[Current recommendations about the diagnosis and treatment of testosterone deficit syndrome: Clinical guidelines]. / Recomendaciones actuales sobre el diagnóstico y tratamiento del SDT: Guías de practica clínica.

Testosterone deficit syndrome (TDS) is a clinical and biochemical syndrome associated with advanced age and characterized by some typical symptoms and decrease in serum testosterone levels, which can affect multiple organs and systems, deteriorating the quality of life of the males who suffer it. Due to the low specificity of the clinical picture, as well as that of the commonly used questionnaires, when there is a diagnostic suspicion, serum testosterone determination is necessary, without a current universally accepted determination method. The increased survival of males in the western world and their demand of a better quality of life,including the preservation of sexual activity, up to increasingly more advanced ages: together with the appearance of new ways of testosterone delivery, make this entity, clinical-biochemical, acquirean increasingly greater importance. From a therapeutic point of view, testosterone replacement therapy has precise indications, with individualized evaluation in each patient on the basis of risk/benefit, and with an adequate, well defined follow up, that will allow the control of possible adverse events. TRT is recommended in patients with diminished testosterone associated with muscle mass and strength loss, decrease of bone density of the lumbar spine or diminished libido and quality of erection. Contraindications for therapy would include active or non treated prostate cancer, PSA >4 ng/ml before evaluation, breast cancer, severe sleep apnea, infertility, hematocrit over 50% or severe LUTS due to BPH.

Observational study comparing the accuracy/variability between the ERSPC and the PCPT risk calculators for the prediction of significant prostate cancer in patients with PSA <10 ng/mL.

INTRODUCTION: Risk calculators (RCs) are easy-to-use tools considering available clinical variables that could help to select those patients with risk of prostate cancer (PCa) who should undergo a prostate biopsy. OBJECTIVE: To perform a comparison for the prediction of significant PCa (SigPCa) between the European Randomised Study of Screening for PCa (ERSPC) and the PCa Prevention Trial (PCPT) RCs in patients with prostate-specific antigen (PSA) between 3 and 10 ng/mL through an evaluation of the accuracy/variability between two consecutive PSA values. SETTING: An observational study in a major university hospital in the south of Spain. METHODS AND PARTICIPANTS: An observational study was performed in patients who underwent a prostate biopsy. SigPCa probabilities were calculated with the two PSA measures using ERSPC3/4+digital rectal examination and PCPT v2+free PSA RCs. The prediction of SigPCa was determined by the area under the receiver operating characteristic curve (AUC). Calibration, discrimination and decision curve analysis were studied. The variability between both RCs' agreement was compared using Cohen's kappa coefficient. RESULTS: 510 patients were analysed (87 diagnosed with SigPCa). The median PSA values were 5.3 and 5 ng/mL for PSA1 and PSA2, respectively. Both RCs overestimated the risk in the case of high-risk probabilities. Discriminative ability for SigPCa was similar between models with an AUC=0.73 (0.68-0.79) for ERSPC-RC versus 0.73 (0.67-0.79) for PCPT-RC. ERSPC-RC showed less variability than PCPT-RC, with a constant agreement (k=0.7-0.8) for usual range of clinical decision-making. Remarkably, a higher number of biopsies would be avoided using the ERSPC-RC, but more SigPCa would be missed along all the risk probabilities. CONCLUSIONS: Both RCs performed similar in the prediction of SigPCa. However, ERSPC-RC seems to be more stable for intraindividual PSA variations.

[When should we perform a bone scintigraphy in patients with new diagnosis of asymptomatic prostate cancer in order to detect bone metastasis?]. / Cuándo debemos realizer un studio de extension en cáncer de próstata asintomático?

OBJECTIVE: To define, based on PSA value, Gleason score (GS), clinical stage and age, those patients diagnosed with asymptomatic prostate cancer whose cases warrant further study of bone metastasis (BMet). METHODS: From January 2006 to May 2010, we evaluated 263 patients diagnosed with prostate cancer who were chosen for further study of bone scintigraphy following the consensus protocol accepted by the Ministry of Health of Andalusia (Integrated Andalusian Process Prostate Cancer-BPH). All selected studies met the criteria defined in the test indications: PSA >10 or Gleason score (GS) ≥7 or positive biopsy of seminal vesicles, all without symptoms of bone pain. A multivariate analysis of potential predictive factors for positive bone scintigraphy was performed and cutoffs were determined by calculating the following diagnostic rates: sensitivity, specificity and positive and negative predictive values with their respective confidence intervals at 95% certainty. RESULTS: BMet were detected in 29 cases (11%). The average age of the patients with a positive bone scan was 65.5 and 68.4 years in those with a negative result (p=0.03). Multivariate analysis showed that GS OR: 2.08 [95% CI (1.34 - 3.18)] (p<0.001) and PSA level 21-200 ng/ml OR: 3.68 [95% CI (1.13-1.02)] (p<0.05) were independent predictive variables for positive bone scan. The cutoffs were estimated by ROC curve analysis, resulting in a cutoff of 16.18 ng/ml for PSA value and 7 for GS (larger area under the curve: 0.864 with a sensitivity of 94.5% and specificity of 47%). CONCLUSIONS: In the group of patients defined in our study, diagnosed with asymptomatic prostate cancer, the assessment of BMet using a bone scan should be carried out with a PSA level ≥ 16.18 ng/ml and GS ≥7 as reference points.

¿Cuándo debemos realizar un estudio de extensión en cáncer de próstata asintomático? / When should we perform a bone scintigraphy in patients with new diagnosis of asymptomatic prostate cancer in order to detect bone metastasis?

OBJETIVO: Definir en función del valor de PSA, grado Gleason (SG), estadio clínico y edad, el grupo de pacientes con diagnostico de cáncer de próstata (CaP) asintomático, en los cuales estaría indicado hacer estudio de extensión de metástasis óseas (MetO). MÉTODOS: Desde Enero 2006 a Mayo de 2010 se estudiaron 263 pacientes con diagnóstico de CaP en los que se solicito gammagrafía ósea como estudio de extensión, siguiendo el protocolo de consenso de Andalucía (Proceso Andaluz integrado HBP-Cáncer de Próstata). Todos los estudios seleccionados cumplían los criterios definidos para la indicación de la prueba: PSA >10 o gleason (SG) ≥7 o biopsia de vesículas seminales positiva, todos sin clínica de dolor óseo. Realizamos un análisis multivariante de los potenciales factores predictores de gammagrafía positiva y establecemos puntos de corte, calculándose los siguientes índices diagnósticos: sensibilidad, especificidad y valores predictivos positivos y negativos, con sus respectivos intervalos de confianza al 95% de seguridad. RESULTADOS: Se detectaron MetO en 29 casos (11%). La edad media de los pacientes con gammagrafía positiva fue 65,5 y 68,4 años en aquellos con resultado negativo (p = 0,03). El análisis multivariante mostró al SG OR: 2,08 [IC 95% (1,34 - 3,18)] (p < 0,001) y al valor de PSA 21-200 ng/ml OR: 3,68 [IC 95% (1,13-12,02)] (p < 0,05) como variables predictoras independientes de gammagrafía positiva. Al realizar las curvas ROC se obtuvo un punto de corte de 16,18 ng/ml para el valor PSA y 7 para el SG (mayor área bajo la curva: 0,864 con una sensibilidad de 94,5% y una especificad del 47 %). Concluisiones: En el grupo de pacientes de nuestro estudio, diagnosticados de CaP asintomático, la evaluación de MetO, mediante gammagrafía ósea, debería ser realizada con un PSA ≥ 16,18 (ng/ml) y un SG ≥ 7 como puntos de referencia

OBJECTIVE: To define, based on PSA value, Gleason score (GS), clinical stage and age, those patients diagnosed with asymptomatic prostate cancer whose cases warrant further study of bone metastasis (BMet). METHODS.- From January 2006 to May 2010, we valuated 263 patients diagnosed with prostate cancer who were chosen for further study of bone scintigraphy following the consensus protocol accepted by the Ministry of Health of Andalusia (Integrated Andalusian Process Prostate Cancer- BPH). All selected studies met the criteria defined in the test indications: PSA >10 or Gleason score (GS) ≥7 or positive biopsy of seminal vesicles, all without symptoms of bone pain. A multivariate analysis of potential predictive factors for positive bone scintigraphy was performed and cutoffs were determined by calculating the following diagnostic rates: sensitivity, specificity and positive and negative predictive values with their respective confidence intervals at 95% certainty. RESULTS- BMet were detected in 29 cases (11%). The average age of the patients with a positive bone scan was 65.5 and 68.4 years in those with a negative result (p = 0.03). Multivariate analysis showed that GS OR: 2.08 [95% CI (1.34 - 3.18)] (p < 0.001) and PSA level 21-200 ng/ml OR: 3.68 [95% CI (1.13-1.02)] (p < 0.05) were independent predictive variables for positive bone scan. The cutoffs were estimated by ROC curve analysis, resulting in a cutoff of 16.18 ng/ml for PSA value and 7 for GS (larger area under the curve: 0.864 with a sensitivity of 94.5% and specificity of 47%). Conclusions.- In the group of patients defined in our study, diagnosed with asymptomatic prostate cancer, the assessment of BMet using a bone scan should be carried out with a PSA level ≥ 16.18 ng/ ml and GS ≥ 7 as reference points

Recomendaciones actuales sobre el diagnóstico y tratamiento del SDT: Guías de práctica clínica / Current recommendations about the diagnosis and treatment of testosterone deficit syndrome: Clinical guidelines

El síndrome de déficit de testosterona, es un síndrome clínico y bioquímico asociado a la edad avanzada y caracterizado por unos síntomas típicos y disminución de las concentraciones de testosterona sérica, que puede afectar a múltiples órganos y sistemas, deteriorando la calidad de vida del varón que lo padece. Debido a la baja especificidad tanto de la clínica, como de los cuestionarios comúnmente utilizados, ante la sospecha clínica, es necesario la determinación de la testosterona sérica, sin que en la actualidad, exista un método de determinación universalmente aceptado. El aumento de la supervivencia de los varones en el mundo occidental y la demanda por éstos de una mejor calidad de vida, hasta edades cada vez más avanzadas, lo que incluye el mantenimiento de la actividad sexual; junto con la aparición de nuevas formas de administración de testosterona, hace que esta entidad, clínico-bioquímica, adquiera cada vez mayor importancia. Desde el punto de vista terapéutico, el tratamiento sustitutivo con testosterona, tiene indicaciones precisas, con valoración individualizada en cada paciente en razón del riesgo/beneficio, y con un seguimiento adecuado y bien definido, que permitirán controlar los posibles efectos adversos. Se recomienda el tratamiento sustitutivo con testosterona en pacientes con disminución de la misma y que asocien pérdida de masa muscular y fuerza, descenso de la densidad ósea en columna lumbar o disminución de la libido y la calidad de la erección. Las contraindicaciones para el tratamiento incluirían el cáncer de próstata activo o no tratado, el PSA > 4 ng/ml pendiente de valoración, el cáncer de mama, la apnea de sueño severa, la infertilidad, el hematocrito por encima de 50% o los síntomas severos del tracto urinario inferior debidos a hipertrofia prostática benigna (AU)

Testosterone deficit syndrome (TDS) is a clinical and biochemical syndrome associated with advanced age and characterized by some typical symptoms and decrease in serum testosterone levels, which can affect multiple organs and systems, deteriorating the quality of life of the males who suffer it. Due to the low specificity of the clinical picture, as well as that of the commonly used questionnaires, when there is a diagnostic suspicion, serum testosterone determination is necessary, without a current universally accepted determination method. The increased survival of males in the western world and their demand of a better quality of life, including the preservation of sexual activity, up to increasingly more advanced ages; together with the appearance of new ways of testosterone delivery, make this entity, clinical-biochemical, acquirean increasingly greater importance. From a therapeutic point of view, testosterone replacement therapy has precise indications, with individualized evaluation in each patient on the basis of risk/benefit, and with an adequate, well defined follow up, that will allow the control of possible adverse events.TRT is recommended in patients with diminished testosterone associated with muscle mass and strength loss, decrease of bone density of the lumbar spine or diminished libido and quality of erection. Contraindications for therapy would include active or non treated prostate cancer, PSA > 4 ng/ml before evaluation, breast cancer, severe sleep apnea, infertility, hematocrit over 50% or severe LUTS due to BPH (AU)