INTRODUCTION:Prostate cancer (PCa) remains one of the leading public health challenges among European men. Despite technological advances, its early detection continues to be controversial due to the risk of overdiagnosis and the limited adoption of organized screening programs. MATERIALS AND METHODS:A review was conducted of scientific literature, institutional reports, and technical documentation from the PRAISE-U project. We describe the key components of its design, implementation and lessons learned at two pilot sites in Spain (Galicia and Manresa), with a focus on personalized strategies and operational efficiency. RESULTS:Based on the European Union recommendation of 2022, the PRAISE-U project promotes a risk-based screening program that incorporates prostate-specific antigen (PSA), magnetic resonance imaging (MRI) and risk calculators (RC). Galicia and Manresa have developed screening circuits adapted to their health systems. Galicia has managed to invite 7000 of the 12,000 target men in less than a year, integrating digital tools and direct contact strategies. Manresa, from primary care, has developed a coordinated approach focused on accessibility and traceability. Both models prioritize equity, adherence and minimization of overtreatment. CONCLUSIONS:The PRAISE-U project offers an innovative and adaptable framework for PCa screening in Europe. The Spanish experience demonstrates that it is possible to implement effective and risk-focused early detection programs, provided that there is sound planning, technological tools and a collaborative approach between levels of care.

OBJECTIVE:Non-muscle-invasive bladder cancer (NMIBC) has a high risk of recurrence and requires intensive long-term surveillance. Existing clinical risk models offer limited prognostic accuracy. Molecular urine-based assays may improve prognostic assessment accuracy of future recurrence. This study evaluated whether Digital Uromonitor® (dUM), detecting TERT and FGFR3 mutations via ddPCR, enhances prognostic assessment of two-year recurrence beyond cystoscopy and cytology in a prospective multicenter cohort. METHODS:This prospective, multicenter observational study (EVALUATION-CUETO; NCT05864599) enrolled consecutive NMIBC patients from 26 institutions. Eligible participants had an index tumor diagnosed 3 months-2 years before recruitment and completed two years of follow-up with sufficient DNA for dUM analysis. Clinical, pathological, and biomarker variables (cystoscopy, cytology, dUM) were collected. Recurrence rate was defined as events per year and classified as high (R > 0.5) or low (R ≤ 0.5). RESULTS:Of 201 included patients, 75 (37%) were dUM-positive; TERT promoter mutations accounted for 88% of these cases. dUM showed prognostic value, correctly identifying 59% of recurrences over two years of standardized FU, outperforming cystoscopy alone (42%), with specificity of 74% and NPV of 78%. Combining dUM with cystoscopy increased sensitivity to 71%. Patients negative for both cystoscopy and TERT had the lowest recurrence risk (14%), whereas dual-positive patients exceeded 80%. High baseline recurrence rate consistently increased risk across all biomarker categories. CONCLUSIONS:dUM provides robust, reproducible prognostic information and significantly improves molecular risk stratification in NMIBC. These findings support its potential integration into risk-adapted surveillance strategies, pending validation in larger populations.

Introduction Prostate cancer (PCa) screening based on prostate-specific antigen (PSA) testing has represented a major milestone in early detection; however, it has also prompted considerable debate due to the risks of overdiagnosis and overtreatment. This review examines the evolution of PCa screening, highlighting its main challenges and emerging approaches aimed at achieving more accurate and individualized detection. Methods A narrative review of the literature was conducted using databases such as PubMed and Google Scholar, applying MeSH terms related to screening, overdiagnosis, and prostate cancer. Clinical studies, systematic reviews, and recent guidelines pertinent to the topic were included. Results The PLCO, ERSPC, and Göteborg trials provide complementary insights into the impact of PSA-based screening, with outcomes ranging from limited benefit to significant reductions in PCa-specific mortality. Based on these this findings, a paradigm shift toward risk-stratified screening strategies has been advocated. The incorporation of new tools such as magnetic resonance imaging, blood and urine biomarkers, risk calculators, and artificial intelligence-based algorithms has improved diagnostic accuracy. These strategies reduce unnecessary biopsies and focus on the detection of clinically significant disease. Current guidelines recommend individualized assessment based on factors such as age, baseline PSA levels, family history, and comorbidities. Conclusion The future of PCa screening resides in personalized medicine, in which the integration of clinical, imaging, and molecular parameters will enable a more efficient approach, minimizing unnecessary interventions and improving overall patient outcomes.

PATIENTS AND METHODS:In this multicenter longitudinal study, data from the Spanish Register in AS (AEU-PIEM/2014/0001) were reviewed. The study focused on a cohort of AS patients registered between 2014 and 2019, featuring open inclusion criteria and diverse follow-up strategies. RESULTS:A total of 3315 AS patients were recruited, with 2881 and 434 categorized into the low and intermediate risk groups based on NCCN grouping at inclusion. The median age was 67 years, and only 11% underwent diagnostic biopsy guided by MRI. The median time between follow-up visits was 6.03 months. Over a median follow-up of 62 months (Q1-3: 43.78-85.58), 37% remained in AS, while 8% transitioned to watchful waiting due to aging or intercurrent disease. Death occurred in 199 (6%) of patients, with 3 due to prostate cancer progression and 196 attributed to other causes. At 2 and 5 years, pathological progression-free survival, metastasis-free survival, and active treatment-free survival were 68% and 51%, 99% and 99%, and 70% and 50%, respectively. CONCLUSIONS:Midterm oncological outcomes of AS in Spain align with major international series. We denote underuse of guideline recommendations such as use of MRI or TP Bx for initial PCa characterization. Collaborative efforts are crucial in the search for algorithms, new imaging, or biomarkers to refine indications and transition to active treatments. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02865330.

Introducción: el cribado del cáncer de próstata (CaP) mediante el antígeno prostático específico (PSA) ha marcado un hito en la detección temprana, pero también ha generado controversias por el sobrediagnóstico y el sobretratamiento. Esta revisión analiza la evolución del cribado del CaP, sus desafíos y las estrategias emergentes para una detección más precisa y personalizada.Métodos: Se realizó una revisión narrativa de la literatura en bases de datos como PubMed y Google Scholar, utilizando términos MeSH relacionados con el cribado, sobrediagnóstico y cáncer de próstata. Se incluyeron estudios clínicos, revisiones sistemáticas y guías recientes relevantes al tema.Resultados: Los ensayos PLCO, ERSPC y Göteborg ofrecen perspectivas complementarias sobre el impacto del cribado con PSA, con resultados que varían desde beneficios limitados hasta reducciones significativas en la mortalidad por CaP. A partir de estos datos, se ha promovido un cambio hacia estrategias de cribado estratificadas por riesgo. La incorporación de nuevas herramientas como la resonancia magnética, biomarcadores en sangre y orina, calculadoras de riesgo y algoritmos basados en inteligencia artificial ha mejorado la precisión diagnóstica. Estas estrategias permiten reducir biopsias innecesarias y centrarse en la detección de tumores clínicamente significativos. Las guías actuales recomiendan una evaluación individualizada basada en factores como edad, niveles basales de PSA, antecedentes familiares y comorbilidades.Conclusión: El futuro del cribado del CaP reside en una medicina personalizada, donde la combinación de herramientas clínicas, imagenológicas y moleculares permitirá un abordaje más eficiente, reduciendo daños innecesarios y mejorando los resultados en salud.

Introducción: El cáncer de próstata (CaP) continúa siendo uno de los principales retos de salud pública entre los hombres europeos. A pesar de los avances tecnológicos, su detección temprana aún genera controversia debido al riesgo de sobrediagnóstico y al limitado uso de programas de cribado organizados.Materiales y métodos: Se revisó literatura científica, informes institucionales y documentación técnica del proyecto PRAISE-U. Se describen los elementos clave de su diseño, implementación y los aprendizajes obtenidos en dos sitios piloto en España (Galicia y Manresa), con un enfoque en estrategias personalizadas y eficiencia operativa.Resultados: A partir de la recomendación de la Unión Europea de 2022, el proyecto PRAISE-U impulsa un modelo de cribado basado en riesgo, que incorpora antígeno prostático especifico (PSA), resonancia magnética (RM) y calculadoras de riesgo (CR). Galicia y Manresa han desarrollado circuitos de cribado adaptados a sus sistemas de salud. Galicia ha logrado invitar a 7.000 de los 12.000 hombres objetivo en menos de un año, integrando herramientas digitales y estrategias de contacto directo. Manresa, desde atención primaria, ha desarrollado un enfoque coordinado centrado en accesibilidad y trazabilidad. Ambos modelos priorizan la equidad, la adherencia y la minimización del sobretratamiento.Conclusiones: El proyecto PRAISE-U ofrece un marco innovador y adaptable para el cribado del CaP en Europa. La experiencia española demuestra que es posible implementar programas de detección temprana eficaces y centrados en el riesgo, siempre que existan una planificación sólida, herramientas tecnológicas y un enfoque colaborativo entre niveles asistenciales.

Triple therapy with docetaxel, androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPIs) has demonstrated survival benefits in patients with metastatic hormone-sensitive prostate cancer (mHSPC), especially in those with high-risk disease. However, once the use of ADT and docetaxel is established, guidelines do not clearly specify which ARPI is most appropriate. In this work, a literature review to identify phase III clinical trials, systematic reviews, meta-analyses, and clinical practice guidelines on triple therapy in mHSPC was carried out. Evidence and recommendations were qualitatively reviewed to provide guidelines on the most suitable ARPI based on patient risk, disease volume, and nature of metastases (synchronous or metachronous). This review aims to update the previously published consensus on the optimal pharmacological treatment for mHSPC and to expose the opinions of hospital pharmacy, urology and medical and radiation oncology experts.

El tratamiento estándar del carcinoma de próstata hormonosensible metastásico (CPHSm) es en la actualidad una combinación de terapia de privación androgénica más una terapia dirigida al receptor androgénico (abiraterona, apalutamida, enzalutamida o darolutamida) con o sin quimioterapia (docetaxel). La selección de pacientes adecuados para cada enfoque terapéutico se ha convertido en un factor determinante para garantizar la eficacia y minimizar los efectos secundarios. Este artículo combina la evidencia clínica reciente con la experiencia acumulada de expertos en oncología médica, oncología radioterápica y urología, para proporcionar una visión integral y recomendaciones terapéuticas para el manejo del CPHSm.

The standard treatment for metastatic hormone-sensitive prostate cancer (mHSPC) is now a combination of androgen deprivation therapy plus an androgen receptor-targeted therapy (abiraterone, apalutamide, enzalutamide or darolutamide), with or without chemotherapy (docetaxel). The selection of suitable patients for each therapeutic approach has become a determining factor to ensure efficacy and minimize side effects. This article combines recent clinical evidence with the accumulated experience of experts in medical oncology, radiation oncology and urology, to provide a comprehensive view and therapeutic recommendations for mHSPC.

La triple terapia con docetaxel, la terapia de privación androgénica (TPA) y los inhibidores de la vía del receptor de andrógenos (ARPI) han mostrado beneficios en la supervivencia en el cáncer de próstata hormonosensible metastásico (CPHSm), especialmente en pacientes de alto riesgo. Sin embargo, una vez establecido el uso de la TPA y docetaxel, las guías no especifican claramente qué ARPI es el más adecuado. En este trabajo, se realizó una revisión de literatura identificando ensayos clínicos de fase III, revisiones sistemáticas, metaanálisis y guías de práctica clínica sobre la triple terapia en el CPHSm. Se revisaron cualitativamente la evidencia y las recomendaciones para ofrecer directrices sobre el ARPI más adecuado según el riesgo del paciente, el volumen de la enfermedad y la naturaleza de las metástasis (sincrónicas o metacrónicas). Esta revisión actualiza el consenso previamente publicado sobre la adecuación farmacológica en CPHSm, y refleja la opinión de expertos en farmacia hospitalaria, oncología médica y radioterápica, y urología.

La implantación de prótesis de pene (PP) es una alternativa eficaz para la disfunción eréctil. Aunque inicialmente la cirugía de PP se realizaba en régimen hospitalario, existe una tendencia creciente a realizar el implante de PP en un modelo de cirugía mayor ambulatoria (CMA). El objetivo de este estudio es realizar una revisión sistemática de la literatura para identificar la evidencia disponible sobre la implantación de PP en el marco de la CMA en comparación con el procedimiento realizado en régimen hospitalario.Se realizó una búsqueda en las bases de datos electrónicas PubMed, EMBASE, Cochrane Library y MEDES y en los suplementos no indexados de los congresos científicos para identificar artículos relacionados con la implantación quirúrgica de PP en CMA hasta febrero de 2021. Los términos de búsqueda incluyeron prótesis de pene, disfunción eréctil, cirugía ambulatoria, atención ambulatoria y cirugía.Entre las 171 publicaciones obtenidas (51 en PubMed, 73 en EMBASE, 3 en Cochrane, 2 mediante MEDES y 42 mediante búsqueda manual), se seleccionaron finalmente 5 estudios. No hubo diferencias significativas entre la CMA y el régimen hospitalario en términos del tipo de dispositivo, el abordaje quirúrgico o la ubicación del reservorio. Las tasas de complicaciones observadas en ambos grupos fueron similares. La implantación de PP en régimen de CMA supuso un menor coste que la cirugía en régimen hospitalario y se asoció con tasas aceptables de satisfacción de los pacientes y un adecuado control del dolor.Los estudios demostraron que la implantación de PP en régimen de CMA puede lograr resultados similares en términos de seguridad y satisfacción a la implantación de PP en el régimen hospitalario, pudiendo también reducir los costes y mejorar la eficiencia. Esta investigación podría ayudar a los responsables de la toma de decisiones a extender la cirugía de PP al régimen ambulatorio.Penile prosthesis (PP) implantation is an effective option for erectile dysfunction. Although initially PP surgery was carried out in an inpatient setting, there is a growing trend to implant PP in a major ambulatory surgery (MAS). This study aimed to perform a systematic review of the literature to identify available evidence of the implantation of PP under MAS setting and go carry out a comparison between MAS and inpatient procedures.PubMed, EMBASE, Cochrane Library and MEDES electronic databases and non-indexed supplements for scientific congresses were searched to identify articles related to the surgical implantation of PP in MAS up to February 2021. Key search terms included penile prosthesis, erectile dysfunction, ambulatory surgery, ambulatory care, and surgery.Among 171 publications retrieved (51 PubMed, 73 EMBASE, 3 Cochrane, 2 using MEDES and 42 manual searching), 5 studies were finally selected. There were no significant differences between MAS or inpatient setting in terms of the type of device, surgical approach, or location of reservoir. Complication rates observed in both groups were similar. Implantation of PP in MAS was less expensive than inpatient surgery and was associated with acceptable patient satisfaction rates and adequate pain control.Studies demonstrated that outpatient PP surgery can achieve similar outcomes in terms of safety and satisfaction to implantation of PP in the inpatient setting, while it could reduce costs and improve the efficiency. This research could provide support decision makers to extend PP surgery into the ambulatory setting.

Patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA alterations have poor outcomes. MAGNITUDE found patients with homologous recombination repair gene alterations (HRR+), particularly BRCA1/2, benefit from first-line therapy with niraparib plus abiraterone acetate and prednisone (AAP). Here we report longer follow-up from the second prespecified interim analysis (IA2).Patients with mCRPC were prospectively identified as HRR+ with/without BRCA1/2 alterations and randomized 1 : 1 to niraparib (200 mg orally) plus AAP (1000 mg/10 mg orally) or placebo plus AAP. At IA2, secondary endpoints [time to symptomatic progression, time to initiation of cytotoxic chemotherapy, overall survival (OS)] were assessed.Overall, 212 HRR+ patients received niraparib plus AAP (BRCA1/2 subgroup, n = 113). At IA2 with 24.8 months of median follow-up in the BRCA1/2 subgroup, niraparib plus AAP significantly prolonged radiographic progression-free survival {rPFS; blinded independent central review; median rPFS 19.5 versus 10.9 months; hazard ratio (HR) = 0.55 [95% confidence interval (CI) 0.39-0.78]; nominal P = 0.0007} consistent with the first prespecified interim analysis. rPFS was also prolonged in the total HRR+ population [HR = 0.76 (95% CI 0.60-0.97); nominal P = 0.0280; median follow-up 26.8 months]. Improvements in time to symptomatic progression and time to initiation of cytotoxic chemotherapy were observed with niraparib plus AAP. In the BRCA1/2 subgroup, the analysis of OS with niraparib plus AAP demonstrated an HR of 0.88 (95% CI 0.58-1.34; nominal P = 0.5505); the prespecified inverse probability censoring weighting analysis of OS, accounting for imbalances in subsequent use of poly adenosine diphosphate-ribose polymerase inhibitors and other life-prolonging therapies, demonstrated an HR of 0.54 (95% CI 0.33-0.90; nominal P = 0.0181). No new safety signals were observed.MAGNITUDE, enrolling the largest BRCA1/2 cohort in first-line mCRPC to date, demonstrated improved rPFS and other clinically relevant outcomes with niraparib plus AAP in patients with BRCA1/2-altered mCRPC, emphasizing the importance of identifying this molecular subset of patients.

Androgen deprivation therapy (ADT) is the mainstay treatment for metastatic hormone-sensitive prostate cancer (mHSPC). The addition of docetaxel or new hormone therapies (abiraterone, apalutamide, or enzalutamide) improves overall survival and is currently the standard of care. However, the decision on the specific regimen to accompany ADT should be discussed with the patient, considering factors such as possible associated toxicities, duration of treatment, comorbidities, patient preferences, as there is no sufficient evidence to recommend one regimen over the other in most cases. This paper summarizes the evidence on the management of mHSPC and provides consensus recommendations on the optimal treatment in combination with ADT in mHSPC patients, with special attention to the patient's clinical profile.

TPS209 Background: Multiple lines of evidence suggest a crosstalk between androgen receptor (AR) signaling and DNA damage repair (DDR) in prostate cancer. Co-targeting both pathways in mHNPC can result in a clinically relevant synergistic effect. ZZFIRST trial is evaluating the combination of TALA –a poly(ADP-ribose) polymerase inhibitor– and EZ –an AR signaling inhibitor– in mHNPC patients. Methods: This is a multicenter, open-label, randomized, investigator-initiated phase 2 clinical trial. Men aged ≥18 years with histologically confirmed mHNPC, an ECOG performance status of 0-1, and a prostate-specific antigen (PSA) ≥4 ng/mL at enrolment are eligible. Patients must have not received previous systemic treatment for locally advanced or mHNPC. A total of 54 patients will start treatment with EZ 160 mg/day for 2 28-day cycles in addition to standard androgen-deprivation therapy (ADT). Patients are then randomized and stratified based on homologous recombination gene alterations on a 1:2 ratio to either continue EZ 160 mg/day, or to receive EZ 160 mg/day plus TALA 0.5 mg/day. In both arms, patients will continue ADT throughout the trial. Treatment will continue until progressive disease (PD) or unacceptable toxicity. PSA will be determined every 4 weeks and radiological tumor extend will be assessed at screening and every 8 weeks for the 6 initial months of treatment and every 12 weeks thereafter until PD. Primary endpoint is PSA-complete response defined as the percentage of patients with PSA < 0.2 ng/mL at 12 months of therapy. Secondary endpoints include PSA-complete response at any time point and at month 7, PSA response ( < 4 ng/ml) at 7 and 12 months, PSA-progression-free survival (PSA-PFS), radiologic PFS, time to castration resistance based on PSA-PFS and rPFS, and overall survival. Safety will be assessed as per NCI-CTCAE 5.0. Exploratory endpoints include analysis of transcriptional changes in AR and DDR pathways and assessment of genomic signatures on tumor and liquid biopsies collected at baseline, 4 weeks, and PD. An imaging sub-study of whole-body diffusion weighted MRI will help to further study antitumor activity and drug resistance mechanisms. This trial was opened to accrual in July 2020. Currently 44 patients have been enrolled (with 37 randomized by cycle 3 day 1) out of 54 expected. Analysis will be assessed with the exact binomial test. At least 11 patients must maintain PSA < 0.2 ng/mL by 12 months of therapy among 32 evaluable patients in the combination arm to justify further investigation of this strategy. A drop-out rate of 10% has been considered. Clinical trial information: NCT04332744.