Advances in urologic oncology "OncoUrology Forum Special Edition": The best of 2020.

OBJECTIVE: To provide latest findings of Urologic Oncology on prostate, kidney, and bladder cancer, and analyze its impact on clinical practice as well as future schemes in the medium- and long-term. METHODS: This document reviews the abstracts on Uro-Oncology presented at the 2020 Congresses (EUA, AUA, ASCO, ESMO and ASTRO), the publications with the highest impact and especially the new lines of development and progress in Uro-Oncology evaluated by the OncoForum committee. RESULTS: The use of prostate-specific membrane antigen (PSMA) radioligands in the diagnosis of prostate cancer may have great potential and utility in the coming years due to their improved sensitivity and specificity. The genetic characterization of the tumor is important at both, germline and somatic levels, due to the significant role of BRCA2 mutations regarding risk. The cohort multiple randomised controlled trial is the most suitable study design at the genitourinary cancer level. The application of big data will lead to process improvements, savings in healthcare costs, and an empowerment of real-life studies through ease of data comparison, management, and storage. CONCLUSIONS: The use of new diagnostic techniques with PSMA ligands will provide a more comprehensive diagnostic modality, increase the number of studies about tumor genetic profiling, and enhance their quality. The practical application of artificial intelligence will improve the treatment genitourinary cancer.

Advances in urologic oncology "OncoForum": The best of 2019. / Avances en uro-oncología «OncoForum¼: lo mejor del 2019.

OBJECTIVE: Review the latest evidence on urologic oncology on kidney, bladder and prostate tumors. METHODS: Abstracts on kidney, bladder and prostate cancer presented at the 2019 congresses (EAU, AUA, ASCO and ESMO) and the publications with the greatest impact in this period, with the highest evaluation by the OncoForum committee, are reviewed. RESULTS: In patients with metastatic kidney cancer, regimens including immunotherapy (nivolumab + ipilimumab, pembrolizumab) have been shown to be superior to sunitinib in terms of survival. In patients with non-muscle invasive bladder cancer, pembrolizumab has been shown to be an effective alternative in those refractory to bacillus Calmette-Guérin, while in patients with metastatic urothelial cancer, third-line enfortumab vedotin achieved a significant response rate (44%). In patients with localized prostate cancer (PCa), ultrafractionated external radiotherapy did not show any greater acute toxicity than fractionated or hypofractionated radiotherapy. The benefit of enzalutamide and apalutamide associated with castration has been confirmed in M1 PCa patients, regardless of disease volume. In patients with castration-resistant M0 PCa, treatment with enzalutamide, apalutamide or darolutamide has been associated with a delay in the occurrence of metastasis and prolonged survival. Cabazitaxel has demonstrated a survival benefit in patients with metastatic CRPC, while olaparib showed anti-tumor activity after chemotherapy in those tumors with mutations in DNA repair genes. CONCLUSIONS: These data show the implementation of immunotherapy as a novel alternative against renal and bladder cancer. The arrival of new agents for advanced urothelial carcinoma should be highlighted, and the efficacy of enzalutamide and apalutamide in de novo metastatic prostate cancer is established. In metastatic CRPC, cabazitaxel and olaparib (targeting mutations) are promising therapeutic options.

Androgen deprivation therapy in patients with localized disease: Comparison with curative intent treatments and time to castration resistance. Results of the Spanish Prostate Cancer Registry. / Terapia de privación de andrógenos en pacientes con enfermedad localizada: comparación de las opciones de tratamiento y tiempo hasta la resistencia a la castración. Resultados del Registro Español de Cáncer de Próstata.

BACKGROUND: The effect of primary androgen deprivation therapy (ADT) in patients with localized prostate cancer (PCa) has not been well documented. The objective of the present study was to analyze the outcome of tumors treated with ADT as primary therapy in the Spanish Prostate Cancer Registry (19.4% of the series). PATIENTS AND METHODS: Patients were classified in three groups: 1) with low/intermediate risk clinically localized tumors; 2) with high risk and locally advanced (T3-4) tumors; 3) with metastatic tumors. Time to castration resistance and overall cancer-specific survival were analyzed. In non-metastatic tumors, survivals in patients treated with ADT were compared with data from patients who underwent local treatments from the Spanish Prostate Cancer Registry. RESULTS: 703 cases were analyzed. There were significant differences in the time to castration resistance, which was lower in the group of metastatic tumors. During follow-up, there were 179 deaths (25.5%) of which 89 (12.6%) were due to PCa. After 3 years of ADT, only 14.6% of patients in group 1 had died (1% due to PCa), 20.5% in group 2 and 46.8% in group 3 (9.2% and 31.3% due to PCa, respectively). Cancer-specific survival was significantly worse in group 1 using ADT than radical prostatectomy or radiotherapy. In high-risk and locally advanced tumors, ADT also had a lower cancer-specific survival than local treatments. CONCLUSION: A longer time until the castration resistance was observed in patients with well- and intermediate-risk localized tumors treated with ADT. Patients with metastatic tumors showed the shortest time to castration resistance.

The impact of time from biopsy to radical prostatectomy on Gleason score undergrading and other related factors. / Impacto del tiempo desde la biopsia a la prostatectomía radical en la infragradación del grado de Gleason y análisis de factores relacionados.

INTRODUCTION: Gleason score biopsy undergrading (GSBU) can have an impact on the management and prognosis of patients with prostate cancer. We analyze the possible impact of time and other clinical and analytical factors in the appearance of GSBU in our series. PATIENTS AND METHOD: Ambispective, multicenter study of 1955 patients with localized prostate cancer undergoing radical prostatectomy between 2005 and 2018. Descriptive statistics and hypothesis testing are reported by univariate and multivariate analyses. RESULTS: Mean age 63.69 (44-80) years, median PSA 8.70 ng / ml (1.23-99). GSBU was observed in 34.7% of the entire cohort. In 72.8% of the cases, the GSBU occurred in one consecutive Gleason score, with the progression from 3 + 3 to 3 + 4 being the most frequent (289 patients, 47.6%). Performing radical prostatectomy 90-180 days before or after the biopsy does not have an impact on its undergrading in any of the groups. In the univariate and multivariate analysis, the presence of tumor or pathological rectal examination in both lobes, the tumor load ≥50% of cylinders and a DPSA ≥0.20, showed independent discriminative capacity to select patients who presented GSBU. CONCLUSIONS: The time from biopsy to radical prostatectomy did not show impact on GSBU. The number of affected cylinders, bilateral tumor and DPSA are easily accessible parameters that can help us select patients with greater probability of presenting GSBU.

PREVALENCE OF FATIGUE AND IMPACT ON QUALITY OF LIFE IN CASTRATION-RESISTANT PROSTATE CANCER PATIENTS: the VITAL study.

BACKGROUND: Fatigue is one of the most prevalent symptoms among cancer patients. Specifically, in metastatic castration-resistant prostate cancer (mCRPC) patients, fatigue is the most common adverse event associated with current treatments. The purpose of this study is to describe the prevalence of fatigue and its impact on quality of life (QoL) in patients with CRPC in routine clinical practice. METHODS: This was a cross-sectional, multicentre study. Male chemo-naïve adults with high-risk non-metastatic (M0) CRPC and metastatic (M1) CRPC (mCRPC) were eligible. Fatigue was measured using the Brief Fatigue Inventory (BFI) and QoL was assessed using the Functional Assessment of Cancer Therapy questionnaire for patients with prostate cancer (FACT-P) and the FACT-General (FACT-G) questionnaire. Data were analysed using Mann-Whitney or Kruskal-Wallis tests (non-parametric distribution), a T-test or an ANOVA (parametric distribution) and the Fisher or chi-squared tests (categorical variables). RESULTS: A total of 235 eligible patients were included in the study (74 [31.5%] with M0; and 161 [68.5%] with M1). Fatigue was present in 74%, with 38.5% of patients reporting moderate-to-severe fatigue. Mean FACT-G and FACT-P overall scores were 77.6 ± 16.3 and 108.7 ± 21.4, respectively, with no differences between the CRPC M0 and CRPC M1 subgroups. Fatigue intensity was associated with decreased FACT-G/P scores, with no differences between groups. Among 151 mCRPC patients with available treatment data, those treated with abiraterone-prednisone ≥3 months showed a significant reduction in fatigue intensity (p = 0.043) and interference (p = 0.04) compared to those on traditional hormone therapy (HT). Patients on abiraterone-prednisone ≥3 months showed significantly better FACT-G/P scores than patients on HT (p = 0.046 and 0.018, respectively). CONCLUSION: Our data show a high prevalence and intensity of fatigue and its impact on QoL in chemo-naïve CRPC patients. There is an association between greater fatigue and less QoL, irrespective of the presence or absence of metastasis. Chemo-naïve mCRPC patients receiving more than 3 months of abiraterone acetate plus prednisone showed an improvement of fatigue and QoL when compared to those on traditional HT. TRIAL REGISTRATION: Not applicable since it is not an interventional study.

Factors related to early castration resistance in metastatic prostate cancer. Results from the National Prostate Cancer Registry in Spain. / Factores relacionados con la resistencia a la castración precoz en el cáncer de próstata metastásico. Resultados del Registro nacional de cáncer de próstata en España.

INTRODUCTION: The objective of the study was to determine the factors independently related with the development of castration resistance (CR) in prostate cancer (PC) in the medium term. MATERIAL AND METHODS: 155 patients diagnosed with metastatic PC with a follow-up of up to 39 months. Data taken from the National PC Registry. The evaluated variables were age, PSA, nadir PSA, Gleason, perineural invasion, TNM stages, and ADT type (intermittent/continuous). RESULTS: Mean follow-up 26,2±13,4 months. 47.1% developed early CR, with mean time until onset of 12,2±8,7 months. Univariate analysis the mean PSA was correlated with CR (290±905,1 ng/mL in non CR, 519,1±1437,2 ng/mL in CR, P<.001), mean age (73,3±8,3 years in non CR, 69,1±9,3 in CR P=.01), mean PSA nadir (15,5±57,3ng/mL in non CR, 15,9±23,7 ng/mL in CR, p<0,001), Gleason (in ≥8, HR:2,11. 95% CI: 1.22-3.65, p=0.006), and T stage (in T3-T4, HR: 2.85. 95% CI: 1.57-5.19, P<.001). Multivariate analysis the independent variables associated to CR are age (HR: 0.96. 95% CI: 0.94-0.99, P=.01), PSA nadir (HR: 1.65. 95% CI: 1,43-1,91, P<.001), and T3-T4 stage (HR: 2.11. 95% CI: 1.10-4.04, P=.02). CONCLUSIONS: PSA nadir and T3-T4 tumor stage at diagnosis are associated to an increased risk of developing CR. In addition, age at diagnosis is shown as a variable that decreases risk. Therefore, an older age would be associated with lower risk probability of CR in the medium term.

Three-year interim results of overall and progression-free survival in a cohort of patients with prostate cancer (GESCAP group). / Resultados preliminares de supervivencia global y libre de progresión a tresaños en una cohorte de pacientes diagnosticados de cáncer de próstata (grupo GESCAP).

AIMS: To describe the 3-year progression-free survival (PFS), overall survival (OS) and disease-specific mortality in the prospective prostate cancer GESCAP cohort, as well as the progression to castration resistance in patients on hormone therapy. MATERIAL AND METHODS: Prospective, observational, epidemiological, multicentre study. Of the 4087 patients recruited, 3843 were evaluable. The variables analysed were the risk group (localized, locally advanced, lymph involvement, metastatic), age, prostate-specific antigen (PSA) levels, Gleason score and initial treatment. Kaplan Meier survival analysis, the log-rank test and the Cox model were used to evaluate the survival data. RESULTS: Three-year PFS was 81.4% and OS was 92.4%. During the 3 years of follow-up, 303 patients died (7.9%), 110 of them (36.3%) due to disease-related causes. The probability of castration resistance for all patients on hormone therapy (n=715) was 14.2%: 5%, 9.9%, 26.1% and 44.4% in localized, locally advanced, lymph involvement and metastatic cancer, respectively (log-rank P<.0001). Patients with metastases had poorer outcomes with respect to PFS, OS, disease-specific mortality and castration resistance. In the multivariate analysis, the Gleason score, PSA and presence of metastases were associated with shorter OS and PFS. CONCLUSIONS: Our study showed stratification of risk, with a more unfavourable prognosis for patients with metastases. Patients with locally advanced disease differed with respect to those with localized disease due to their higher risk as regards disease-specific mortality. (Controlled-trials.com ISRCTN19893319).

Radium-223 for the treatment of metastatic castration-resistant prostate cancer: A window of opportunity. / Radio-223 en el tratamiento del cáncer de próstata resistente a la castración metastásico: una ventana de oportunidad.

CONTEXT: The elimination of bone metastases, restoration and/or preservation of bone morphology and prevention and/or delay of skeletal events are a fundamental objective in the management of metastatic castration-resistant prostate cancer (mCRPC). Radium-223 is the first targeted alpha therapy with effects on bone that has been shown to increase survival in these patients, besides providing other bone-related benefits. OBJECTIVE: To analyze the impact of bone metastasis on mCRPC, and the benefits and the window of opportunity provided by radium-223 in the treatment of patients with mCRPC in the current treatment era. EVIDENCE ACQUISITION: A bibliographic search of PubMed and Spanish and international congresses on radium-223 and other first-line treatments for mCRPC was performed. Recent guidelines and recommendations by experts were also consulted. SUMMARY OF THE EVIDENCE: Evidence for the mechanism of action of radium-223 widen its effects to the tumor bone environment. Survival of patients treated with radium-223 is higher in those with mild symptoms as opposed to those with moderate-severe symptoms. The presence of visceral metastases even in the early stages of mCRPC supports starting radium-223 therapy before the symptoms become clinically relevant. A 3-year study has confirmed its good safety profile. Changes in tALP and LDH may be useful markers for monitoring the treatment with radium-223, but they are not predictors of overall survival. CONCLUSION: Radium-223 is a valuable therapeutic alternative in the treatment of patients with mCRPC in early stages of the disease, with a good safety profile. Its benefits extend to the bone environment.

Developments in urologic oncology "OncoForum": The best of 2017. / Avances en uro-oncología «OncoForum¼: lo mejor del 2017.

OBJECTIVE: To put forth new findings of urologic oncology with impact on clinical practice presented during 2017 in the main annual meetings. METHODS: This document reviews abstracts on prostate, kidney and bladder cancer presented at the congresses of 2016 (EAU, AUA, ASCO, ESMO and ASTRO) and publications with the highest impact in this period valued with the highest scores by the OncoForum committee. RESULTS: Among patients at high risk of recurrent renal cell carcinoma after nephrectomy, adjuvant sunitinib compared to placebo showed a benefit in patients at higher risk of recurrence. In cisplatin-ineligible advanced urothelial cancer, pembrolizumab elicits clinically meaningful, durable responses. Among patients with localized prostate cancer, treatment for disease progression was less frequent (absolute difference, 26.2 percentage pontis) and adverse events was more frequent with surgery than with observation. Among patients with locally advanced or merastatic prostate cancer, androgen-deprivation therapy plus abiraterone and prednisolone resulted in fewer deaths and fewer treatment-failure events (P<.001). Among patients with metastatic castration-resistant prostate cancer previously treated with abiraterone acetate, enzalutamide median radiographic progression free survival was 8,1 months and enzalutamide median overall survival was not reached. CONCLUSIONS: Among patients at high risk of recurrent renal cell carcinoma after nephrectomy, adjuvant sunitinib showed a benefit across subgroups including patients at higher risk of recurrence. Among patients with localized prostate cancer, surgery was not associated with significantly lower all-cause or porstate-cancer mortality than observation. Among patients with locally advanced or merastatic prostate cancer, androgen-deprivation therapy plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than androgen-deprivation therapy alone. In patients with metastatic castration-resistant prostate cancer previously treated with abiraterone enzalutamide remained active.

Actual incidence of prostate cancer in healthcare areas of the autonomous community of Castilla-Leon during 2014. CAPCYL registry data. / Incidencia real de cáncer de próstata en las áreas sanitarias de la comunidad autónoma de Castilla y León durante el año 2014. Datos del registro CAPCYL.

OBJECTIVE: To determine the actual incidence of prostate cancer (PC) in the healthcare areas of Castilla-Leon in 2014. MATERIAL AND METHODS: A multicentre study was conducted with the participation of 7 of the 9 healthcare areas of Castilla-Leon. We collected retrospective data that included 87.8% of the target population (men diagnosed with PC with histopathological confirmation in 2014). We calculated the raw and age-adjusted incidence rates based on the direct method and consulted the community and national epidemiological data in the Spanish National Institute of Statistics. RESULTS: A total of 1198 new cases of PC were diagnosed, with a raw incidence rate in the community of 109.54 cases per 100,000 men. The adjusted rates for the Spanish and European populations were 115.41 and 110.07, respectively. The age group with the highest diagnostic concentration was the 60-70-year group, with 41.97% of the diagnoses. The group with the highest incidence was the 70-80-year group, with 438.87 cases per 100,000 inhabitants. There were differences in the raw and age-adjusted incidence rates and in the age at diagnosis among the various included healthcare areas. CONCLUSIONS: The community raw incidence rate was higher than most existing data. We observed significant differences among the various geographical areas, which could be explained mainly by the age distribution and the opportunistic screening policies for each area.

Developments in urologic oncology «OncoForum¼: The best of 2016. / Avances en uroncología «OncoForum¼: lo mejor de 2016.

OBJECTIVE: To put forth new findings of urologic oncology with impact on clinical practice presented during 2016 in the main annual meetings. ACQUISITION OF EVIDENCE: This document reviews abstracts on prostate, kidney and bladder cancer presented at the congresses of 2016 (EAU, AUA, ASCO, ESMO and ASTRO) and publications with the highest impact in this period valued with the highest scores by the OncoForum committee. SYNTHESIS OF EVIDENCE: In High-Risk Renal-Cell carcinoma after nephrectomy, disease-free survival was significantly greater for sunitinib than placebo group, with adverse events more frequents. In locally advanced and metastatic urotherial carcinoma patients, aletozumab achieved overall response rate in all subgroups of patients, included poor prognostic. In localized prostate cancer, the difference of prostate-cancer-specific mortality among active monitoring, radical prostatectomy and external-beam radiotherapy was not significant (P=0,48). In TERRAIN study, with castration-resistant prostate cancer patients, adverse events was reported in 31% and 23% of patients treated with enzalutamide and bicalutamide, respectively. Moreover, enzalutamide significantly improved median progression-free survival (15.7 months) compared bicalutamide (5.8 months) (P<.0001). In SRTIVE study, Enzalutamide reduced the risk of progression or death by 76% compared with bicalutamide (P<.001). CONCLUSIONS: In high-risk renal-cell carcinoma after nephrectomy, sunitinb has been considered as treatment choice. In localized prostate cancer, prostate-cancer-specific mortality was low irrespective of the treatment assigned (active monitoring, radical prostatectomy and external-beam radiotherapy). In metastatic castration-resistant prostate cancer new results of treatment with enzalutamide and abiraterone has been published, wich have been shown beneficial effects in metastatic and no metastatic patients.

A novel capillary nano-immunoassay for assessing androgen receptor splice variant 7 in plasma. Correlation with CD133 antigen expression in circulating tumor cells. A pilot study in prostate cancer patients.

PURPOSE: Androgen receptor (AR) splice variant 7 (AR-V7) has been related with both a higher risk of prostate cancer (PC) progression and differential responsiveness to hormonal agents versus chemotherapy. The objective of this study was to investigate the feasibility of a novel capillary nano-immunoassay in assessing AR-V7 in plasma from PC patients. METHODS: Patients with either localized or advanced PC were included in the study. Assessment of AR-V7 in plasma was performed through a capillary nano-immunoassay platform. Correlation with clinical data, stem cell biomarkers (such as CD133+), AR amplification and PTEN status was identified. RESULTS: The study included 72 PC patients. AR-V7 signal was detected in 21 (29%) patients: 17 (81%) had a Gleason score ≥7, 15 (71%) castration-resistant prostate cancer (CRPC), 18 (86%) metastatic disease and PSA (median) high than AR-V7 negative (p < 0.05). CD133 was expressed in 69 (96%) patients. The median CD133+ expression in circulating tumor cells CTCs was higher among the 21 AR-V7 positive cases versus AR-V7 negative (7 vs. 3). Androgen Receptor and PTEN fluorescence in situ hybridization (FISH) on CD133+ captured cells were performed: 37 cases showed ≥four CD133+ CTCs, of which 81% showed an increased AR copy number. This percentage was similar in both AR-V7-positive and AR-V7-negative patients. A total of 68% of the cases showed deletion of PTEN: 70% were ARV-7 positive vs. 67%, which were AR-V7 negative. CONCLUSIONS: Assessing the presence of AR-V7 in plasma from PC patients is feasible by a novel capillary nano-immunoassay. AR-V7 was observed in 29% of the tumors and is more frequent in aggressive tumors.

Diagnosis and treatment for clinically localized prostate cancer. Adherence to the European Association of Urology clinical guidelines in a nationwide population-based study - GESCAP group. / Diagnóstico y tratamiento del cáncer de prostata clínicamente localizado. Adherencia a las guías clínicas en un estudio poblacional nacional ­ GESCAP.

OBJECTIVE: To assess the adherence to European Association of Urology (EAU) guidelines in the management of prostate cancer (PCa) in Spain. PATIENTS AND METHODS: Epidemiological, population-based, study including a national representative sample of 3,918 incident patients with histopathological confirmation during 2010; 95% of the patient's sample was followed up for at least one year. Diagnosis along with treatment related variables (for localized PCa -low, intermediate, high and locally-advanced by D'Amico risk stratification) was recorded. Differences between groups were tested with Chi-squared and Kruskal-Wallis tests. RESULTS: Mean (SD) age of PCa patients was 68.48 (8.18). Regarding diagnostic by biopsy procedures, 64.56% of all patients had 8-12 cores in first biopsy and 46.5% of the patients over 75 years, with PSA<10ng/mL were biopsied. Staging by Computer Tomography (CT) or Bone Scan (BS) was used for determining tumor extension in 60.09% of high-risk cases and was applied differentially depending on patients' age; 3,293 (84.05%) patients received a treatment for localized PCa. Radical prostatectomy was done in 1,277 patients and 206 out of these patients also had a lymphadenectomy, being 4.64% low-risk, 22.81% intermediate-risk and 36.00% high-risk patients; 86.08% of 1,082 patients who had radiotherapy were treated with 3D or IMRT and 35.77% received a dose ≥75Gy; 419 patients were treated with brachytherapy (BT): 54.81% were low-risk patients, 22.84% intermediate-risk and 12.98% high-risk. Hormonotherapy (HT, n=521) was applied as single therapy in 9.46% of low-risk and 17.92% of intermediate-risk patients. Additionally, HT was combined with RT in 14.34% of lower-risk patients and 58.26% of high-risk patients, and 67.19% low-intermediate risk with RT and/or BT received neoadjuvant/concomitant/adjuvant HT. Finally, 83.75% of high-risk patients undergoing RT and/or BT also received HT. CONCLUSIONS: Although EAU guidelines for PCa management are easily available in Europe, the adherence to their recommendations is low, finding the highest discrepancies in the need for a prostate biopsy and the diagnostic methods. Improve information and educational programs could allow a higher adherence to the guidelines and reduce the variability in daily practice. (Controlled-trials.com: ISRCTN19893319).

Influence of demographic and tumour variables on prostate cancer treatment with curative intent in Spain. Results of the 2010 national prostate cancer registry. / Influencia de las variables demográficas y tumorales en el tratamiento del cáncer de próstata con fines curativos en España. Resultados del Registro nacional de cáncer de próstata 2010.

OBJECTIVE: The aim of this study is to determine which cancer and demographic criteria influence the indication for surgery (radical prostatectomy) or radiation therapy (external or brachytherapy) in the treatment of prostate cancer. MATERIAL AND METHODS: An analysis of the 2714 patients of the 2010 National Prostate Cancer Registry treated with curative intent. The analysed variables were age, prostate-specific antigen (PSA), prostate volume, the number of biopsy cores, the percentage of positive cores, the stage, Gleason score, the type of pathologist, the presence of perineural invasion and the study centre. We analysed the association among these variables and the type of treatment (surgery vs. radiation therapy/brachytherapy), using a univariate analysis (Student's t test and chi-squared) and a binary multiple logistic regression. RESULTS: The 48.12% of the patients (1306/2714) were treated with surgery, and 51.88% (1,408/2,714) underwent radiation therapy/brachytherapy. Differences were observed between the patients treated with prostatectomy and those treated with radiation therapy/brachytherapy (p<.05) in age (63.50±6.5 vs. 69.0±6.7), PSA (8.76±16.97 vs. 13.21±15.88), biopsied cores, percentage of positives cores (30.0±22 vs. 38.7±29), Gleason score (G6: 53.9% vs. 46.1%; G7: 45% vs. 55% G8-10: 26.6%, 73.4%), stage (localised: 50% vs. 50%; locally advanced: 14.6% vs. 85.4%), perineural invasion and hospital centre. In the multivariate analysis, the selected independent variables were age, PSA, percentage of positives cores, stage, Gleason score and hospital centre. CONCLUSION: According to our study, age, tumour aggressiveness and stage and the centre where the patient will be treated affect the selection of curative treatment for prostate cancer.

Developments in urologic oncology «OncoForum¼: The best of 2015. / Avances en uro-oncología «OncoForum¼: lo mejor de 2015.

OBJECTIVE: To review the latest evidence on the oncologic urology of prostate, renal and bladder tumours, analysing their impact on daily clinical practice and future medium to long-term regimens. METHODS: We review the abstracts on prostate, renal and bladder cancer presented at the 2015 congresses (EAU, AUA, ASCO, ESMO y ASTRO) that received the best evaluations by the OncoForum committee. RESULTS: Cabozantinib could represent a new second-line (or subsequent) treatment option for patients with advanced renal cancer. In muscle-invasive bladder cancer, the genetic expression profile could predict the clinical benefit of neoadjuvant therapy in treating urothelial tumours. In metastatic castration-resistant prostate cancer, results were presented from various studies that evaluated the addition of chemotherapy to standard treatment with androgen deprivation, showing a reduction in the progression risk and higher PSA response rates. CONCLUSIONS: New options for the second-line treatment of renal cancer were presented. In metastatic castration-resistant prostate cancer, various studies have been published on treatment with enzalutamide, which has been shown to delay the symptomatic disease and benefit overall survival.

Treatment trends for clinically localised prostate cancer. National population analysis: GESCAP group. / Tendencias de tratamiento en el cáncer de próstata clínicamente localizado. Análisis poblacional a nivel nacional: grupo GESCAP.

OBJECTIVES: To describe the established therapies for localised prostate cancer (PC) in Spain and to assess compliance with the 2010 UAE guidelines. PATIENTS AND METHODS: This was an epidemiological, observational, prospective and multicentre study. Of the 3,918 patients diagnosed with PC during 2010, only those patients with localised PC were included. Follow-up was ultimately conducted for a minimum of one year from the diagnosis for 3,713 patients (94.77%). The treatment groups assessed were as follows: radical prostatectomy, radiation therapy, hormone therapy, brachytherapy, active surveillance or observation and experimental local treatment (cryotherapy or other treatment). Compliance with the recommendations of the EAU guidelines was studied, describing the treatment groups according to D'Amico risk stratification criteria (localised [low, intermediate and high risk] and locally advanced), age, PSA and Gleason score. RESULTS: By applying the D'Amico criteria, we included 3,641 (92.93%) patients. Based on the UAE recommendations: 1) 68.87% of the patients at low-intermediate risk aged≤65 years underwent radical prostatectomy; 2) 34.51% of the patients>65 years at high risk with locally advanced disease were administered radiation therapy and hormone therapy; 3) 30.36% of the patients at high risk with locally advanced disease were only treated with hormone therapy; 4) 15.20% of the patients at low risk were only treated with brachytherapy; 5) active surveillance or observation was selected for 2.44% of the patients aged≤65 years and for 10.63% of the patients at low-intermediate risk who were>65 years. Lastly, 86.5% of the patients at low risk underwent a single treatment, and 43.62% of the patients at high risk with locally advanced disease underwent combined treatments. CONCLUSIONS: This is the first national European study to evaluate the therapeutic management of localised PC based on the risk group to which the patient belonged. Most young patients (≤65 years) with low-intermediate risk localised PC were treated with surgery, which adheres to the recommendations of the 2010 UAE guidelines. Various therapeutic combinations have been employed for patients with high-risk, locally advanced localised tumours, revealing the need for a multidisciplinary approach (Controlled-trials.com number: ISRCTN19893319).

Adherence to the lymphadenectomy recommendations of the 2009 clinical guidelines in the 2010 National Prostate Cancer Registry.

OBJECTIVE: To assess the adherence to the recommendations of the 2009 clinical guidelines in the implementation of lymphadenectomy during radical prostatectomy and analysis of the variables that influence this decision in the 2010 National Prostate Cancer Registry. MATERIAL AND METHOD: Analysis of 1,272 patients who underwent prostatectomy in 25 national hospitals. Patient classification according to the pathological node-positive (pN+) risk criteria included in the clinical guidelines of the European Association of Urology (EAU) and National Comprehensive Cancer Network (NCCN). Calculation of the raw agreement and index of agreement kappa. Logistic regression to assess the predictors in the decision to perform lymphadenectomy. RESULTS: Lymphadenectomy was performed on 225 (17.7%) patients, with a variability among centers of 0-62.2% (p<.001). There was lymphocytic invasion (pN+) in 17 (7.5%) patients. The raw agreement with the EAU-09 clinical guidelines was .672 (.48-.96 in the various centers), and the kappa index was .289. The raw agreement with the NCCN-09 clinical guidelines was.814 (.51-1 in the various centers), and the kappa index was .228. In the multivariate analysis, the independent predictors for performing lymphadenectomy were the Gleason score, the clinical stage, the prostate-specific antigen, the hospital center and the surgical approach route to prostatectomy (all P<.001). CONCLUSIONS: In our study, adherence to the recommendations of the clinical guidelines on the implementation of lymphadenectomy was moderate. When deciding on lymphadenectomy, the determinants (in addition to the classic clinical variables) were the approach route and the hospital where the prostatectomy was performed.

Drug Cost Avoidance in Prostate Cancer Clinical Trials.

OBJECTIVES: Economic impact of prostate cancer is increasing in relation to its increased incidence and increased patient survival. Clinical trials are essential to evaluate the efficacy and safety of new treatments but may also result in economic benefits by avoiding the cost of the drug. Our objective is to determine the avoided cost in investigational drugs in clinical trials of prostate cancer conducted in a period of 18 years in a tertiary center. MATERIAL AND METHODS: We carried out an observational of prevalence study with retrospective collected data of clinical trials involving currently marketed drugs and cost avoidance during the study period (1996-2013) was calculated. RESULTS: We include in this review five clinical trials on prostate cancer that met selection criteria of 18 performed. All of them were phase III, multicenter, international and with current marketed drugs. 136 patients were included. Total cost avoidance of 696,002€ and an average cost avoidance by clinical trial of 139,200€ were obtained. Average cost avoidance per patient was 5,118€. CONCLUSION: Cost avoidance in investigational drugs is a tangible benefit of clinical trials, whose realization is a source of economic benefits for the hospital, not only by directly generated by each trial. Clinical trials are an exceptional framework for progress in clinical research and real savings for the health system.

Developments in urologic oncology 'OncoForum': The best of 2014.

OBJECTIVE: To review the latest evidence on the oncologic urology of prostate, renal and bladder tumors, analyzing their impact on daily clinical practice and the future medium to long-term regimens. METHODS: We review the abstracts on prostate, renal and bladder cancer presented at the 2014 congresses (European Association of Urology, American Urological Association, American Society of Clinical Oncology and American Society for Radiation Oncology) that received the best evaluations by the OncoForum committee. RESULTS: The committee considered the following messages important: cytoreductive nephrectomy followed by treatment with a tyrosine-kinase inhibitor can significantly increase the overall survival of patients with metastatic renal cancer; for advanced bladder cancer, early adjuvant chemotherapy after cystectomy is preferable because it significantly increases progression-free survival; and several studies have shown that multiparametric magnetic resonance imaging and fusion imaging improve the diagnosis of prostate cancer and provide greater possibilities for placing patients in the appropriate risk group in order to offer them the best treatment possible. The results of the PREVAIL study have demonstrated the efficacy of enzalutamide on the overall survival of men with castration-resistant prostate cancer and metastases, with no prior chemotherapy. The study also demonstrated the drug's favorable safety profile. CONCLUSIONS: Progress is continuing in renal and bladder cancer, improving the approach and clinical results with current therapeutic options. There is constant progress in castration-resistant prostate cancer; in 2014, prechemotherapy treatments were consolidated.

Bone health in patients with prostate cancer.

CONTEXT: In patients with prostate cancer, bone health is compromised by advanced age at diagnosis, androgen suppression treatments and the developmentofbone metastases. In this paper the medical literature is reviewed in order to update the state of the art on their incidence, prevention and management. EVIDENCE ACQUISITION: A literature review about bone involvement in patients with prostate cancer in different clinical settings is performed. SYNTHESIS OF THE EVIDENCE: Decreased bone mineral density is higher in patients diagnosed of prostate cancer before starting treatment than in healthy men with the same age. During the first year of treatment, a severe loss bone density is reported due to androgen suppression therapy. From then on, loss bone density seems to slow down, persisting at long-term. It is important to know the starting point and the dynamics of loss bone in order to prevent its progression. The skeletal events have an important impact on quality of life in patients with prostate cancer. Both Denosumab and Zoledronic Acid have proven effective in reducing loss bone. CONCLUSIONS: The prevention and management of bone involvement in patients with prostate cancer is critical to quality of life in these patients and requires an individualized approach. Before starting a prolonged androgen deprivation, baseline risk of fracture should be evaluated in order to adopt the proper protective measures. In patients with metastases, early treatments reducing the risk of bone events should be taken into account.