Determination of Free-PSA (fPSA) and fPSA/PSA-Ratio Using A Point-of-Care Device.

BACKGROUND: Prostate specific antigen (PSA) and free PSA (fPSA) are important tools for diagnosing prostate cancer (PC). Efforts are continuously undertaken to provide more patient-centered healthcare. The application of point-of-care (POC) systems for laboratory analyses represents a step in this direction. Previous investigations on total PSA measurements using a POC system (concile® Ω100 POC reader) showed good concordance with standard laboratory measurements. For the same POC reader a novel system for fPSA was developed. In the current study, we prospectively evaluated the quality of the POC system for fPSA. METHODS: Sixty-four patients undergoing PSA measurements in our outpatient clinic between 06/2015 and 09/2015 were enrolled in the study. We measured total PSA (tPSA) and fPSA with a POC reader system (concile® Ω100) and a standard laboratory system (Siemens Immulite 2000®) and compared the respective results using linear regression analyses for PSA, fPSA, and fPSA/tPSA ratio (%fPSA). RESULTS: The coefficients of determination (r²) for fPSA and %fPSA were 0.85 (p < 0.001) and 0.82 (p < 0.001) in the subgroup with total PSA between 4 and 10 ng/mL. In the subgroup with tPSA ≤ 4 ng/mL, r² for fPSA concile® was 0.55 (p < 0.001) and 0.10 (p = 0.088) for %fPSA. In the subgroup of tPSA > 10 ng/mL the r² for fPSA and %fPSA was 0.50 (p = 0.022) and 0.50 (p = 0.022), respectively. CONCLUSIONS: The POC fPSA values correlated well with the laboratory analyses, specifically in the clinically relevant diagnostic range of tPSA 4 - 10 ng/mL. These results complement the tPSA data obtained previously and indicate the reliability of the fPSA method and the resulting %fPSA score.

Inmunotherapy in prostate cancer / Inmunoterapia en cáncer de próstata

Prostate cancer (PCa) is the second most commonly diagnosed cancer. Although systemic chemotherapeutic agents, such as cabazitaxel, abiraterone and enzalutamde have become available to patients over the last decade, metastatic PCa is still an incurable disease. Immunotherapy is showing great promise in a wide range of other cancer types. To this day, the only immunotherapy approved by the FDA for PCa is the Sipuleucel-T vaccine, which showed significant clinical efficacy. Multiple clinical studies on immunotherapy in PCa are currently underway. Objectives: Recent clinical trials have shown promising results in immunotherapeutic in treatment for PCa. The authors review previous clinical trials, as well as discuss and emphasize important emerging immunotherapies for PCa. Methods: Review of the published evidence related to immunotherapy in PCa. PubMed and clinicaltrials.gov databases were used to search for English papers and clinical trials. Results: Multiple clinical trials are testing different immunotherapeutic agents, as well as combinations thereof. The low grade of toxicity associated with these immunotherapies is an appealing advantage for patients, leading to an increased appreciation of theses types of treatments. Until now, only one clinical trial led to a new immunotherapeutic agent to be FDA approved. Important phase II/III clinical trials are being conducted, and in the near future the concept of PCa treatment might be re-challenged. Conclusions: Many trials are ongoing to determine the effects of immunotherapy in PCa. These studies may harvest important confirmatory data in the next years, with the potential to reshape PCa treatment

El cáncer de próstata (CaP) es el segundo cáncer más frecuente. Aunque durante la última década se han hecho disponibles agentes quimioterápicos como Cabazitaxel, Abiraterona y Enzalutamida, el CaP metastásico es todavía una enfermedad incurable. La inmunoterapia está mostrándose muy prometedora en un amplio rango de cánceres de otro tipo. Hasta la fecha, la única inmunoterapia aprobada por la FDA para el CaP es la vacuna Sipuleucel-T, que demostró eficacia clínica significativa. Actualmente, hay múltiples ensayos clínicos de inmunoterapia en CaP en marcha. Objetivos: Ensayos clínicos recientes han mostrado resultados prometedores de la inmunoterapia en CaP. Los autores revisan los ensayos clínicos previos y también discuten y enfatizan importantes tratamientos inmunoterapéuticos emergentes en CaP. MÉTODOS: Revisión de la evidencia publicada relacionada con inmunoterapia en CaP. Se utilizaron las bases de datos PubMed y clinicaltrials.gov para buscar artículos en inglés y ensayos clínicos. Resultados: Múltiples ensayos clínicos están evaluando diferentes agentes inmunoterapicos, así como combinaciones. El bajo grado de toxicidad asociado con estas inmunoterapias es una ventaja atractiva para los pacientes, que conduce a un aumento de la valoración de este tipo de tratamientos. Hasta ahora, solamente un ensayo clínico ha llevado a la aprobación por la FDA de un nuevo agente inmunoterapico. Se están llevando a cabo importantes ensayos clínicos fase II/III, y en un futuro próximo el concepto de tratamiento del CaP podría ser desafiado de nuevo. Conclusiones: Están en marcha muchos ensayos clínicos para determinar los efectos de la inmunoterapia en CaP. Estos estudios pueden obtener importantes datos confirmatorios en los próximos años, con el potencial de redefinir el tratamiento del CaP