Prostate Cancer
Conditions
Interventions
Gold Standard:Systemtic biopsy (training
validation)
Index test:Combine patient s age, PSA, prostate volume, digital rectal examination (DRE), PSMA PET/CT lesion score, and mpMRI lesion score (training)
A Comprehensive Diagnosis and Prediction Model for
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Meet the prostate biopsy indications recommended by the current guidelines, as follows: a T-PSA=10ng/ml B. When T-PSA is between 4-10ng/ml, PSA density (PSAD)>0.16 or F-PSA/T-PSA<0.15; C. Abnormal DRE, such as palpation of nodules or palpation of hard prostate; D. Abnormal prostate imaging findings, such as abnormal nodules found by prostate ultrasound or prostate magnetic resonance imaging. E. The patient or family member can understand the study protocol and is willing to participate in the study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: When a patient has any of the following conditions, he cannot be selected for clinical study: a In acute infection and fever; B. Disease with serious bleeding tendency; C. Serious internal and external hemorrhoids, perimuscular or rectal lesions; D. Severe cardiopulmonary insufficiency. E. Patients or family members cannot understand the conditions and objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;specificity;negative predictive value;positive predictive value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Related complications;IPSS score; | — |
Countries
China
Contacts
Public ContactZhien Zhou
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed