The incidence of prostate cancer in China is gradually increasing, and the proportion of newly diagnosed patients with advanced stages is higher in most regions than in Europe and the United States, which will have a direct impact on the treatment outcome and long-term survival of prostate cancer patients in China. In order to promote the scientific and standardized early diagnosis of prostate cancer in urology, the members of this study have developed this “Expert Consensus on Early Diagnosis of Prostate Cancer in China” based on the “Chinese Guidelines for Diagnosis and Treatment of Urological Diseases”, the current situation of early diagnosis of prostate cancer in China, and the latest literature reports with reference to the relevant contents of foreign guidelines. The first “Expert Consensus on Early Diagnosis of Prostate Cancer in China” is based on the current situation of early diagnosis of prostate cancer in China, referring to overseas guidelines and latest literature. The incidence of prostate cancer has significant geographical and racial differences. The incidence of prostate cancer is the second most common malignant tumor in men worldwide. The incidence rate of prostate cancer in China is low, but it has been on a significant rise in recent years. Since 2008, prostate cancer has become the malignant tumor with the highest incidence in the urinary system, and the incidence rate reached 9.92/100,000 in 2009. In 2009, the incidence rates of prostate cancer in Beijing, Shanghai and Guangzhou reached 19.30/100,000, 32.23/100,000 and 17.57/100,000 respectively. At present, the accepted clinical diagnosis model of prostate cancer is the “three-step” method: (1) detecting suspicious cases through tumor markers such as PSA and digital rectal examination (DRE); (2) choosing transrectal prostate ultrasound (TPE) as appropriate. The localization of the suspected lesions can be done by ultrasound (transreetal uhrasonography, TRUS), multiparametric magnetic resonance imaging (MRI), etc.; (3) pathological diagnosis can be obtained by TRUS-guided prostate system biopsy. I. PSA examination 1. PSA screening: PSA-based prostate cancer screening specifically refers to PSA examination in a specific population of healthy men without symptoms, with the aim of early detection of prostate cancer and ultimately reducing its morbidity and mortality. PSA as a single test has a higher predictive rate of positive prostate cancer diagnosis compared to DRE and TRUS. However, PSA screening in healthy male population may bring about overdiagnosis and overtreatment of prostate cancer, and the pros and cons of this screening system have been hotly debated by a wide range of clinicians in Europe and the United States. In China, there is no PSA screening system and no large-scale PSA screening studies, so the results of some large foreign prostate cancer screening studies are worthy of reference and consideration by domestic physicians. The European ERSPC screening study clearly demonstrated that PSA screening can reduce the death rate of prostate cancer and improve long-term survival. However, 23% to 42% of the diagnosed cases were incidental cancer, reflecting the overdiagnosis associated with PSA screening. Another randomized controlled trial of PSA screening for prostate, lung, and colon cancers, PLCO, also showed that PSA screening led to overdiagnosis of prostate cancer. The American Urological Association (AUA) and the American Society of Clinical Oncology (ASCO) recommend that men over the age of 50 should receive annual DRE and PSA screening, and for those with a family history of prostate cancer, annual PSA screening should begin at age 45. men under the age of 70 can benefit from PSA screening, but men older than 70 or with a life expectancy of less than 10 years are not included in the PSA screening population. Combined with the relevant literature base of PSA screening at home and abroad, this consensus expert group recommends that, until specific data are obtained through large domestic prostate cancer screening studies, it is not appropriate to promote PSA screening based on the whole population in China at present. 2. Clinical PSA examination and result determination: PSA examination is different from PSA screening, and clinical PSA examination in China often occurs in urology clinics and annual health checkups. Clinical PSA examination requires attention to the following points. (1) PSA test indications: (1) Men over 50 years old with lower urinary tract symptoms need to undergo PSA test; (2) Men with a family history of prostate cancer, PSA test should be advanced to 45 years old; (3) Men with abnormal DRE or prostate imaging should also undergo PSA test; (2) Test frequency: 0) 45-49 years old, with normal DRE and PSA >1ug/L, 1 (2) PSA should be rechecked in 1-2 years; ② for those with normal DRE and PSA ≤1ug/L, recheck at age 50; (3) PSA should be rechecked in 1-2 years if DRE is normal, PSA <3ug/L and there are no other indications for puncture above age 50; (3) Influencing factors: factors affecting serum PSA levels include mechanical prostate extrusion (such as DRE, urinary retention, cystoscopy, etc.) and urinary tract infection, hematuria, etc. Therefore, the examination should be performed 24h after ejaculation, 48h after cystoscopy, catheterization and other operations, 1 week after DRE examination, and 1 month after prostate puncture. It is recommended that routine urine examination be performed at the same time as PSA testing to exclude the effects of hematuria and/or inflammation; (4) Normal PSA values: serum total PSA ( tPSA) >4.0ug/L is considered abnormal, and retesting in a few weeks is recommended for those with initial PSA abnormalities. The serum PSA is affected by age and prostate size and other factors. Some data show that the PSA levels of men in China at different ages are ≤2.15ug/L for 40-49 years, ≤3.20ug/L for 50-59 years, ≤4.10ug/L for 60-69 years, and ≤5.37ug/L for 70-79 years All of them are lower than that of men in western countries. 3, PSA-derived indicators: It is generally believed that when PSA is between 4 and 10ug / L (gray area), in order to avoid unnecessary puncture, the following PSA-derived indicators can be used. (1) Free PSA ratio (%fPSA): Free PSA can improve the detection rate of prostate cancer with PSA in the gray zone. It is recommended to use 0.16 as the reference value of %fPSA. The positive rate of puncture is 11.6% when %fPSA>0,16, 17.4% when <0.16, and up to 56% when <0.10. (2) PSA density (PSAD): the ratio of serum PSA value to prostate volume. The normal value should be <0.15. When the patient's PSA is at the high limit of normal or mildly elevated, the use of PSAD can guide the physician in deciding whether to perform a puncture biopsy or follow-up; (3) PSA rate (PSAV): the amount of change in PSA per unit of time, calculated by testing PSA at least 3 times over a 2-year period, with a normal value of <0, 75ug/L per year. PSAV in prostate cancer is is significantly higher than that of BPH and normal population. If the PSAV is >0.75ug/L per year, the possibility of prostate cancer should be suspected. In recent years, some other prostate cancer markers other than PSA have been gradually considered to have potential diagnostic value. The long chain non-coding RNA prostate cancer antigen 3 (PCA3) gene has been approved by the US FDA as a marker for prostate cancer diagnosis. The use of PCA3 as a diagnostic marker in patients with elevated PSA improves the diagnostic accuracy of prostate cancer over the use of tPSA, %fPSA, etc. EAU guidelines recommend PCA3 testing in patients who have a negative initial prostate puncture but still suspect prostate cancer. The fusion gene TMPRSS2-ERG has been found to be more widespread in the European and American prostate cancer populations and may also improve the diagnostic accuracy of prostate cancer. The molecular isomer of free PSA, p2PSA, was approved as a prostate cancer test by the FDA in 2005. The accuracy and specificity of the p2PSA-based prostate health index (PHI) for prostate cancer diagnosis is better than that of PSAll41. Given the significant racial differences in prostate cancer, it is cautious whether these new diagnostic indices can be used directly in domestic clinical practice. In the meantime, some of the latest studies in China have also shown that the PSAll41 is more accurate than the PSAll41. In the meantime, some recent studies in China have found some early diagnostic indicators that are unique to the national population. DRE is easy to perform and painless for patients, and is an important test for early diagnosis of prostate cancer. Most prostate cancers originate in the peripheral zone of the prostate and are easily detected by DRE when the tumor volume exceeds 0.2 ml. About 18% of prostate cancer patients are detected by DRE alone, and patients with abnormal DRE tend to have a higher score of prostate cancer. Imaging 1. TRUS: In TRUS examination, typical hypoechoic nodal signs in the peripheral zone of prostate cancer are not common, especially for patients with early prostate cancer, TRUS examination has limited value and low diagnostic specificity. In addition, point-of-interest puncture guided by TRUS alone cannot replace systemic puncture; 2. MRI: The value of MRI in the diagnosis of prostate cancer has gained more and more widespread recognition in recent years, especially the multiparametric MRI technique combining sequences such as wave spectrum analysis and dynamic diffusion weighting, which is of greater value for early diagnosis and clinical staging of prostate cancer. Since early prostate cancer lesions are small in size, multifocal and scattered in growth, therefore, for patients with negative initial puncture, targeted prostate puncture biopsy can be performed by TRUS and multiparametric MRI image fusion technique, which can improve the detection rate of early prostate cancer by about 20% as reported in foreign literature; 3. Other: CT and whole-body nuclide bone scan techniques have limited clinical value in the early diagnosis of prostate cancer. They are only useful for determining lymph node and bone metastasis. Prostate puncture biopsy is the most reliable means to confirm the diagnosis of prostate cancer, and an accurate and effective prostate puncture biopsy is important for the diagnosis of early prostate cancer. The results of a survey on the status of prostate puncture biopsy conducted by the China Prostate Cancer Consortium (CPCC) showed that patients with prostate puncture biopsy in China are older, have higher PSA, smaller prostate volume, higher Gleason score and lower positive rate compared to those in Europe and the United States. This may be related to the different puncture strategies adopted in different regions. The indications for prostate puncture biopsy recommended by this consensus include: ①DRE findings of prostate nodules, any PSA value; ②MRI and TRUS findings of abnormalities, any PSA value; ③PsA>10ug/L; ④PSA 4 to 10ug/L, abnormal f/t PSA or abnormal PSAD value. When PSA is 4 to 10ug/L, if % fPSA, PSAD and imaging are normal, close follow-up should be performed. Puncture should take into account both the patient’s age, comorbidities, and treatment outcome. Some commonly used risk calculation tools from abroad, such as Sunnybrook and ERSPC, can be used to predict the risk of positive puncture in individuals and are important tools to reduce unnecessary punctures. However, these prediction models based on foreign samples need to be clinically validated across ethnic groups for use in our population. The indications for repeat puncture biopsy after initial negative puncture include: ① atypical hyperplasia or high-grade PIN found by first puncture pathology, especially multiple stitches pathology results as above; ② review PSA >10ug/L; ③ review PSA 4-10ug/L, % fPSA, PSAD value, DRE or abnormal imaging performance, such as TRUS or MRI examination suggesting suspicious cancer foci, which can be detected in imaging If PSA is >10ug/L for 2 consecutive times or PSAV is >0,75ug/L per year. Prostate puncture biopsy should be performed under ultrasound guidance and routine use of prophylactic antibiotics and local anesthesia is recommended. anesthesia. Transrectal puncture is more widely used clinically, and transperineal puncture has a similar detection rate of prostate cancer as transrectal puncture. The number of puncture stitches: A prostate with a volume of 30-40 ml requires no less than 8 puncture biopsies. 10-12 stitches systematic puncture is the most widely used baseline (initial) prostate puncture strategy in clinical practice. The main complications of prostate puncture include hematuria, hematospermia, and infection.