Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis.

Aim: Darolutamide significantly prolonged metastasis-free survival (MFS) versus placebo in the Phase III ARAMIS study. We analyzed outcomes in Spanish participants in ARAMIS. Patients & methods: Patients with high-risk nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide 600 mg twice daily or placebo, plus androgen-deprivation therapy. The primary end point was MFS. Descriptive statistics are reported for this post hoc analysis. Results: In Spanish participants, darolutamide (n = 75) prolonged MFS versus placebo (n = 42): hazard ratio 0.345, 95% confidence interval 0.175-0.681. The incidence and type of treatment-emergent adverse events were comparable between treatment arms. Conclusion: For Spanish participants in ARAMIS, efficacy outcomes favored darolutamide versus placebo, with a similar safety profile, consistent with the overall ARAMIS population. Clinical Trials Registration: NCT02200614 (ClinicalTrials.gov).

Darolutamide is an oral treatment for a type of prostate cancer that has stopped responding to other treatments and is at risk of spreading to other parts of the body (termed "nonmetastatic castration-resistant prostate cancer" or "nmCRPC"). In the international ARAMIS study, patients treated with darolutamide lived longer without their cancer spreading than patients who were given placebo (sugar) pills. We wanted to know whether Spanish patients in ARAMIS had similar characteristics and treatment outcomes to other patients in the study. We found that the 75 Spanish patients who were treated with darolutamide had a significantly lower risk of their cancer spreading than the 42 Spanish patients who received placebo. The two groups of Spanish patients had similar side effects.

Safety and outcomes of new generation hormone-therapy in elderly chemotherapy-naive metastatic castration-resistant prostate cancer patients in the real world.

BACKGROUND: Abiraterone acetate and enzalutamide are standard treatments for chemotherapy-naive metastatic castration-resistant prostate cancer (CN-mCRPC). The purpose of this study was to evaluate the effectiveness and safety of these medications in elderly (≥ 75 years old) compared with young CN-mCRPC patients in a real-world clinical setting. Secondarily, we explored the survival prognostic value of different anatomo-clinical factors in elderly group. METHODS: In this retrospective observational multicentre study, we included 134 consecutive CN-mCRPC patients, 64 young and 70 elderly men, who had received AA or Enz. RESULTS: We did not find significant differences in treatment duration [16.6 months, (95% CI 9-24.2 months) vs. 16.8 months (95% CI: 6.3-27.2 months); p = 0.926] and overall survival [median not reached vs. 23.3 months (95% CI 10.2-36.3 months); p = 0.131] between the young and elderly groups. In elderly group, the only predictors of overall survival with AA or Enz were good ECOG performance status and high G8 score. Adverse events of grade ≥3 was similar in elderly group (12.9%) and in the young group (15.6%). Treatment was discontinued due to AEs in 6.3% of young group and 18.6% of elderly group. CONCLUSIONS: Effectiveness and safety of treatment of CN-mRCPC with Abiraterone acetate and enzalutamide were similar in older and younger patients, although treatment discontinuation due to AEs was more frequent in the older age group. In addition to ECOG PS, assessment using specific geriatric scales as G8 screening tool could help to identify patients aged ≥75 who would most benefit from treatment with new-generation hormone therapy.

Radical Prostatectomy after Vascular Targeted Photodynamic Therapy with Padeliporfin: Feasibility, and Early and Intermediate Results.

PURPOSE: Vascular targeted photodynamic therapy with TOOKAD® is a new therapeutic option for localized prostate cancer management. The objectives of this study were to assess the feasibility of radical prostatectomy after vascular targeted photodynamic therapy and describe functional and oncologic outcomes. MATERIALS AND METHODS: We retrospectively included in study 45 patients who underwent salvage radical prostatectomy after vascular targeted photodynamic therapy for recurrent prostate cancer at a total of 14 surgical centers in Europe between October 2008 and March 2017. Of the 42 radical prostatectomies performed 16 were robot-assisted, 6 were laparoscopic and 20 were open surgery. Primary end points were morbidity and technical difficulties. Secondary end points were early and intermediate postoperative functional and oncologic outcomes. RESULTS: Median operative time was 180 minutes (IQR 150-223). Median blood loss was 200 ml (IQR 155-363). According to the surgeons the surgery was easy in 29 patients (69%) and difficult in 13 (31%). Nerve sparing was feasible in 14 patients (33%). Five postoperative complications (12%) were found, including 2 Clavien I, 2 Clavien II and 1 Clavien IIIB complications. Of the cases 13 (31%) were pT3 and 21 (50%) were pT2c. Surgical margins were positive in 13 patients (31%). Prostate specific antigen was undetectable at 6 to 12 months in 37 patients (88%). Nine patients underwent complementary radiotherapy. Four patients had final prostate specific antigen greater than 0.2 ng/ml at a median followup of 23 months (IQR 12-36). At 1 year 27 patients (64%) were completely continent (no pads) and 10 (24%) had low incontinence (1 pad). Four patients (11%) recovered potency without treatment and 23 (64%) recovered potency with appropriate treatment. CONCLUSIONS: Salvage radical prostatectomy after vascular targeted photodynamic therapy treatment was feasible and safe without difficulty for most of the surgeons.

Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy

ABSTRACT Introduction There is a growing interest in achieving higher survival rates with the lowest morbidity in localized prostate cancer (PC) treatment. Consequently, minimally invasive techniques such as low-dose rate brachytherapy (BT) and robotic-assisted prostatectomy (RALP) have been developed and improved. Comparative analysis of functional outcomes and quality of life in a prospective series of 51BT and 42Da Vinci prostatectomies DV Materials and Methods Comparative analysis of functional outcomes and quality of life in a prospective series of 93 patients with low-risk localized PC diagnosed in 2011. 51patients underwent low-dose rate BT and the other 42 patients RALP. IIEF to assess erectile function, ICIQ to evaluate continence and SF36 test to quality of life wee employed. Results ICIQ at the first revision shows significant differences which favour the BT group, 79% present with continence or mild incontinence, whereas in the DV group 45% show these positive results. Differences disappear after 6 months, with 45 patients (89%) presenting with continence or mild incontinence in the BT group vs. 30 (71%) in the DV group. 65% of patients are potent in the first revision following BT and 39% following DV. Such differences are not significant and cannot be observed after 6 months. No significant differences were found in the comparative analysis of quality of life. Conclusions ICIQ after surgery shows significant differences in favour of BT, which disappear after 6 months. Both procedures have a serious impact on erectile function, being even greater in the DV group. Differences between groups disappear after 6 months.

Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy.

INTRODUCTION: There is a growing interest in achieving higher survival rates with the lowest morbidity in localized prostate cancer (PC) treatment. Consequently, minimally invasive techniques such as low-dose rate brachytherapy (BT) and robotic-assisted prostatectomy (RALP) have been developed and improved. Comparative analysis of functional outcomes and quality of life in a prospective series of 51BT and 42Da Vinci prostatectomies DV Materials and Methods: Comparative analysis of functional outcomes and quality of life in a prospective series of 93 patients with low-risk localized PC diagnosed in 2011. 51patients underwent low-dose rate BT and the other 42 patients RALP. IIEF to assess erectile function, ICIQ to evaluate continence and SF36 test to quality of life wee employed. RESULTS: ICIQ at the first revision shows significant differences which favour the BT group, 79% present with continence or mild incontinence, whereas in the DV group 45% show these positive results. Differences disappear after 6 months, with 45 patients (89%) presenting with continence or mild incontinence in the BT group vs. 30 (71%) in the DV group. 65% of patients are potent in the first revision following BT and 39% following DV. Such differences are not significant and cannot be observed after 6 months. No significant differences were found in the comparative analysis of quality of life. CONCLUSIONS: ICIQ after surgery shows significant differences in favour of BT, which disappear after 6 months. Both procedures have a serious impact on erectile function, being even greater in the DV group. Differences between groups disappear after 6 months.

Lithiasis size estimation variability depending on image technical methodology.

UNLABELLED: The lithiasic size is a determining factor in selecting the most suitable treatment, surgical or medical. However, the method for obtaining a reliable lithiasic size is not standardized. Our objetives are to determine the differences between the estimated lithiasic sizes shown by plain radiography test and by computerized axial tomography (CT) scan (using different techniques) in relation to the actual size, and to establish which is the ideal type of imaging for this purpose. We present an in vitro model with lithiasis obtained in cooperation with four centers. INCLUSION CRITERIA: lithiasis >0.5 cm, intact, and visible via simple radiography. A sample of 245 lithiases was obtained, with 87 rejected as they did not fulfill the inclusion criteria. Initially the three main actual diameters of each lithiasis were measured with a calibrator, then a plain X-ray and a CT scan were taken of the samples to determine the surface size in cm(2) for simple radiography; surface size and volume in cm(3) for CT scan, in bone window and soft tissue (Toshiba Aquillion 64, sections of 0.5 mm, 120 Kv, 250 mA). The tomographic area was calculated by employing the formula recommended by the European Association of Urology and scanner software. The actual, radiographic and tomographic measurements were taken by three different researchers who were unaware of the results obtained by the each other. The statistics program IBM SPSS Statistics(®) 19 was used. Differences were analyzed using the Wilcoxon sign test. The bone window CT scan slightly overestimated the actual lithiasic size (0.12 vs. 0.17 cm(3)), while in soft tissue window the actual volume was practically doubled (0.12 vs. 0.21 cm(3)) (p < 0.05). We did not find statistically significant differences in the comparison between actual surface size (0.39 cm(2)) and bone window CT scan size when using the EAU formula or scanner software (0.36/0.37 cm(2)). Resulting measurements in soft tissue window tended to significantly overestimate the surface size, although only slightly (0.42/0.44 cm(2)), whilst the plain radiography underestimated it slightly but significantly (0.37 cm(2)). CT scan, using the bone window, is the technical methodology with which the greatest in vitro accuracy in which actual lithiasis measurements can be estimated, although the craniocaudal diameter measurement will be overestimated. Using soft tissue window gives an overestimated size.

[Prognostic factors in renal cell carcinoma]. / Factores pronósticos del carcinoma de células renales.

Renal cancer has been increasingly diagnosed in recent decades. In addition, morphological diversity of renal neoplasms has led to consider that the concept of renal cell (RC) carcinoma encompasses a wide variety of conditions. The recently published EROCARE-4 study showed a 5-year overall survival rate of 59.2%. In this and any other neoplastic disease, determination of adequate prognostic factors would help decide the most appropriate therapeutic strategy in each case, guide future treatments, and develop specific follow-up schemes for our patients. The different prognostic factors for RC may currently be classified into four groups: anatomical, clinical, histological and molecular. This paper analyzes these prognostic factors and reviews the nomograms most commonly used.

Reconstrucción vésico-ureteral completa con íleon en un caso de tuberculosis genitourinaria / Complete vesico-ureteral reconstruction with ileum in a case of genitourinary tuberculosis

Introducción: La tuberculosis genitourinaria representa el 3,2% del total de las localizaciones posibles de la enfermedad. La ausencia de tratamiento o su manejo inadecuado, puede desencadenar complicaciones severas. Presentamos un caso clínico y realizamos una revisión bibliográfica de una paciente con tuberculosis genitourinaria que requirió una reconstrucción vésico ureteral completa. Caso clínico: Mujer de 39 años con antecedentes personales de tuberculosis pulmonar, que debuta con dolor lumbar y ureterohidronefrosis izquierda que precisa derivación urinaria percutánea con diagnóstico de tuberculosis en urocultivo. A los 18 meses del diagnóstico presentó una anulación renal derecha por la que se decidió nefrectomía derecha y estenosis ureteral distal izquierda en cuyo intento de corrección quirúrgica se produjo desinserción de uréter un cm por debajo de la unión pieloureteral que obligó a nefrostomía en raqueta definitiva. A todo ello se sumó en los meses siguientes, retracción progresiva vesical. Debido a la edad de la paciente y el deterioro de su calidad de vida se realizó una reconstrucción completa de la vía urinaria izquierda mediante una neovejiga y neoureter con ileon. Discusión y conclusiones: La reconstrucción de vejiga y uréter con íleon, es una buena opción en casos complejos en los que la vía urinaria está ausente o lesionada de forma irreversible. La reconstrucción vesicoureteral, permitiendo micción por uretra mejora sustancialmente la calidad de vida de estos pacientes (AU)

Introduction: Genitourinary tuberculosis represent 3,2% of the possible sites of the disease. The lack of treatment or an inadecuate one may lead to severe complications. We report a case and review thoroughly the literature of genitourinary tuberculosis which needed a complete vesico-ureteral reconstruction. Clinical case: A 39 year old female patient with history of pulmonary tuberculosis who had lumbar pain and left ureterohydronephosis. She required a percutaneous urinary derivation and was diagnosed of tuberculosis by means of the urine culture. 18 months afterwards she had a right renal annulation and a left distal ureteral stenosis. A right nephectomy was performed and the left proximal ureter was desinserted accidentally, 1 cm below the pielo-ureteral junction, which required a permanent nephostomy. Then her bladder became gradually retractile. Because she was a young patient and had bad quality of life a complete reconstruction of her left urinary way was performed with an ileum made neobladder and neoureter. Discussion and Conclussions: Bladder and ureter reconstruction with ileum is a good option in difficult cases of lack or irreversible damage of the urinary way. Vesico-ureteral reconstruction letting urethral miction improves quality of life (AU)

Factores pronósticos del carcinoma de células renales / Prognostic factors in renal cell carcinoma

El diagnóstico del cáncer renal ha aumentado en las últimas décadas. A esto hay que sumar la diversidad morfológica de las neoplasias renales, llegando a plantearse la existencia de una gran variedad de entidades bajo el concepto de carcinoma renal (CR). El estudio EROCARE-4, publicado recientemente, muestra una supervivencia global a los 5 años del 59,2%. En este contexto, y como ocurre en toda patología oncológica, la determinación adecuada de factores pronósticos ayudaría a plantear la estrategia terapéutica más apropiada en cada caso, dirigir futuros tratamientos y desarrollar esquemas específicos de seguimiento para nuestros pacientes. En la actualidad los diferentes factores pronósticos de CR podemos clasificarlos en cuatro grupos: anatómicos, clínicos, histológicos y moleculares. En este trabajo analizamos estos factores pronósticos y revisamos los nomogramas más extendidos en la actualidad (AU)

Renal cancer has been increasingly diagnosed in recent decades. In addition, morphological diversity of renal neoplasms has led to consider that the concept of renal cell (RC) carcinoma encompasses a wide variety of conditions. The recently published EROCARE-4 study showed a 5-year overall survival rate of 59.2%. In this and any other neoplastic disease, determination of adequate prognostic factors would help decide the most appropriate therapeutic strategy in each case, guide future treatments, and develop specific follow-up schemes for our patients. The different prognostic factors for RC may currently be classified into four groups: anatomical, clinical, histological and molecular. This paper analyzes these prognostic factors and reviews the nomograms most commonly used (AU)

[Ultrasound guided transrectal prostatic biopsy and pain. Prospective randomized study comparing lubricant gel, lidocaine gel, and anesthetic blockage of the neurovascular bundles with 1% lidocaine]. / Biopsia prostática transrectal ecodirigida y dolor. Estudio prospectivo aleatorizado comparando gel lubricante, gel con lidocaína y bloqueo anestésico de haces neurovasculares con lidocaína 1%.

OBJECTIVES: To quantify anxiety and immediate and late pain, efficacy of the common analgesic methods, and complications. METHODS: 117 patients were randomized to three groups: 1 (39): lubricant gel; 2 (38): intrarectal lidocaine gel; 3 (40): anesthetic blockage with 1% lidocaine. Complications and immediate and late pain were collected, these latter with a visual analogic scale. RESULTS: 70% of the patients were not much anxious. We did not find significant differences between the analgesia achieved in group 1 (4.37 +/- 2.41) and group 2 (4.22 +/- 2.46), but we found with group 3 (1.88 +/- 2.03). Mean pain score the afternoon after biopsy was lower in group 3 (2.08 +/- 2.28) than in groups 1 and 2 (4.06 +/- 2.80 and 2.42 +/- 2.03), without statistical significance. The patients did not show a difference in pain during the pass of the transrectal transducer, varying between 2.34 for group 3 and 3.38 for group 2. Grouped by sphincter tone we find differences (low 2.71 +/- 2.76, medium 3.23 +/- 2.38, high 4.99 +/- 2.22). Patients feeling very nervous before the test had a pain score of 4.98 +/- 2.57, significantly greater than the pain of those not feeling nervous (2.59 +/- 2.21). We did not find differences in complications between the three groups. CONCLUSIONS: The use of intrarectal lidocaine gel did not demonstrated being more effective in pain control in our series than the use of lubricant gel, but lidocaine injected into the apex and seminal vesicles was. Sphincter tone and pretest anxiety are the most determinants factors for pain.

Biopsia prostática transrectal ecodirigida y dolor. Estudio prospectivo aleatorizado comparando gel lubricante, gel lidocaína y bloqueo anestésico de haces neurovasculares con lidocaína 1% / Ultrasound guided transrectal prostatic biopsy and pain. Prospective randomized study comparing lubricant gel, lidocaine gel, and anesthetic blockage of the neurovascular bundles with 1% lidocaine

Objetivo: Cuantificar ansiedad y dolor inmediato y tardío producidos, efectividad de los métodos analgésicos comunes y complicaciones. Métodos: 117 pacientes fueron distribuidos aleatoriamente en tres grupos: 1 (39): lubricante gel, 2 (38): lidocaína en gel intrarrectal, 3 (40): bloqueo anestésico con lidocaína al 1%. Se recogieron las complicaciones y el dolor inmediatos y tardíos mediante una escala visual analógica. Resultados: 70% de pacientes estaban poco ansiosos. No encontramos diferencias significativas entre la analgesia conseguida en el grupo 1 (4.37±2.41) y 2 (4.22±2.46), pero sí con el 3 (1.88±2.03). La media de dolor la tarde tras la prueba fue menor en el grupo 3 (2.08 ± 2.28) que en 1 y 2 (4.06±2.80 y 2.42±2.03), pero sin significación estadística. Los pacientes no mostraron un dolor distinto al paso del transductor transrectal, oscilando entre 2.34 para el grupo 3 y 3.38 para el grupo 2. Agrupados según tono esfinteriano, sí encontramos diferencias (bajo 2.71±2.76, medio 3.23±2.38, alto 4.99±2.22). El dolor presentado por los pacientes que decían estar muy nerviosos pre-prueba fue de 4.98±2.57, significativamente mayor que el presentado por los que decían estar nada nerviosos (2.59±2.21). No encontramos diferencias en las complicaciones entre los tres grupos. Conclusiones: El empleo de gel intrarrectal de lidocaína no ha demostrado en nuestra serie ser más eficaz que el uso de lubricante para el control del dolor, pero sí la lidocaína inyectada en ápex y vesículas seminales. Tono esfinteriano y ansiedad preprueba son los factores más determinantes en el grado de dolor (AU)

Objectives: To quantify anxiety and immediate and late pain, efficacy of the common analgesic methods, and complications. Methods: 117 patients were randomized to three groups: 1(39): lubricant gel; 2 (38): intrarectal lidocaine gel; 3 (40): anesthetic blockage with 1% lidocaine. Complications and immediate and late pain were collected, these latter with a visual analogic scale. Results: 70% of the patients were not much anxious. We did not find significant differences between the analgesia achieved in group 1 (4.37± 2.41) and group 2 (4.22± 2.46), but we found with group 3 (1.88± 2.03). Mean pain score the afternoon after biopsy was lower in group 3 (2.08± 2.28) than in groups 1 and 2 (4.06± 2.80 and 2.42± 2.03), without statistical significance. The patients did not show a difference in pain during the pass of the transrectal transducer, varying between 2.34 for group 3 and 3.38 for group 2. Grouped by sphincter tone we find differences (low 2.71± 2.76, medium 3.23± 2.38, high 4.99+- 2.22). Patients feeling very nervous before the test had a pain score of 4.98± 2.57, significantly greater than the pain of those not feeling nervous (2.59± 2.21). We did not find differences in complications between the three groups. Conclusions: The use of intrarectal lidocaine gel did not demonstrated being more effective in pain control in our series than the use of lubricant gel, but lidocaine injected into the apex and seminal vesicles was. Sphincter tone and pre-test anxiety are the most determinants factors for pain (AU)