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CAULI, ALBERTO, DAFNA D. GLADMAN, ALESSANDRO MATHIEU, IGNAZIO OLIVIERI, GIOVANNI PORRU, PAUL P. TAK, CLAUDIA SARDU, et al. "Patient Global Assessment in Psoriatic Arthritis: A Multicenter GRAPPA and OMERACT Study." Journal of Rheumatology 38, no. 5 (February 15, 2011): 898–903. http://dx.doi.org/10.3899/jrheum.100857.
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Objective.During OMERACT 8, delegates selected patient global assessment (PGA) of disease as a domain to be evaluated in randomized controlled trials in psoriatic arthritis (PsA). This study assessed the reliability of the PGA, measured by means of 0–100 mm visual analog scale (VAS), and the additional utility of separate VAS scales for joints (PJA) and skin (PSA).Methods.In total, 319 consecutive patients with PsA (186 men, 133 women, mean age 51 ± 13 yrs) were enrolled. PGA, PJA, and PSA were administered at enrolment (W0) and after 1 week (W1). Detailed clinical data, including ACR joint count, Psoriasis Area and Severity Index (PASI), and Hospital Anxiety and Depression Scale, were recorded.Results.Comparison of W0 and W1 scores showed no significant variations (intraclass correlation coefficients for PGA 0.87, PJA 0.86, PSA 0.78), demonstrating the reliability of the instrument. PGA scores were not influenced by patient anxiety or depression, but were dependent on PJA and PSA (p = 0.00001). PJA was dependent on the number of swollen and tender joints (p < 0.00001). PSA scores were influenced by the extent of skin psoriasis and by hand skin involvement (p = 0.00001). Joint and skin disease were found not to correlate in terms of disease activity as evidenced by the swollen joint count compared to PASI (r = 0.11) and by the PJA compared to PSA (r = 0.38).Conclusion.PGA assessed by means of VAS is a reliable tool related to joint and skin disease activity. Because joint and skin disease often diverge it is suggested that in some circumstances both PJA and PSA are also assessed.
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Oldenburg, Jan, Johan Lars Bjerner, Lara Pasovic, Stig Müller, Sophie D. Fossa, Sigrid V. Carlsson, and Peter C. Albertsen. "The performance of prostate specific antigen (PSA) testing in the population based NPCC cohort." Journal of Clinical Oncology 41, no. 16_suppl (June 1, 2023): 5029. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.5029.
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5029 Background: Prostate cancer (PCa) screening using prostate-specific antigen (PSA) is controversial. Benign prostate hyperplasia increases PSA in aging men independent of PCa such that PSA’s test performance differs between younger and older men. Age-specific cut-off values might therefore be advisable. The large Norwegian Prostate Cancer Consortium (NPCC) database might be able to contribute with clinically relevant information on age-specific PSA cut-off values. Methods: The Norwegian Prostate Cancer Consortium (NPCC) collected 8 857 761 PSA tests from 1.291.151 men. Results were linked with the date of diagnosis and grade of PCa. Analyses were restricted to men aged 45-75 years. PSA results were grouped into two groups: PCa negative vs PCa positive. The PCa negative group comprised PSA measurements from 2005 to 2015 men being alive and without PCa diagnosis five years after PSA measurement, in total 1 775 986 PSA measurements from 533 216 men. The PCa positive group comprised PSA measurements from 2005 to 2020 of men diagnosed with PCa during this period. PCa diagnoses at autopsy, as incidental finding at cystectomy, with metastases or with PSA > 50 ng/ml were excluded, in total 242 874 PSA measurements from 48 659 men with PCa. Sensitivity, specificity, area under the curve (AUC) as well as top decile and proportion of PCa in the top decile were calculated. Results: For men of 50 years of age, PSA at a threshold of 3 ng/ml yielded a sensitivity and specificity of ~ 95%. In 70–74-year-old men, a 3 ng/ml PSA threshold resulted in a 95% sensitivity but declining specificity of 70%. Maintaining specificity requires increasing PSA cut-off values to 4.5, 6, 7 and 8 ng/ml for men aged 55-59, 60-64, 65-69 and 70-74 years, respectively. The increasing cut-off values for the top PSA decile as well as the decreasing proportion of PCA within the top decile are in line with a declining AUC in older men. Conclusions: PSA test performance declines with increasing age. PCa screening in well-informed men should take into account age adjusted PSA cut-off values. [Table: see text]
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Zhang, Wan-Ming, Patrik Finne, Jari Leinonen, Satu Vesalainen, Stig Nordling, and Ulf-HÅkan Stenman. "Measurement of the Complex between Prostate-specific Antigen and α1-Protease Inhibitor in Serum." Clinical Chemistry 45, no. 6 (June 1, 1999): 814–21. http://dx.doi.org/10.1093/clinchem/45.6.814.
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Abstract Background: Prostate-specific antigen (PSA) occurs in serum both free and in complex with protease inhibitors. The complex with α1-antichymotrypsin (ACT) is the major form in serum, and the proportion of PSA-ACT is higher in prostate cancer (PCa) than in benign prostatic hyperplasia (BPH). PSA also forms a complex with α1-protease inhibitor (API) in vitro, and the PSA-ACT complex has been detected in serum from patients with prostate cancer. The aim of the present study was to develop a quantitative method for the determination of PSA-API and to determine the serum concentrations in patients with PCa and BPH. Methods: The assay for PSA-API utilizes a monoclonal antibody to PSA as capture and a polyclonal antibody to API labeled with a Eu-chelate as a tracer. For calibrators, PSA-API formed in vitro was used. Serum samples were obtained before treatment from 82 patients with PCa, from 66 patients with BPH, and from 22 healthy females. Results: The concentrations of PSA-API are proportional to the concentrations of total PSA. PSA-API comprises 1.0–7.9% (median, 2.4%) of total immunoreactive PSA in PCa and 1.3–12.2% (median, 3.6%) in BPH patients with serum PSA concentrations >4 μg/L. In patients with 4–20 μg/L total PSA, the proportion of PSA-API serum is significantly higher in BPH (median, 4.1%) than in PCa (median, 3.2%; P = 0.02). Conclusions: The proportion of PSA-API in serum is lower in patients with PCa than in those with BPH. These results suggest that PSA-API is a potential adjunct to total and free PSA in the diagnosis of prostate cancer.
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Algotar, Amit Mohan, Mitchell Sokoloff, Chiu-Hsieh Hsu, Parminder Singh, and Steven Paul Stratton. "Negative association of smoking with PSA and PSA velocity." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e16060-e16060. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e16060.
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e16060 Background: Smoking and obesity have been implicated in the pathogenesis of various chronic diseases and carcinogenic processes. However, their role in prostate cancer (PCa) & their association with important biomarkers such as prostate specific antigen (PSA) & PSA velocity (rate of PSA change over time) remains unresolved. This study investigates the association of these risk factors with PSA & PSA velocity (PSAV) in men at high risk for PCa. Methods: Data were obtained from 699 men participating in a Phase 3 clinical trial aimed at investigating the effect of selenium supplementation on incidence of PCa. During the course of this trial 73 men were diagnosed with PCa. Multiple linear regressions were used to investigate the association with PSA and mixed effects models were used to investigate the association with PSAV. Results: As compared to non-smokers, smokers demonstrated statistically significant negative association with PSA (8.0 & 6.7ng/ml, p=0.02). This association was more pronounced in men diagnosed with PCa (14.7 & 9.9ng/ml) as compared to those not diagnosed with PCa (4.5 & 3.6ng/ml). As compared to non-obese subjects, obese subjects did not demonstrate a statistically significant association with PSA (6.8 & 7.1ng/ml, p= 0.64) nor do these results change after stratifying the analysis by PCa status. Smoking was associated with statistically significant lower PSAV (p=0.008) whereas obesity was not (p=0.42). Using the standard PSA level of 4ng/ml as a cut off for conducting prostate biopsy, 14.6% of smokers in this study would not have been prescribed a prostate biopsy and thus misclassified as being negative for PCa. Conclusions: The negative association of smoking with PSA and PSA velocity could potentially be due to its negative effect on testosterone. Hence, increased vigilance may be warranted among smokers with borderline PSA to prevent the risk of delayed diagnosis and metastasis thus reducing morbidity and mortality associated with PCa.
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Balk, Steven P., Yoo-Joung Ko, and Glenn J. Bubley. "Biology of Prostate-Specific Antigen." Journal of Clinical Oncology 21, no. 2 (January 15, 2003): 383–91. http://dx.doi.org/10.1200/jco.2003.02.083.
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Prostate-specific antigen (PSA) is an androgen-regulated serine protease produced by both prostate epithelial cells and prostate cancer (PCa) and is the most commonly used serum marker for cancer. It is a member of the tissue kallikrein family, some of the members of which are also prostate specific. PSA is a major protein in semen, where its function is to cleave semenogelins in the seminal coagulum. PSA is secreted into prostatic ducts as an inactive 244–amino acid proenzyme (proPSA) that is activated by cleavage of seven N-terminal amino acids. PSA that enters the circulation intact is rapidly bound by protease inhibitors, primarily alpha1-antichymotrypsin, although a fraction is inactivated in the lumen by proteolysis and circulates as free PSA. This proteolytic inactivation, as well as the cleavage of proPSA to PSA, is less efficient in PCa. Serum total PSA levels are increased in PCa, and PSA screening has dramatically altered PCa presentation and management. Unfortunately, although high PSA levels are predictive of advanced PCa, a large fraction of organ-confined cancers present with much lower total PSA values that overlap those levels found in men without PCa. Measurement of free versus total PSA can increase specificity for PCa, and tests under development to measure forms of proPSA may further enhance the ability to detect early-stage PCa. PSA is also widely used to monitor responses to therapy and is under investigation as a therapeutic target. Finally, recent data indicate that there may be additional roles for PSA in the pathogenesis of PCa.
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Joshi, S., M. A. Tilak, and S. Jadhav. "SIGNIFICANCE OF DETECTION OF FREE/TOTAL PSA RATIO AND OTHER BIOCHEMICAL PARAMETERS IN PATIENTS WITH BPH, CARCINOMA PROSTATE AND ITS CLINICOPATHOLOGIC CORRELATION." International Journal of Medicine and Medical Research 7, no. 1 (November 22, 2021): 42–50. http://dx.doi.org/10.11603/ijmmr.2413-6077.2021.1.12122.
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Background. Benign prostatic hyperplasia (BPH) can raise prostate-specific antigen (PSA) levels two to three times higher than the normal level. An increased PSA level does not indicate Prostate Cancer (PCa), but the higher the PSA level, the higher the chance of having PCa. Detection and treatment have been profoundly affected by the advent of Free/Total PSA ratio testing. Objectives. The aim of the study was to estimate free, total PSA levels and its ratio for serum levels of calcium, acid phosphatase and alkaline phosphatase in patients with BPH and PCa; to correlate clinical, biochemical and histopathological findings in the above patients. Methods. PSA levels were detected by Chemiluminescent assay; serum calcium – by Modified Arsenazo method; serum acid phosphatase – by Doumas et al method; and Alkaline phosphatase – by Lowry et al method. Results. Present study found high levels of total PSA in BPH and PCa. Levels of free PSA were high in BPH as compared to PCa rate. Free/Total PSA ratio is reduced considerably in PCa as compared to BPH. Serum acid phosphatase and alkaline phosphatase were considerably higher in PCa as compared to BPH. Serum calcium levels did not show significant difference in control and study groups. Conclusions. It was established that patients with PCa have a greater fraction of bound PSA and a lower percentage of free PSA than in those without PCa. Therefore, in clinical practice Free/Total PSA ratio helps clinicians to decide if a biopsy is necessary. Objectives: The study was carried out with the following objectives: to estimate free, total PSA levels and calculate Free/Total PSA ratio in patients with BPH and Carcinoma Prostate, to study the serum levels of calcium, acid phosphates, and alkaline phosphatase in patients with BPH and PCa. and to correlate clinical, biochemical and histopathological findings in the above patients. Methods. Free and total PSA levels were detected by Chemiluminescent assay; Serum Calcium was detected by Modified Arsenazo method. Serum acid phosphatase was detected by Doumas et al method and Alkaline phosphatase were detected by Lowry et al method Results: Present study found high levels of Total PSA in BPH and PCa. Levels of free PSA were high in BPH as compared to PCa ate. Free /Total PSA ratio is reduced considerably in PCa as compared to BPH. Serum acid phosphatase and alkaline phosphatase were slightly raised in PCa as compared to BPH. Serum calcium levels did not show a significant difference in control and study groups. Conclusion: We concluded that patients with PCa have a greater fraction of bound PSA and a lower percentage of free PSA than in men without PCa. There was a negative correlation found between the free/total PSA ratio and the histopathologic findings. The lower the ratio higher is the grade of malignancy. Therefore in clinical practice Free/Total PSA ratio helps clinicians to decide if a biopsy is necessary
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Jung, K., C. Stephan, M. Lein, W. Henke, D. Schnorr, B. Brux, P. Schürenkämper, and S. A. Loening. "Analytical performance and clinical validity of two free prostate-specific antigen assays compared." Clinical Chemistry 42, no. 7 (July 1, 1996): 1026–33. http://dx.doi.org/10.1093/clinchem/42.7.1026.
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Abstract We compared two recently introduced commercial assays (CanAg and Immulite) for measuring free prostate-specific antigen (f-PSA), total PSA (t-PSA), and the ratio of t-PSA/f-PSA (f-PSA%) in control materials and sera of 54 healthy men, 50 patients with benign prostatic hyperplasia (BPH), and 45 patients with prostate cancer (PCa). The lower detection limits for f-PSA were 0.038 microgram/L and 0.004 microgram/L for the CanAg and Immulite assays, respectively. The within-run and between-day precisions of the Immulite assay were < 5%; the CanAg assay showed a poorer precision. Whereas f-PSA values differed between controls and patients but not between BPH and PCa patients, the f-PSA% values were lower in PCa patients than in BPH patients and controls. The receiver-operating characteristic (ROC) curve showed an improved diagnostic power of f-PSA% compared with t-PSA to discriminate between BPH and PCa. Discrimination limits of 16% (CanAg assay), and 15% (Immulite assay) are recommended for f-PSA%.
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Rai, Samarpit, Nicola Pavan, Nachiketh Soodana-Prakash, Bruno Nahar, Yan Dong, Ramgopal Satyanarayana, Dipen Parekh, and Sanoj Punnen. "Defining the optimal PSA range for the maximal predictive efficacy of PSA density to detect prostate cancer on biopsy: Results from a multi-institutional and prospective contemporary cohort." Journal of Clinical Oncology 34, no. 2_suppl (January 10, 2016): 70. http://dx.doi.org/10.1200/jco.2016.34.2_suppl.70.
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70 Background: PSA density (PSAD) is an important predictor of prostate cancer (PCa). We assessed whether the predictive accuracy of PSAD varied based on the range of PSA or whether the patient had a previous negative prostate biopsy (PB). Methods: We assessed a prospective cohort of men who were referred for a PB due to suspicion of PCa at 26 different sites across USA. The area under the receiver operating characteristic curve (AUC) was used to assess the added predictive accuracy of PSAD versus PSA across 3 different PSA ranges ( < 4, 4 – 10, > 10 ng/mL) and in men with or without a prior negative PB for the detection of any and significant (Gleason ≥ 7) PCa. Results: Of the 1,290 men, 585 (45%) and 284 (22%) had any and significant PCa, respectively. PSAD was significantly more predictive than PSA for detecting any PCa in the PSA ranges of 4 – 10 (AUC 0.70 vs 0.53, P < 0.00001) and > 10 (AUC 0.84 vs 0.65, P < 0.00001) ng/mL. Similarly, for significant PCa, PSAD was more predictive than PSA in the PSA ranges of 4 – 10 (AUC 0.72 vs 0.57, P < 0.00001) and > 10 (AUC 0.82 vs 0.68, P = 0.0001) ng/mL. Furthermore, PSAD was significantly more predictive than PSA in detecting PCa in men that had a prior negative PB (AUC 0.69 vs 0.56, P = 0.0001 for any PCa and AUC 0.81 vs 0.70, P = 0.0042 for significant PCa), and those that didn’t (AUC 0.72 vs 0.67, P = 0.0001 for any PCa and AUC 0.77 vs 0.73, P = 0.0026 for significant PCa). However the difference between the AUC of PSAD and PSA (ΔAUC) was a lot more pronounced in men that had a prior negative PB (ΔAUC = 0.13 for any PCa and ΔAUC = 0.11 for significant PCa) as opposed to those that didn’t (ΔAUC = 0.05 for any PCa and ΔAUC = 0.04 for significant PCa), suggesting that PSAD is a much better predictor than PSA alone in men who have undergone a previous PB. Conclusions: As PSA increases, the predictive accuracy of PSAD over PSA appears to improve for the detection of any PCa and significant PCa. Additionally, PSAD has a more pronounced predictive value over PSA in detecting any and significant PCa in men who have undergone a prior negativePB. We support the use of PSAD testing to avoid unnecessary biopsies in men who have elevated PSA secondary to an enlarged prostate.
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Zhu, Lei, Hannu Koistinen, Ulf Landegren, and Ulf-Håkan Stenman. "Proximity Ligation Measurement of the Complex between Prostate Specific Antigen and α1-Protease Inhibitor." Clinical Chemistry 55, no. 9 (September 1, 2009): 1665–71. http://dx.doi.org/10.1373/clinchem.2009.127779.
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Abstract Background: Prostate specific antigen (PSA)–α1-protease inhibitor complex (PSA-API) is a minor form of PSA in serum. It may be useful for prostate cancer (PCa) diagnosis, but its specific detection is hampered by nonspecific background. To avoid this, we developed an immunoassay for PSA-API based on proximity ligation. Methods: We used a monoclonal antibody (mAb) to total PSA (tPSA) to capture PSA, while using another anti-tPSA mAb together with an anti-API mAb as probes. We measured PSA-API by quantification of amplified DNA strands conjugated to the probes. We measured serum PSA-API in 84 controls and 55 men with PCa who had PSA concentrations of 4.0–10 μg/L. Results: The detection limit of the assay was 6.6 ng/L. The proportion of PSA-API to tPSA (%PSA-API) tended to be lower in men with PCa (2.8%) than without cancer (3.3%) but was not statistically significant (P = 0.363). When used alone, %PSA-API [area under the curve (AUC) 0.546] did not improve detection of PCa, whereas %fPSA (AUC 0.710) and the sum of %fPSA and %PSA-API (AUC 0.723) did. At 90% diagnostic sensitivity, the diagnostic specificity for cancer was not significantly better for %fPSA + %PSA-API than for %fPSA alone (36% vs 30%). Conclusions: Proximity ligation eliminated nonspecific background, enabling accurate measurement of PSA-API in serum specimens with moderately increased tPSA. The combined use of %PSA-API and %fPSA provided a modest improvement for PCa detection, but based on the current study cohort, it is uncertain whether the improvement has clinical utility. .
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Caglayan, Volkan, Efe Onen, Sinan Avci, Murat Sambel, Metin Kilic, Sedat Oner, Mustafa Murat Aydos, and Halil Emre Yıldız. "Lymphocyte-to-monocyte ratio is a valuable marker to predict prostate cancer in patients with prostate specific antigen between 4 and 10 ng/dl." Archivio Italiano di Urologia e Andrologia 90, no. 4 (January 17, 2019): 270–75. http://dx.doi.org/10.4081/aiua.2018.4.270.
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Objective: To evaluate the diagnostic value of serum inflammation markers derived from complete blood count in diagnosis of prostate cancer (PCa). Methods: We retrospectively analyzed the data of 621 patients who underwent prostate biopsy between March 2013 and April 2018. Age, prostate specific antigen (PSA), free PSA, platelet count, neutrophil count, lymphocyte count, monocyte count, prostate volume (PV) and pathology result of the patients were recorded. Patients were grouped as benign prostatic hyperplasia (BPH), prostatitis and PCa. Patients were also grouped according to PSA values, as PSA < 4 , PSA 4-10 and PSA > 10 ng/dl. Results: The mean lymphocyte-to-monocyte ratio (LMR) value of the patients with PCa was significantly lower in the entire cohort (p = 0.047). In the PSA 4-10 ng/dl range, LMR value wassignificantly lower in patients with PCa than those with BPH or prostatitis (p = 0.012). In this PSA range, free/total PSA ratio and LMR were significant factors to predict PCa. The cut-off values of LMR, free/total PSA were 3.05 and 0.15 respectively. The sensitivities, spesificities, positive predictive values (PPV) and negative predictive values using LMR cut-off, free/total PSA cut-off and their combination were assessed. Specificity and PPV of the combination group were higher (97.2%, 83.3% respectively) compared to free/total PSA cut-off group (91.6%, 76.6%) and LMR cut-off group (67.8%, 43.7%).Conclusions: LMR is a useful tool at detecting PCa especially in patients with PSA value between 4 and 10 ng/dl. The combination of free/total PSA ratio and LMR improves the diagnostic accuracy more than the use of free/total PSA ratio alone.
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Guo, Zhui-Feng, Fan Yang, Xu-Wei Lu, Jia-Wen Wu, Chang He, and Cong-Hui Han. "Significance of the prostate central gland and total gland volume ratio in the diagnosis of prostate cancer patients in the prostate specific antigen grey zone." Journal of International Medical Research 49, no. 7 (July 2021): 030006052110198. http://dx.doi.org/10.1177/03000605211019879.
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Objective To explore the significance of the prostate central gland to total gland volume ratio (PVc/PV) in the diagnosis of prostate cancer (PCa) in patients with prostate specific antigen (PSA) levels in the grey zone (4–10 ng/ml). Methods This retrospective study enrolled patients that had undergone prostate biopsy. The volume of the prostate and the central prostate gland were measured. The differences in PSA, the ratio of free to total PSA (f/tPSA), PSA density (PSAD) and PVc/PV between the PCa and non-PCa groups were compared. Receiver operating characteristic curve analysis for PCa and clinically significant PCa (csPCa) diagnosis were calculated according to PSA (reference), f/tPSA, PSAD and PVc/PV. Results This study enrolled 136 patients. There was no significant difference in PSA and f/tPSA between the PCa and non-PCa groups, while there were significant differences in PSAD and PVc/PV. The area under the curve values of PVc/PV for PCa or csPCa diagnosis were 0.876 and 0.933, respectively; and for PSAD, they were 0.705 and 0.790, respectively. These were significantly different compared with the PSA curve, whereas f/tPSA showed no significant difference from the PSA curve. Conclusion PVc/PV could be a predictor of PCa when PSA is between 4–10 ng/ml.
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Rai, Samarpit, Nachiketh Soodana-Prakash, Nicola Pavan, Bruno Nahar, Amil Patel, Yan Dong, Ramgopal Satyanarayana, Dipen Parekh, and Sanoj Punnen. "Can PSA density and free-to-total PSA ratio improve our ability to predict prostate cancer on biopsy? Results from a prospective, multi-institutional, and contemporary cohort." Journal of Clinical Oncology 34, no. 2_suppl (January 10, 2016): 57. http://dx.doi.org/10.1200/jco.2016.34.2_suppl.57.
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57 Background: Several studies have reported an increased value of PSA density (PSAD) and free−to−total PSA ratio (f/t PSA) over PSA alone in predicting prostate cancer (PCa). Despite this, they remain underutilized. This study analyzed a cohort of men referred for prostate biopsy (PB) to determine if PSAD and f/t PSA enhanced the prediction of any PCa and/or significant PCa (Gleason score ≥ 7) compared to PSA. Methods: 1,370 prospectively enrolled patients were referred for a PB across 26 urological centers. A phlebotomy was performed immediately prior to PB for PSA and f/t PSA measurement. PSAD was calculated using prostate volume obtained during the trans−rectal ultrasound (TRUS) guided PB. The area under the receiver operating characteristic curve (AUC) was used to assess the added discriminative value of PSAD and f/t PSA when added to a base model consisting of PSA, age, prior biopsy status, and DRE for the prediction of any and significant PCa. Results: Of the 1,290 men in the final cohort, 301 (23%) and 284 (22%) men were diagnosed with low−grade (Gleason score = 6) and significant PCa respectively. The median PSAD values in men with no PCa, low−grade PCa, and significant PCa were 0.09, 0.11, and 0.17 ng/mL/cc, respectively (P < 0.0001). The median f/t PSA in men with no PCa, low−grade PCa, and significant PCa was 0.21, 0.17, and 0.12 respectively (P < 0.0001). The AUC for a model incorporating PSAD showed superior predictive value compared to the base model for diagnosing any PCa (AUC 0.76 versus 0.70, P < 0.0001) and significant PCa (AUC 0.82 versus 0.77, P < 0.0001). Similarly, a model with f/t PSA showed superior predictive value compared to the base model for diagnosing any PCa (AUC 0.73 vs 0.70, P < 0.0001) and significant PCa (AUC 0.82 versus 0.77, P < 0.0001). While PSAD showed superior predictive value over f/t PSA for predicting any PCa (AUC 0.76 versus 0.73, P = 0.0062), there was no difference in their discrimination of significant PCa. Conclusions: PSAD and f/t PSA add substantial predictive power to the diagnostic armamentarium for any and significant PCa. Their calculation may reduce the number of unnecessary biopsies being performed for PCa detection.
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Zhang, Wan-Ming, Patrik Finne, Jari Leinonen, Satu Vesalainen, Stig Nordling, Sakari Rannikko, and Ulf-Håkan Stenman. "Characterization and immunological determination of the complex between prostate-specific antigen and α2-macroglobulin." Clinical Chemistry 44, no. 12 (December 1, 1998): 2471–79. http://dx.doi.org/10.1093/clinchem/44.12.2471.
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Abstract Prostate-specific antigen (PSA) rapidly forms a complex with α2-macroglobulin (A2M) in vitro; however, PSA complexed with A2M (PSA-A2M) is not detected by conventional immunoassays for PSA because it is encapsulated by the A2M. In this study, we show that denaturation of PSA-A2M at high pH renders PSA immunoreactive. Part of the complexed PSA is released in free form and part remains bound to denatured A2M. These forms can be measured by a conventional immunoassay for PSA. This finding enabled us to design a dissociation assay for the detection of PSA-A2M, which was based on the removal of immunoreactive PSA in serum by immunoadsorption, denaturation of PSA-A2M at high pH, and measurement of the released PSA immunoreactivity by a conventional PSA immunoassay. This PSA-A2M assay was calibrated with PSA-A2M formed in vitro. The detection limit of the assay was 0.14 μg/L. Inter- and intraassay coefficients variation were 4–9% and 8–14%, respectively. When purified PSA was incubated with A2M, the loss of PSA immunoreactivity was highly correlated with the PSA-A2M formed, as measured by the dissociation assay for PSA-A2M (r = 0.99; P <0.0001). The concentration of PSA-A2M in serum correlated with that of total PSA both in prostate cancer (PCa) and benign prostatic hyperplasia (BPH); however, the ratio of PSA-A2M in relation to total PSA was significantly higher in BPH than in PCa (P <0.0003). ROC curve analysis suggested that measurement of the ratio of PSA-A2M to total PSA in serum improves the diagnostic accuracy for PCa compared with assays for total PSA only.
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Srinivasan, Srilakshmi, Carson Stephens, Emily Wilson, Janaththani Panchadsaram, Kerry DeVoss, Hannu Koistinen, Ulf-Håkan Stenman, et al. "Prostate Cancer Risk-Associated Single-Nucleotide Polymorphism Affects Prostate-Specific Antigen Glycosylation and Its Function." Clinical Chemistry 65, no. 1 (January 1, 2019): e1-e9. http://dx.doi.org/10.1373/clinchem.2018.295790.
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Abstract BACKGROUND Genetic association studies have reported single-nucleotide polymorphisms (SNPs) at chromosome 19q13.3 to be associated with prostate cancer (PCa) risk. Recently, the rs61752561 SNP (Asp84Asn substitution) in exon 3 of the kallikrein-related peptidase 3 (KLK3) gene encoding prostate-specific antigen (PSA) was reported to be strongly associated with PCa risk (P = 2.3 × 10−8). However, the biological contribution of the rs61752561 SNP to PCa risk has not been elucidated. METHODS Recombinant PSA protein variants were generated to assess the SNP-mediated biochemical changes by stability and substrate activity assays. PC3 cell–PSA overexpression models were established to evaluate the effect of the SNP on PCa pathogenesis. Genotype-specific correlation of the SNP with total PSA (tPSA) concentrations and free/total (F/T) PSA ratio were determined from serum samples. RESULTS Functional analysis showed that the rs61752561 SNP affects PSA stability and structural conformation and creates an extra glycosylation site. This PSA variant had reduced enzymatic activity and the ability to stimulate proliferation and migration of PCa cells. Interestingly, the minor allele is associated with lower tPSA concentrations and high F/T PSA ratio in serum samples, indicating that the amino acid substitution may affect PSA immunoreactivity to the antibodies used in the clinical immunoassays. CONCLUSIONS The rs61752561 SNP appears to have a potential role in PCa pathogenesis by changing the glycosylation, protein stability, and PSA activity and may also affect the clinically measured F/T PSA ratio. Accounting for these effects on tPSA concentration and F/T PSA ratio may help to improve the accuracy of the current PSA test.
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Stanton, Whitney N., E. David Crawford, Paul Arangua, John Hoenemeyer, Francisco G. La Rosa, Adrie van Bokhoven, M. Scott Lucia, Wendy Poage, and Priya N. Werahera. "Evaluation of prostate cancer risk in men with PSA < 1.5." Journal of Clinical Oncology 36, no. 6_suppl (February 20, 2018): 64. http://dx.doi.org/10.1200/jco.2018.36.6_suppl.64.
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64 Background: Prostate Specific Antigen (PSA) screening remains controversial primarily because of over detection and treatment. There is an unmet clinical need to identify patients at increased risk for high-grade (HG – Gleason Score ≥7) prostate cancer (PCa) since PSA has low sensitivity. Combining PSA with well-validated prostate cancer biomarkers (PCM) can improve risk assessment. We investigated the performance of three PCMs (phi – prostate health index, 4KScore, and SelectMDx) on patients with PSA levels < 1.5 ng/mL that represent a “safe zone” where risk of any PCa is rare Methods: 652 men were screened for PCa during the annual Prostate Cancer Awareness Week at the University of Colorado Hospital. This study was supported by Prostate Condition Education Council and the Schramm Foundation. phi is evaluated using p2PSA, total PSA, and free PSA in serum. Phi < 52.7 suggests absence of HG PCa. 4KScore incorporates four kallikrein protein biomarkers: total PSA, free PSA, intact PSA, human kallikrein protein, and clinical information. A 4KScore < 20% suggests absence of HG PCa. The SelectMDx post-DRE urine test measures mRNA levels of the homeobox C6 and distal-less homeobox 1 biomarkers. SelectMDx score of 0% indicates absence of HG PCa. Results: No patients with a PSA < 1.5 had SelectMDx > 0% and/or phi > 52.7. One patient had a 4KScore of 27%, indicating a risk for HG PCa. For patients with PSA between 1.5-3.99, 2.9% (4/135), 7.4% (4/54), and 2.3% (2/85) had positive phi, 4KScore, and SelectMDx results, respectively. Conclusions: Men with PSA <1.5 ng/mL are at very low risk for HG PCa. Men with PSA between 1.5-3.99 with positive PCM results may be referred for further evaluation. [Table: see text]
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Orugbo, V. P., and M. Ntaji. "DISTRIBUTION OF AGE-SPECIFIC PROSTATE SPECIFIC ANTIGEN PROFILES IN MEN BETWEEN 40 AND 80 YEARS TESTED IN A UROLOGY CLINIC IN OGHARA, DELTA STATE, NIGERIA." African Journal of Health, Safety and Environment 3, no. 1 (March 29, 2022): 11–18. http://dx.doi.org/10.52417/ajhse.v3i1.195.
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Prostate cancer (PCa) is one of the most common cancers in men, and it is the leading cause of cancer deaths in the world today. PCa is detected via a Prostate Specific Antigen (PSA) test. PSA is a protein produced by malignant and noncancerous tissue in the prostate gland. Although PSA levels grow as a result of prostate cancer, a high PSA test result does not always mean a man has prostate cancer. Several studies have corroborated this assertion of the inability of elevated PSA levels to most effectively indicate carcinoma without necessarily following up with histological examination. This study considered men within the 40 – 80 age bracket, who presented at the Urology Clinic of Delta State University Teaching Hospital. Results showed that whereas the mean PSA value for normotensive participants was 8.0 ng/ml (or the 95th percentile of 46.6 ng/ml), the mean PSA of 15.3 ng/ml (or 72.2 ng/ml as the 95th percentile) for those participants with BPH was reported. For study participants with PCa, a mean PSA of 43.2 ng/ml was reported. Although the statutory level for PSA within that age bracket is 4.0 ng/ml, significant increases in the normotensive participants mean that elevated PSA may not have been due to either BPH or carcinoma. Although there was a strong association between PSA levels and PCa based on the Phi and Cramer’s V value of 0.221, sensitivity was 50% and the positive predictive value was less than 20%. With the report of PSA elevations in normotensive individuals, and also with reports of some patients with reported PCa who had low PSA levels, it is suggested PSA levels may not be used in isolation. There is a need therefore to enhance the reliance on PSA or the development of more accurate biomarkers for PCa.
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Nurmikko, Pauliina, Kim Pettersson, Timo Piironen, Jonas Hugosson, and Hans Lilja. "Discrimination of Prostate Cancer from Benign Disease by Plasma Measurement of Intact, Free Prostate-specific Antigen Lacking an Internal Cleavage Site at Lys145-Lys146." Clinical Chemistry 47, no. 8 (August 1, 2001): 1415–23. http://dx.doi.org/10.1093/clinchem/47.8.1415.
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Abstract Background: The proportion of free prostate-specific antigen (PSA) is higher in the sera of patients with benign prostatic hyperplasia compared with patients with prostate cancer (PCa). We developed an immunoassay that measures intact, free PSA forms (fPSA-I), but does not detect free PSA that has been internally cleaved at Lys145-Lys146 (fPSA-N), and investigated whether this form could discriminate patients with PCa from those without PCa. Methods: The assay for fPSA-I uses a novel monoclonal antibody (MAb) that does not detect PSA that has been internally cleaved at Lys145-Lys146. A MAb specific for free PSA was used as a capture antibody, and purified recombinant proPSA was used as a calibrator. The concentrations of fPSA-I, free PSA (PSA-F), and total PSA (PSA-T) were analyzed in EDTA-plasma samples (n = 276) from patients who participated in a screening program for PCa (PSA-T, 0.83–76.3 μg/L). Results: The detection limit of the fPSA-I assay was 0.035 μg/L. Both the measured concentrations of fPSA-I and the concentrations of fPSA-N (calculated as PSA-F − fPSA-I) provided statistically significant discrimination of the two clinical groups. By contrast, PSA-F did not discriminate between these groups. Each of the ratios fPSA-I/PSA-F, fPSA-N/PSA-T, and PSA-F/PSA-T separated cancer samples from noncancer samples in a statistically significant manner (P <0.0001). The ratio fPSA-I/PSA-F was significantly higher in cancer (median, 59%) compared with noncancer samples (47%). Conclusions: The ratio fPSA-I/PSA-F is significantly higher in cancer compared with noncancer. The percentages of both fPSA-N/PSA-T and fPSA-I/PSA-F may provide interesting diagnostic enhancements alone or in combination with other markers and require further studies.
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Fulla, Yvonne, Catherine Vuillemard, Maya Megarbane, Luc Nonnenmacher, Bernard Debré, Sophie Conquy, Thierry Flam, Nicolas Thiounn, and Marc Zerbib. "Discordances entre les dosages de PSA : comparaison PSA, PSA libre, PSA complexé." Revue Française des Laboratoires 1999, no. 312 (April 1999): 85–90. http://dx.doi.org/10.1016/s0338-9898(99)80317-5.
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Rais-Bahrami, Soroush, Minhaj Siddiqui, Srinivas Vourganti, Baris Turkbey, Ardeshir Rastinehad, Lambros Stamatakis, Hong Truong, et al. "Diagnostic value of biparametric MRI as an adjunct to PSA-based detection of prostate cancer." Journal of Clinical Oncology 32, no. 4_suppl (February 1, 2014): 193. http://dx.doi.org/10.1200/jco.2014.32.4_suppl.193.
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193 Background: To determine the diagnostic yield of analyzing a fast, cost-conscious biparametric (T2 and diffusion-weighted) MRI (B-MRI) for prostate cancer (PCa) detection as an adjunct to to standard digital rectal exam (DRE) and prostate specific antigen (PSA)-based screening. Methods: Review of patients who were enrolled in a trial to undergo MP-MRI and MR/US fusion-guided prostate biopsy at our institution identified 143 men who underwent MP-MRI in addition to standard DRE and PSA-based PCa screening prior to any other prior prostate biopsy sessions. Patient demographics, DRE staging, PSA, PSA density (PSAD), and B-MRI findings were assessed for association with PCa detection on biopsy. Results: Men with detected PCa tended to be older, with higher PSA, higher PSAD, and increased number of screen positive lesions (#SPL) on B-MRI. B-MRI performed well for the detection of PCa with an area under the curve (AUC) of 0.80 (compared to 0.66 and 0.74 for PSA and PSAD). We derived PSA and MRI-based combined screening formulas for detection of PCa with optimized thresholds. (1) for PSA and B-MRI: PSA + 6 x (#SPL) > 14 and (2) for PSAD and B-MRI: 14 x (PSAD) + (#SPL) > 4.25. Area under the curve for equations 1 and 2 were 0.83 and 0.87 and overall accuracy of PCa detection was 79% in both models. Furthermore, the model integrating PSA with #SPL on B-MRI, was much more efficient at maximally identifying men with Gleason 7 or higher disease compared to PSA-screening alone. Use of model combining PSAD and MRI, the number of bGS 7 or higher cancers that were missed was minimized. Overall, combined use of PSA or PSAD coupled with B-MRI #SPL improved the true positive yield of identifying men with bGS 7 or higher while minimizing the false positive number of men identified as “screen-positive,” but with no cancer on biopsy. Conclusions: Number of positive lesions on B-MRI outperforms PSA alone in detecting PCa, supporting the use of this limited, non-contrast MRI as a potential adjunct tool in PCa screening. Furthermore, this imaging criteria coupled as an adjunct with PSA and PSAD, provides even more accuracy in detecting clinically-significant PCa.
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Jean, SOSSA, and AVAKOUDJO Dedjinnin Josue Georges. "The Prevalence and the Pathological Characteristics of the Prostate Cancer in 138 Consecutive Transrectal Ultrasonography-Guided Prostate Biopsies." SAS Journal of Surgery 9, no. 10 (October 9, 2021): 553–56. http://dx.doi.org/10.36347/sasjs.2021.v07i10.006.
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Objective: To determine the prevalence and pathological characteristics of the prostate cancer in our institution’s TRUS-guided prostate biopsied patients. Patients and method: The age, the PSA level and the pathological data were collected and analyzed by means of Excel 2010®. Concerned patients were those who had consecutively undergone a TRUS-guided prostate biopsy between October 17, 2013 and July 31, 2021. Results: Among 138 patients whose age ranged from 42 to 96 years (mean=65.7years), 81 or 58.7% had a PCa. 97,5% of those PCa were in patients with PSA>30ng/mL whereas 40.2% of them were in patients with PSA<30ng/mL (p=0.000). The age discrepancy between the PCa patients and the non PCa patients was not significant (p = 0.291). The percentage of positive cores was significantly higher in the PCa patients with PSA>30ng/mL than in the PCa patients with PSA<20ng/mL (p=0.000 for PSA<10ng/mL and p=0.001 for PSA<20ng/mL). 74,2% of the PCa with a GS>7 had a PSA>30ng/mL whereas 50% of the PCa with a GS 6 had a PSA<10ng/mL (p=0.004). 76, 2% of the PCa with PSA>30ng/mL belonged to the ISUP grade group 5 whereas 50% of the PCa with PSA<10ng/mL belonged to the ISUP grade group 1 (p=0.003). The GS and the percentage of positive cores increased together and that interdependent increment was significant between GS 6 and 7 (p=0.005), 6 and >7 (p=0.000), 7 and >7 (p=0.013). The percentage of positive cores also increased as the ISUP grade group was rising and again the interdependent increment was significant between the ISUP grade group 1 and 3 (p=0.001), 1 and 4 (p=0.000), 1 and 5 (p=0.000), 2 and 5 (p=0.006). Conclusion: The prevalence of the PCa was 58.7% among the 138 biopsied patients. It was 2.4 times higher in the patients with PSA>30ng/mL (95.7%) than in the patients with PSA<30ng/mL (40.2%). The majority of the PCa patients (54.3%) had a PSA>30ng/mL and presented a more elevated Gleason score, a more elevated ISUP grade group and a more elevated percentage of .......
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Goč, Sanja, and Miroslava Janković. "Evaluation of Molecular Species of Prostate-Specific Antigen Complexed with Immunoglobulin M in Prostate Cancer and Benign Prostatic Hyperplasia." Disease Markers 35 (2013): 847–55. http://dx.doi.org/10.1155/2013/923819.
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This study was aimed at defining molecular species of prostate-specific antigen (PSA) in immune complexes with immunoglobulin M (IgM). Having in mind the oligoreactivity of IgM and its preference for carbohydrate antigens, there is the possibility that it can selectively recognize known PSA glycoisoforms. PSA-IgM complexes and free PSA fractions were separated from the sera of subjects with prostate cancer (PCa) and benign prostatic hyperplasia (BPH) by gel filtration and subjected to on-chip immunoaffinity and ion-exchange chromatography. PSA-immunoreactive species were detected using surface-enhanced laser desorption/ionization time of flight mass spectrometry. The obtained spectra were analyzed for protein and glycan composition. The general pattern of the molecular species of PCa PSA and BPH PSA found in complexes with IgM was similar. It comprised major peaks at 17 kDa and minor peaks at 28 kDa, corresponding to the entire mature glycosylated PSA. The main difference was the presence of incompletely glycosylated 26.8 kDa species, having putative paucimannosidic structures, observed in PCa PSA-IgM, but not in BPH PSA-IgM. Characteristic PCa PSA-IgM glycoforms pose the question of the possible role of glycosylation as a framework for immune surveillance and may be of interest in light of recent data indicating mannose-containing glycans as cancer biomarker.
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von Eyben, Finn Edler, Kalevi Kairemo, and Daniel S. Kapp. "Prostate-Specific Antigen as an Ultrasensitive Biomarker for Patients with Early Recurrent Prostate Cancer: How Low Shall We Go? A Systematic Review." Biomedicines 12, no. 4 (April 8, 2024): 822. http://dx.doi.org/10.3390/biomedicines12040822.
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Serum prostate-specific antigen (PSA) needs to be monitored with ultrasensitive PSA assays (uPSAs) for oncologists to be able to start salvage radiotherapy (SRT) while PSA is <0.5 µg/L for patients with prostate cancer (PCa) relapsing after a radical prostatectomy (RP). Our systematic review (SR) aimed to summarize uPSAs for patients with localized PCa. The SR was registered as InPLASY2023110084. We searched for studies on Google Scholar, PUBMED and reference lists of reviews and studies. We only included studies on uPSAs published in English and excluded studies of women, animals, sarcoidosis and reviews. Of the 115 included studies, 39 reported PSA assay methods and 76 reported clinical findings. Of 67,479 patients, 14,965 developed PSA recurrence (PSAR) and 2663 died. Extremely low PSA nadir and early developments of PSA separated PSAR-prone from non-PSAR-prone patients (cumulative p value 3.7 × 1012). RP patients with the lowest post-surgery PSA nadir and patients who had the lowest PSA at SRT had the fewest deaths. In conclusion, PSA for patients with localized PCa in the pre-PSAR phase of PCa is strongly associated with later PSAR and survival. A rising but still exceedingly low PSA at SRT predicts a good 5-year overall survival.
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Zhou, A. M., P. C. Tewari, B. I. Bluestein, G. W. Caldwell, and F. L. Larsen. "Multiple forms of prostate-specific antigen in serum: differences in immunorecognition by monoclonal and polyclonal assays." Clinical Chemistry 39, no. 12 (December 1, 1993): 2483–91. http://dx.doi.org/10.1093/clinchem/39.12.2483.
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Abstract Prostate-specific antigen (PSA) in serum is primarily complexed with alpha 1-antichymotrypsin (alpha 1-ACT). However, 12-15% of prostate cancer (PCa) patients present with the predominant form being uncomplexed (free) PSA (Lilja et al., Clin Chem 1991;37:1618-24). We report that commercial immunoassays demonstrate variations in reactivity, especially to the uncomplexed form. We fractionated and analyzed commercial controls, PSA complexes prepared in vitro, and sera from patients with PCa or benign prostatic hyperplasia, using molecular sieve chromatography and Hybritech Tandem-R, Abbott IMx, and Ciba Corning ACS PSA assays. Peak integration of PCa samples demonstrated ACS:Tandem-R ratios of 1-1.3 for PSA/alpha 1-ACT complex. In contrast, ratios of uncomplexed peaks ranged from 2 to 4, suggesting a greater reactivity of the uncomplexed form in the ACS PSA assay. Discrepancies between assays, when PSA was measured in unfractionated sera, correlated directly with the percentage of the uncomplexed form. In controls, fractionation revealed the presence of uncomplexed PSA only, with ratios of ACS:Tandem-R and IMx:Tandem-R of 3:1 and 1.8:1, respectively. Immunoblots of PCa sera detected uncomplexed PSA (approximately 30 kDa) and PSA complexes of approximately 95 kDa (PSA/alpha 1-ACT) and > 200 kDa, indicative of alpha 2-macroglobulin. Maximal recognition of all forms of PSA may be important for early detection of disease progression.
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Lee, Hahn-Ey, ByungWon Kim, Hyun Sik Yoon, Jungyo Suh, and Seung-June Oh. "Outcome of Patients With Elevated Prostate-Specific Antigen and Lower Urinary Tract Symptoms Receiving Holmium Laser Enucleation of the Prostate." International Neurourology Journal 26, no. 3 (September 30, 2022): 248–57. http://dx.doi.org/10.5213/inj.2244176.088.
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Purpose: This study investigated functional outcomes in lower urinary tract symptoms (LUTS), the incidence of incidental prostate cancer (PCa), and changes in prostate-specific antigen (PSA) levels after holmium laser enucleation of the prostate (HoLEP) in patients with elevated PSA and benign prostatic hyperplasia (BPH).Methods: A retrospective review of a prospectively designed protocol for patients who underwent HoLEP at our institution from January 2010 to May 2020 was conducted. Patients were classified into low-PSA (<3.0 ng/mL) and high-PSA (≥3.0 ng/mL) groups at baseline. Follow-up for PSA was performed at the sixth postoperative month. Baseline and postoperative clinical parameters, functional parameters, PCa incidence, and postoperative changes in PSA were compared between the lowand high-PSA groups.Results: The baseline PSA of 1,296 patients (mean age, 69.7±6.8 years) was 4.0±4.1 ng/mL, with 712 patients (55.0%) in the low-PSA group (1.6±0.8 ng/mL), and 584 patients (45.0%) in the high-PSA group (6.9±4.7 ng/mL). Incidental PCa was detected in 82 patients (6.3%), with a similar incidence in the low-PSA (41 patients, 5.9%) and high-PSA (41 patients, 7.0%) groups (P>0.05). At 6 months postoperatively, both groups showed significant improvements in the maximum flow rate, postvoid residual volume, and all domains of the International Prostate Symptom Score (P<0.05). At postoperative 6 months, the PSA level significantly decreased by 66.6%±23.6% in all patients (54.3%±23.9% in the low-PSA group; 79.6%±14.7% in the high-PSA group) (P<0.05), and the PSA levels of 1,264 patients (97.6%) had normalized.Conclusions: In patients with elevated PSA presenting with LUTS/BPH, our study demonstrated significant improvements in functional parameters and decreased PSA after HoLEP. The incidental PCa detection rate did not show a statistically significant difference between the low- and high-PSA groups. Timely surgery for LUTS/BPH without delay due to PSA monitoring should be considered.
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Zani, Danilo, Silvia Costa, Lorenzo Gatti, Nicola Pesenti, Alberto Pettenò, Tiziano Zambolin, Claudio Simeone, et al. "The Association of PSA-IGM and Total PSA Improves the Diagnosis of Prostate Cancer." International Journal of Biological Markers 24, no. 3 (July 2009): 212. http://dx.doi.org/10.1177/172460080902400338.
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Background and aim The specific causes of prostate cancer (Pca) are unknown but the main risk factors of tumor development are associated with age, genetic factors, ethnicity, diet and lifestyle. Prostate cancer is rare in men under 45 years of age, but becomes more common with advancing age. The main diagnostic tools for demonstrating the presence of PCa include digital rectal examination, transrectal ultrasonography, and serum measurement of prostate specific antigen (PSA) followed by prostate biopsy for confirmation of the diagnosis. While the measurement of PSA levels has revolutionized the diagnosis of PCa, it has also increased its overdiagnosis due to the poor diagnostic accuracy. Scientific evidence indicates that biomarkers for different types of cancer such as liver and colorectal cancer circulate in the blood associated with immunoglobulin M (IgM) to form complexes that allow a better diagnosis in comparison to circulating free biomarkers. In prostate cancer it has been demonstrated that testing for serum levels of the PSA-IgM immune complex improves the diagnostic performance of total PSA. The aim of this study was to evaluate the diagnostic accuracy of PSA-IgM compared to total PSA for the selection of patients to be submitted to transrectal ultrasound-guided prostate biopsy. Patients and methods Serum samples from 67 male patients, 33 affected by PCa with a Gleason score from 5 to 7, and 34 affected by benign prostate hypertrophy (BPH), were collected by the Department of Urology of the Spedali Civili of Brescia. The samples were immediately snap frozen at −80°C. Serum levels of PSA-IgM were assessed using Prostate-IC (Xeptagen, Italy) while PSA levels were determined with the Immulite 2000 of Medical Systems S.p.A. Results Patients were stratified into 2 groups according to age; the first group consisted of 24 patients with PCa and 20 with BPH aged between 60 and 70 years and the second group consisted of 9 patients with PCa and 14 with BPH aged between 70 and 80 years. Serum levels of PSA and PSA-IgM were analyzed in the 2 groups using cutoff values of 4 ng/mL for PSA and 145 AU/mL for PSA-IgM. In the first group, 1 8 of 24 PCa patients were positive for PSA (75% sensitivity) with a specificity of 50% (10 of 20 BPH patients), and 1 0 of 24 PCa patients were positive with the PSA-IgM assay (42% sensitivity), which had a higher specificity (70%; 6 of 20 BPH patients). The combination of both biomarkers resulted in a sensitivity of 38% (9 of 24 patients with PCa) but showed a significant improvement in specificity up to 90%, since 18 of 20 patients with BPH were negative for at least one test. In the second group of patients aged 70 to 80 years, the PSA test had a sensitivity of 67% (6/9 PCa patients) and a specificity of 78% (3/14 BPH patients) compared with a sensitivity of 44% for the PSA-IgM test (4/9 PCa patients) with a specificity of 71% (4/14 BPH patients). The combination of PSA and PSA-IgM had a sensitivity of 30% (3/9) but the highest specificity (93%, 13/14 BPH patients). Conclusion The results of the study demonstrate the diagnostic value of the PSA-IgM assay compared with the total PSA test. The combination of PSA-IgM with total PSA was the best approach to reduce the number of false-positive results, thus improving the diagnosis of prostate cancer.
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Crawford, E. D., and J. Moul. "Use of PSA threshold to identify an increased 4-year risk of a prostate cancer diagnosis in U.S. men." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 5051. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.5051.
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5051 Background: Recent studies have shown that prostate specific antigen (PSA) values can be used to predict risk of developing prostate cancer (PCa) in the future. In the European Randomized Study of Screening for PCa (ERSPC) subjects with PSA of ≥1.5 ng/mL had a significantly greater risk of developing PCa after 4 years than subjects with PSA of <1.5 ng/mL (9.2% vs 1.5%, respectively; OR = 7.466; p < 0.001). This current analysis aimed to validate the ability of PSA of ≥1.5 ng/mL to predict the future risk of PCa in a US population of men within the Henry Ford Healthcare System (HFHS). Methods: This is a retrospective analysis of men enrolled in the Health Alliance Plan of the HFHS between 1997–2004 with at least 4 years of follow-up data. Men ≥40 years of age, with a baseline PSA value between 0–4.0 ng/mL, not receiving 5-alpha reductase inhibitors were included. Men were followed for 4 years after their first PSA value. The risk of 4-year PCa diagnosis was evaluated based on a 1.5 ng/mL PSA threshold, and was assessed by logistic regression, controlling for age and race. Results: A total of 21,502 patients were included in the analysis. At baseline, patients had a mean age of 55 years and a mean PSA of 1.0 ng/mL. Overall, 7.9% of patients with baseline PSA of 1.5–4 ng/mL were diagnosed with PCa after 4 years, compared to 0.5% of patients with a baseline PSA of <1.5 ng/mL. In a multivariate analysis (controlling for race and age), patients with a baseline PSA of 1.5–4 ng/mL were 12 times more likely to be diagnosed with PCa over 4 years than patients with baseline PSA of <1.5 ng/mL (OR = 12.4; 95% CI: 9.7–15.9; p < 0.0001). African Americans (n = 6,367) with baseline PSA 1.5–4 ng/mL vs baseline PSA<1.5 ng/mL had an even higher risk of being diagnosed with PCa over 4 years (OR = 17.0; 95% CI: 11.0–26.1; p < 0.0001). Conclusions: This analysis validates that men with PSA values 1.5 to 4 ng/mL are at a significantly increased risk for developing future prostate cancer compared to those with a PSA value below the 1.5 threshold. This threshold also confers increased 4-year risk in African American men. [Table: see text]
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Hassan, Adel Hassan Mohamed, Tarek Huissen kamel, and Nesreen Ahmed Mosalam. "Correlation Between the Prostate-Specific Antigen Level and Bone Metastasis in Prostate Cancer. (Retrospective Study)." Journal of Cancer Research Reviews & Reports 2, no. 2 (December 31, 2020): 1–6. http://dx.doi.org/10.47363/jcrrr/2020(2)113.
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Background: The most common non-cutaneous malignancy for men is Prostate cancer (PCa). PCa diagnosed by biopsy and PSA detection. Bone metastasis (BM) causes a lot of complications, such as bone pain and pathological fracture that cause overall compromised quality of life. Bone scintigraphy (BS) is commonly used for monitoring and detection of (BM). Objective: To correlate between serum PSA level and BM in PCa patients on series of 250 patients through detecting PSA levels and BSs. Patients and Methods: In the present study Patients were stratified (group A) & (group B) according to BM. Out of the 250 patients, 180 patients (Group A localized PCa) were with age range from 57 -92 years, the remaining 70 patients (Group B metastasis PCa) the age range was 53-88 years. Prostate specific antigen (PSA) level for both groups were detected. Results: By comparing group A and group B there was a highly significant difference in PSA value in favor of positive BS group (p-value < 0.001). The present study recommends BS in asymptomatic patients with PSA above 60 Ng/ml. Conclusion: PCa is the most common malignant non-cutaneous tumor for men. The most common spread for PCa is bone spread. Age doesn’t correlate with BM in PCa patients. PSA total show highly significance with BM in PCa patients. PSA cut-off value for BM in PCa patients was 60 Ng/ml so it was recommended to perform BS for asymptomatic patients with PSA total above 60 Ng/ml.
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Bhuyan, Soumitra S., Aastha Chandak, Niodita Gupta, Sudhir Isharwal, Chad LaGrange, Asos Mahmood, and Dan Gentry. "Patient–Provider Communication About Prostate Cancer Screening and Treatment." American Journal of Men's Health 11, no. 1 (July 7, 2016): 134–46. http://dx.doi.org/10.1177/1557988315614082.
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The American Urological Association, American Cancer Society, and American College of Physicians recommend that patients and providers make a shared decision with respect to prostate-specific antigen (PSA) testing for prostate cancer (PCa). The goal of this study is to determine the extent of patient–provider communication for PSA testing and treatment of PCa and to examine the patient specific factors associated with this communication. Using recent data from the Health Information National Trends Survey, this study examined the association of patient characteristics with four domains of patient–provider communication regarding PSA test and PCa treatment: (1) expert opinion of PSA test, (2) accuracy of PSA test, (3) side effects of PCa treatment, and (4) treatment need of PCa. The current results suggested low level of communication for PSA testing and treatment of PCa across four domains. Less than 10% of the respondents report having communication about all four domains. Patient characteristics like recent medical check-up, regular healthcare provider, global health status, age group, marital status, race, annual household income, and already having undergone a PSA test are associated with patient–provider communication. There are few discussions about PSA testing and PCa treatment options between healthcare providers and their patients, which limits the shared decision-making process for PCa screening and treatment as recommended by the current best practice guidelines. This study helps identify implications for changes in physician practice to adhere with the PSA screening guidelines.
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Junker, Ralf, Burkhard Brandt, Christian Zechel, and Gerd Assmann. "Comparison of prostate-specific antigen (PSA) measured by four combinations of free PSA and total PSA assays." Clinical Chemistry 43, no. 9 (September 1, 1997): 1588–94. http://dx.doi.org/10.1093/clinchem/43.9.1588.
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Abstract We compared prostate-specific antigen (PSA) assay systems [i.e., free PSA (f-PSA) and the corresponding total PSA (t-PSA) assay] from four different manufacturers as well as the f-PSA/t-PSA ratios with regard to their ability to discriminate between benign prostate hyperplasia (BPH) and prostate cancer (PCA). ROC analysis showed similar areas under the curves (AUCs) with different assay systems. For the entire patient population the AUCs of the f-PSA/t-PSA ratio were not or slightly increased compared with the sole measurement of t-PSA (t-PSA, 0.792–0.820; f-PSA/t-PSA ratio, 0.685–0.859). In contrast, for only those patients who showed t-PSA concentrations within the diagnostic gray area of 4–25 μg/L t-PSA, the AUCs were greater for the f-PSA/t-PSA ratio than for measurement of t-PSA alone (t-PSA, 0.608–0.647; f-PSA/t-PSA ratio, 0.690–0.806). These results were confirmed by the predictive values of the negative results (NPVs) of the t-PSA assays and the f-PSA/t-PSA ratios (assay thresholds corresponding to a 95% detection limit). Compared with the sole t-PSA measurement there was no mentionable increase in the NPVs due to the f-PSA/t-PSA ratio for the entire patient population, but an increase up to 49% when limited to t-PSA concentrations within 4–25 μg/L. We therefore conclude that the f-PSA/t-PSA ratio may be helpful for differential diagnosis of BPH and PCA within the diagnostic gray area of 4–25 μg/L t-PSA.
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Starostzik, Christine. "Weniger PCA-Diagnosen ohne PSA-Screening." Uro-News 24, no. 2 (February 2020): 48. http://dx.doi.org/10.1007/s00092-020-4063-3.
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Y.-M.D. "Pas de PSA à la maison !" Option/Bio 23, no. 478 (October 2012): 5. http://dx.doi.org/10.1016/s0992-5945(12)71013-9.
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Lu-Yao, Grace L., Nikita Nikita, Scott W. Keith, Joshua Banks, Nathan Handley, Timothy Rebbeck, Jennifer Cullen, Josep Domingo-Domenech, and William Kevin Kelly. "Racial differences in long-term prostate cancer specific mortality following conservative management for low-risk prostate cancer: A population-based study." Journal of Clinical Oncology 37, no. 7_suppl (March 1, 2019): 121. http://dx.doi.org/10.1200/jco.2019.37.7_suppl.121.
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121 Background: It is uncertain whether the same criteria for active surveillance can be applied universally across races. This population-based study was undertaken to quantify racial differences in long-term risk of prostate cancer-specific mortality (PCSM) among patients with low-risk prostate cancer (PCa) receiving conservative management. Methods: We used the Surveillance, Epidemiology, and End Results (SEER) database to identify patients who had low-risk PCa (T1-T2a & Gleason 6 & PSA ≤ 10 ng/mL & N0 & M0) diagnosed in 2004 – 2015 and did not receive radical prostatectomy or radiation therapy within one year of diagnosis. Kaplan-Meier analysis was used to calculate PCSM. The Clopper-Pearson method was used to calculate associated 95% confidence intervals. Hazard ratio of PCSM among those with a high PSA (PSA 4-10) compared to those with a low PSA (PSA < 4) was calculated using Cox proportional hazards models adjusted for covariates (including age, race, marital status, insurance status, U.S. region, year of diagnosis, and AJCC clinical tumor stage). Results: Among 33,740 patients with low-risk PCa, long-term PCSM varied with race and PSA levels at diagnosis. For instance, 10-year PCSM was 2.62% (95% CI: 1.15%-5.05%) among African Americans with PSA 4-10 and 0.98% (95% CI:0.16%-3.12%) among Caucasian patients with PSA < 4. There was no significant statistical interaction between race and PSA level on PCSM (p = 0.81). After adjusting for potential confounders, men with PSA 4-10 experienced 2-fold higher PCSM relative to those with PSA < 4 (HR = 1.96, p = 0.011) and African Americans men experienced a 43% higher PCSM compared to Caucasians (HR = 1.43, p = 0.03). Conclusions: Among men diagnosed with low-risk PCa, long-term PCSM varies by race and PSA at diagnosis. More refined risk stratification may improve PCa management among low-risk PCa patients. [Table: see text]
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Logozzi, Mariantonia, Daniela F. Angelini, Alessandro Giuliani, Davide Mizzoni, Rossella Di Raimo, Martina Maggi, Alessandro Gentilucci, et al. "Increased Plasmatic Levels of PSA-Expressing Exosomes Distinguish Prostate Cancer Patients from Benign Prostatic Hyperplasia: A Prospective Study." Cancers 11, no. 10 (September 27, 2019): 1449. http://dx.doi.org/10.3390/cancers11101449.
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Prostate Specific Antigen (PSA) fails to discriminate between benign prostatic hyperplasia (BPH) and Prostate Cancer (PCa), resulting in large numbers of unnecessary biopsies and missed cancer diagnoses. Nanovesicles called exosomes are directly detectable in patient plasma and here we explore the potential use of plasmatic exosomes expressing PSA (Exo-PSA) in distinguishing healthy individuals, BPH, and PCa. Exosomes were obtained from plasma samples of 80 PCa, 80 BPH, and 80 healthy donors (CTR). Nanoparticle Tracking Analysis (NTA), immunocapture-based ELISA (IC-ELISA), and nanoscale flow-cytometry (NSFC), were exploited to detect and characterize plasmatic exosomes. Statistical analysis showed that plasmatic exosomes expressing both CD81 and PSA were significantly higher in PCa as compared to both BPH and CTR, reaching 100% specificity and sensitivity in distinguishing PCa patients from healthy individuals. IC-ELISA, NSFC, and Exo-PSA consensus score (EXOMIX) showed 98% to 100% specificity and sensitivity for BPH-PCa discrimination. This study outperforms the conventional PSA test with a minimally invasive widely exploitable approach.
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Zhu, Lei, Jari Leinonen, Wan-Ming Zhang, Patrik Finne, and Ulf-Håkan Stenman. "Dual-Label Immunoassay for Simultaneous Measurement of Prostate-specific Antigen (PSA)-α1-Antichymotrypsin Complex Together with Free or Total PSA." Clinical Chemistry 49, no. 1 (January 1, 2003): 97–103. http://dx.doi.org/10.1373/49.1.97.
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Abstract Background: A major portion of prostate-specific antigen exists in circulation as a complex with α1-antichymotrypsin (PSA-ACT), whereas a minor part is free (fPSA). The proportion of PSA-ACT is increased in prostate cancer (PCa), but immunologic determination of PSA-ACT is hampered by a background produced by nonspecific adsorption of ACT to the solid phase. To reduce the nonspecific interference, we produced an antibody specific for complexed ACT and developed immunofluorometric assays (IFMAs) for simultaneous measurement of fPSA + PSA-ACT (fPSA/PSA-ACT) and PSA-ACT + total PSA (tPSA, PSA-ACT/tPSA). Methods: Monoclonal antibodies (MAbs) were produced by immunization with PSA-ACT. The dual-label time-resolved IFMAs for fPSA/PSA-ACT and PSA-ACT/tPSA used a capture MAb to tPSA, an Eu3+-labeled MAb to fPSA or complexed ACT, and an Sm3+-labeled MAb to complexed ACT or to tPSA as tracer antibodies. The clinical utility was evaluated using serum samples from individuals with or without PCa with PSA concentrations of 2.0–20.0 μg/L. Results: One MAb (1D10) showed low cross-reactivity with free ACT and cathepsin G-ACT. A sandwich assay for PSA-ACT with 1D10 as tracer had a detection limit of 0.05 μg/L, and with this assay, PSA-ACT was undetectable in female sera. The detection limit for fPSA was 0.004 μg/L. Determinations of the ratio of fPSA to PSA-ACT and the proportions of fPSA/tPSA and PSA-ACT/tPSA provided the same clinical specificity for PCa and provided significantly better clinical specificity than did tPSA. Conclusions: Background problems observed in earlier PSA-ACT assays are eliminated by the use of a MAb specific for complexed ACT as a tracer. The same clinical validity can be obtained by determination of fPSA or PSA-ACT together or in combination with tPSA.
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Jayalath, Viranda H., Katherine Lajkosz, Neil E. Fleshner, Robert J. Hamilton, and David J. A. Jenkins. "The effect of lowering cholesterol through diet on serum prostate-specific antigen levels: A secondary analysis of clinical trials." Canadian Urological Association Journal 16, no. 8 (July 21, 2022): 279–82. http://dx.doi.org/10.5489/cuaj.7975.
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Importance: Statins appear to lower serum prostate-specific antigen (PSA) and improve prostate cancer (PCa) outcomes through cholesterol-dependent and independent mechanisms. While dietary modifications have an established role in serum cholesterol reduction, whether diet-driven cholesterol reductions yield similar PCa benefits to that observed with statins is unclear. We aimed to study the effect of diet-driven cholesterol reduction on serum PSA and estimated-PCa risk. Methods: A total of 291 men from six published randomized controlled trials of dietary interventions were included. Men were aged ≥40 years, free of PCa, and had baseline PSA <10.0 ng/mL. Participants received one of four diets (high-fiber, low-glycemic index, low-glycemic load, or cholesterol-lowering) for 8–24 weeks. The primary outcome evaluated the association between change from baseline low-density lipoprotein cholesterol (LDL-C) and PSA. How cholesterol reduction modified PCa risk was estimated using the Prostate Cancer Prevention Trial (PCPT) risk calculator (limited to age ≥55 years, baseline PSA ≥1.0 ng/mL). Results: Baseline PSA was 0.90 ng/mL (interquartile range [IQR] 0.55–1.60) and LDL-C was 90 mg/dL (IQR 69–125). In multivariate regression, PSA decreased 1.9% (95% confidence interval [CI] 0.55–3.2, p=0.005) per 10% reduction in LDL-C. This regression was greater in men with baseline PSA ≥2.0 ng/mL (-5.4%, 95% CI 2.2–8.6] per 10% LDL-C reduction, p-interaction=0.001). In men with estimable PCPT risk, statin-comparable LDL-C reductions (≥15%) reduced PSA by 12% (p<0.001) and estimated PCa risk by 6.5% (p=0.005). Conclusions: This is the first study to show that serum cholesterol reduction through dietary interventions significantly lowered serum PSA and estimated PCa risk. Whether cholesterol-lowering diets improve PCa outcomes warrants investigation.
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Herrera-Caceres, Jaime Omar, Eduardo Gonzalez-Cuenca, Andrea G. Manzanera, Laura K. Aguilar, Estuardo Aguilar-Cordova, Ricardo Alonso Castillejos-Molina, and Guillermo Feria Bernal. "Population based PSA screening in Mexico City." Journal of Clinical Oncology 35, no. 6_suppl (February 20, 2017): 92. http://dx.doi.org/10.1200/jco.2017.35.6_suppl.92.
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92 Background: Since the U.S. Preventive Task Force recommended against PSA screening in 2012, the polemic between the benefit of early detection and the risk of early overtreatment, has been heightened. Furthermore, in countries where diagnosis is delayed even in symptomatic men and resources are limited for treating advanced disease, the impact of limiting PSA screening may be greater resulting in a shorter incidence/mortality ratio. In Mexico PSA screening is not widely used and many men are never diagnosed with PCa. Thus, the true incidence of PCa is unknown and yet it is the number one cause of cancer morbidity and mortality in men. The current study was designed to evaluate the incidence of PCa in a random population of men from Mexico City using PSA screening. Methods: Prospective enrollment of 3,837 men > 50 years old without previous history of PCa underwent PSA testing. Men with a PSA > 4ng/ml were selected for a second analysis and for completion of a questionnaire on prostate health history. Men with confirmed elevated PSA are being invited to further evaluation and possible biopsy by a urologist. Results: Median age was 59 years (interquartile range 56 to 63 years). In this cohort, 412 (10.8%) men had a total PSA > 4ng/ml (5% of those < 55 years vs. 26% of those > 70 years). From these men, 284 had a repeat PSA approximately 3 months after the first evaluation (median 98 days). A total of 229 men had a 2nd PSA above 4mg/ml, 25 had PSA > 20ng/ml. During evaluations, 309 men completed the questionnaire showing that 29% had previous PSA testing, 11% had a previous DRE, 4% had history of a previous biopsy and 2% identified having a family history of PCa. Conclusions: Greater than 10% (n = 412/3837) of men from a random screen in Mexico City were found to have elevated PSA ( > 4ng/ml). Of these, 12% (n = 48) and 6% (n = 25) had levels consistent with intermediate- and high-risk disease, respectively. Most of these ”high-PSA” patients did not have a previous PSA evaluation despite symptoms, representing a considerable number of patients in whom screening could be life-saving intervention. A low awareness of family history of PCa could be representative of both the lack of diagnosis of PCa and general ignorance regarding this disease. We continue evaluating and doing biopsies to patients with indication.
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Ferraro, Simona, Marco Bussetti, Niccolò Bassani, Roberta Simona Rossi, Giacomo Piero Incarbone, Filippo Bianchi, Marco Maggioni, Letterio Runza, Ferruccio Ceriotti, and Mauro Panteghini. "Definition of Outcome-Based Prostate-Specific Antigen (PSA) Thresholds for Advanced Prostate Cancer Risk Prediction." Cancers 13, no. 14 (July 6, 2021): 3381. http://dx.doi.org/10.3390/cancers13143381.
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We defined prostate-specific antigen (PSA) thresholds from a well calibrated risk prediction model for identifying and excluding advanced prostate cancer (PCa). We retrieved 902 biopsied patients with a pre-biopsy PSA determination (Roche assay). A logistic regression model predictive for PCa including the main effects [i.e., PSA, age, histological evidence of glandular inflammation (GI)] was built after testing the accuracy by calibration plots and Hosmer-Lemeshow test for goodness of fit. PSA thresholds were derived by assuming a diagnostic sensitivity of 95% (rule-out) and 80% (rule-in) for overall and advanced/poorly differentiated PCa. In patients without GI, serum PSA concentrations ≤ 4.1 (<65 years old) and ≤3.7 μg/L (≥65 years old) excluded an advanced PCa (defined as Gleason score ≥ 7 at biopsy), with a negative predictive value of 95.1% [95% confidence interval (CI): 83.0–98.7] and 88.8% (CI: 80.2–93.9), respectively, while PSA > 5.7 (<65) and >6.1 μg/L (≥65) should address biopsy referral. In presence of GI, PSA did not provide a valid estimate for risk of advanced cancer because of its higher variability and the low pre-test probability of PCa. The proposed PSA thresholds may support biopsy decision except for patients with asymptomatic prostatitis who cannot be pre-biopsy identified.
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Wu, Ping, Lei Zhu, Ulf-Håkan Stenman, and Jari Leinonen. "Immunopeptidometric Assay for Enzymatically Active Prostate-Specific Antigen." Clinical Chemistry 50, no. 1 (January 1, 2004): 125–29. http://dx.doi.org/10.1373/clinchem.2003.026146.
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Abstract Background: Determinations of certain forms of prostate-specific antigen (PSA) have been shown to increase the specificity for prostate cancer (PCa). One such variant, proteolytically active PSA, is a potentially useful tumor marker, but it is not specifically recognized by antibodies. Using phage display libraries, we previously identified a “family” of peptides that bind specifically to active PSA. We used these to develop an immunopeptidometric assay (IPMA) that specifically detects this form of PSA. Methods: Microtitration plates coated with a PSA antibody were used to capture PSA, and a PSA-binding glutathione S-transferase (GST) fusion peptide was used as a tracer. Bound tracer was detected with an antibody to GST labeled with a europium chelate. PSA isoenzymes with high and low enzymatic activity were used to study binding specificity. Results: The IPMA detected enzymatically active PSA but not internally cleaved PSA and pro-PSA, which are enzymatically inactive. The assay detected 1–10% of free PSA in serum from PCa patients. Conclusions: Peptides identified by phage display can be used to develop assays with unique specificities for enzymatically active PSA. IPMA represents a new assay principle with wide potential utility.
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Ko, Young Hwii, Byung-Hoon Kim, Wonho Jung, Ji Yong Ha, Taek Jun Shin, Se Yun Kwon, Hyun Jin Jung, Yoon Soo Hah, and Tae Hyo Kim. "Delaying a Biopsy With Serial Prostate-Specific Antigen Checkup Helps to Identify a Significant Prostate Cancer: A Strategy to Evade Unnecessary Procedures." Korean Journal of Urological Oncology 20, no. 3 (August 31, 2022): 177–85. http://dx.doi.org/10.22465/kjuo.2022.20.3.177.
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Purpose: To differentiate a non-cancer-related temporary increase in prostate-specific antigen (PSA) triggering unnecessary biopsy, we intentionally delayed biopsy with a serial follow-up, then investigated the efficacy of this strategy in identifying a significant prostate cancer (PCa).Materials and Methods: Retrospective data of patients who initially presented with a suspicious level of serum PSA (3–20 ng/mL), managed using the delayed strategy, and then eventually underwent biopsy were obtained from 4 tertiary centers between 2018–2020.Results: The collected 271 subjects had a median (interquartile range) PSA, age, and prostate volume of 5.03 ng/mL (4.46–7.79 ng/mL), 67 years (61–73 years), and 38 g (28–50 g), respectively. During the delay period of 8 weeks (4–19 weeks), most were managed with alpha-blockers (85.6%, n=232). Ninety-four (34.7%) experienced a PSA decrease of 20.53% (8.82–38.16). Eventual biopsy revealed 115 PCa cases (42.5%) including 82 significant ones and 46 high-risk diseases. Men with a PSA decrease had a lower probability of PCa (31.9% vs. 48%, p=0.014), a significant disease (21.3% vs. 35.0%, p=0.026), and high-risk PCa (7.4% vs. 22.0%, p=0.002) than the PSA-elevated counterparts. However, the degree of PSA decrease was not associated with the presence or the severity of PCa. In patients with PSA normalization (≤3 ng/mL), though 4 patients of them (66%) had PCa including a single significant disease, none had high-risk disease.Conclusions: About one-third of individuals initially indicated for transrectal biopsy experienced a decrease in PSA, and their chance for significant PCa was diminished. This retrospective study suggests PSA normalization could be an acceptable notion, though requires further investigation.
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Stephan, Carsten, Kerstin Siemßen, Henning Cammann, Frank Friedersdorff, Serdar Deger, Mark Schrader, Kurt Miller, Michael Lein, Klaus Jung, and Hellmuth-Alexander Meyer. "Between-Method Differences in Prostate-Specific Antigen Assays Affect Prostate Cancer Risk Prediction by Nomograms." Clinical Chemistry 57, no. 7 (July 1, 2011): 995–1004. http://dx.doi.org/10.1373/clinchem.2010.151472.
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BACKGROUND To date, no published nomogram for prostate cancer (PCa) risk prediction has considered the between-method differences associated with estimating concentrations of prostate-specific antigen (PSA). METHODS Total PSA (tPSA) and free PSA were measured in 780 biopsy-referred men with 5 different assays. These data, together with other clinical parameters, were applied to 5 published nomograms that are used for PCa detection. Discrimination and calibration criteria were used to characterize the accuracy of the nomogram models under these conditions. RESULTS PCa was found in 455 men (58.3%), and 325 men had no evidence of malignancy. Median tPSA concentrations ranged from 5.5 μg/L to 7.04 μg/L, whereas the median percentage of free PSA ranged from 10.6% to 16.4%. Both the calibration and discrimination of the nomograms varied significantly across different types of PSA assays. Median PCa probabilities, which indicate PCa risk, ranged from 0.59 to 0.76 when different PSA assays were used within the same nomogram. On the other hand, various nomograms produced different PCa probabilities when the same PSA assay was used. Although the ROC curves had comparable areas under the ROC curve, considerable differences were observed among the 5 assays when the sensitivities and specificities at various PCa probability cutoffs were analyzed. CONCLUSIONS The accuracy of the PCa probabilities predicted according to different nomograms is limited by the lack of agreement between the different PSA assays. This difference between methods may lead to unacceptable variation in PCa risk prediction. A more cautious application of nomograms is recommended.
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Jung, Klaus, Brigitte Brux, Michael Lein, Birgit Rudolph, Glen Kristiansen, Steffen Hauptmann, Dietmar Schnorr, Stefan A. Loening, and Pranav Sinha. "Molecular Forms of Prostate-specific Antigen in Malignant and Benign Prostatic Tissue: Biochemical and Diagnostic Implications." Clinical Chemistry 46, no. 1 (January 1, 2000): 47–54. http://dx.doi.org/10.1093/clinchem/46.1.47.
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Abstract Background: Patients with prostate cancer (PCa) show a lower ratio of free prostate-specific antigen (fPSA) to total PSA (tPSA) in serum than patients with benign prostatic hyperplasia (BPH). The patterns of the intracellular PSA isoforms in malignant and benign prostatic tissue have been studied as potential molecular reasons for this phenomenon. Methods: Prostatic tissue samples were obtained after cystoprostatectomy from patients with bladder cancer (n = 10), from BPH patients (transurethral resection of the prostate, n = 10; adenomectomy, n = 10), and from the cancerous and noncancerous parts of the same prostates removed surgically by prostatectomy because of PCa (n = 20). PSA pattern was characterized by gel filtration, immunoblotting, and immunoassays for tPSA, fPSA, α1-antichymotrypsin-PSA (ACT-PSA), and complexed PSA (Bayer Immuno 1 assay). Comparisons were made with the PSA concentrations in serum. Results: The major portion of tPSA in all tissue samples was fPSA; complexed PSA forms were <2%. Samples from cystoprostatectomy patients had the lowest and those from adenomectomy patients the highest values of tPSA and fPSA. PSA concentrations were lower in cancerous than in the noncancerous parts of the prostate. No significant correlations were found between tumor stage or grade and the amounts of tPSA, fPSA, and ACT-PSA in tissue. Tissue PSA values were not correlated with the serum PSA concentrations nor with the ratios fPSA/tPSA and ACT-PSA/tPSA in sera. Conclusions: The amounts of tPSA and the PSA isoforms in prostatic tissue explain neither the concentrations of tPSA and PSA isoforms in serum nor the behavior of the ratio fPSA/tPSA in patients with BPH and PCa.
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Tkac, Jan, Veronika Gajdosova, Stefania Hroncekova, Tomas Bertok, Michal Hires, Eduard Jane, Lenka Lorencova, and Peter Kasak. "Prostate-specific antigen glycoprofiling as diagnostic and prognostic biomarker of prostate cancer." Interface Focus 9, no. 2 (February 15, 2019): 20180077. http://dx.doi.org/10.1098/rsfs.2018.0077.
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The initial part of this review details the controversy behind the use of a serological level of prostate-specific antigen (PSA) for the diagnostics of prostate cancer (PCa). Novel biomarkers are in demand for PCa diagnostics, outperforming traditional PSA tests. The review provides a detailed and comprehensive summary that PSA glycoprofiling can effectively solve this problem, thereby considerably reducing the number of unnecessary biopsies. In addition, PSA glycoprofiling can serve as a prognostic PCa biomarker to identify PCa patients with an aggressive form of PCa, avoiding unnecessary further treatments which are significantly life altering (incontinence or impotence).
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Kachuri, Linda, Rebecca E. Graff, Sonja I. Berndt, Mitchell Machiela, Neal D. Freedman, Stephen J. Chanock, John P. Shelley, et al. "Abstract 1441: Genetic determinants of PSA levels improve prostate cancer screening." Cancer Research 82, no. 12_Supplement (June 15, 2022): 1441. http://dx.doi.org/10.1158/1538-7445.am2022-1441.
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Abstract Prostate-specific antigen (PSA) screening for prostate cancer (PCa) remains controversial due to poor sensitivity and specificity that lead to overdiagnosis and overtreatment. The aim of our study is to characterize genetic determinants of PSA levels in cancer-free men in order to personalize PCa screening. We hypothesize that test accuracy may be improved by accounting for PSA variation that is due to genetic factors and does not reflect PCa. We conducted the largest ever genome-wide association study (GWAS) of PSA in men without PCa (N=95,768; 85,924 predominantly European ancestry) using data from the UK Biobank, BioVU, PLCO, and Kaiser Permanente cohorts. Our GWAS discovered 129 PSA-associated variants (P<5×10-8), 82 of which were novel. A polygenic score (PGSPSA) comprised of these 129 variants was successfully validated in two cancer prevention trials: PCPT (n=5737) and SELECT (n=22,247). PGSPSA explained 7.3% (p=7.0×10-98) of variation in baseline PSA in PCPT and 8.7% (p=7.0×10-476) in SELECT. Importantly, PGSPSA was not associated with PCa status in PCPT (OR=0.98, p=0.71) or SELECT (OR=1.04, p=0.98), which confirms that it reflects benign PSA variation. Potential clinical utility of PSA genetic adjustment was explored by examining reclassification at thresholds used for biopsy referrals in a real-world setting at Kaiser Permanente. We estimated that correction using PGSPSA would have avoided 21.2% of negative biopsies in non-cases. Reclassification below the biopsy referral threshold was also more common in cases, particularly with low-grade disease with Gleason score <7 (7.3% below vs. 2.6% above). Overall, genetic correction of PSA appeared to improve the accuracy of referral decisions, with a Net Reclassification Index of 0.148. Next, we evaluated genetically adjusted PSA in the context of detection of aggressive PCa, defined as Gleason score ≥7, PSA ≥10 ng/mL, T3-T4 stage, and/or distant or nodal metastases. Genetically adjusted baseline PSA was more robustly associated with aggressive PCa than observed PSA and yielded a higher area under the curve (AUC) in PCPT (OR=3.03, p=3.5×10-7; AUC: 0.72 vs. 0.68) and SELECT (OR=3.37, p=3.5×10-11; AUC: 0.78 vs. 0.74) when added to a baseline model with age and trial arm. Furthermore, genetically adjusted PSA provides complementary information to PCa risk variants. In PCPT, a logistic regression model that included genetically corrected PSA and the 269-variant PGSPCa achieved a significantly higher AUC than PGSPCa-269 alone for aggressive PCa (AUC: 0.73 vs. 0.65, p=3.3×10-4) and overall PCa (AUC=0.69 vs. 0.66, p=3.3×10-6). Our work provides evidence that accounting for genetic determinants of PSA has the potential to reduce unnecessary testing and overdiagnosis of low-risk PCa, as well as increase detection of aggressive disease. Larger and more diverse study populations are required to fully characterize the genetic basis of PSA variation and optimize its clinical utility. Citation Format: Linda Kachuri, Rebecca E. Graff, Sonja I. Berndt, Mitchell Machiela, Neal D. Freedman, Stephen J. Chanock, John P. Shelley, Kerry Schaffer, Jonathan D. Mosley, Phyllis J. Goodman, Cathee Till, Ian Thompson, Robert J. Klein, Stephen K. Van Den Eeden, Thomas J. Hoffmann, John S. Witte. Genetic determinants of PSA levels improve prostate cancer screening [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 1441.
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Porcaro, Antonio B., Beatrice Caruso, Alessandro Terrin, Nicolò De Luyk, Giovanni Cacciamani, Paolo Corsi, Davide Inverardi, et al. "The preoperative serum ratio of total prostate specific antigen (PSA) to free testosterone (FT), PSA/FT index ratio, and prostate cancer. Results in 220 patients undergoing radical prostatectomy." Archivio Italiano di Urologia e Andrologia 88, no. 1 (March 31, 2016): 17. http://dx.doi.org/10.4081/aiua.2016.1.17.
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Objectives: To evaluate associations of preoperative total prostate specific antigen (PSA) to free testosterone (FT), the PSA/FT index ratio, with features of pathology prostate cancer (PCA) and to investigate its prognostic potential in clustering the PCA population. Patients and methods: After excluding criteria, the records of 220 patients who underwent radical prostatectomy (RP) were retrospectively reviewed. Serum samples of PSA, total testosterone (TT) and FT were collected at 8.00 A.M., one month after biopsies and before RP. The PSA/FT ratio was computed in the population of patients who were clustered in groups according to ranking intervals of the PSA/FT ratio which identified at least 4 clusters which were coded as A, B, C, and D. The independent associations of the PSA/FT index ratio were assessed by statistical methods and a two-sided P < 0.05 was considered to indicate statistical significance. Results: TT correlated to FT which was a significant predictor of PSA in the population of patients who were subsequently clustered, according to increasing interval values of the PSA/FT index ratio, in groups that showed a stronger linear association of FT with PSA. The PSA/FT index ratio significantly associated with pathology features of prostate cancer such as pathology Gleason score (pGS), invasion of the seminal vesicles (pT3b), proportion of positive cores (P+) and proportion of cancer involving the volume of the prostate. In the population of patients, TT, PSA/FT index ratio and P+ independently associated with pGS ≥ 7 and pT3b; moreover, the odds ratio (OR) of the PSA/FT index ratio resulted 9.11 which was stronger than TT (OR = 1.11) and P+ (OR = 8.84). In the PCA population, TT, PSA/FT index ratio and P+ also independently associated with pT3b PCA; interestingly, the OR of PSA/FT index resulted 54.91 which was stronger than TT (OR = 1.31) and P+ (26.43). Conclusions: Preoperative PSA/FT index ratio is an independent strong factor which directly associates with aggressive features of pathology PCA; moreover, it might express prognostic potential for clustering the patient population in risk classes. Confirmatory studies are required.
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Benecchi, L. "PSA velocity and PSA slope." Prostate Cancer and Prostatic Diseases 9, no. 2 (March 28, 2006): 169–72. http://dx.doi.org/10.1038/sj.pcan.4500866.
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Wesseling, Sebastian, Carsten Stephan, Axel Semjonow, Michael Lein, Brigitte Brux, Pranav Sinha, Stefan A. Loening, and Klaus Jung. "Determination of Non-α1-Antichymotrypsin-complexed Prostate-specific Antigen as an Indirect Measurement of Free Prostate-specific Antigen: Analytical Performance and Diagnostic Accuracy." Clinical Chemistry 49, no. 6 (June 1, 2003): 887–94. http://dx.doi.org/10.1373/49.6.887.
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Abstract Background: A new assay measures prostate-specific antigen (PSA) not complexed to α1-antichymotrypsin (nACT-PSA) after removing PSA complexed to ACT by use of anti-ACT antibodies. We evaluated nACT-PSA and its ratio to total PSA (tPSA) as alternatives to free PSA (fPSA) and its ratio to tPSA in differentiating prostate cancer (PCa) and benign prostatic hyperplasia (BPH) in patients with tPSA of 2–20 μg/L. Methods: PSA in serum of 183 untreated patients with PCa and 132 patients with BPH was measured retrospectively on the chemiluminescence immunoassay analyzer LIAISON® (Byk-Sangtec Diagnostica) with the LIAISON tPSA and LIAISON fPSA assays. The nACT-PSA fraction was determined with a prototype assay measuring the residual PSA after precipitation of ACT-PSA with an ACT-precipitating reagent. Results:nACT-PSA was higher than fPSA in samples with fPSA concentrations <1 μg/L but lower in samples with >1 μg/L fPSA. The median ratios of fPSA/tPSA and of nACT-PSA/tPSA were significantly different between patients with BPH and PCa (19.4% vs 12.2% and 17.4% vs 13.0%, respectively). Within the tPSA ranges tested (2–20, 2–10, and 4–10 μg/L), areas under the ROC curves for the fPSA/tPSA ratios were significantly larger than those for nACT-PSA/tPSA. In the tPSA ranges <10 μg/L, the areas under the ROC curves for fPSA/tPSA were significantly larger than those for tPSA, whereas the areas for nACT-PSA/tPSA were not. At decision limits for 95% sensitivity and specificity, both ratios significantly increased specificity and sensitivity, respectively, compared with tPSA, but the fPSA/tPSA ratio showed higher values. Conclusions: nACT-PSA and its ratio to tPSA provide lower diagnostic sensitivity and specificity than fPSA/tPSA. The fPSA/tPSA ratio represents the state-of-the-art method for differentiating between PCa and BPH.
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Carrot, Aurore, Reza-Thierry Elaidi, Olivier Colomban, Denis Maillet, Michel Tod, Benoit You, and Stéphane Oudard. "Modeled Early Longitudinal PSA Kinetics Prognostic Value in Rising PSA Prostate Cancer Patients after Local Therapy Treated with ADT +/− Docetaxel." Cancers 14, no. 3 (February 5, 2022): 815. http://dx.doi.org/10.3390/cancers14030815.
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Background: In metastatic prostate cancer (PCa) patients, androgen-deprivation therapy (ADT) combined with chemotherapy or next-generation androgen receptor targeted agents is a new standard treatment. The objective of the present study is to assess longitudinal PSA kinetics during treatment using mathematical modeling, to identify the modeled PSA kinetic parameters able to exhibit early prognostic/predictive values. Methods: Phase III clinical trial dataset (NCT00764166) comparing ADT +/− docetaxel in 250 locally treated patients for PCa with rising PSA levels, who were at high risk of metastatic disease was assessed. A kinetic-pharmacodynamic (K-PD) model was used to fit PSA kinetics during the first 100 treatment days, to estimate the modeled PSA production rate K (KPROD) and elimination constant rate K (KELIM). The prognostic value of these parameters, considered as categorized (favorable vs. unfavorable) covariates regarding PSA progression-free survival (PSA-PFS) and overall survival (OS), was assessed using univariate/multivariate analyses. Results: Data from 177/250 patients was assessed. KELIM exhibited a significant prognostic value regarding PSA-PFS and KPROD regarding OS (univariate analysis). In the PSA-PFS final multivariate model, KELIM and the primary therapy type were significant. The OS multivariate model integrated both KPROD and baseline PSA doubling-time. Conclusion: In this first study assessing the modeled PSA kinetics prognostic value in PCa patients treated with systemic treatments, KELIM and KPROD exhibited respective prognostic values regarding PSA-PFS and OS.
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An, Hengqing, Ning Tao, Jia Li, Yonghui Guan, Wenguang Wang, Yujie Wang, and Feng Wang. "Detection of Prostate Cancer Metastasis by Whole Body Magnetic Resonance Imaging Combined with Bone Scintigraphy and PSA Levels." Cellular Physiology and Biochemistry 40, no. 5 (2016): 1052–62. http://dx.doi.org/10.1159/000453161.
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Background/Aims: The combined role of whole-body magnetic resonance imaging (WB-MRI), bone scintigraphy and prostate specific antigen (PSA) were considered in predicting metastases and prognosis of prostate cancer (PCa). Methods: Totally 38 PCa patients underwent WB-MRI, bone scintigraphy and PSA detections, and 34 benign prostate hyperplasia (BPH) patients were checked with PSA. Pearson correlations were performed to determine associations among PSA, apparent diffusion coefficient (ADC) and Gleason scoring. Specificity and sensitivity were for comparison of diagnostic accuracies. Patients' baseline PSA, PSA nadir and time to the prostate-specific antigen nadir (TTPN) were analyzed, and Kaplan-Meier survival curves were also established. Results: ADC values were negatively correlated with PSA levels (rs = -0.389, P = 0.016) and Gleason scores (rs = -0.432, P = 0.006), while PSA levels were positively correlated with Gleason scoring (rs = 0.493, P = 0.002). Diagnostic efficacy of whole body-diffusion weighted imaging (WB-DWI) combined with PSA seemed the most favorable, and bone scintigraphy was advantageous in identifying bone metastasis. PSA levels (> 61.60 µg/L), Gleason scores (> 6) and ADC (< 0.81 × 10-3 mm2/s) could all predict pessimistic prognosis (HR = 7.65; HR = 6.09; HR = 7.28). Smaller PSA nadir (≤ 1.0 µg/L) and longer TTPN (> 3 months) were associated with increased 5-year survival rate (P < 0.05). Conclusions: The combined efficacies of WB-MRI, bone scintigraphy and PSA levels were desired in identifying PCa lesions and prognosis.
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Schneider, H., C. D. Schaub, C. A. Chen, K. A. Andreoni, A. R. Schwartz, P. L. Smith, J. L. Robotham, and C. P. O'Donnell. "Neural and local effects of hypoxia on cardiovascular responses to obstructive apnea." Journal of Applied Physiology 88, no. 3 (March 1, 2000): 1093–102. http://dx.doi.org/10.1152/jappl.2000.88.3.1093.
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Obstructive sleep apnea (OSA) acutely increases systemic (Psa) and pulmonary (Ppa) arterial pressures and decreases ventricular stroke volume (SV). In this study, we used a canine model of OSA ( n = 6) to examine the role of hypoxia and the autonomic nervous system (ANS) in mediating these cardiovascular responses. Hyperoxia (40% oxygen) completely blocked any increase in Ppa in response to obstructive apnea but only attenuated the increase in Psa. In contrast, after blockade of the ANS (20 mg/kg iv hexamethonium), obstructive apnea produced a decrease in Psa (−5.9 mmHg; P < 0.05) but no change in Ppa, and the fall in SV was abolished. Both the fall in Psa and the rise in Ppa that persisted after ANS blockade were abolished when apneas were induced during hyperoxia. We conclude that 1) hypoxia can account for all of the Ppa and the majority of the Psa response to obstructive apnea, 2) the ANS increases Psa but not Ppa in obstructive apnea, 3) the local effects of hypoxia associated with obstructive apnea cause vasodilation in the systemic vasculature and vasoconstriction in the pulmonary vasculature, and 4) a rise in Psa acts as an afterload to the heart and decreases SV over the course of the apnea.
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Biddle, Caitlin, Alicia Brasel, Willie Underwood, and Heather Orom. "Experiences of Uncertainty in Men With an Elevated PSA." American Journal of Men's Health 11, no. 1 (June 23, 2016): 24–34. http://dx.doi.org/10.1177/1557988315584376.
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A significant proportion of men, ages 50 to 70 years, have, and continue to receive prostate specific antigen (PSA) tests to screen for prostate cancer (PCa). Approximately 70% of men with an elevated PSA level will not subsequently be diagnosed with PCa. Semistructured interviews were conducted with 13 men with an elevated PSA level who had not been diagnosed with PCa. Uncertainty was prominent in men’s reactions to the PSA results, stemming from unanswered questions about the PSA test, PCa risk, and confusion about their management plan. Uncertainty was exacerbated or reduced depending on whether health care providers communicated in lay and empathetic ways, and provided opportunities for question asking. To manage uncertainty, men engaged in information and health care seeking, self-monitoring, and defensive cognition. Results inform strategies for meeting informational needs of men with an elevated PSA and confirm the primary importance of physician communication behavior for open information exchange and uncertainty reduction.