Grupos de riesgo de recidiva bioquímica tras prostatectomía radical de la Asociación Europea de Urología: validación externa e identificación de factores de riesgo de progresión y mortalidad / European Association of Urology biochemical recurrence risk groups after radical prostatectomy: external validation and identification of independent risk factors for progression and death

Contexto La EAU propuso una clasificación del riesgo de progresión y muerte en pacientes con recidiva bioquímica tras prostatectomía radical (PR). Objetivo Validar la clasificación de riesgo de RB de la EAU en nuestro contexto e identificar los factores asociados con la progresión y la muerte. Material y métodos Estudio multicéntrico, retrospectivo y observacional que incluyó a 2140 pacientes sometidos a PR entre 2011 y 2015. Los pacientes con RB fueron identificados y estratificados en grupos de riesgo bajo (TD-PSA >1 año y pGS <8) o alto (TD-PSA <=1 año o pGS=>8). Se calcularon la supervivencia libre de progresión por PSA y supervivencia libre de metástasis (SLP-PSA, SLM), la supervivencia cáncer específica y la supervivencia global (curvas de Kaplan Meier y log-rank test). Se identificaron factores de riesgo independientes (regresión de Cox). Resultados Un total de 427 pacientes experimentaron RB (32,3% de bajo riesgo y 67,7% de alto riesgo). La mediana de SLP-PSA fue de 135,0 m (IC 95% 129,63-140,94) y 115,0 m (IC 95% 104,02-125,98) (p < 0,001) para los grupos de bajo y alto riesgo, respectivamente. Hubo diferencias significativas en la SLM y la supervivencia global entre ambos grupos. El grupo de riesgo de RB de la EAU fue un factor independiente de progresión del PSA (HR 2,55; p 0,009). El tiempo transcurrido entre la PR y la RB fue un factor independiente de aparición de metástasis (HR 0,43; IC 95%: 0,18-0,99; p 0,044) y muerte (HR 0,17; IC 95%: 0,26-0,96; 23 p 0,048). Se hallaron diferencias en la SLM (p 0,001) y la supervivencia cáncer específica (p 0,004) para <12, ≥ 12-<36 y ≥36 meses transcurridos entre la PR y la RB. Otros factores independientes fueron la radioterapia de rescate precoz y el PSA en el momento de aparición de la RB (AU)

Background The EAU proposed a progression and death risk classification in patients with biochemical recurrence after radical prostatectomy (PR). Objective To validate the EAU BCR-risk classification in our setting and to find factors related to progression and death. Material and methods Multicenter, retrospective, observational study including 2140 patients underwent RP between 2011 and 2015. Patients with BCR were identified and stratified in low risk (PSA-DT>1 yr and pGS <8) or high-risk (PSA-DT <=1 yr or pGS=>8) grouping. PSA and metastatic free survival (PSA-PFS, MFS), cancer specific survival and overall survival were calculated (Kaplan Meier curves and log-rank test). Independent risk factors were identified (Cox regression). Results 427 patients experienced BCR (32.3% low-risk and 67.7% high-risk). Median PSA-PFS was 135.0 mo (95% CI 129.63-140.94) and 115.0 mo (95% CI 104.02-125.98) (p < .001), for low and high-risk groups, respectively. There was also significant differences in MFS and overall survival. The EAU BCR risk grouping was independent factor for PSA-progression (HR 2.55, p 0.009). Time from PR to BCR, was an independent factor for metastasis onset (HR 0.43, 95% CI 0.18-0.99; p 0.044) and death (HR 0.17, 95% CI 0.26.0.96; 23 p 0.048). Differences in MFS (p 0.001) and cancer specific survival (p 0.004) were found for <12, ≥12-<36 and≥36 months from PR to BCR. Others independent factors were early salvage radiotherapy and PSA at BCR. Conclusions High-risk group is a prognostic factor for biochemical progression, but it has a limited accuracy on MP and death in our setting. The inclusion of other factors could increase its predictive power (AU)

[Castleman's disease in the rheumatological practice]. / Morbus Castleman in der rheumatologischen Praxis.

The term Castleman's disease encompasses a group of rare lymphoproliferative diseases that show histopathological similarities in lymph node biopsy. Diagnostic criteria and a specific ICD-10 code have been available for a few years. Case studies listed at the beginning illustrate that close cooperation between clinicians and pathologists is required to enable a reliable diagnosis. For an optimal histopathological assessment, the pathologist is also dependent on the removal of a complete lymph node. Before distinguishing a potentially fatal multicentric idiopathic Castleman's disease from the resectable unicentric form, which is important in terms of prognosis and treatment, early diagnosis presupposes that Castleman's disease is considered in the differential diagnosis. Various immune phenomena and overlaps with autoimmune diseases can increase the probability of misdiagnosis or undetected cases in the clinical routine of rheumatologists. The intention of the present overview is therefore to point out the similarities with autoimmune diseases that are relevant for differential diagnoses and to point out situations that justify a review of the previous diagnosis.

European Association of Urology biochemical recurrence risk groups after radical prostatectomy: External validation and identification of independent risk factors for progression and death.

BACKGROUND: The EAU proposed a progression and death risk classification in patients with biochemical recurrence after radical prostatectomy (PR). OBJECTIVE: To validate the EAU BCR-risk classification in our setting and to find factors related to progression and death. MATERIAL AND METHODS: Multicenter, retrospective, observational study including 2140 patients underwent RP between 2011 and 2015. Patients with BCR were identified and stratified in low risk (PSA-DT >1yr and pGS <8) or high-risk (PSA-DT ≤1yr or pGS ≥8) grouping. PSA and metastatic free survival (PSA-PFS, MFS), cancer specific survival (CSS) and overall survival (OS) were calculated (Kaplan Meier curves and log-rank test). Independent risk factors were identified (Cox regression). RESULTS: 427 patients experienced BCR (32.3% low-risk and 67.7% high-risk). Median PSA-PFS was 135,0 mo (95% CI 129,63-140,94) and 115,0 mo (95% CI 104,02-125,98) (p<0,001), for low and high-risk groups, respectively. There were also significant differences in MFS and OS. The EAU BCR risk grouping was independent factor for PSA-progression (HR 2.55, p 0.009). Time from PR to BCR, was an independent factor for metastasis onset (HR 0.43, 95% CI 0.18-0.99; p 0.044) and death (HR 0.17, 95% CI 0.26.0.96; 23 p 0.048). Differences in MFS (p 0.001) and CSS (p 0.004) were found for <12, ≥12-<36 and ≥36 months from PR to BCR. Others independent factors were early salvage radiotherapy and PSA at BCR. CONCLUSIONS: High-risk group is a prognostic factor for biochemical progression, but it has a limited accuracy on MP and death in our setting. The inclusion of other factors could increase its predictive power.

The MCP2 and the wrist plus two extensor compartments are the most affected and responsive joints/tendons out of the US7 score in patients with rheumatoid arthritis-an observational study.

BACKGROUND: There is no international consensus on an optimal ultrasound score for monitoring of rheumatoid arthritis (RA) on patient-level yet. Our aim was to reassess the US7 score for the identification of the most frequently pathologic and responsive joint/tendon regions, to optimize it and contribute to an international consensus. Furthermore, we aimed to evaluate the impact of disease duration on the performance of the score. METHODS: RA patients were assessed at baseline and after 3 and 6 months of starting/changing DMARD therapy by the US7 score in greyscale (GS) and power Doppler (PD). The frequency of pathologic joint/tendon regions and their responsiveness to therapy were analyzed by Friedman test and Cochrane-Q test respectively, including the comparison of palmar vs. dorsal regions (chi-square test). The responsiveness of different reduced scores and the amount of information retained from the original US7 score were assessed by standardized response means (SRM)/linear regression. Analyses were also performed separately for early and established RA. RESULTS: A total of 435 patients (N = 138 early RA) were included (56.5 (SD 13.1) years old, 8.2 (9.1) years disease duration, 80% female). The dorsal wrist, palmar MCP2, extensor digitorum communis (EDC) and carpi ulnaris (ECU) tendons were most frequently affected by GS/PD synovitis/tenosynovitis (wrist: 45%/43%; MCP2: 35%/28%; EDC: 30%/11% and ECU: 25%/11%) and significantly changed within 6 months of therapy (all p ≤0.003 by GS/PD). The dorsal vs. palmar side of the wrist by GS/PD (p < 0.001) and the palmar side of the finger joints by PD (p < 0.001) were more frequently pathologic. The reduced US7 score (GS/PD: palmar MCP2, dorsal wrist, EDC and ECU, only PD: dorsal MCP2) showed therapy response (SRM 0.433) after 6 months and retained 76% of the full US7 score's information. No major differences between the groups of early and established RA could be detected. CONCLUSIONS: The wrist, MCP2, EDC, and ECU tendons were most frequently pathologic and responsive to therapy in both early and established RA and should therefore be included in a comprehensive score for monitoring RA patients on patient-level.

Monitoring of patients with rheumatoid arthritis by indocyanine green (ICG)-enhanced fluorescence optical imaging treated with anti-TNFα therapy.

BACKGROUND: Fluorescence optical imaging (FOI) enables visualisation of inflammation in both hands in rheumatoid arthritis (RA). OBJECTIVE: To investigate the usefulness of FOI in treatment monitoring under anti-TNFα therapy with certolizumab pegol (CZP) in patients with RA in comparison to clinical and laboratory outcome parameters. METHODS: CZP-naïve patients with RA were eligible for this open-label study with an observational period of 52 weeks. Disease activity was monitored by the clinical score DAS28, tender/swollen joint count (TJC-28/SJC-28) and laboratory outcomes for systemic inflammation (CRP and ESR). FOI results were analysed in three different phases (P1-3) and PrimaVistaMode (PVM) by the FOI activity score (FOIAS). RESULTS: Twenty-eight RA patients (median age 52.5 years, 26 females, thirteen with a history of other biologic therapy) were included. DAS28 (CRP) decreased from moderate disease activity at baseline (median 4.6, IQR 1.8) to low disease activity at week (w)52 (median 2.7, IQR 2.1; p < 0.001). Statistically significant decreases could also be demonstrated for SJC-28 and TJC-28. CRP/ESR were reduced numerically from baseline to w52. FOIAS in P1 (early phase) showed a continuous decrease of enhancement during the course of treatment period: from baseline (median 1.5, IQR 9.3) over w6 (median 1.0, IQR 3.0; p = 0.069), w12 (median 0.5, IQR 3.0; p = 0.171), w24 (n = 27, median 0.0, IQR 3.0; p = 0.004), until w52 (n = 18, median 0.0, IQR 2.8; p = 0.091), which could not be presented for FOIAS in P2, P3 and PVM. CONCLUSION: FOI in P1 appears to be a valuable tool for fast and easy monitoring of treatment response to certolizumab in a clinical setting.

Terapia de radiación corporal estereotáctica en pacientes con cáncer de próstata oligorrecurrente metacrónico. Experiencia de un centro / Stereotactic body radiation therapy in patients with metachronous oligorecurrent prostate cancer: A single-center experience

Introducción y objetivo: La oligorrecurrencia metacrónica en el cáncer de próstata (CaP) la constituyen los pacientes que empezaron con enfermedad localizada y que, tras un tratamiento radical fallido, desarrollan oligometástasis. La radioterapia estereotáctica (SBRT) dirigida a las metástasis busca retrasar el inicio de la privación androgénica. En este estudio, mostramos nuestra experiencia para elucidar el papel de la SBRT en una población seleccionada de pacientes con oligorrecurrencia metacrónica.Material y métodos: Análisis retrospectivo de pacientes tratados con SBRT por CaP oligorrecurrente entre noviembre de 2015 y diciembre de 2020. Detallamos las características clinicopatológicas al inicio de la enfermedad (edad, PSA, estadificación, tratamiento primario), escenario clínico al diagnóstico de la oligorrecurrencia (PSA, velocidad del PSA, características de las metástasis), supervivencia libre de progresión, supervivencia hasta la resistencia a la castración, dosis y toxicidad de la SBRT. Solo 2pacientes presentaron toxicidad de grado 1.Conclusiones: La SBRT en pacientes con CaP en situación de oligorrecurrencia metacrónica constituye un tratamiento seguro y efectivo que permite retrasar el inicio de la terapia de radiación androgénica y el tiempo hasta la resistencia a la castración, con niveles bajos de toxicidad. (AU)

Introduction and objective: Metachronous oligorecurrence in prostate cancer (PCa) occurs in patients with localized disease who, after failed radical treatment, develop oligometastases. Metastasis-directed stereotactic radiotherapy (SBRT) aims to delay androgen deprivation therapy. In this study, we report our experience to elucidate the role of SBRT in a selected population of patients with metachronous oligorecurrence.Material and methods: Retrospective analysis of patients treated with SBRT for oligorecurrent PCa between November 2015 and December 2020. We detailed clinicopathological characteristics at disease onset (age, PSA, stage, primary treatment), clinical scenario at diagnosis of oligorecurrence (PSA, PSA velocity, metastases characteristics), progression-free survival, castration resistance-free survival, dose, and toxicity of SBRT.Results: Thirty-eight SBRT treatments were applied to 13 lymph node and 25 bone metastases in a total of 28 patients. After a follow-up of 34.57 months (21.17-57.59), 17 patients had radiological progression of the disease and 11 presented castration resistant PCa. PFS and CRFS were 21.93 and 44.13 months, respectively. Only 2patients presented grade 1 toxicity.ConclusionsIn patients with metachronous oligorecurrent PCa, SBRT constitutes a safe and effective treatment that allows delaying the onset of androgen deprivation therapy and the time to castration resistance, assuming low levels of toxicity. (AU)

Stereotactic body radiation therapy in patients with metachronous oligorecurrent prostate cancer: A single-center experience.

INTRODUCTION AND OBJECTIVE: Metachronous oligorecurrence in prostate cancer (PCa) occurs in patients with localized disease who, after failed radical treatment, develop oligometastases. Metastasis-directed stereotactic radiotherapy (SBRT) aims to delay androgen deprivation therapy. In this study, we report our experience to elucidate the role of SBRT in a selected population of patients with metachronous oligorecurrence. MATERIAL AND METHODS: Retrospective analysis of patients treated with SBRT for oligorecurrent PCa between November 2015 and December 2020. We detailed clinicopathological characteristics at disease onset (age, PSA, stage, primary treatment), clinical scenario at diagnosis of oligorecurrence (PSA, PSA velocity, metastases characteristics), progression-free survival, castration resistance-free survival, dose, and toxicity of SBRT. RESULTS: Thirty-eight SBRT treatments were applied to 13 lymph node and 25 bone metastases in a total of 28 patients. After a follow-up of 34.57 months (21.17-57.59), 17 patients had radiological progression of the disease and 11 presented castration resistant PCa. PFS and CRFS were 21.93 and 44.13 months, respectively. Only 2 patients presented grade 1 toxicity. CONCLUSIONS: In patients with metachronous oligorecurrent PCa, SBRT constitutes a safe and effective treatment that allows delaying the onset of androgen deprivation therapy and the time to castration resistance, assuming low levels of toxicity.

Does active surveillance avoid overtreatment in prostate cancer? Lessons learned from salvage radical prostatectomies.

OBJECTIVE: Determine whether our institution´s active surveillance (AS) protocol is a suitable strategy to minimise prostate cancer overtreatment. MATERIAL AND METHODS: Retrospective analysis of 516 patients on AS after prostate cancer diagnosis. Population divided into "per-protocol" vs "induced" AS depending on fulfilment of protocol´s inclusion criteria. Radical prostatectomies after AS were selected and stratified based on: reclassification, progression or patient anxiety. Clinicopathological features and biochemical relapse-free survival were studied. Primary endpoint was overtreatment ratio based on the presence of insignificant prostate cancer and adverse pathological features in the surgical specimen. Kaplan-Meier curves were used to estimate the biochemical relapse-free survival and compared with log-rank test. RESULTS: 304 patients fulfilled inclusion criteria; 100 proceeded to radical prostatectomy (31% "induced", 69% "per-protocol" AS). Surgery indications were reclassification, progression and anxiety in 66%, 18% and 16% of patients respectively. Rate of positive lymph nodes was higher in the progression group (11%) compared to reclassification and anxiety (5% and 0% respectively, P = .002). Positive surgical margins were more frequently reported in the progression cohort compared to reclassification (28% vs 20%). Median follow-up from diagnosis until last radical prostatectomy was 48.3 months (32.4-70). 3 year biochemical relapse-free survival in the salvage radical prostatectomy was 85.4% (95 CI 78.3-93.2). Insignificant cancer was noticed in 7% of patients (Epstein´s vs 24% Wolters´ criteria). Rate of patients with adverse pathological features was 36%. CONCLUSIONS: The majority of patients who underwent salvage surgery after AS were not overtreated. Radical prostatectomy should be considered a safe rescue treatment.

¿La vigilancia activa evita el sobretratamiento en el cáncer de próstata? Lecciones aprendidas de prostatectomías radicales de rescate / Does active surveillance avoid overtreatment in prostate cancer? Lessons learned from salvage radical prostatectomies

Objetivo: Determinar si el protocolo de vigilancia activa (VA) de nuestra institución es una estrategia adecuada para minimizar el sobretratamiento del cáncer de próstata.Material y métodosAnálisis retrospectivo de 516 pacientes en VA tras el diagnóstico de cáncer de próstata. La población se dividió en «VA por protocolo» vs. «VA inducida», dependiendo del cumplimiento de los criterios de inclusión del protocolo. Las prostatectomías radicales después de la VA fueron seleccionadas y estratificadas en base a reclasificación, progresión o ansiedad del paciente. Se estudiaron las características clinicopatológicas y la supervivencia libre de recidiva bioquímica. La variable principal del estudio fue el porcentaje de sobretratamiento con relación a la presencia de un cáncer de próstata insignificante y de características patológicas adversas en la pieza quirúrgica. Se utilizaron las curvas de Kaplan-Meier para estimar la supervivencia libre de recidiva bioquímica y se compararon con la prueba log-rank.ResultadosUn total de 304 pacientes cumplieron los criterios de inclusión; 100 procedieron a una prostatectomía radical (31% «VA inducida», 69% «VA por protocolo»). Las indicaciones para la cirugía fueron la reclasificación, la progresión y la ansiedad de los pacientes (66, 18 y 16%, respectivamente). (AU)

Objective: Determine whether our institution's active surveillance (AS) protocol is a suitable strategy to minimise prostate cancer overtreatment.Material and methodsRetrospective analysis of 516 patients on AS after prostate cancer diagnosis. Population divided into «per-protocol» vs «induced» AS depending on fulfilment of protocol's inclusion criteria. Radical prostatectomies after AS were selected and stratified based on reclassification, progression or patient anxiety. Clinicopathological features and biochemical relapse-free survival were studied. Primary endpoint was overtreatment ratio based on the presence of insignificant prostate cancer and adverse pathological features in the surgical specimen. Kaplan-Meier curves were used to estimate the biochemical relapse-free survival and compared with log-rank test.Results304 patients fulfilled inclusion criteria; 100 proceeded to radical prostatectomy (31% «induced», 69% «per-protocol» AS). Surgery indications were reclassification, progression and anxiety in 66%, 18% and 16% of patients, respectively. Rate of positive lymph nodes was higher in the progression group (11%) compared to reclassification and anxiety (5% and 0%, respectively; P=.002). Positive surgical margins were more frequently reported in the progression cohort compared to reclassification (28% vs 20%). Median follow-up from diagnosis until last radical prostatectomy was 48.3months (32.4-70). Three year biochemical relapse-free survival in the salvage radical prostatectomy was 85.4% (95%CI: 78.3-93.2). Insignificant cancer was noticed in 7% of patients (Epstein's vs 24% Wolters’ criteria). Rate of patients with adverse pathological features was 36%. (AU)

Pregnancy outcome in women with different rheumatic diseases: a retrospective analysis.

Objective: Pregnancy may influence the course of inflammatory rheumatic diseases and, conversely, rheumatic and musculoskeletal diseases (RMDs) can affect the outcome of pregnancy. This study aimed to retrospectively analyse the outcome of pregnancy and disease in women with RMDs.Method: Subjects were patients with high-risk pregnancy and connective tissue diseases (CTDs) or inflammatory joint diseases (IJDs) managed at a specialized rheumatology outpatient clinic from 2007 to 2014. Data from conception to 6 months postpartum were collected from medical records and a questionnaire, and analysed regarding clinical symptoms, medications, pregnancy complications, birth outcomes, and infant development. Generalized estimating equations were used to compare the groups (CTD vs IJD).Results: The eligible 66 pregnancies in 57 RMD patients were divided into two groups by RMD type: CTD (n = 48) or IJD (n = 18). The live birth rate was 97% overall. Pregnancy complications (excluding two twin pregnancies) were incurred in 39.1%: miscarriage (n = 2), premature delivery (n = 12), small-for-gestational-age infants (n = 5), and/or pregnancy-related diseases (n = 14). Three children born to women with CTDs had affected development (autism spectrum disorder, congenital heart disease, bronchopulmonary dysplasia). CTD infants had a significantly lower mean gestational age (in weeks) (p = 0.042), weight (p = 0.009), and length (p = 0.016) at birth than IJD infants.Conclusion: Although the live birth rate was high, complications occurred in 39.1% of pregnancies in this cohort. Therefore, interdisciplinary management of pregnant women with RMDs at specialized clinics is strongly recommended.

La relación entre hernia inguinal y cirugía mínimamente invasiva para el cáncer de próstata: revisión sistemática de la literatura / The relationship between inguinal hernia and minimally-invasive surgery for prostate cancer: A systematic review of the literatura

OBJETIVO: Hemos realizado una revisión sistemática sobre la relación entre la hernia inguinal y la cirugía para el cáncer de próstata. Contexto: El diagnóstico de defectos de la pared abdominal y el cáncer de próstata puede suceder de manera sincrónica o metacrónica. La utilidad y seguridad de la cirugía combinada, la incidencia de hernias tras la cirugía prostática y la viabilidad de la prostatectomía en pacientes con hernioplastia laparoscópica previa siguen siendo debatidas hoy en día. MÉTODOS: Se consultaron PubMed y Embase con los textos de búsqueda correspondientes. De manera independiente, 2 investigadores revisaron las referencias bibliográficas y seleccionaron los artículos de interés, incluyendo revisiones. RESULTADOS: Se evaluaron 65 estudios, 22 de los cuales analizan la viabilidad y los resultados de una cirugía combinada (prostatectomía radical y herniorrafia o hernioplastia en un mismo acto quirúrgico). La bibliografía respalda la intervención combinada en pacientes que padecen una hernia inguinal y un cáncer de próstata subsidiario de prostatectomía radical. Se evaluaron 16 estudios que abordan el potencial incremento de las hernias inguinales tras una prostatectomía radical. Aproximadamente un 15% de los pacientes que reciben prostatectomía radical retropúbica clásica desarrollarán hernias inguinales. Es posible que esta incidencia se vea reducida en la prostatectomía laparoscópica, y probablemente sea menor aún con el abordaje transperitoneal. El tiempo medio hasta la aparición de la hernia es de alrededor de 6 meses. Tras la evaluación de 14 estudios, se concluye que la hernioplastia laparoscópica no imposibilita la prostatectomía, pero dificulta la cirugía pélvica ulterior. CONCLUSIONES: La hernioplastia y la prostatectomía radical combinadas en un mismo acto quirúrgico son aceptables, excepto en el caso de estar indicada la linfadenectomía o si la anastomosis uretrovesical no queda estanca a la hidrodistensión intraoperatoria. El asesoramiento adecuado del paciente y el formulario de consentimiento informado son obligatorios en el marco de un equipo multidisciplinario experimentado

OBJECTIVE: We aimed to perform a systematic review about the relationship between inguinal hernia and surgery for prostate cancer. BACKGROUND: Diagnosis of abdominal wall defects and prostate cancer may be either synchronous or metachronous. The convenience and safety of combined prostatectomy and hernioplasty, the incidence of hernias after prostatectomy and the feasibility of prostatectomy in patients with previous laparoscopic hernioplasty are still debated. METHODS: PubMed and Embase were queried by dedicated search strings. Two researchers independently reviewed the pooled references and selected the articles of interest, including reviews. RESULTS: Sixty-five studies were evaluated, 22 of them analysed the feasibility and the outcomes of a combined surgery, namely one-stage radical prostatectomy and herniorrhaphy or hernioplasty. Literature evidences support the combined intervention to patients suffering from an inguinal hernia and a prostate cancer amenable of radical prostatectomy. Sixteen studies addressing the potential increase in the occurrence of inguinal hernia after radical prostatectomy were evaluated. Approximately 15% of patients who undergo retro-pubic radical prostatectomy will develop inguinal hernia. It is suggested that the incidence might be lower in laparoscopic prostatectomy series, particularly in case of transperitoneal approach. The median time to the appearance of the hernia is around 6 months. After evaluation of 14 studies, it is concluded that laparoscopic hernioplasty does not preclude prostatectomy but hinders further pelvic surgery. CONCLUSIONS: One-stage combined hernioplasty and radical prostatectomy may be accepted except in cases of lymph-nodes dissection and/or positive hydro-distress test of the urethro-vesical anastomosis. Accurate patient's counselling and dedicated consent form are mandatory, in the setting of an experienced multidisciplinary team

The relationship between inguinal hernia and minimally-invasive surgery for prostate cancer: A systematic review of the literature. / La relación entre hernia inguinal y cirugía mínimamente invasiva para el cáncer de próstata: revisión sistemática de la literatura.

OBJECTIVE: We aimed to perform a systematic review about the relationship between inguinal hernia and surgery for prostate cancer. BACKGROUND: Diagnosis of abdominal wall defects and prostate cancer may be either synchronous or metachronous. The convenience and safety of combined prostatectomy and hernioplasty, the incidence of hernias after prostatectomy and the feasibility of prostatectomy in patients with previous laparoscopic hernioplasty are still debated. METHODS: PubMed and Embase were queried by dedicated search strings. Two researchers independently reviewed the pooled references and selected the articles of interest, including reviews. RESULTS: Sixty-five studies were evaluated, 22 of them analysed the feasibility and the outcomes of a combined surgery, namely one-stage radical prostatectomy and herniorrhaphy or hernioplasty. Literature evidences support the combined intervention to patients suffering from an inguinal hernia and a prostate cancer amenable of radical prostatectomy. Sixteen studies addressing the potential increase in the occurrence of inguinal hernia after radical prostatectomy were evaluated. Approximately 15% of patients who undergo retro-pubic radical prostatectomy will develop inguinal hernia. It is suggested that the incidence might be lower in laparoscopic prostatectomy series, particularly in case of transperitoneal approach. The median time to the appearance of the hernia is around 6 months. After evaluation of 14 studies, it is concluded that laparoscopic hernioplasty does not preclude prostatectomy but hinders further pelvic surgery. CONCLUSIONS: One-stage combined hernioplasty and radical prostatectomy may be accepted except in cases of lymph-nodes dissection and/or positive hydro-distress test of the urethro-vesical anastomosis. Accurate patient's counselling and dedicated consent form are mandatory, in the setting of an experienced multidisciplinary team.

Frecuencia de PSA indetectable en pacientes con cáncer de próstata N+ baja carga tras prostatectomía radical y linfadenectomía ampliada / Undetectable PSA after radical prostatectomy is more likely in low burden N+ prostate cancer patients when an extended lymph node dissection is performed

Objetivos: Analizar la probabilidad de PSA indetectable (< 0,01 ng/ml) tras disección ampliada de los ganglios linfáticos pélvicos (DGLP-ampliada) versus disección estándar de los ganglios linfáticos (GL) pélvicos (DGLP-estándar) en pacientes pN+. Materiales y métodos: Se realizó una investigación en la base de datos institucional de cáncer de próstata para obtener información sobre pacientes que se sometieron a prostatectomía radical (PR) con DGLP, con hallazgos de 3 o menos metástasis ganglionares entre 2007 y 2017. La DGLP ampliada se definió de acuerdo con el número de GL. Los pacientes con un percentil 75 o superior de ganglios linfáticos extraídos conformaron el grupo DGLPa; los pacientes con un percentil 25 o inferior se adjudicaron al grupo DGLPe (DGLP estándar). Se compararon las variables clínicas y patológicas entre ambos grupos. Se utilizaron la prueba de la t de Student para comparar las variables continuas y la prueba de la chi al cuadrado para las variables categóricas. La regresión logística multivariable evaluó la probabilidad de PSA indetectable al tercer mes desde la operación. El método de Kaplan-Meier estimó la probabilidad de recurrencia bioquímica. Las diferencias entre los grupos se compararon mediante la prueba de log-rank. Resultados: De 1.478 pacientes tratados en el periodo considerado, se seleccionó a 95 con 3 o menos metástasis en los ganglios linfáticos. Tras aplicar los criterios de inclusión, 23 pacientes con una mediana de 11 GL extraídos se incluyeron en el grupo PGLPe (percentil 25) y 23 pacientes con > 27 GL se incluyeron en el grupo PGLPa (percentil 75). El tiempo quirúrgico fue más largo para el grupo de DGLPa. Dieciséis pacientes (69,6%) tratados con DGLPa presentaron PSA indetectable tras la operación. En el análisis multivariable, la probabilidad de PSA indetectable a los 3 meses fue mayor en los pacientes tratados con DGLPa (HR = 5,18; IC del 95%, 1,16-23,11; p = 0,03). Conclusiones: Independientemente de las características de la enfermedad, la DGLPa tiene más probabilidades de predecir un PSA indetectable al tercer mes tras la PR

Objectives: To analyze the likelihood of undetectable PSA (< 0.01 ng/mL) after extended (ePLND) versus standard pelvic lymph-nodes dissection (sPLND) in pN+ patients. Materials and methods: The institutional prospectively maintained Prostate Cancer Database was queried for patients who underwent radical prostatectomy with PLND and were found with 3or less lymph-nodal metastases between 2007 and 2017. The extension of the PLND was defined according to the number of lymph-nodes (LN) removed. Patients in the 75th or higher percentile of lymph-nodes removed were considered as the ePLND group; patients in the 25th or lower percentile in the sPLND group. Groups were compared in clinical and pathological variables. Student T-test was used for comparing continuous variables; chi-square test was used for categorical variables. Multivariable logistic regression assessed the probability of undetectable PSA at 3rd month postoperatively. Kaplan-Meier method estimated the probability of biochemical recurrence. Differences between the groups were compared by Log-rank test. Results: 1478 patients were treated within the time span considered. 95 with 1 to 3 lymph-nodal metastases were extracted. After accounting for inclusion criteria, 23 patients with a median of 11 LN removed were included in the sPLND group (25th percentile); 23 patients with > 27 LN were included in ePLND group (75th percentile). Surgical time was longer for ePLND. Sixteen patients (69.6%) who underwent ePLND had undetectable PSA postoperatively. At multivariable analysis, the probability of undetectable PSA at 3rd month was higher in patients who received an ePLND (HR = 5.18; IC 95% = 1.16-23.11; P = .03). Conclusions: ePLND is more likely to predict undetectable PSA at third month after radical prostatectomy, irrespective of disease characteristics

Undetectable PSA after radical prostatectomy is more likely in low burden N+ prostate cancer patients when an extended lymph node dissection is performed. / Frecuencia de PSA indetectable en pacientes con cáncer de próstata N+ baja carga tras prostatectomía radical y linfadenectomía ampliada.

OBJECTIVES: To analyze the likelihood of undetectable PSA (< 0.01 ng/mL) after extended (ePLND) versus standard pelvic lymph-nodes dissection (sPLND) in pN+ patients. MATERIALS AND METHODS: The institutional prospectively maintained Prostate Cancer Database was queried for patients who underwent radical prostatectomy with PLND and were found with 3or less lymph-nodal metastases between 2007 and 2017. The extension of the PLND was defined according to the number of lymph-nodes (LN) removed. Patients in the 75th or higher percentile of lymph-nodes removed were considered as the ePLND group; patients in the 25th or lower percentile in the sPLND group. Groups were compared in clinical and pathological variables. Student T-test was used for comparing continuous variables; chi-square test was used for categorical variables. Multivariable logistic regression assessed the probability of undetectable PSA at 3rd month postoperatively. Kaplan-Meier method estimated the probability of biochemical recurrence. Differences between the groups were compared by Log-rank test. RESULTS: 1478 patients were treated within the time span considered. 95 with 1 to 3 lymph-nodal metastases were extracted. After accounting for inclusion criteria, 23 patients with a median of 11 LN removed were included in the sPLND group (25th percentile); 23 patients with > 27 LN were included in ePLND group (75th percentile). Surgical time was longer for ePLND. Sixteen patients (69.6%) who underwent ePLND had undetectable PSA postoperatively. At multivariable analysis, the probability of undetectable PSA at 3rd month was higher in patients who received an ePLND (HR=5.18; IC 95%=1.16-23.11; P=.03). CONCLUSIONS: ePLND is more likely to predict undetectable PSA at third month after radical prostatectomy, irrespective of disease characteristics.

Association between baseline clinical and imaging findings and the development of digital ulcers in patients with systemic sclerosis.

OBJECTIVE: Systemic sclerosis (SSc) can lead to ischemic complications such as digital ulcers (DUs). The aim of the study was to find predictors of DUs by clinical and new imaging methods. PATIENTS AND METHODS: All 79 SSc patients included in the study received a clinical, colour Doppler ultrasound (CDUS), fluorescence optical imaging (FOI) and capillaroscopy examination at baseline, and their capacity to predict new DU development was analysed in 76 patients at 12 months follow-up. RESULTS: Twenty-two of 76 patients (28.9%) developed new ulcers during follow-up (diffuse SSc 48.1%; limited SSc 18.4%). Receiver operating characteristic (ROC) curve analysis revealed an area under the curve of 0.7576 for DU development, with a specificity of 87% and a sensitivity of 54.6% (p = 0.0003, OR = 8.1 [95%CI 2.5-25.6]) at a cut-off of ≥ 21 points (ACR/EULAR classification criteria for SSc). Capillaroscopy and CDUS had high sensitivity (100% and 95.5%) but low specificity (28.9% and 22.2%) for ulcer occurrence when used alone, but better specificity (46.3%) when combined (OR = 18.1 [95%CI 2.3-144.4]; p = 0.0004). Using FOI, fingers with pathologic staining had a higher risk for new ulcer development in the same finger (p = 0.0153). General future DU (i.e. DU also in other fingers) was associated with a missing FOI signal in the right digit III at baseline (p = 0.048). CONCLUSION: New imaging modalities can predict digital ulcer development in SSc patients with high sensitivity for capillaroscopy and CDUS and enhanced specificity when combined. A missing signal of FOI in the right digit III at baseline was associated with general future DU.

Resultados oncológicos a largo plazo del tratamiento cáncer de próstata de alto riesgo mediante prostatectomía radical en un hospital oncológico / Long-term oncological results of treatment for high-risk prostate cancer using radical prostatectomy in a cancer hospital

Objetivos: Analizar los resultados oncológicos más relevantes en el tratamiento mediante prostatectomía radical (PR) en el cáncer de próstata de alto riesgo (CPAR) en un hospital oncológico. Material y métodos: Estudio retrospectivo descriptivo de las PR realizadas en nuestro centro desde 1986 a 2017 en CPAR para conocer como objetivo primario las supervivencia global (SG) y cáncer específica (SCE), y como objetivos secundarios las supervivencias libre de progresión bioquímica (SLPB), libre de progresión metastática (SLPM), la necesidad de tratamiento de rescate (SLTR), la necesidad de hormonoterapia (SLHT) y finalmente el desarrollo de cáncer de próstata resistente a la castración. Se realizan análisis de regresión de Cox para establecer modelos predictivos y conocer el peso de cada variable definitoria de alto riesgo. Resultados: Se realizaron 2.093 PR de las cuales 480 (22,9%) fueron en CPAR. La mediana de seguimiento de la serie global fue 79,57 meses (P25-75 37,92-135,16). No se realizó linfadenectomía (LDN) en el 6,5% de los casos, mientras que fue LDN obturatriz en 51,2% y extensa en 42,3%. La SG a 5, 10 y 15 años fue de 89,8% (IC 95%: 86,7-92,9%), 73,3% (IC 95%: 68-78,6%) y 51,4% (IC 95%: 43,8-59%). La SCE a 5, 10 y 15 años fue de 94,8% (IC 95%: 92,4-97,2%), 84,0% (IC 95%: 79,3-88,7%) y 75,5% (IC 95%: 68,8-82,2%) La SLPM a 5, 10 y 15 años fue de 87,4% (IC 95%: 84,1-90,7%), 72,2% (IC 95%: 66,7-77,7%) y 61,7% (IC 95%: 54,3-69,1%) respectivamente. Se requirió radioterapia de rescate en 120 pacientes de 477 analizados (25,1%) y 293/477 nunca han requerido hormonoterapia (61,4%). En relación con el uso de HT en los 93 pacientes pN1, 33 (35,5%) no la han necesitado. El tiempo desde la PR a la progresión bioquímica es la variable de mayor peso pronóstico para la SLPM, la SCE y la SG. Conclusiones: La PR más LDN extensa debería ser la primera maniobra terapéutica cuando es factible dentro de una estrategia multimodal. Es necesario un seguimiento mayor de la serie para validar la hipótesis de unos mejores resultados oncológicos basándose en una aplicación más precoz de la RT de rescate, una LDN extensa y los fármacos prolongadores de supervivencia en la fase de CPRC

Objectives: To analyse the most relevant oncologic results of treatment using radical prostatectomy (RP) for high-risk prostate cancer (HRPC) in a specialist cancer hospital. Material and methods: A descriptive retrospective study of RP was conducted at our centre from 1986 to 2017 on HRPC whose primary objective was to determine overall survival (OS) and cancer-specific survival (CSS). The study's secondary objectives were to determine biochemical progression-free survival (BPFS), metastasis-free survival (MFS), rescue therapy-free survival (RTFS), hormone therapy-free survival (HTFS) and the development of castration-resistant prostate cancer. We performed a Cox regression analysis to establish predictive models and to better understand the weight of each variable that defines high risk. Results: A total of 2093 RPs were performed, 480 (22.9%) of which were for HRPC. The median follow-up for the overall series was 79.57 months (P25-75 37.92-135.16). Lymphadenectomy was not performed in 6.5% of the cases. The lymphadenectomy was of the obturator type in 51.2% of the cases and extended in 42.3%. Overall survival at 5, 10 and 15 years was 89.8% (95% CI 86.7-92.9%), 73.3% (95% CI 68-78.6%) and 51.4% (95% CI 43.8-59%), respectively. CSS at 5, 10 and 15 years was 94.8% (95% CI 92.4-97.2%), 84.0% (95% CI 79.3-88.7%) and 75.5% (95% CI 68.8-82.2%), respectively. MFS at 5, 10 and 15 years was 87.4% (95% CI 84.1-90.7%), 72.2% (95% CI 66.7-77.7%) and 61.7% (95% CI 54.3-69.1%), respectively. A total of 120 patients of 477 analysed (25.1%) required rescue radiation therapy, and 293/477 never required hormone therapy (61.4%). Of the 93 pN1 patients, 33 (35.5%) did not require hormone therapy. The time from RP to biochemical progression was the variable with the greatest prognostic weight for MFS, CSS and overall survival. Conclusions: RP plus extended lymphadenectomy should be the first therapeutic manoeuvre when feasible within a multimodal strategy. A longer follow-up of the series is needed to validate the hypothesis of better oncologic results based on the earlier implementation of rescue radiation therapy, extended lymphadenectomy and drugs that prolong survival in the CRPC phase

Long-term oncological results of treatment for high-risk prostate cancer using radical prostatectomy in a cancer hospital. / Resultados oncológicos a largo plazo del tratamiento cáncer de próstata de alto riesgo mediante prostatectomía radical en un hospital oncológico.

OBJECTIVES: To analyse the most relevant oncologic results of treatment using radical prostatectomy (RP) for high-risk prostate cancer (HRPC) in a specialist cancer hospital. MATERIAL AND METHODS: A descriptive retrospective study of RP was conducted at our centre from 1986 to 2017 on HRPC whose primary objective was to determine overall survival (OS) and cancer-specific survival (CSS). The study's secondary objectives were to determine biochemical progression-free survival (BPFS), metastasis-free survival (MFS), rescue therapy-free survival (RTFS), hormone therapy-free survival (HTFS) and the development of castration-resistant prostate cancer. We performed a Cox regression analysis to establish predictive models and to better understand the weight of each variable that defines high risk. RESULTS: A total of 2093 RPs were performed, 480 (22.9%) of which were for HRPC. The median follow-up for the overall series was 79.57 months (P25-75 37.92-135.16). Lymphadenectomy was not performed in 6.5% of the cases. The lymphadenectomy was of the obturator type in 51.2% of the cases and extended in 42.3%. Overall survival at 5, 10 and 15 years was 89.8% (95% CI 86.7-92.9%), 73.3% (95% CI 68-78.6%) and 51.4% (95% CI 43.8-59%), respectively. CSS at 5, 10 and 15 years was 94.8% (95% CI 92.4-97.2%), 84.0% (95% CI 79.3-88.7%) and 75.5% (95% CI 68.8-82.2%), respectively. MFS at 5, 10 and 15 years was 87.4% (95% CI 84.1-90.7%), 72.2% (95% CI 66.7-77.7%) and 61.7% (95% CI 54.3-69.1%), respectively. A total of 120 patients of 477 analysed (25.1%) required rescue radiation therapy, and 293/477 never required hormone therapy (61.4%). Of the 93 pN1 patients, 33 (35.5%) did not require hormone therapy. The time from RP to biochemical progression was the variable with the greatest prognostic weight for MFS, CSS and overall survival. CONCLUSIONS: RP plus extended lymphadenectomy should be the first therapeutic manoeuvre when feasible within a multimodal strategy. A longer follow-up of the series is needed to validate the hypothesis of better oncologic results based on the earlier implementation of rescue radiation therapy, extended lymphadenectomy and drugs that prolong survival in the CRPC phase.

Radioterapia para la oligorrecurrencia en cáncer de próstata. Resultados preliminares en nuestro centro / Radiation therapy for oligorecurrence in prostate cancer. Preliminary results of our centre

Introducción y objetivo: Existe un interés creciente por el uso de modalidades terapéuticas más agresivas en el cáncer de próstata metastásico. En el presente estudio abordamos el uso de la radioterapia estereotáctica (SBRT) en pacientes con cáncer de próstata oligorecurrente. Analizamos la respuesta bioquímica y la toxicidad de los pacientes a quienes se les administró en nuestro centro. Material y método: Se seleccionaron los pacientes que padecieron una oligorrecurrencia desde enero de 2015 hasta diciembre de 2016 y se administro?? SBRT. La asociación de privación androgénica (DA) quedo?? a decisión de cada caso en el comité de tumores. Describimos la situación clínica al diagnóstico de las oligorrecurrencias, el tratamiento administrado y la respuesta bioquímica. Consideramos respuesta bioquímica un descenso del 50% en las cifras absolutas del PSA. Resultados: Se administró SBRT a 11 pacientes con oligometástasis óseas (82%) y/o ganglionares (18%). El esquema de tratamiento en las óseas fue de 27 Gy repartidos en 3 sesiones, mientras que en las ganglionares se llegó a 70 Gy. Siete pacientes no tenían ningún tratamiento en el momento del diagnóstico, 2 estaban en fase de resistencia a la castración, un paciente estaba con DA intermitente fase OFF y un paciente con DA adyuvante por pN1. Siete pacientes presentaron una respuesta bioquímica con disminución de PSA entre el 75% y el 100%. En 4 pacientes la respuesta no fue valorable por persistir con DA adyuvante. Con un seguimiento medio de 10,5 meses solo han progresado 2 pacientes. Únicamente se detectó toxicidad gastrointestinal grado i en un paciente. Conclusión: Nuestros datos sugieren que el uso de la SBRT en pacientes cuidadosamente seleccionados oligorrecurrentes metastásicos de cáncer de próstata puede lograr respuesta bioquímica y potencialmente retrasar la progresión y el uso de tratamientos sistémicos

Introduction and objective: There is growing interest in the use of more aggressive therapeutic modalities for treating metastatic prostate cancer. In this study, we examine the use of stereotactic body radiation therapy (SBRT) for patients with oligorecurrent prostate cancer. We analysed the biochemical response and toxicity of patients who underwent this therapy at our centre. Material and method: We selected patients who experienced oligorecurrence between January 2015 to December 2016 and were administered SBRT. The association of androgen deprivation (AD) was left in each case to the decision of the tumour committee. We describe the clinical situation at diagnosis of oligorecurrence, the treatment administered and the biochemical response. We considered a biochemical response to be a 50% reduction in the absolute prostate-specific antigen (PSA) readings. Results: SBRT was administered to 11 patients with bone (82%) and/or lymph node oligometastasis (18%). The treatment regimen for bone oligometastasis was 27 Gy divided into 3 sessions, while the treatment for lymph node oligometastasis reached 70 Gy. Seven patients had no treatment at the time of diagnosis, 2 were in the castration-resistant phase, 1 patient was in the off phase of intermittent AD, and 1 patient had adjuvant AD for pN1. Seven patients presented a biochemical response with a PSA reduction of 75-100%. The response was not assessable in 4 patients due to the continuing adjuvant AD. With a mean follow-up of 10.5 months, only 2 patients had progressed. Grade 1 gastrointestinal toxicity was detected in only 1 patient. Conclusion: Our data suggest that the use of SBRT in carefully selected patients with metastatic oligorecurrence of prostate cancer can achieve biochemical response and potentially delay progression and the use of systemic treatments

Radiation therapy for oligorecurrence in prostate cancer. Preliminary results of our centre. / Radioterapia para la oligorrecurrencia en cáncer de próstata. Resultados preliminares en nuestro centro.

INTRODUCTION AND OBJECTIVE: There is growing interest in the use of more aggressive therapeutic modalities for treating metastatic prostate cancer. In this study, we examine the use of stereotactic body radiation therapy (SBRT) for patients with oligorecurrent prostate cancer. We analysed the biochemical response and toxicity of patients who underwent this therapy at our centre. MATERIAL AND METHOD: We selected patients who experienced oligorecurrence between January 2015 to December 2016 and were administered SBRT. The association of androgen deprivation (AD) was left in each case to the decision of the tumour committee. We describe the clinical situation at diagnosis of oligorecurrence, the treatment administered and the biochemical response. We considered a biochemical response to be a 50% reduction in the absolute prostate-specific antigen (PSA) readings. RESULTS: SBRT was administered to 11 patients with bone (82%) and/or lymph node oligometastasis (18%). The treatment regimen for bone oligometastasis was 27Gy divided into 3 sessions, while the treatment for lymph node oligometastasis reached 70Gy. Seven patients had no treatment at the time of diagnosis, 2 were in the castration-resistant phase, 1 patient was in the off phase of intermittent AD, and 1 patient had adjuvant AD for pN1. Seven patients presented a biochemical response with a PSA reduction of 75-100%. The response was not assessable in 4 patients due to the continuing adjuvant AD. With a mean follow-up of 10.5 months, only 2 patients had progressed. Grade 1 gastrointestinal toxicity was detected in only 1 patient. CONCLUSION: Our data suggest that the use of SBRT in carefully selected patients with metastatic oligorecurrence of prostate cancer can achieve biochemical response and potentially delay progression and the use of systemic treatments.

PCA3 como biomarcador de segunda línea en un programa de screening oportunista prospectivo, aleatorizado y controlado / PCA3 as a second-line biomarker in a prospective controlled randomized opportunistic prostate cancer screening programme

Objetivos: Determinar el comportamiento del PCA3 como un marcador de segunda línea en un programa de cribado oportunista de cáncer de próstata (CaP) y su comparación con la calculadora de riesgo 3 del cribado aleatorizado europeo en cáncer de próstata (ERSPC RC-3). Material y métodos: En total de 5.199 hombres de 40-75 años se hicieron la prueba del antígeno prostático específico (PSA) y un tacto rectal (TR). Aquellos con TR normal y PSA ≥ 3ng/ml se realizaron un PCA3. Todos los hombres con PCA3 ≥ 35 se hicieron biopsia inicial (BxI) -12 cilindros-. Aquellos con PCA3 < 35 se aleatorizaron 1:1 a BxI u observación. Los resultados se comparan con los obtenidos con la aplicación de la calculadora ERSPC RC-3. Resultados: PCA3 se testó en 838 hombres (16,1%). En los grupos PCA3(+) y PCA3(-), las tasas de detección global de CaP fueron del 40,9 y del 14,7% a una mediana de seguimiento de 21,7 meses (p < 0,001. En el grupo PCA3(+) (n = 301, 35,9%), se identificó CaP en 115 hombres en BxI (38,2%). En el brazo aleatorizado, 256 se hicieron BxI y se objetivó CaP en 46 (18,0%) (p < 0,001). La potencial tasa de ahorro de biopsias siguiendo el corte PCA3 = 35 hubiera sido de 64,1% frente a la de 76,6% si hubiéramos usado ERSPC RC-3. Sin embargo, la tasa estimada de falsos negativos de CaP de alto grado (CaPAG = Gleason ≥ 7) se hubiera reducido un 37,1% (de 89 a 56 pacientes) al usar el PCA3. Si hubiéramos usado el corte 35 de PCA3 para no realizar BxI, hubiésemos dejado de diagnosticar un 14,7% de CaP y un 9,1% de CaP clínicamente significativo, a un seguimiento medio aproximado de 2 años. Conclusiones: Cuando se usa PCA3-35 como biomarcador de segunda línea en hombres con PSA ≥ 3ng/ml y TR normal, se puede obviar la BxI un 12,5% menos que usando la ERSPC RC-3, pero reduciendo los falsos negativos un 36,2%. A un seguimiento de 21,7 meses, este protocolo dual no hubiera detectado un 9,1% de CaP clínicamente significativo, por lo que el seguimiento con estrictos criterios de biopsia basados en PSA y TR es obligatorio en casos con PCA3 < 35

Objectives: PCA3 performance as a single second line biomarker is compared to the European Randomised Study of Screening for Prostate Cancer risk calculator model 3 (ERSPC RC-3) in an opportunistic screening in prostate cancer (PCa). Material and methods: 5,199 men, aged 40-75y, underwent prostate-specific antigen (PSA) screening and digital rectal examination (DRE). Men with a normal DRE and PSA ≥3ng/ml had a PCA3 test done. All men with PCA3 ≥ 35 underwent an initial biopsy (IBx) -12 cores-. Men with PCA3 < 35 were randomized 1:1 to either IBx or observation. We compared them to those obtained with ERSPC RC-3. Results: PCA3 test was performed on 838 men (16.1%). In PCA3(+) and PCA3(-) groups, global PCa detection rates were 40.9% and 14.7% with a median follow-up (FU) of 21.7 months (P <.001). In the PCA3(+) arm (n = 301, 35.9%), PCa was identified in 115 men at IBx (38.2%). In the randomized arm, 256 underwent IBx and PCa was found in 46 (18.0%) (P < .001). The biopsy-sparing potential would have been 64.1% as opposed to 76.6% if we had used ERSPC RC-3. However, the estimated false negative cases for HGPCa would have been reduced by 37.1% (89 to 56 patients). Moreover, if we had applied PCA3-35 to avoid IBx, 14.7% PCa and 9.1% of clinical significant PCa patients would not have been diagnosed during this FU. Conclusions: When PCA3-35 is used as a second-line biomarker when PSA ≥ 3ng/ml and DRE is normal, IBx could be avoided in 12.5% less than if ERSPC RC-3 is used and would reduce the false negative cases by 36.2%. At a FU of 21.7 months, this dual protocol would miss 9.1% of clinically significant PCa, so strict FU is mandatory with established biopsy criteria based on PSA and DRE in cases with PCA3 < 35