PCa) screening program 1097 men attended to a new rescreen round. Sextant prostate biopsy was recommended when PSAor =3 ng/ml. We also recommended to undergo biopsy in the range 1.0-2.99 ng/ml when free to total (f/t) PSA ratioor =20%. Detection rate was calculated and clinical features of the cancers detected were studied.Mean age was 61.1 years. A total of 497 (45.3%) had total PSA1.0 ng/ml, 439 (40%) between 1.0 and 2.99 ng/ml, and 161 (14.7%)or =3.0 ng/ml. In the group with PSA between 1.0 and 2.99 ng/ml and f/t PSA ratioor =20% a total of 249 biopsies were indicated (159 performed, acceptance 63.9%), and 15 cancers detected (detection rate 9.4%). Biopsy was recommended to 72 men with PSA between 3.0 and 3.99 ng/ml, performed in 56 (77.8%), and 12 tumors detected (detection rate 21.4%). All cancers in the study were clinically localized. Only 4 out of 15 cancers with PSA in the range 1.0-2.99 ng/ml (26.7%) fulfilled clinical criteria of insignificant cancer. Two were poorly differentiated and found to have patologically extracapsular disease. None of the 12 patients with PCa and PSA between 3.0 and 3.99 ng/ml had poorly differentiated features and only one complied with criteria of insignificant cancer. One out of seven who underwent RRP was found to have extracapsular disease.Cancer detection in low PSA ranges is lower but still relevant. The detection of potentially aggresive cancers is still of concern.

The objective of this paper is to validate prostate specific antigen (PSA) density (PSAD) routine use to enhance PSA specificity in men with normal digital rectal examination and intermediate PSA values. It is a retrospective study of 235 men from a prostate cancer (PCa) screening program. All of them presented PSA values between 4 and 10 ng/ml, normal digital rectal examination, and a transrectal ultrasound (TRUS) guided biopsy available (PSA/=4 ng/ml as the sole criterion for biopsy). Multivariate analysis failed to demonstrate higher PSAD values in men with PCa. PSAD cutoff points higher than 0.07 ng/ml per cc were considered as unacceptable, with less than 95% sensitivity. When a cutoff point of 0.15 was considered, as many as 30.6% of the cancers were missed. In conclusion we cannot recommend the use of this parameter for the above mentioned purpose.Prostate Cancer and Prostatic Diseases (2001) 4, 146-149.

We address long-term within individual variation of serum prostate specific antigen (PSA) in men without clinical or biopsy evidence of prostate cancer.We studied 943 men from a prostate cancer screening program with 2 PSA (PSA1 and PSA2) measurements available. A third PSA (PSA3) was obtained from 571 men. Only participants with no clinical evidence of cancer were included in the study. Within individual PSA variability was calculated based on indexes of percent coefficient of variation, ratio difference and PSA velocity. The relationship among these indexes, interval between measurements and number of PSA samples was assessed.Mean interval was 670.4 days between PSA1 and PSA2, and 801.8 days between PSA2 and PSA3 (p0.001). Mean coefficient of variation was 18% after 2 and 15.7% after 3 PSA measurements. Mean ratio differences were -0.047 ng./ml. for 2 and 0.033 ng./ml. for 3 samples. Mean PSA velocity was -0.128 ng./ml. per year for 2 and -0.055 ng./ml. per year for 3 samples, with 95% confidence intervals of 0.634 and 0.315, respectively. Variability was higher if only 2 PSA measurements were done (p0.001). No clear relationship was found between individual variability and interval between measurements.PSA velocity is within normal limits in almost all men (more than 95%) without clinically relevant prostate cancer. PSA individual variability is not fully dependent on the time between measurements when intervals are long, and can be substantially decreased with a third PSA sample.

Objectives: To establish the reliability of three cytopathologists for cytological diagnosis of primary bladder tumors. Methods: Preoperative voided urine specimens of 71 patients with bladder cancer and 55 noncancer controls were retrospectively and blindly reviewed by 3 independent cytologists, and their results compared. The estimation of the interobserver agreement was calculated using the weighted κ coefficient. A multivariate analysis was carried out to identify the factors associated with the disagreement between the three observers. The sensitivity and specificity for each of the participants was calculated in order to clearly identify the origin of the disagreement, in terms of the performance of the diagnostic test in the hands of each observer. A comparison of the overall diagnostic performance was made by plotting sensitivity versus 1-specificity. Results: The weighted κ coefficient among the 3 observers was 0.46. The multivariate analysis did not identify any variable that could have caused such disagreement. Vast differences in sensitivity and specificity were detected between observer 1 (sens. 0.90, spec. 0.45) and observers 2 (sens. 0.67, spec. 0.72) and 3 (sens. 0.71, spec. 0.80), but the overall diagnostic performance (sensitivity vs. 1-specificity) was superimposable in the 3 cases (p = NS). Conclusions: Simple, reproducible and agreed-on-diagnostic criteria should be established to yield reliable results in a group of cytologists. The consideration of individual diagnostic performances can give a false idea of homogeneity between observers. In this field, concordance analysis makes quality control reliable and should be a routine procedure of any pathology department.

To detect curable prostate cancer in a male Spanish population. The results of screening 2,576 men are reported.Patients underwent digital rectal examination (DRE) and serum prostate-specific antigen (PSA) determination. Any patient with suspicious DRE or PSA4 ng/ml was further evaluated with transrectal ultrasonography (TRUS) and biopsy. The sensitivity, specificity and predictive value of the tests or combinations of tests were determined.Mean age was 59.9 years (median 58 years). Ninety-four patients (3.6%) had abnormal DRE while PSA was4 ng/ml in 169 patients (6.5% of the total). We needed 6.8 biopsies to prove one cancer. PSA had the highest sensitivity (93%), whereas DRE had the highest specificity (97%). The positive predictive value rose to 78.9% when both DRE and PSA were abnormal. Clinically advanced tumor stages (or = T3) were commoner (39.4%) than in similar series.PSA should be the first diagnostic test in a screening program for prostate cancer. Neither DRE nor TRUS are necessary in patients with PSA4 ng/ml. In the light of our findings, we cannot encourage screening programs for prostate cancer for the time being.

To analyze the effects of major pelvic ganglion (MPG) excision on the structure of rat prostate.We studied 80 Sprague-Dawley rats (300-350 gm. weight). Forty-two were anesthetized and the right MPG excised. After 28-30 days, the same-side prostatic ventral lobe (VL) was obtained for macroscopic, light (LM), and transmission electron microscopy (TEM) evaluation. A computerized morphometric analysis was performed on epithelial and muscle cells. Results were compared with 38 right VL of non-operated, same-aged rats.A 36.6% reduction (0.14 gm.) of VL fresh weight was found in the denervated group (p0.001). Mean tissue proportions observed in the LM study were 27.9% (epithelial), 48.3% (stromal), and 51.8% (glandular) in the non-operated group, versus 14.8% (p0.001), 55.7%, and 44.4% (not significant) respectively, after MPG excision. No difference was found regarding the vascular pattern. In the denervated rats, TEM analysis found a significant reduction in total and supranuclear cell height (change in cell polarity), as well as in cytoplasm, Golgi and endoplasmic reticulum areas. Secretory granule count, total area (p0.001), and density of apical microvilli were also reduced. On the other hand, only an increase in the area of cytoplasm ribosomal aggregates was detected in the smooth muscle cell analysis.Our study demonstrated a rat prostatic VL atrophy in the denervated side, due to a shrinkage in the epithelial component of the gland. Ultrastructural findings also suggest an overall decrease of epithelial cell secretory activity. Finally, the increase of ribosomal aggregates found in stromal smooth muscle could reflect an activation of these cells after denervation.