Free Antigen Research Articles

Evaluation of endocrine therapy combined with intensity modulated radiation therapy in patients with advanced prostate cancer

Abstract Objective The aim of this study was to study the effect of endocrine therapy combined with intensity-modulated radiation therapy in patients with advanced prostate cancer. Methods The clinical data of 231 patients with advanced prostate cancer treated with radiotherapy in our hospital from May 2010 to March 2018 were collected. A total of 135 patients were treated with endocrine therapy combined with intensity-modulated radiotherapy, and 96 patients were treated with intensity-modulated radiotherapy only because of drug allergy, serious adverse reactions, and economic reasons. Two months after the end of the treatment, the short-term curative effect was evaluated using imaging reexamination. The total prostate-specific antigen (TPSA) and free prostate-specific antigen (FPSA) were detected before and 2 months after the end of the treatment. All patients were followed up for at least 3 years, and the metastasis-free survival rate and cumulative survival rate of the two groups were calculated. Results The remission rates (RRs) of the observation and control groups were 64.45% and 46.87%, respectively; the difference was not statistically significant (P > 0.05); however, the efficacy distribution of the endocrine therapy combined with intensity-modulated radiotherapy group was significantly better than that of the intensity-modulated radiotherapy group (P < 0.05). There was no significant difference in clinical efficacy between the two groups in different TNM stages and Gleason grades. After treatment, the levels of TPSA and FPSA were significantly decreased compared with those before treatment; however, the decrease in the endocrine therapy combined with the intensity-modulated radiation therapy (IMRT) group was significantly higher than that in the IMRT group (P < 0.05). Although there were no significant differences in the 1-year and 3-year cumulative survival rates between the two groups, the 1-year and 3-year metastasis-free survival rates of the endocrine therapy combined with the IMRT group were 60% and 38.17%, respectively, which were significantly higher than those of the IMRT group (37.5% and 20.83%, P < 0.05). Conclusion Endocrine therapy combined with IMRT significantly improved the clinical efficacy of advanced prostate cancer, reduced PSA (prostate specific antigen) levels, and improved the metastasis-free survival rates.

Serum Total and Free Prostate Specific Antigen Levels as Novel Biomarker in Patients with COVID-19

Objectives: This study aimed to evaluate the diagnostic value of TPSA and FPSA for early detection of COVID-19 and compare it with a control group. Methods: This is a retrospective study of 146 patients from the Respiratory Clinic in Sebha city, 73 of whom have COVID-19 PCR-confirmed and 73 who do not have COVID-19 (group control). Results: The mean and standard division age in the PCR-confirmed COVID-19 group was 61.51±16.40. In the PCR-confirmed COVID-19 group, the mean and standard division serum biomarker level for TPSA was 0.51±.26 ng/ml, and 0.57± 0.32 for FPSA. Conclusion: For the biomarkers TPSA and FPSA, there were no significant differences between the control and PCR-confirmed COVID-19 groups. These findings suggest that the tumor biomarker may be ineffective in detecting COVID-19.

Retrospective observation of the efficacy and safety of prostatic artery embolization combined with transurethral resection of the prostate and simple transurethral resection of the prostate in the treatment of large (> 100mL) benign prostatic hyperplasia.

To retrospectively compare the efficacy and safety of prostatic artery embolization (PAE) combined with transurethral resection of the prostate (TURP) and simple TURP in treating large (> 100mL) benign prostatic hyperplasia (BPH). We retrospectively analyzed the clinical data of 13 and 17 patients with large BPH who underwent TURP and PAE + TURP, respectively, from January 2016 to January 2020. The changes in various indices before and after surgery were compared between the two groups. In the PAE + TURP group, the operation time (OT), intraoperative blood loss (BL), postoperative bladder flushing time (PBFT), and postoperative catheter retention time (PCRT) were lower, and the speed of the excised lesion (SEL) was higher than that in the TURP group (P < 0.05). Following-up for 12months, the prostatic volume (PV), maximum urinary flow rate (Qmax), postvoid residual volume (PVR), International Prostate Symptom Score (IPSS), quality of life (QoL) score, total prostate-specific antigen (T-PSA), and free prostate-specific antigen (F-PSA) in each group improved as compared to before the surgery (P < 0.05), and the above improved indicators, IPSS ratio, and obstructive symptoms in the PAE + TURP group were higher than those in the TURP group (P < 0.05). The incidence of postoperative complications in the PAE + TURP group was lower than that in the TURP group. We obtained the pathological picture of a prostate biopsy after PAE for the first time. Compared to TURP alone, PAE + TURP should be promoted, because of its greater efficacy and safety in treating large BPH and fewer post-surgical complications.

The Percentage of [-2]Pro-Prostate-Specific Antigen and the Prostate Health Index Outperform Prostate-Specific Antigen and the Percentage of Free Prostate-Specific Antigen in the Detection of Clinically Significant Prostate Cancer and Can Be Used as Reflex Tests.

There is a need to avoid the overdiagnosis of prostate cancer (PCa) and to find more specific biomarkers. To evaluate the clinical utility of [-2]pro-prostate-specific antigen ([-2]proPSA) derivatives in detecting clinically significant PCa (csPCa) and to compare it with prostate-specific antigen (PSA) and with the percentage of free PSA (%fPSA). Two hundred thirty-seven men (PSA: 2-10 ng/mL) scheduled for a prostate biopsy were enrolled. Parametric and nonparametric tests, receiver operating characteristic curves, and logistic regression analysis were applied. Outcomes were csPCa and overall PCa. Both [-2]proPSA derivatives were significantly higher in csPCa and overall PCa (P < .001). The areas under the curves for the prediction of csPCa were higher for the percentage of [-2]proPSA (%[-2]proPSA) (0.781) and the prostate health index (PHI) (0.814) than for PSA (0.651) and %fPSA (0.724). There was a gain of 11% in diagnostic accuracy when %[-2]proPSA or PHI were added to a base model with PSA and %fPSA. Twenty-five percent to 29% of biopsies could have been spared with %[-2]proPSA (cutoff: ≥1.25%) and PHI (cutoff: ≥27), missing 10% of csPCas. The same results could have been achieved by using [-2]proPSA as a reflex test, when %fPSA was 25% or less (cutoffs: ≥1.12% and ≥24 for %[-2]proPSA and PHI, respectively). The [-2]proPSA derivatives improve the diagnostic accuracy of csPCa when the PSA value is between 2 and 10 ng/mL, sparing unnecessary biopsies and selecting patients for active surveillance. [-2]proPSA can be used as a reflex test when %fPSA is 25% or less, without reducing the diagnostic accuracy for csPCa and the number of spared biopsies.

Serum gonadotropins, cortisol, PSA, and micronutrient levels among men with prostate carcinoma

BackgroundProstate cancer (PrCa) is a malignant tumour of the prostate that has many associated risk factors. There is continuous rise in the incidence among adult blacks which is a reflection of racial differences in testosterone concentrations.MethodsThe study involves 50 PrCa patients attending or referred to two tertiary health Institutions and 25 healthy men as controls. Weight and height of participants were measured, and body mass index (BMI) was calculated. Ten millilitres of venous blood sample was collected from each participant, allowed to clot, and then centrifuged at 5000 rpm for 5 min at room temperature (22–28 °C) to obtain the serum. Serum cortisol, testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), total prostate-specific antigen (TPSA), free prostate-specific antigen (FPSA), selenium, copper, magnesium, and zinc were determined. Prostate ultrasonography and biopsy were also done for histopathological studies.ResultFrom this study, a significant increase (p < 0.05) in weight, BMI, serum FPSA, TPSA, and copper; a non-significant increase (p > 0.05) in serum cortisol, testosterone; a significant decrease (p < 0.05) in serum LH, selenium, zinc, and magnesium; and a non-significant decrease (p > 0.05) in serum FSH were observed among people living with PrCa when compared to the controls. However, no significant difference (p > 0.05) was observed in the height between the two groups. Ultrasonography and histology revealed evidence of prostatitis, hypertrophy, and carcinoma among the test group.ConclusionIt can be concluded that PrCa is associated with increase serum cortisol, testosterone, and copper; and decreased serum LH, FSH, selenium, zinc, and magnesium concentrations and combination of biochemical, ultrasonographic, and histologic features are of diagnostic importance.

Applying Chitosan-Modified Nanoemulsion in Nasal Vaccine Delivery

To prepare a chitosan-modified cationic nanoemulsion that could be used to prolong the residence time of nasal vaccines in the nasal cavity and improve the cellular uptake efficiency so as to enhance the immune efficacy of nasal vaccines. A nanoemulsion-based vaccine coated with chitosan was prepared, and the particle size, potential, antigen encapsulation efficiency, stability as well as cytotoxicity were examined. The uptake efficiency of vaccine on different cells and the residence time of vaccine in the nasal cavity were measured. Finally, nasal vaccine was administered on mice and the antibody levels in the serum and in the nasal lavage fluids of the immunized mice were examined. The nanoemulsion-based vaccine had an average particle size of (167.2±0.75) nm, a polydispersity index (PDI) of 0.21±0.01, and an average potential of (13.7±0.85) mV. The encapsulation efficiency of antigen was 92.7%. The nanoemulsion-based vaccine had good stability and did not show obvious cytotoxicity in Madin-Darby canine kidney (MDCK) epithelial cells. The vaccine demonstrated relatively high cellular uptake of antigens on DC2.4 and MDCK cells at (49.7±3.45)% and (59.7±2.19)%, respectively. Besides, the cationic nanoemulsion also significantly increased the residence time of the antigen, and a considerable amount of nanoemulsion-based vaccine was found remaining in the nasal cavity 60 minutes after administration. Compared with free antigen and the nanoemulsion without chitosan modification, the chitosan-modified nanoemulsion vaccine induced higher systemic and mucosal antibody levels in mice after nasal immunization ( P<0.01). The chitosan-modified nanoemulsion vaccine prepared in the study can enhance the immune efficacy of nasal vaccines, showing great potential to be used as a delivery carrier for nasal vaccines.

The European Biological Variation Study (EuBIVAS): a summary report.

Biological variation (BV) data have many important applications in laboratory medicine. Concerns about quality of published BV data led the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) 1st Strategic Conference to indicate need for new studies to generate BV estimates of required quality. In response, the EFLM Working Group on BV delivered themulticenter European Biological Variation Study (EuBIVAS). This review summarises the EuBIVAS and its outcomes. Serum/plasma samples were taken from 91 ostensibly healthy individuals for 10 consecutive weeks at 6 European centres. Analysis was performed by Siemens ADVIA 2400 (clinical chemistry), Cobas Roche 8000, c702 and e801 (proteins and tumor markers/hormones respectively), ACL Top 750 (coagulation parameters), and IDS iSYS or DiaSorin Liaison (bone biomarkers). A strict preanalytical and analytical protocol was applied. To determine BV estimates with 95% CI, CV-ANOVA after analysis of outliers, homogeneity and trend analysis or a Bayesian model was applied. EuBIVAS has so far delivered BV estimates for 80 different measurands. Estimates for 10measurands (non-HDL cholesterol, S100-β protein, neuron-specific enolase, soluble transferrin receptor, intact fibroblast growth-factor-23, uncarboxylated-unphosphorylated matrix-Gla protein, human epididymis protein-4, free, conjugated and %free prostate-specific antigen), prior to EuBIVAS, have not been available. BV data for creatinine and troponin I were obtained using two analytical methods in each case. The EuBIVAS has delivered high-quality BV data for a wide range of measurands. The BV estimates are for many measurands lower than those previously reported, having an impact on the derived analytical performance specifications and reference change values.

Multi-antigen vaccination with LPD nanoparticles containing rgp63 and rLmaC1N proteins induced effective immune response against leishmaniasis in animal model

An effective Leishmania vaccine must induce strong Th1 immune responses and generate long-term effectiveness in the host. To date, most designated anti-Leishmania vaccines have shown poor efficacy in clinical studies. One of the most effective approaches in enhancing the efficacy of vaccines to generate protective immunity is the use of multiple distinct antigens in a single vaccination regimen. For this reason, we investigated the immunogenicity and protective efficacy of liposomal formulation composed of DOTAP:Cholesterol, protamine and CpG ODNs (LPD NPs) containing rLmaC1N and rgp63 recombinant proteins (LPD-rLmaC1N/rgp63) as an effective vaccine. Then, we have investigated the immunogenicity and protective efficacy of LPD-rLmaC1N/rgp63 in experimental animal model of cutaneous leishmaniasis compared to free antigens. Our study showed that mice immunization with LPD-rLmaC1N/rgp63 significantly activates Th1 immune response and enhances IFN-γ production and IgG2a levels. Notably, LPD-rLmaC1N/rgp63 immunization greatly reduced the number of live parasites in the spleen and footpads of immunized mice compared to other vaccinated groups. As well, the thickness of footpad was remarkably smaller in mice immunized with LPD-rLmaC1N/rgp63. In conclusion, our study indicated that LPD-rLmaC1N/rgp63 could be regarded as a promising multiple-antigen candidate vaccine compared to single antigen counterparts to generate protective immunity against leishmaniasis. The potential advantages of this formulation may warrant further investigation.

In-Situ Detection of Saliva Cortisol with Cu-MOF Catalyst Integrated-Antibody Based on Portable E-Eye

In-Situ Detection of Saliva Cortisol with Cu-MOF Catalyst Integrated-Antibody Based on Portable E-Eye

Dihydrotestosterone and Free/Total Prostatic Specific Antigen Ratio in Diagnosis and Prognosis of Prostatic Disease

Background: Both benign prostatic hyperplasia (BPH) and prostate cancer (Pca) include prostate enlargement. The second most common cancer among men worldwide is prostate cancer. It has been documented that by the time they reach their 60s, most men will experience benign prostatic hyperplasia. There is a real difficulty differentiating between benign prostatic hyperplasia and prostate cancer, the prostatic specific antigen (PSA) is not used as a reliable marker of prostate cancer. It is a specific biomarker measure specific to prostate tissues and not prostate cancer. Aims In the analysis of the gray zone of tPSA (4-10 ng/ml), add these biochemical markers and differentiate the root cause of prostate tumor in order to minimize painful and intrusive prostate biopsy. Materials and Methods: A cross-sectional and case control study. It included 110 patients ages range (45-81 years) with benign prostatic hyperplasia (n=55) and prostate cancer (n=55). Forty -five apparently healthy subjects were also included as controls. Peripheral blood samples from controls and patients were collected before obtaining a prostatic biopsy from patients. Serum samples were used for measurements of total Prostate Specific Antigen (tPSA), Free Prostate Specific Antigen (fPSA), and Dihydrotestosterone (DHT) by using ELISA technique. Result: Mean (±SD) serum tPSA and fPSA values for Pca were substantially improved compared to both BPH and control (p=0.001 for all), while mean fPSA/tPSA values for PCa were significantly decreased compared to BPH and control values (p=0.001). In PCa, the mean +SD value of the DHT ratios was significantly lower than in each BHP, and controls (P&lt;0.001) were significantly lower in PCa than in each BHP and regulation (P&lt;0.001). The mean DHT values for BPH were significantly higher as compared to control values (p&lt; 0.001). Conclusion: The level of serum tPSA is 4.2 ng/ml for prostate tumor screening, while 10.1 ng/ml for PCa and BPH differentiation.

Predictive value of standard serum markers for bone metastases in prostate cancer

BackgroundThe early detection of bone metastases is very important in prostate cancer follow-up. This study aimed to compare conventional tumor markers, namely free prostate-specific antigen (free PSA), total prostate-specific antigen (total PSA), free PSA/total PSA ratio, alkaline phosphatase (ALP) values, Gleason scores and 99 m Tc-MDP bone scintigraphy findings in the prediction of bone metastases in prostate cancer.MethodsIn total, 175 patients with prostate cancer who underwent whole-body bone scintigraphy were included in the study. All selected scintigraphic studies were reprocessed. Free PSA, total PSA, free PSA/total PSA ratio, alkaline phosphatase (ALP) values and Gleason scores of patients were recorded.ResultsThe results of our study show that the presence of bone metastasis correlates very weakly with free PSA/total PSA ratio (rho = 0.179), weakly with total PSA (rho = 0.318) and Gleason score (rho = 0.382), moderately with ALP (rho = 0.539), free PSA (0.416). Only ALP variable had a diagnostic value and ALP cutoff value was 76.50 IU/L, with 80% sensitivity and 82.1% specificity.ConclusionAccording to the results of our study; the free PSA, total PSA, free PSA/total PSA ratio and Gleason score values were not considered as a reliable parameter in the prostate cancer cases follow-up for bone metastasis development. Only ALP had a diagnostic value and ALP cutoff value was 76.50 IU / L with 80% sensitivity and 82.1% specificity in predicting bone metastases in prostate cancer.

Evaluation of the hemostatic capacity of methylene blue-treated liquid (not frozen) plasma stored up 14 days at 2° to 6°C.

Early plasma transfusion for management of bleeding, particularly trauma, is associated with better outcomes. Improving the availability/safety of plasma transfusion for patients is essential for transfusion services. The aim of this study is to evaluate the hemostatic capacity of methylene-blue (MB) liquid (not frozen) plasma over time. Twenty whole blood-derived plasma units collected from male donors were separated and processed within 18 h of collection. Individual plasmas were treated with MB and stored in liquid status at 2-6°C for 14 days. A range of coagulation assays, including thrombin generation, rotational thromboelastometry (ROTEM), and Thrombodynamics were tested at different time-points, together with bacterial growth. Apart from Factor (F)XII, other coagulation factors (fibrinogen, FV, FVIII, FXI) reduced significantly after MB treatment, with levels remaining stable except for FVIII afterward. By day 14, most clotting factors were >0.7IU/ml, apart from FVIII. There was a disproportionate decrease in Protein S (PS) activity compared to free PS antigen and by day 14 its value was ~50%. There was no significant difference in maximum clot formation (ROTEM) and clot-density (Thrombodynamics) over time. Endogenous thrombin potential (Thrombin-Generation), clot-size, and velocity index (Thrombodynamics) decreased significantly over time consistent with clotting factor reduction. There was no bacterial growth. MB-treated liquid plasma stored at 2-6°C can be used for up to 14 days: the long shelf-life, the liquid status, and the MB treatment will improve its availability for management of bleeding as well as providing a safe component from pathogens.

Detection of N,N-diacetyllactosamine (LacdiNAc) containing free prostate-specific antigen for early stage prostate cancer diagnostics and for identification of castration-resistant prostate cancer patients

Prostate cancer (PCa) is one of the most common cancer types among men and also acommon cause of death globally. With an increasing incidence, there is aneed for low-cost, reliable biomarkers present in samples, which could be provided non-invasively (without a need to perform prostate biopsy). Glycosylation changes of free-PSA (fPSA) are considered cancer-specific, while the level of different PSA forms can increase under other than cancerous conditions. In the present study, we investigated the role ofN,N-diacetyllactosamine (LacdiNAc) epitope of fPSA (i.e. glycoprofile of fPSA or gPSA) in combination with total-PSA (tPSA), prostate volume, and tPSA density (tPSA level divided by prostate volume i.e. PSAd) as biomarkers for monitoring of PCa development and progression in 105 men. Furthermore, we applied an genetic (evolutionary) algorithm to identify any suspicious individuals in abenign cohort having benign prostatic hyperplasia (BPH). We identified 3 suspicious men originally diagnosed with BPH using gPSA analysis. In thefollow-up we found out that two men should not be considered as BPH patients since multiparametric magnetic resonance imaging (mpMRI) identified one man with clinically significant PCa via Prostate Imaging – Reporting and Data System (PI RADS v2 = 4) and the second man was with High-gradeprostatic intraepithelial neoplasia (HG PIN), commonly described as apre-cancerous stage. Moreover, in the study we described for the first time that changed LacdiNAc on PSA can be applied to identify prostatitis patients and most importantly this is the first study suggesting that changed glycosylation on PSA can be applied to identify castration-resistant prostate cancer (CRPCa) patients.

Vaccine Efficacy of Self-Assembled Multimeric Protein Scaffold Particles Displaying the Glycoprotein Gn Head Domain of Rift Valley Fever Virus.

Compared to free antigens, antigens immobilized on scaffolds, such as nanoparticles, generally show improved immunogenicity. Conventionally, antigens are conjugated to scaffolds through genetic fusion or chemical conjugation, which may result in impaired assembly or heterogeneous binding and orientation of the antigens. By combining two emerging technologies—i.e., self-assembling multimeric protein scaffold particles (MPSPs) and bacterial superglue—these shortcomings can be overcome and antigens can be bound on particles in their native conformation. In the present work, we assessed whether this technology could improve the immunogenicity of a candidate subunit vaccine against the zoonotic Rift Valley fever virus (RVFV). For this, the head domain of glycoprotein Gn, a known target of neutralizing antibodies, was coupled on various MPSPs to further assess immunogenicity and efficacy in vivo. The results showed that the Gn head domain, when bound to the lumazine synthase-based MPSP, reduced mortality in a lethal mouse model and protected lambs, the most susceptible RVFV target animals, from viremia and clinical signs after immunization. Furthermore, the same subunit coupled to two other MPSPs (Geobacillus stearothermophilus E2 or a modified KDPG Aldolase) provided full protection in lambs as well.

Verification of Harmonization of Serum Total and Free Prostate-Specific Antigen (PSA) Measurements and Implications for Medical Decisions.

Previous studies have shown that the harmonization of prostate-specific antigen (PSA) assays remained limited even after the introduction of WHO International Standards. This information needs updating for current measuring systems (MS) and reevaluation according to established analytical performance specifications (APS) and the characteristics of antibodies used. Total (tPSA) and free (fPSA) PSA were measured in 135 and 137 native serum samples, respectively, by Abbott Alinity i, Beckman Access Dxl, Roche Cobas e801, and Siemens Atellica IM MSs. Passing-Bablok regression and difference plots were used to compare results from each MS to the all-method median values. Agreement among methods was evaluated against APS for bias derived from biological variation of the 2 measurands. The median interassay CV for tPSA MSs (11.5%; 25-75th percentiles, 9.2-13.4) fulfilled the minimum APS goal for intermethod bias (15.9%), while the interassay CV for fPSA did not [20.4% (25-75th percentiles, 18.4-22.7) vs goal 17.6%]. Considering the all-method median value of each sample as reference, all tPSA MSs exhibited a mean percentage bias within the minimum goal. On the other hand, Alinity (+21.3%) and Access (-24.2%) were out of the minimum bias goal for fPSA, the disagreement explained only in minimal part by the heterogeneity of employed antibodies. The harmonization among tPSA MSs is acceptable only when minimum APS are applied and necessitates further improvement. The marked disagreement among fPSA MSs questions the use of fPSA as a second-level test for biopsy referral.

Impact of early hypothalamic-pituitary-gonadal axis maturation on prostate cancer:Cross-sectional analysis of a Veterans Affairs cohort.

255 Background: Early onset of puberty, resulting in more prolonged exposure to higher androgen levels, has been hypothesized to be a risk factor for more aggressive prostate cancer (PCa) later in life. We sought to determine whether earlier age of first shave and height, as surrogates of pubertal onset, were associated with worsening PCa characteristics. Methods: A prospectively collected registry of patients presenting for a prostate biopsy at the Charlie Norwood Veterans Affairs Medical Center in Augusta, GA between July 1995 and June 2016 was utilized. Age of first shave and height were compared to the risk of cancer on prostate biopsy, high grade cancer (i.e. Gleason score 8 or higher), and high volume disease (i.e. at least 50% of total cores were positive) using univariable and multivariable logistic regression analysis, controlling for patient age, race, prostate specific antigen, percent free prostate specific antigen, clinical stage, prostate volume, body mass index, family history. Statistical significance was set at p &lt; 0.05 and all statistical analyses were performed using R version 3.6.1. Results: Of the 1,176 patients analyzed, 599 (50.9%) had a cancer on prostate biopsy, of which 141 (23.5%) and 194 (32.4%) had high grade and volume disease, respectively. Median age of first shave was 17.0 years (interquartile range 16.0-19.0) and height was 177.8 cm (172.7-182.9). On multivariable analysis, later age of first shave was significantly associated with increased odds of a positive prostate biopsy (odds ratio for &gt; 18 years versus &lt; 16 years: 5.36, p = 0.03) and taller patients had significantly increased odds of high-grade cancer (odds ratio for 175-180 cm versus &lt; 175 cm 7.41, p = 0.038). Conclusions: Among patients presenting for a prostate biopsy, those with a later age of first shave and taller height had an increased risk of a positive prostate biopsy and high-grade PCa, respectively. This suggests that patients with later age of puberty, and thus later testosterone surges, are at increased risk of overall and high-grade PCa. [Table: see text]

Integrating inflammatory serum biomarkers into a risk calculator for prostate cancer detection

Improved prostate cancer detection methods would avoid over-diagnosis of clinically indolent disease informing appropriate treatment decisions. The aims of this study were to investigate the role of a panel of Inflammation biomarkers to inform the need for a biopsy to diagnose prostate cancer. Peripheral blood serum obtained from 436 men undergoing transrectal ultrasound guided biopsy were assessed for a panel of 18 inflammatory serum biomarkers in addition to Total and Free Prostate Specific Antigen (PSA). This panel was integrated into a previously developed Irish clinical risk calculator (IPRC) for the detection of prostate cancer and high-grade prostate cancer (Gleason Score ≥ 7). Using logistic regression and multinomial regression methods, two models (Logst-RC and Multi-RC) were developed considering linear and nonlinear effects of the panel in conjunction with clinical and demographic parameters for determination of the two endpoints. Both models significantly improved the predictive ability of the clinical model for detection of prostate cancer (from 0.656 to 0.731 for Logst-RC and 0.713 for Multi-RC) and high-grade prostate cancer (from 0.716 to 0.785 for Logst-RC and 0.767 for Multi-RC) and demonstrated higher clinical net benefit. This improved discriminatory power and clinical utility may allow for individualised risk stratification improving clinical decision making.

A novel robust nomogram based on peripheral monocyte counts for predicting lymph node metastasis of prostate cancer.

Accurate methods for identifying pelvic lymph node metastasis (LNM) of prostate cancer (PCa) prior to surgery are still lacking. We aimed to investigate the predictive value of peripheral monocyte count (PMC) for LNM of PCa in this study. Two hundred and ninety-eight patients from three centers were divided into a training set (n = 125) and a validation set (n = 173). In the training set, the independent predictors of LNM were analyzed using univariate and multivariate logistic regression analyses, and the optimal cutoff value was calculated by the receiver operating characteristic (ROC) curve. The sensitivity and specificity of the optimal cutoff were authenticated in the validation cohort. Finally, a nomogram based on the PMC was constructed for predicting LNM. Multivariate analyses of the training cohort demonstrated that clinical T stage, preoperative Gleason score, and PMC were independent risk factors for LNM. The subsequent ROC analysis showed that the optimal cutoff value of PMC for diagnosing LNM was 0.405 × 109 l−1 with a sensitivity of 60.0% and a specificity of 67.8%. In the validation set, the optimal cutoff value showed significantly higher sensitivity than that of conventional magnetic resonance imaging (MRI) (0.619 vs 0.238, P < 0.001). The nomogram involving PMC, free prostate-specific antigen (fPSA), clinical T stage, preoperative Gleason score, and monocyte-to-lymphocyte ratio (MLR) was generated, which showed a robust predictive capacity for predicting LNM before the operation. Our results indicated that PMC as a single agent, or combined with other clinical parameters, showed a robust predictive capacity for LNM in PCa. It can be employed as a complementary factor for the decision of whether to conduct pelvic lymph node dissection.

Prostate-specific antigen and free prostate-specific antigen/prostate-specific antigen ratio in patients with benign prostatic hyperplasia and prostate cancer

Background: Prostate cancer is one of the most common cancers in men, worldwide. Many markers are suggested for prostate cancer with different specificity and sensitivity. Objectives: This study is aimed is to examine the possible utility of prostate-specific antigen indices as markers of prostate cancer. Methods: A case-control study was conducted in the Department of Chemistry and Biochemistry, College of Medicine, Al-Nahrain University, Baghdad, Iraq from July 2018 till March 2019, includes 84 subjects divided into three groups: twenty-four patients with prostate cancer (PCA), thirty patients with benign prostatic hyperplasia (BPH) and thirty healthy subjects as a control group were examined in this study. Blood samples from all participants were collected, and before obtaining a prostatic biopsy from patients. Serum prostate-specific antigen (PSA) and free prostate-specific antigen (fPSA) levels were quantified by the ELISA technique. Results: PSA cut-off value was found to be more than 9.57 ng/ml for PCA patients, values range between 3.17–9.57 ng/ml for BPH patients and cut-off value for control was found to be less than 3.17 ng/ml, while serum (fPSA/PSA)% cut-off value was less than 11.1% for PCA patients, values range between 11.1%—31 % for BPH patients, and cut-off value was greater than 31% for the control group. Conclusion: There is a highly significant difference in serum PSA levels and (fPSA/PSA)% between the PCA and control groups. Body mass index showed an inverse association with the risk of prostate cancer.

Research and discussion on the evaluation scheme of reagent lot‐to‐lot differences in 16 chemiluminescence analytes, established by the EP26‐A guidelines of the CLSI

BackgroundVerification of new reagent lots is a part of the crucial tasks in clinical laboratories. The Clinical and Laboratory Standards Institute (CLSI) EP26‐A guideline provides laboratories with an evaluation method for reagent verification. The purpose of this study was to compare the performance of EP26‐A with our laboratory reagent lot verification protocol and get the final scheme.Method16 chemiluminescence analytes including estradiol (E2), progesterone (P), ferritin (FER), cortisol (COR),carbohydrate antigen 153 (CA153), and free prostate‐specific antigen (FPSA). were prospectively evaluated in two reagent lots. The laboratory's lot verification process included evaluating 5 patient samples with the current and new lots and acceptability according to a predefined criteria. For EP26‐A, method imprecision data and critical differences at medical decision points were important factors affecting the sample size requirements and rejection limits.ResultThe number of samples required for EP26‐A was 3 to 12, of which P, CA153, and FPSA had increased by more than 5 samples compared with the current protocol. Of the 16 chemiluminescence analytes, 11 had higher rejection limits when using EP26‐A than the current laboratory scheme. Our current protocol and EP26‐A were in agreement in 32 of the 32 (100%) paired verifications.ConclusionThe EP26‐A protocol is an important tool to find the differences between reagent lots, and it makes up for the loopholes in the statistical efficiency, sample concentration and quantity, and the selection of rejection limits in the current protocol.