Prostate cancer and benign prostate hyperplasia
Conditions
Interventions
Gold Standard:Pathological diagnosis results after prostate biopsy or surgery
Index test:A diagnostic model based on the methylation signal values of multiple differentially methylated regions in prostate fluid
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for patients in the prostate cancer group: 1) Prostate cancer indicated by pathological results after puncture or surgery; 2) The patient is willing to undergo prostate massage to remove the prostatic fluid. 2. Inclusion criteria for patients with BPH in the control group: 1) age matching with the group of prostate cancer patients; 2) color ultrasound showed prostatic hyperplasia; 3) Patient is willing to undergo prostate massage to remove prostatic fluid. 3.Inclusion criteria for patients with prostate needle biopsy: Patients have indications for prostate puncture ((1) PSA>10 ng/ml; (2) f/t PSA 0.15 ng/ml2, and/or PSA increase rate > 0.75 ug/L per year; (3) Other abnormal prostate-related test results, such as abnormally elevated prostate health index, positive urine prostate cancer antigen 3; 2) The patient is willing to undergo prostate massage to remove the prostatic fluid
Exclusion criteria
Exclusion criteria: 1. Patients in the prostate cancer group 1) Presence of acute prostatitis and other serious urinary tract infections; 2) There are circumstances that affect the removal of prostatic fluid, such as indwelling urinary catheter; 3) Suffering from other malignant tumors; 4) Those who are in critical condition or suffer from physical and mental diseases and are unable to cooperate with the test; 5) There are other factors that the investigator considers to be unsuitable for inclusion 2. Control group BPH patients 1) Presence of acute prostatitis and other serious urinary tract infections; 2) There are circumstances that affect the removal of prostatic fluid, such as indwelling urinary catheter; 3) Suffering from other malignant tumors; 4) Those who are in critical condition or suffer from physical and mental diseases and are unable to cooperate with the test; 5) There are other factors that the investigator considers to be unsuitable for inclusion 3. Patients with prostate needle biopsy 1) Presence of acute prostatitis and other serious urinary tract infections; 2) There are circumstances that affect the removal of prostatic fluid, such as indwelling urinary catheter; 3) Suffering from other malignant tumors; 4) Those who are in critical condition or suffer from physical and mental diseases and are unable to cooperate with the test; 5) There are other factors that the investigator considers to be unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the profile of differentially methylated regions after DNA methylation test in prostate fluid or post DRE voided urine.;Sensitivity;Specificity;positive predictive value;negative predictive value;Area under ROC curve; | — |
Countries
China
Contacts
Public ContactWenhao Shen
The First Affiliated Hospital of Army Medical University
Outcome results
None listed