Establishment Of Reference Values Of Prostate Specific Antigen And Related Parameters In The North Of China

Backgroud:Prostate specific antigen(PSA)is one of the most commonly used methods for screening prostate cancer,PSA velocity(PSAV),PSA density(PSAD)and free to total prostate specific antigen(f/tPSA)are parameters that improve the ability of PSA to screen prostate cancer when PSA is located in the grey area(PSA4-10ng/ml).At present,PSA has been widely used in clinic,but the single application of PSA in detection of prostate cancer still has defects:1.PSA has racial differences.The critical values of PSA and its related parameters for clinical diagnosis of prostate cancer in China are mostly based on foreign data;2.PSA is different in age and region.Different reference values of PSA are used in different age and local population;3.When PSA is located in the grey area(PSA4-10ng/ml),f/tPSA and PSAD are the most commonly used indicators to improve the diagnostic accuracy,but their sensitivity and specificity are low and conflicting results often appear.Objective:The focus of this research is to retrospectively analyze the information of the patients who were diagnosed and treated in our hospital,and through the diagnosis,treatment and treatment of prostate-related diseases,according to PSA and related parameters,firstly;the normal values of PSA and related parameters in screening for prostate cancer in the north of China were determined;secondly the age-specific PSA reference value of population in the north of China was established;finally the diagnostic value of new parameters(f/t)/PSAD in PSA(2.5-10ng/ml)was evaluated.Thus,the diagnostic accuracy of prostate cancer screening can be improved and needless biopsy can be reduced.Methods:The retrospective study was conducted to collect the clinical date of healthy people or patients who underwent prostate-related examinations in our hospital from July 2005 to April 2014,including age,tPSA,fPSA,imaging examination,pathological results and patient's diagnosis and treatment records.This topic is divided into three parts and is developed separately.The inclusion and exclusion criteria are described in detail in each part.1.To collect the clinical information of patients who underwent ultrasound-guided systematic prostate puncture in the northern area of our hospital.The detection rate of prostate cancer and the diagnostic value of f/tPSA and PSAD in each PSA level group were calculated,and the normal reference value of prostate cancer screening in northern China was determined.2.To retrospectively analyze the clinical data of normal physical examination or PSA examination in our hospital,including age,tPSA,fPSA,pathological and imaging examination data,and screen healthy people without prostate cancer.The normal reference values of PSA in different age groups were determined,and the correlation between age and PSA was analyzed,and compared with the data at home and abroad.3.Pathological,clinical and imaging data were obtained from patients undergoing ultrasound-guided systematic prostate puncture in our hospital.The diagnostic value of(f/t)/PSAD,PSAD and f/tPSA for prostate cancer was compared between PSA 2.5 and 20ng/ml intervals;the normal reference value of(f/t)/PSAD for prostate cancer screening was determined;the correlation between(f/t)/PSAD and age and prostate volume was analyzed,and the incidence of prostate cancer was evaluated when the values of(f/t)/PSAD were taken.Results:1.A total of 1070 patients were enrolled in this study.According to PSA level,they were divided into five groups:0-2.5ng/ml,2.6-4ng/ml,4.1-10ng/ml,10.1-20ng/ml,and>20ng/ml.The detection rates of prostate cancer in each group were 6.4%,12.5%,36.4%,45.2%and 75.8%,respectively(P<0.01).When PSA was 4.1-20ng/ml,there were significant differences in f/tPSA and PSAD between prostate cancer group and non-prostate cancer group P<0.01).When the sensitivity was 95%,the cut-off value of PSAD was 0.09,the specificity of screening prostate cancer was 30.4%,and the cut-off value of f/tPSA was 0.27,the specificity was 13.5%.2.A total of 24194 cases were included in this study.Serum PSA level was positively correlated with age(r=0.27,P<0.01).Normal serum PSA upper levels in each age group were 1.79ng/ml,1.92ng/ml,2.63ng/ml,4.41ng/ml,6.20ng/ml,6.54ng/ml,respectively.3.A total of 660cases were included in this study.Prostate cancer group(f/t)/PSAD was lower than benign lesion group(P<0.01),and the area under ROC curve(AUC)was higher than PSAD and f/tPSA.Under the premise of 90%sensitivity,f/tPSA value of 1.38,the specificity of prostate cancer screening is higher than PSAD,f/tPSA.(flt)/PSAD was positively correlated with age and prostate volume.The detection rate of prostate cancer decreased with the increase of(f/t)/PSAD level in all age groups and prostate volume group(P<0.01).Conclusions:1.The normal reference value for screening prostate cancer in this study is PSA4.0ng/ml,and the corresponding sensitivity is higher,which is consistent with the domestic and foreign studies.f/tPSA and PSAD have diagnostic value for prostate cancer in the range of PSA4.1-20ng/ml.f/tPSA>0.27 or PSAD<0.09 are normal reference values for prostate cancer screening in the north China.2.Age is correlated with normal serum PSA level in general.Our results showed that the normal upper age-specific PSA level of population in the north China is lower than that in Taiwan and other Western countries.3.(f/t)/PSAD can improve the diagnostic accuracy of prostate cancer patients with a PSA level of 2.5-20ng/ml,and yield higher specificity than f/tPSA and PSAD under high sensitivity.The reference value of(f/t)/PSAD>1.38 is recommended for the screening of prostate cancer patients aged>50 years.Elderly patients with low(f/t)/PSAD level and small prostate volume have a high risk of prostate cancer.