Obligatory information that a patient diagnosed of prostate cancer and candidate for an active surveillance protocol must know.

OBJECTIVES: To know the necessary information to reproduce the results found in the literature on active surveillance (AS) in prostate cancer (PCa) in our own center so that the information would be objective and correctly given to the patients. We have aimed to study the percentage of candidates for AS chosen in our setting, and the data on infrastaging, subgrading and prediction of insignificant PCa, debugging the predictive value of clinical variables to improve our selection criteria and finally to analyze the results of our patients enrolled in AS. MATERIALS AND METHODS: A retro- and prospective review of our data bases was performed. A one-year period was analyzed to know AS candidates. Analysis of our radical prostatectomy specimens for infrastaging, subgrading and prediction of insignificant PCa (Epstein's criteria) was made as well as a uni/multivariate analysis of clinical variables in patients with insignificant PCa in the specimen. A prospective validation was performed with overall survival and survival free of active treatment (SFAT) as endpoints in patients enrolled in AS. RESULTS: Between October-2010/October-2011, 44.7% of our PCa were candidates for AS, but only 11.2% choose it. The percentages found for infrastaging, subgrading and prediction of insignificant PCa were 14%, 31.4% and 55.7%, respectively. However, only just 6 patients (6.97%) had≥pT3a+Gleason≥7+volume>0.5cc PCa. The multivariate analysis showed that PSA density and number of affected cores were independent predictors of insignificant PCa. With a mean follow-up of 36±39months, 63 out of 232 patients enrolled in AS went on to active treatment (27.1%), with only 13 due to anxiety without pathologic progression. Median time of SFAT was 72.7 months (CI 95% 30.9-114.4). SFAT at 24 months was 76.4% (69.7-83.1%) and at 48 months 58.1% (48.8-67.4%). Only 10 patients died (4.3%), 9 due to causes different of PCa. Estimated overall survival at 5 years was 92.8% (CI 95% 86.7-98.9%). CONCLUSIONS: It should be mandatory to have the exact knowledge of the local data of each Center in order to objectively inform patients about prostate biopsy efficiency, and if percentages of infrastaging, subgrading and prediction of insignificant PCa are in accordance with the literature. At 3 years, we reproduced the results of the longest series of AS, so we have ascertained that our AS protocol can be implemented with increasingly more patients.

La prostatectomía radical es un tratamiento razonable para los pacientes mayores de 70 años / Radical Prostatectomy is a Reasonable Treatment for Patients Over 70 Years of Age

Objetivo: Comparar la naturaleza tumoral y la evolución oncológica de los pacientes intervenidos mediante prostatectomía radical en 3 grupos de edad. Material y método: De la base de datos de cumplimentación prospectiva de nuestro Servicio, analizamos 1.012 pacientes intervenidos entre los años 1986 y diciembre de 2009. Se excluyeron los pacientes con tratamiento neo o adyuvante y aquellos con PSA preoperatorio mayor de 50. Se dividió la muestra en 3 grupos: menores de 60, de 61 a 69 y los de 70 y mayores. Se analizaron las variables clínicas, patológicas, la evolución bioquímica y la necesidad de rescate. Consideramos recidiva bioquímica cuando los valores de PSA alcanzan cifras mayores de 0,4 en 2 mediciones consecutivas. Se definió rescate como la necesidad de tratamiento hormonal o de la administración de radioterapia. Procedimos a un estudio comparativo, un análisis de supervivencia univariante mediante curvas de Kaplan y Meyer y multivariante mediante regresión de Cox. Resultados: La mediana de seguimiento fue de 55,1 meses. De los 1.012 pacientes incluidos en el estudio 317 pacientes (31,3%) experimentaron progresión bioquímica y 259 (25,6%) necesitaron rescate. Observamos que los grupos de mayor edad tenían un PSA significativamente más alto y mayores estadios que el resto. No se objetivaron diferencias en el Gleason de la pieza quirúrgica ni en el estado de los márgenes quirúrgicos. La supervivencia libre de recidiva bioquímica a los 5 años fue del 72,3% (IC 95%: 66,4-78,2) en los pacientes menores de 60 años, del 65,3% (IC 95%: 60,6-70,0) para los pacientes menores de 70 y del 62,2% (IC 95%: 53,2-71,1) para los pacientes con 70 o más años; p < 0,05. En el estudio univariante la edad fue un factor que se asoció significativamente a la recidiva bioquímica; sin embargo, en el estudio multivariante pierde su interés y lo cobrabá el PSA, el estado patológico y el Gleason. La supervivencia libre de rescate no difería por grupos de edad. Conclusiones: En el presente estudio se objetivó una peor evolución bioquímica de los pacientes mayores de 70 años, sin embargo esta peor evolución bioquímica estuvo condicionada por tumores clínicamente más agresivos, lo que a nuestro juicio justifica la decisión tomada en cuanto a la actitud quirúrgica para con estos pacientes

Objective: To compare the tumor nature and oncological course of patients operated on by radical prostatectomy in three age groups. Materials and methods: From the prospective completion of the data base of our department, we analyzed 1012 patients operated on between 1986 and December 2009. Patients with neo- or adjuvant treatment and those with pre-operative PSA over 50 were excluded. The sample was divided into three groups: younger than 60, 60-69 and over 70. The clinical, pathological variables, biochemical course and need for rescue treatment were analyzed. We consider biochemical relapse as when the PSA values reached values greater than 0.4 in two consecutive measurements. Rescue was defined as the need for hormone treatment or radiotherapy. We then made a comparative study, a univariate survival analysis by Kaplan and Meyer Curves and multivariate by Cox's regression. Results: The median follow-up was 55.1 months. Of the 1012 patients included in the study, 317 patients (31.3%) had biochemical progression and 259 (25.6%) required rescue treatment. We observed that the groups with the older age had a significantly higher PSA and higher stages than the rest. No differences were observed in the Gleason score of the surgical specimen or in the state of the surgical margins. Biochemical relapse free survival at 5 years was 72.3% (CI 66.4-78.2) in patients under 60 years, 65.3% (CI 60.6-70.0) for patients under 70 and 62.2% (CI 53.2-71.1) for patients of 70 years or older; P < 0.05. In the univariate study, age was a factor that was significantly associated to biochemical relapse. However, it loses interest in the multivariate study and PSA, pathological state and Gleason score regain interest. Rescue treatment free survival did not differ by age groups. Conclusions: In the current study, worse biochemical evolution of patients over 70 was observed. However, this worse biochemical course was conditioned by clinically more aggressive tumors that, in our opinion, justifies the decision made in regards to the surgical approach taken with these patients

Optimizing prostate cancer screening; prospective randomized controlled study of the role of PSA and PCA3 testing in a sequential manner in an opportunistic screening program.

OBJECTIVES: To reduce unnecessary biopsies (Bx) in an opportunistic screening programme of prostate cancer. MATERIAL AND METHODS: We perform a prospective evaluation of PCA3 as a second line biomarker in an opportunistic screening for prostate cancer (PCa). From September-2010 until September-2012, 2,366 men, aged 40-74 years and with >10 years life expectancy, were initially screened with PSA/digital rectal examination (DRE). Men with previous Bx or with recent urine infections were excluded. Men with abnormal DRE and/or PSA >3 ng/ml were submitted for PCA3. All men with PCA3 ≥ 35 underwent an initial biopsy (IBx) -12cores-. Men with PCA3 < 35 were randomized 1:1 to either IBx or observation. Re-biopsy(16-18 cores) criteria were PSA increase >.5 ng/ml at 4-6 months or PSAv > .75 ng/ml/year. RESULTS: With median follow-up (FU) of 10.1 months, PCA3 was performed in 321/2366 men (13.57%), 289 at first visit and 32 during FU. All 110 PCA3+ men (34.3%) were biopsied and PCa was identified in 43 men in IBx (39.1%). In the randomized arm, 110 were observed and 101 underwent biopsy, finding 12 PCa (11.9%), showing a statistically significant reduction of PCa detection rate in this cohort (P<.001). Global PCa detection rates were 40.9% and 9.5% for the PCA3+ and PCA3- branches, respectively (P<.001). Area under the curve for PSA and PCA3 were .601 and .74, respectively. This is an ongoing prospective study limited by its short follow-up period and still limited enrolment. CONCLUSIONS: PCA3 as a second line biomarker within an opportunistic dual screening protocol, can potentially avoid 65.7% and 50.1% biopsies at first round and at median FU of 10.1 months, respectively, just missing around 3.2% of high grade PCa.

Radical prostatectomy is a reasonable treatment for patients over 70 years of age.

OBJECTIVE: To compare the tumor nature and oncological course of patients operated on by radical prostatectomy in three age groups. MATERIAL AND METHOD: From the prospective completion of the data base of our department, we analyzed 1012 patients operated on between 1986 and December 2009. Patients with neo- or adjuvant treatment and those with pre-operative PSA over 50 were excluded. The sample was divided into three groups: younger than 60, 60 to 69 and over 70. The clinical, pathological variables, biochemical course and need for rescue treatment were analyzed. We consider biochemical relapse as when the PSA values reached values greater than 0.4 in two consecutive measurements. Rescue was defined as the need for hormone treatment or radiotherapy. We then made a comparative study, a univariate survival analysis by Kaplan and Meyer Curves and multivariate by Cox's regression. RESULTS: The median follow-up was 55.1 months. Of the 1012 patients included in the study, 317 patients (31.3%) had biochemical progression and 259 (25.6%) required rescue treatment. We observed that the groups with the older age had a significantly higher PSA and higher stages than the rest. No differences were observed in the Gleason score of the surgical specimen or in the state of the surgical margins. Biochemical relapse free survival at 5 years was 72.3% (CI 66.4-78.2) in patients under 60 years, 65.3% (CI 60.6-70.0) for patients under 70 and 62.2% (CI 53.2-71.1) for patients of 70 years or older; P<.05. In the univariate study, age was a factor that was significantly associated to biochemical relapse. However, it loses interest in the multivariate study and PSA, pathological state and Gleason score regain interest. Rescue treatment free survival did not differ by age groups. CONCLUSIONS: In the current study, worse biochemical evolution of patients over 70 was observed. However, this worse biochemical course was conditioned by clinically more aggressive tumors that, in our opinion, justifies the decision made in regards to the surgical approach taken with these patients.

Resultados del uso expandido del PCA3 score en una población española con sospecha de cáncer de próstata / Outcomes of Expanded Use of PCA3 Testing in a Spanish Population with Clinical Suspicion of Prostate Cancer

Objetivos: La expresión del gen DD3PCA3 (PCA3) es específica del cáncer de próstata. El porcentaje de biopsias que se pueden ahorrar con este biomarcador es de 35-67%. Nuestro objetivo es analizar los resultados en uso rutinario y establecer en qué subgrupo de pacientes es más rentable según el número de biopsias previas. Material y métodos: Analizamos a 474 pacientes, biopsiados previamente (grupo A, n=337) o no (grupo B, n=134) en los que se solicitó el PCA3. Subdividimos el grupo A en A1 (una biopsia previa, n=182) y A2 (>1 biopsia previa, n=155). La recomendación de biopsiar o no se tomó de forma independiente por cada uno de los urólogos del Servicio junto con el antígeno prostático específico (PSA) y tacto rectal. Resultados: La mediana de edad fue 65 años (rango 38-84). La tasa informativa del PCA3 score fue del 99,6% y su mediana 29 (rango 1-3245). El porcentaje de ahorro de biopsias fue 49%. Las áreas bajo la curva ROC para PSA y PCA3 fueron de 0,532(p=0,417) y 0,672(p<0,0001). La sensibilidad de PSA≥4 y PCA3≥35 fueron 87 y 85%, la especificidad 12 y 33%, el valor predictivo positivo (VPP) 34 y 39% y el valor predictivo negativo (VPN) 63 y 81%. Tomado el valor de PCA3 como variable contínua, a mayor PCA3 obtenemos mayor porcentaje de biopsias positivas (p<0,0001). Conclusiones: El uso rutinario del PCA3 ahorra la mitad de las biopsias, basándose sobre todo en su alto VPN. La mayor rentabilidad diagnóstica del PCA3 la obtenemos en pacientes sin biopsia. Entre los pacientes ya biopsiados, los resultados son ligeramente mejores en aquellos con solo una (AU)

Objectives: DD3PCA3 (PCA3) gene expression is prostate cancer-specific. Routine use of this biomarker has resulted in a 35-67% reduction in the number of required biopsies. The aim of this study is to evaluate our outcomes in its routine use and to establish in which group of patients this is the most efficient, depending on the number of previous PCA3 biopsies. Material and methods: A total of 474 consecutive patients who had previously undergone a biopsy (group A, n=337) or not (group B, n=134) for whom a PCA3 was requested were analyzed. We subdivided group A into A1 (a previous biopsy, n=182) and A2 (<1 previous biopsy, n=155). The recommendation of whether to perform a biopsy or not was made independently by each of the 11 clinicians and guided by prostatic specific antigen (PSA) levels and digital rectal examination. Results: Median age was 65 years (range 38 to 84). PCA3 score had an informative ratio of 99.6%, with a median of 29 (range 1-3245). The percentage of biopsy sparing was 49% of the cases. ROC analysis demonstrated an AUC for PSA and PCA3 of 0.532 (P=.417) and 0.672 (P<.0001), respectively. Sensitivities of PSA≥ 4 and PCA3≥ 35 were 87% vs. 85%, with specificities of 12% vs. 33%, PPV 34% vs. 39% and NPV 63% vs. 81%, respectively. The PCA3 score showed direct correlation with the percentage of positive biopsies (P<.0001). Conclusions: Routine use of PCA3, due to its high NPV, results in a significant reduction in the number of biopsies. PCA3 appears to be more efficient in biopsy-naive patients. Among patients already biopsied, the results are superior in those biopsied only once (AU)

[Outcomes of expanded use of PCA3 testing in a Spanish population with clinical suspicion of prostate cancer]. / Resultados del uso expandido del PCA3 score en una población española con sospecha de cáncer de próstata.

OBJECTIVES: DD3(PCA3) (PCA3) gene expression is prostate cancer-specific. Routine use of this biomarker has resulted in a 35-67% reduction in the number of required biopsies. The aim of this study is to evaluate our outcomes in its routine use and to establish in which group of patients this is the most efficient, depending on the number of previous PCA3 biopsies. MATERIAL AND METHODS: A total of 474 consecutive patients who had previously undergone a biopsy (group A, n=337) or not (group B, n=134) for whom a PCA3 was requested were analyzed. We subdivided group A into A(1) (a previous biopsy, n=182) and A(2) (<1 previous biopsy, n=155). The recommendation of whether to perform a biopsy or not was made independently by each of the 11 clinicians and guided by prostatic specific antigen (PSA) levels and digital rectal examination. RESULTS: Median age was 65 years (range 38 to 84). PCA3 score had an informative ratio of 99.6%, with a median of 29 (range 1-3245). The percentage of biopsy sparing was 49% of the cases. ROC analysis demonstrated an AUC for PSA and PCA3 of 0.532 (P=.417) and 0.672 (P<.0001), respectively. Sensitivities of PSA≥ 4 and PCA3≥ 35 were 87% vs. 85%, with specificities of 12% vs. 33%, PPV 34% vs. 39% and NPV 63% vs. 81%, respectively. The PCA3 score showed direct correlation with the percentage of positive biopsies (P<.0001). CONCLUSIONS: Routine use of PCA3, due to its high NPV, results in a significant reduction in the number of biopsies. PCA3 appears to be more efficient in biopsy-naive patients. Among patients already biopsied, the results are superior in those biopsied only once.

Resultados de implante de semillas de iodo-125 con sistema de preplanificación en 250 pacientes con carcinoma de próstata / Results of 125-Iodine seed implant with preplanning system in 250 patients with prostate cancer

Objetivo: Revisar la experiencia con implantes permanentes de semillas de I-125 en carcinoma de próstata y el resultado a los 8 años de comenzar la técnica. Material y métodos: De 2002 a 2007 hemos realizado 250 implantes con braquiterapia de baja tasa con RapidStrand® y sistema de preplanificación. La edad media fue 68 años (49-78). El PSA medio fue 7,32 (2,31-14,6), 98% T1-T2a, 96% Gleason ≤ 6, 81% de bajo riesgo y 19% de riesgo intermedio (10 de estos últimos recibieron 46 Gy de radioterapia externa). Un 42% recibieron hormonoterapia. Resultados: Con seguimiento medio de 48 meses, 14 pacientes (5,7%) tuvieron recaída bioquímica (RB). En 11 pacientes (4,5%) con teórica RB el PSA descendió espontáneamente sin tratamiento. La supervivencia actuarial sin recaída bioquímica a 5 años fue del 91% (92% bajo riesgo, 86% riesgo intermedio); 92 vs 81% en pacientes con PSA < 10 vs > 10 (p < 0,05). Hubo complicaciones rectales G2 en el 0,6%, sondaje vesical en un 6,5%; el 60% conservaron la función sexual. El V100 medio fue del 89% y el D90 143 Gy. Conclusión: El resultado en carcinoma de próstata de bajo riesgo mediante semillas de Iodo-125es muy bueno con muy pocas complicaciones. Las elevaciones de PSA deberían ser controladas antes de dar tratamiento de rescate (AU)

Introduction: We review the experience with prostate carcinoma patients treated with permanent implants of 125-I seeds and the outcome eight years after the beginning of this technique. Material and methods: From 2002 to 2007 we have performed 250 implants with LDR brachytherapy with RapidStrand® and preplanning system. Mean age was 68 (49-78). Mean PSA was 7.32 (2.31 - 14.6). T1-T2a was the stage in 98%, and Gleason ≤ 6 in 96%. Low risk cases were 81% and intermediate risk 19% (ten of them received 46 Gy EBRT). Hormonal treatment was used in 42%. Results: With a mean follow-up of 48 months, 14 patients (5.7%) showed biochemical failure (BF). Eleven patients (4.5%) with theoretical BF were observed and PSA decreased without treatment. Actuarial PSA relapse-free survival at 5 years was 91%, (92% low risk, 86% intermediate cases), and 92% vs 81% with PSA <10 vs >10 (p < 0.05). Rectum complications were G2 in0 .6%. A urinary catheter was necessary in 6.5%. Sexual function was conserved in 60%. Mean V100 was 89% and D90 143 Gy. Conclusion: The outcome of patients with low risk prostate carcinoma treated with I-125 seed is very good with very low complications rate. Cases with PSA bounces should be controlled before starting a salvage treatment (AU)

[Results of 125-iodine seed implant with preplanning system in 250 patients with prostate cancer]. / Resultados de implante de semillas de iodo-125 con sistema de preplanificación en 250 pacientes con carcinoma de próstata.

INTRODUCTION: We review the experience with prostate carcinoma patients treated with permanent implants of 125-I seeds and the outcome eight years after the beginning of this technique. MATERIAL AND METHODS: From 2002 to 2007 we have performed 250 implants with LDR brachytherapy with RapidStrand(®) and preplanning system. Mean age was 68 (49-78). Mean PSA was 7.32 (2.31 - 14.6). T1-T2a was the stage in 98%, and Gleason ≤ 6 in 96%. Low risk cases were 81% and intermediate risk 19% (ten of them received 46 Gy EBRT). Hormonal treatment was used in 42%. RESULTS: With a mean follow-up of 48 months, 14 patients (5.7%) showed biochemical failure (BF). Eleven patients (4.5%) with theoretical BF were observed and PSA decreased without treatment. Actuarial PSA relapse-free survival at 5 years was 91%, (92% low risk, 86% intermediate cases), and 92% vs 81% with PSA <10 vs >10 (p<0.05). Rectum complications were G2 in 0.6%. A urinary catheter was necessary in 6.5%. Sexual function was conserved in 60%. Mean V100 was 89% and D90 143 Gy. CONCLUSION: The outcome of patients with low risk prostate carcinoma treated with I-125 seed is very good with very low complications rate. Cases with PSA bounces should be controlled before starting a salvage treatment.

Reconstrucción del glande con injerto cutáneo libre según técnica de Bracka / Reconstruction of the Glans With Free-Skin Graft Applying the Bracka Technique

Introducción: Analizamos nuestra experiencia en el manejo conservador y reconstructivo de los pacientes tratados de cáncer de pene y/o patologías cutáneas del pene en nuestra institución. Material y métodos: Hemos revisado retrospectivamente todos los procedimientos de injerto cutáneo realizados en la cirugía peneana a lo largo de los últimos 8 años. Se presentan las indicaciones y resultados de estas cirugías y el procedimiento quirúrgico detallado descrito originalmente por Bracka. Resultados: Diez pacientes fueron sometidos a extirpación parcial del pene seguida de técnica quirúrgica reconstructiva con injerto libre de piel creando un neoglande. No se han registrado casos de complicaciones mayores; dos pacientes tuvieron pérdida parcial del injerto y ninguno ha presentado recidiva local. Seis pacientes comunicaron haber reanudado su actividad sexual después de la curación completa. Conclusión: Existe un grupo importante de pacientes con cáncer de pene y/o otras patologías en el glande donde es posible realizar una cirugía reconstructiva peneana no mutilante con resultados oncológicos, estéticos y funcionales satisfactorios (AU)

Introduction: We analyse our experience in the conservative surgical management of penile cancer and/or penile skin pathologies at our institution. Material and methods: We have retrospectively reviewed all the skin grafting procedures performed in penile surgery in the last eight years. We show the indications and results of these surgical procedures and the detailed surgical technique originally described by Bracka. Results: Ten patients had several types of partial penile removal surgery followed by free-skin graft resurfacing, creating a neoglans. There were no relevant or major complications; two patients suffered partial necrosis of the skin graft. There was no local recurrence. 6 Patients returned to normal sexual activity after complete healing. Conclusions: There is a significant number of patients with penile cancer and/or other penile skin pathologies who can undergo definitive and non-mutilating surgery with excellent oncologic, cosmetic and functional results with skin grafting (AU)

[Reconstruction of the glans with free-skin graft applying the Bracka technique]. / Reconstrucción del glande con injerto cutáneo libre según técnica de Bracka.

INTRODUCTION: We analyse our experience in the conservative surgical management of penile cancer and/or penile skin pathologies at our institution. MATERIAL AND METHODS: We have retrospectively reviewed all the skin grafting procedures performed in penile surgery in the last eight years. We show the indications and results of these surgical procedures and the detailed surgical technique originally described by Bracka. RESULTS: Ten patients had several types of partial penile removal surgery followed by free-skin graft resurfacing, creating a neoglans. There were no relevant or major complications; two patients suffered partial necrosis of the skin graft. There was no local recurrence. 6 Patients returned to normal sexual activity after complete healing. CONCLUSIONS: There is a significant number of patients with penile cancer and/or other penile skin pathologies who can undergo definitive and non-mutilating surgery with excellent oncologic, cosmetic and functional results with skin grafting.

Progresión metastática, mortalidad cáncer específica y necesidad de tratamientos de segunda línea en pacientes con cáncer de próstata de alto riesgo tratados inicialmente mediante prostatectomía radical / Metastatic progression, cancer-specific mortality and need for secondary treatments in patients with clinically high-risk prostate cancer treated initially with radical prostatectomy

Objetivos: Determinar nuestros resultados en pacientes con cáncer de próstata (CaP) de alto riesgo (AR) tratados mediante prostatectomía radical (PR) y establecer criterios pronósticos preoperatorios. Material y métodos: Estudio retrospectivo de 925 PR. El seguimiento medio fue 89,8+/−53,6 meses para el grupo de CaP de AR. Siguiendo los criterios NCCN, operamos 210 (22,7%) PR de AR y 715 (77,3%) de riesgo bajo/intermedio. Se utilizó el método Kaplan-Meier para análisis de supervivencia y el modelo de Cox para el análisis multivariado de factores pronósticos para progresión metastática. Resultados: Periodo revisado; 1986–2007. Cincuenta y cuatro pacientes de AR (25,7%) estaban libres de progresión y 8 pacientes (3,8%) murieron por otras causas libres de enfermedad. El CaP progresó en 148 pacientes (70,5%). Murieron por progresión tumoral 42 pacientes (20%) y por otras causas 25 pacientes (11,9%). Setenta y nueve pacientes de AR (38%) frente a 549 de riesgo bajo/intermedio (78,5%) no necesitaron más líneas de tratamiento (p<0,001). Los análisis uni y multivariados demostraron que tanto el score Gleason en biopsia (RR=1,922; 95% CI 1,106–3,341, p=0,020) como el estadio clínico (RR=2,290; 95% CI 1,269–4,133, p=0,006) mostraron valor pronóstico independiente para progresión metástasica, pero no el PSA. Conclusiones: Un paciente con CaP de AR que se opere tiene un 25% de posibilidades de curarse y podrá necesitar un tratamiento multimodal en más de la mitad de los casos. Recomendamos PR en un paciente joven si el tumor se considera resecable, sobre todo si el único factor pronóstico que lo encasilla como AR es la elevación del PSA (AU)

Purpose: To determine our results in high risk (HR) prostate cancer (PCa) patients treated with radical prostatectomy (RP) and to establish preoperative prognosis factors. Material and methods: Retrospective study of 925 RP. Mean follow-up for the HR group was 89.8+/−53.6 months. Following NCCN criteria, we operated 210 (22.7%) HR and 715 (77.3%) low/intermediate risk patients. End point was metastatic progression. Kaplan-Meier method for survival comparison among groups and Cox regression model for multivariate analysis of preoperative prognostic factors were used. Results: Revised period; 1986–2007. Fifty-four patients (25.7%) were free of disease and 8 patients (3.8%) died for other causes free of disease. Disease progressed in 148 patients (70.5%); death due to tumour progression occurred in 42 cases (20%) and due to other causes in 25 patients (11.9%). Seventy-nine patients in HR group (38%) vs 549 low/intermediate risk group (78.5%) did not deserve further treatments (p<0.001). The uni and multivariate analysis for metastatic progression showed both Gleason score at biopsy (RR=1.922; 95% CI 1.106–3.341, p=0.020) and clinical stage (RR=2.290; 95% CI 1.269–4.133, p=0.006) showed independent prognostic value for metastatic progression, but not PSA. Conclusions: A HR patient can be cured in a third of the cases and will need multimodal treatments in more than half of the times. We prompt surgery in a young healthy patient with a resectable tumour, mainly if just one bad prognostic factor is present and defiantly if this is just PSA elevation (AU)

[Metastatic progression, cancer-specific mortality and need for secondary treatments in patients with clinically high-risk prostate cancer treated initially with radical prostatectomy]. / Progresión metastática, mortalidad cáncer específica y necesidad de tratamientos de segunda línea en pacientes con cáncer de próstata de alto riesgo tratados inicialmente mediante prostatectomía radical.

PURPOSE: To determine our results in high risk (HR) prostate cancer (PCa) patients treated with radical prostatectomy (RP) and to establish preoperative prognosis factors. MATERIAL AND METHODS: Retrospective study of 925 RP. Mean follow-up for the HR group was 89.8+/-53.6 months. Following NCCN criteria, we operated 210 (22.7%) HR and 715 (77.3%) low/intermediate risk patients. End point was metastatic progression. Kaplan-Meier method for survival comparison among groups and Cox regression model for multivariate analysis of preoperative prognostic factors were used. RESULTS: Revised period; 1986-2007. Fifty-four patients (25.7%) were free of disease and 8 patients (3.8%) died for other causes free of disease. Disease progressed in 148 patients (70.5%); death due to tumour progression occurred in 42 cases (20%) and due to other causes in 25 patients (11.9%). Seventy-nine patients in HR group (38%) vs 549 low/intermediate risk group (78.5%) did not deserve further treatments (p<0.001). The uni and multivariate analysis for metastatic progression showed both Gleason score at biopsy (RR=1.922; 95% CI 1.106-3.341, p=0.020) and clinical stage (RR=2.290; 95% CI 1.269-4.133, p=0.006) showed independent prognostic value for metastatic progression, but not PSA. CONCLUSIONS: A HR patient can be cured in a third of the cases and will need multimodal treatments in more than half of the times. We prompt surgery in a young healthy patient with a resectable tumour, mainly if just one bad prognostic factor is present and defiantly if this is just PSA elevation.

[Is radical cystectomy justified in patients over 75 years old?]. / Está justificada la cistectomía radical en pacientes mayores de 75 años?

INTRODUCTION AND OBJECTIVES: Radical cystectomy is the standard treatment for invasive bladder cancer. The objectives are to evaluate intraoperative and postoperative complications and to determine overall disease-free interval and overall time to progression in patients over tha age of 75 and to compare these with younger patients. MATERIAL AND METHODS: Between august 1980 and october 2004 , 495 patients underwent radical cistectomy. Patients with palliative surgery were excluded. Patients were divided in two groups according to age: control group (<75 years old) and elderly group (> or =75 years old). RESULTS: Four hundred and two patients were evaluated: 39 patients (35 male and 5 female) in the elderly group and 363 in the control group (321 males and 42 females). Mean age was 76 (range: 75-82) and 62 (range: 35-74) respectively. Mean followup was 38 months in the elderly group and 64 months in the control group. Thirty one patients (80.4%) in the elderly group and 211 patients (58.2%) in the control had non organ-confined tumour in cystectomy specimen (pT3-pT4) (p=0.0096) and ten patients (28.6%) in the elderly and 111 patients (31.4%) in the control group had positive nodes (p=0.84). There were no differences in postoperative surgical complications (p=0.08), postoperative reoperation rate (p=0.58) and postoperative mortality (p=0.28) in both groups. During postoperative time, 11 patients (28%) in the elderly group and 50 patients (13.8%) in the control had medical complications (p=0.03). Fourteen patients (35.9%) in the elderly group and 104 patients (39.4%) in the control group died due to tumour during follow-up (p=0.73). Kaplan-Meier survival curve revealed no differences between two groups in overall disease-free interval and overall time to progression. CONCLUSIONS: Radical cystectomy is a safe and effective treatment in elderly patients with invasive bladder cancer. It is necessary to evaluate co-morbidity in this group because there is an increase in postoperative medical complications. There were no differences between the two groups in overall disease-free interval and overall time to progression.

Secondary effects and biochemical control in patients with early prostate cancer treated with (125)-I seeds.

OBJECTIVE: To retrospectively evaluate the toxicity of low-dose-rate brachytherapy and to relate it to the dose-volume to organs at risk. MATERIAL AND METHODS: We study 160 patients with early prostate cancer, treated with (125)-I implants. Most of them were T1c (63.1%), T2a (35.6%) and Gleason < or =6 (96.2%). Median PSA was 7.2 ng/ml (2.3-13.5); 85.6% were lowrisk cases and 14.4% high-risk cases. Mean follow-up was 24 months (7-48). RESULTS: Acute urinary toxicity related to urological quality of life (UQL=CVU) was tolerable in 75% and unsatisfactory in 25%. Urinary retention was present in 6.9%. IPSS, V100 and D90 were related to the urinary toxicity grade. Rectal toxicity (RTOG) G2 was 0.6%. Sexual potency showed no changes with regard to the basal in 69%. Actuarial biochemical control was 89.8% at four years. CONCLUSIONS: Brachytherapy with (125)-I seeds yields acceptable toxicity and excellent biochemical control.

Secondary effects and biochemical control in patients with early prostate cancer treated with (125)-I seeds

OBJECTIVE: To retrospectively evaluate the toxicity of low-dose-rate brachytherapy and to relate it to the dose-volume to organs at risk. MATERIAL AND METHODS: We study 160 patients with early prostate cancer, treated with (125)-I implants. Most of them were T1c (63.1%), T2a (35.6%) and Gleason < or =6 (96.2%). Median PSA was 7.2 ng/ml (2.3-13.5); 85.6% were lowrisk cases and 14.4% high-risk cases. Mean follow-up was 24 months (7-48). RESULTS: Acute urinary toxicity related to urological quality of life (UQL=CVU) was tolerable in 75% and unsatisfactory in 25%. Urinary retention was present in 6.9%. IPSS, V100 and D90 were related to the urinary toxicity grade. Rectal toxicity (RTOG) G2 was 0.6%. Sexual potency showed no changes with regard to the basal in 69%. Actuarial biochemical control was 89.8% at four years. CONCLUSIONS: Brachytherapy with (125)-I seeds yields acceptable toxicity and excellent biochemical control (AU)

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Conservative elective treatment of upper urinary tract tumors: a multivariate analysis of prognostic factors for recurrence and progression.

PURPOSE: We evaluate the safety and efficacy of conservative elective treatment of upper urinary tract tumors, and determine predictive factors for recurrence and progression to optimize indications of this type of treatment. MATERIALS AND METHODS: Since 1984 we have performed a prospective study of conservative treatment of single, low grade and stage, less than 3 cm. upper tract tumors. The study includes 54 patients with a normal contralateral kidney who had been followed for more than 36 months. Open conservative surgery was performed in 31 cases and endourological surgery in 23. Minimum followup was 36 months, maximum 210 and mean 84.8. Univariate and multivariate analyses of recurrence and progression were performed in relation to age, sex, association with a bladder tumor, bladder tumor stage and grade, sequence of bladder tumor in relation to upper urinary tract tumor, number of previous bladder tumor recurrences, association with bladder carcinoma in situ, upper urinary tract tumor grade, stage, location, size and therapy, and upper urinary tract cytology. RESULTS: Of the 54 patients 19 (35%) had recurrence, which was bilateral recurrence in 4, and progression occurred in 9 (16%). At the end of analysis 44 (62.9%) patients were disease-free and alive at a mean time of 92.88 months, 13 (24%) died disease-free at a mean of 72.7 months and 7 (12.9%) died of disease at a mean of 97.85 months. Cause specific mortality occurred in 7 (12.9% cases). Among the 54 initially conservatively treated units 42 (77.7%) kidneys were ultimately preserved. On univariate and multivariate analysis tumor location in the renal pelvis and association with a previous multi-recurrent bladder tumor were variables significantly related to recurrence and progression, as well as bilateral recurrence. CONCLUSIONS: Conservative treatment is an optional approach for select upper urinary tract tumors. The strongest risk factors for recurrence and progression were association with a previous multi-recurrent bladder tumor and tumor location in the renal pelvis but these conditions were also the strongest risk factors for bilateral recurrence. Conservative treatment can also be recommended in these cases but only with compliant patients and close followup.

Clinical panurothelial disease in patients with superficial bladder tumors: therapeutic implications.

PURPOSE: We established the prognostic and therapeutic implications of panurothelial involvement in patients with superficial bladder tumors for optimizing therapeutic approaches in those at risk for panurothelial involvement. MATERIALS AND METHODS: We studied the records of 35 patients with clinical panurothelial disease. Since all of these patients presented with high risk superficial bladder cancer during followup, they were included in specific therapeutic and followup regimens. Radical procedures or conservative therapies were indicated mainly according to pathological examination and the recurrence pattern. RESULTS: Panurothelial involvement was a late stage of a recurrent and diffuse process that essentially developed in sequences, in which all patients presented with high risk superficial bladder tumors. This process involved continued relapse after panurothelial involvement developed. Notably 19 patients (79.1%) at risk for recurrence had repeat relapse in the urothelium. In the upper urinary tract 12 patients (34.3%) had bilateral involvement, including 7 (41.2%) of 17 patients after cystectomy. We identified 2 subgroups of patients. The subgroup with a better prognosis included 27 patients in whom late panurothelial disease developed step by step after a complete response to intravesical therapy, including 14 (51.8%) who were free of disease. The other subgroup with a poor prognosis included 8 patients with concurrent bladder carcinoma in situ and prostate involvement as well as early panurothelial disease, of whom only 2 (25%) were disease-free. All patients underwent many therapeutic approaches. A mean of 7.5 surgical procedures per patient were done, including a mean of 5.5 transurethral resections, a mean of 1 conservative approach to the upper urinary tract and a mean of 1.1 radical procedures. At a median followup of 111 months 10 patients (28.5%) were disease-free but only 7 (20%) retained the bladder, while 19 (54.3%) died of tumor. CONCLUSIONS: Patients with high risk superficial bladder multifocal tumors and associated bladder carcinoma in situ are at high risk for panurothelial involvement. Radical cystectomy may be recommended in these patients when initially or during followup, concurrent high risk superficial bladder tumors and prostate involvement develop or prostate involvement recurs. For the upper urinary tract conservative therapies may be advisable when noninfiltrating tumors are diagnosed even after cystectomy due to the high rate of bilateral new onset disease. When cystectomy is performed, extended excision of the upper urinary tract and pyelo-intestinal anastomosis may be considered.

Prospective validation of the association of local tumor stage and grade as a predictive factor for occult lymph node micrometastasis in patients with penile carcinoma and clinically negative inguinal lymph nodes.

PURPOSE: We prospectively validated the association of local tumor stage and grade as a predictive factor for occult lymph node micrometastasis in patients with penile carcinoma and clinically negative lymph nodes. MATERIALS AND METHODS: In a retrospective study of 66 patients we demonstrated the predictive value of the association of local tumor stage and grade for occult micrometastasis, identifying 3 risk groups. A therapy strategy was designed according to these risk groups. A total of 37 consecutive patients were included in a prospective study in which the same criteria for risk group allocation and the same therapeutic recommendations were used as in the retrospective study. RESULTS: In the prospective study we noted positive lymph nodes in 11% of stage T1, 63% of stages T2-3, 15% of grade 1, 67% of grade 2 and 75% of grade 3 cases. The incidence of positive nodes was 0% in the low, 83.3% in the high and 33.3% in the intermediate risk group. These rates were similar to those in the retrospective study with no significant difference. CONCLUSIONS: The predictive value of the association of local tumor stage and grade for occult lymph node micrometastasis was validated in a prospective study. This factor allows the differentiation of 3 risk groups of patients with high reliability in the low and high risk groups. However, other prognostic factors are needed in the intermediate risk group to improve the prediction of lymph node involvement.

Effectiveness of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer: short and long-term followup.

PURPOSE: We analyze the impact of a single mitomycin C instillation in patients with low risk superficial bladder cancer with short and long-term followup. MATERIALS AND METHODS: A total of 131 patients with low risk superficial bladder cancer were included in a prospective randomized controlled trial. All patients had a 3 cm or less single, papillary, primary or recurrent tumor and were disease-free for more than 1 year. Patients with muscular invasion, G3 tumor or bladder carcinoma in situ on pathological examination were excluded from study. The tumor was completely resected before patients were randomized into 2 arms of no further treatment (control group) and a single immediate instillation of 30 mg mitomycin C (mitomycin C group). Recurrences were considered early within the first 2 years of followup. RESULTS: At 24-month followup the recurrence-free interval was significantly increased, and recurrence, and recurrence and tumor per year rates were decreased in the mitomycin C compared to the control group. However, at long-term followup these differences were not statistically significant and the recurrence-free interval curves were parallel. A shorter hospital stay and catheterization period were noted in the mitomycin C group compared to the control group, which were not significant. Early recurrences were concentrated in the first year in the control but not in the mitomycin C group. A significant relationship between early and late recurrences was found in the mitomycin C but not in the control group. CONCLUSIONS: Our analysis confirms the positive effect of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer. This benefit is limited to early recurrence and is not maintained with long-term followup. Thus, this approach is an alternative to observation or endovesical chemotherapy. Our study also suggests that cell implantation as a mechanism of early recurrence can be controlled with a single mitomycin C instillation.

Feasibility of transurethral resection for muscle infiltrating carcinoma of the bladder: long-term followup of a prospective study.

PURPOSE: We analyzed the long-term results of radical transurethral resection for the treatment of a large series of patients with muscle infiltrating bladder cancer entered into a prospective study to determine progression predictive factors. MATERIALS AND METHODS: The study included 133 patients with invasive bladder cancer treated by radical transurethral resection who had negative biopsies of the muscle layer of the tumor bed. Followup was more than 5 years for all subjects and more than 10 years in 59 (44.4%). A comparative nonrandomized study was performed of a control group of 76 patients with invasive pathological stage pT2-3a, N0-3 bladder cancer treated by cystectomy. In those patients treated by radical transurethral resection univariate and multivariate analyses were performed to establish clinical progression predictive factors. RESULTS: At 5 and 10 years of followup cause specific survival rates were 80.5 and 74.5%, and bladder preservation rates were 82.7 and 79.6%, respectively. No significant difference was noted in terms of cause specific survival, with respect to the control group. The initial presence of associated bladder carcinoma in situ was the only independent progression predictive factor. CONCLUSIONS: For patients with invasive bladder cancer radical transurethral resection is justified when the tumor is clinically limited to the muscular layer and when all biopsies of the periphery and depth of the tumor bed show muscular tissue negative for tumor cells. Patients with initial associated bladder carcinoma in situ should not be excluded from this treatment but endovesical bacillus Calmette-Guerin immunotherapy should be administered and a closer followup is recommended.