ProsTAV, a clinically useful test in prostate cancer: an extension study.

PURPOSE: To assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa). METHODS: Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center's routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined. RESULTS: The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI. CONCLUSIONS: ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.

ProsTAV, a novel blood-based test for biopsy decision management in significant prostate cancer.

BACKGROUND: Current pathways in early diagnosis of prostate cancer (PCa) can lead to unnecessary biopsy procedures. Here, we used telomere analysis to develop and evaluate ProsTAV®, a risk model for significant PCa (Gleason score >6), with the objective of improving the PCa diagnosis pathway. METHODS: This retrospective, multicentric study analyzed telomeres from patients with serum PSA 3-10 ng/mL. High-throughput quantitative fluorescence in-situ hybridization was used to evaluate telomere-associated variables (TAVs) in peripheral blood mononucleated cells. ProsTAV® was developed by multivariate logistics regression based on three clinical variables and six TAVs. The predictive capacity and accuracy of ProsTAV® were summarized by receiver operating characteristic (ROC) curves and its clinical benefit with decision curves analysis. RESULTS: Telomeres from 1043 patients were analyzed. The median age of the patients was 63 years, with a median PSA of 5.2 ng/mL and a percentage of significant PCa of 23.9%. A total of 874 patients were selected for model training and 169 patients for model validation. The area under the ROC curve of ProsTAV® was 0.71 (95% confidence interval [CI], 0.62-0.79), with a sensitivity of 0.90 (95% CI, 0.88-1.0) and specificity of 0.33 (95% CI, 0.24-0.40). The positive predictive value was 0.29 (95% CI, 0.21-0.37) and the negative predictive value was 0.91 (95% CI, 0.83-0.99). ProsTAV® would make it possible to avoid 33% of biopsies. CONCLUSIONS: ProsTAV®, a predictive model based on telomere analysis through TAV, could be used to increase the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/mL.

Telomere-based risk models for the early diagnosis of clinically significant prostate cancer.

BACKGROUND: The objective of this study was to explore telomere-associated variables (TAV) as complementary biomarkers in the early diagnosis of prostate cancer (PCa), analyzing their application in risk models for significant PCa (Gleason score > 6). METHODS: As part of a larger prospective longitudinal study of patients with suspicion of PCa undergoing prostate biopsy according to clinical practice, a subgroup of patients (n = 401) with PSA 3-10 ng/ml and no prior biopsies was used to evaluate the contribution of TAV to discern non-significant PCa from significant PCa. The cohort was randomly split for training (2/3) and validation (1/3) of the models. High-throughput quantitative fluorescence in-situ hybridization was used to evaluate TAV in peripheral blood mononucleated cells. Models were generated following principal component analysis and random forest and their utility as risk predictors was evaluated by analyzing their predictive capacity and accuracy, summarized by ROC curves, and their clinical benefit with decision curves analysis. RESULTS: The median age of the patients was 63 years, with a median PSA of 5 ng/ml and a percentage of PCa diagnosis of 40.6% and significant PCa of 19.2%. Two TAV-based risk models were selected (TAV models 1 and 2) with an AUC ≥ 0.83 in the full study cohort, and AUC > 0.76 in the internal validation cohort. Both models showed an improvement in decision capacity when compared to the application of the PCPT-RC in the low-risk probabilities range. In the validation cohort, with TAV models 1 and 2, 33% /48% of biopsies would have been avoided losing 0/10.3% of significant PCa, respectively. The models were also tested and validated on an independent, retrospective, non contemporary cohort. CONCLUSIONS: Telomere analysis through TAV should be considered as a new risk-score biomarker with potential to increase the prediction capacity of significant PCa in patients with PSA between 3-10 ng/ml.

Comorbilidad y factores sociodemográficos asociados a litiasis renal en personas de 40 a 65 años: estudio transversal / Comorbidity and socio-demographic factors associated with renal lithiasis in persons aged 40 to 65: A cross-sectional study

Fundamento y objetivo: La litiasis renal es una de las enfermedades urológicas más importantes. Parece estar relacionada con factores sociodemográficos y climáticos, estilos de vida y comorbilidad preexistente. El objetivo de este trabajo fue examinar la relación entre variables sociodemográficas, ciertos factores de riesgo y enfermedades crónicas, y la litiasis renal. Pacientes y método: Se realizó un estudio transversal, seleccionando a población española de 40 a 65 años, combinando 2 muestras aleatorias (PreLiRenA y PreLiRenE). Los datos fueron recogidos por encuestas telefónicas personales, recopilando información sobre variables sociodemográficas y la morbilidad percibida. También se recogieron datos sobre las temperaturas medias anuales en cada región española. Se realizó un análisis bivariado y multivariado. Resultados: Fueron encuestados 4.894 sujetos; el 51,3% eran mujeres; el 25% tenían entre 40 y 45 años; el 36% tenían educación primaria y el 31,4% eran de clase social baja. La prevalencia global de litiasis renal fue del 15,0% (intervalo de confianza al 95% [IC 95%] 14,5-15,5). Por medio del análisis multivariado, las variables que mostraron una fuerte relación estadística con la presencia de litiasis renal fueron: edad avanzada (61-65 años, OR=1,39; IC 95% 1,06-1,8), clase social alta (OR=1,98; IC 95% 1,29-2,62), antecedentes familiares de litiasis renal (OR=2,22; IC 95% 1,88-2,65), hipertensión arterial (OR=1,68; IC 95% 1,39-2,02) y sobrepeso/obesidad (OR=1,31; IC 95% 1,12-1,54). Se observó una correlación entre la litiasis renal y las temperaturas medias anuales en las regiones españolas (r=0,59; p=0,013). Conclusiones: Existe relación entre litiasis renal y edad avanzada, pertenecer a clases sociales altas, existencia de antecedentes familiares de urolitiasis, y tener hipertensión y sobrepeso/obesidad. La prevalencia de la litiasis renal es mayor en las zonas climáticas más cálidas (AU)

Background and objective: Renal lithiasis is one of the most important urological diseases. It seems to be related to different socio-demographic and climatic factors, lifestyle and pre-existing comorbidity. The aim of this study was to examine the relationship between socio-demographic variables, certain risk factors and chronic diseases and the renal lithiasis. Patients and method: A cross-sectional population-based study was carried out, selecting the Spanish population aged from 40 to 65 years, combining 2 random samples (PreLiRenA and PreLiRenE studies). Data were collected by personal telephone surveys, gathering information on socio-demographic variables and perceived morbidity. Data on annual average temperatures in each Spanish region were also collected. A bivariate and multivariate analysis was performed. Results: A total of 4,894 subjects were surveyed; 51.3% were women; 25% were aged 40-45 years, 36% had primary school education and 31.4% were of low social class. The overall prevalence of renal lithiasis was 15.0% (95% confidence interval [95% CI] 14.5-15.5). By means of multivariate analysis, the variables that showed a strong statistical relationship with the presence of renal lithiasis were: older age (61-65 years; OR=1.39; 95% CI 1.06-1.80), high social class (OR=1.98; 95% CI 1.29-2.62), family history of renal lithiasis (OR=2.22; 95% CI 1.88-2.65), high blood pressure (OR=1.68; 95% CI 1.39-2.02) and overweight/obesity (OR=1.31; 95% CI 1.12-1.54). A correlation was observed between renal lithiasis and average annual temperatures in the Spanish regions (r=0.59; P=.013). Conclusions: A relationship was observed between renal lithiasis and older age, belonging to higher social classes, the existence of a family history of urolithiasis, and hypertension and overweight or obesity. The prevalence of renal lithiasis is greater in warmer climate zones (AU)

Comorbidity and socio-demographic factors associated with renal lithiasis in persons aged 40 to 65: A cross-sectional study. / Comorbilidad y factores sociodemográficos asociados a litiasis renal en personas de 40 a 65 años: estudio transversal.

BACKGROUND AND OBJECTIVE: Renal lithiasis is one of the most important urological diseases. It seems to be related to different socio-demographic and climatic factors, lifestyle and pre-existing comorbidity. The aim of this study was to examine the relationship between socio-demographic variables, certain risk factors and chronic diseases and the renal lithiasis. PATIENTS AND METHOD: A cross-sectional population-based study was carried out, selecting the Spanish population aged from 40 to 65 years, combining 2 random samples (PreLiRenA and PreLiRenE studies). Data were collected by personal telephone surveys, gathering information on socio-demographic variables and perceived morbidity. Data on annual average temperatures in each Spanish region were also collected. A bivariate and multivariate analysis was performed. RESULTS: A total of 4,894 subjects were surveyed; 51.3% were women; 25% were aged 40-45 years, 36% had primary school education and 31.4% were of low social class. The overall prevalence of renal lithiasis was 15.0% (95% confidence interval [95% CI] 14.5-15.5). By means of multivariate analysis, the variables that showed a strong statistical relationship with the presence of renal lithiasis were: older age (61-65 years; OR=1.39; 95% CI 1.06-1.80), high social class (OR=1.98; 95% CI 1.29-2.62), family history of renal lithiasis (OR=2.22; 95% CI 1.88-2.65), high blood pressure (OR=1.68; 95% CI 1.39-2.02) and overweight/obesity (OR=1.31; 95% CI 1.12-1.54). A correlation was observed between renal lithiasis and average annual temperatures in the Spanish regions (r=0.59; P=.013). CONCLUSIONS: A relationship was observed between renal lithiasis and older age, belonging to higher social classes, the existence of a family history of urolithiasis, and hypertension and overweight or obesity. The prevalence of renal lithiasis is greater in warmer climate zones.