The present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy
Age ≥40 years, male;
Serum PSA level 4-20 ng/mL;
Serum PSA level 4-20 ng/mL;
No contraindications to PSMA-PET/CT or MRI;
Serum PSA >20 ng/mL;
History of prostate surgery/radiotherapy;
Acute prostatitis;
Coagulation disorders or active infection;
Parallel
Prostate biopsy guided by PSMA PET/CT
Diagnostic testThe patient will undergo pelvic non-contrast CT imaging. After co-registration of the CT images with 68Ga-PSMA PET/CT data at corresponding anatomical levels, a percutaneous gluteal approach will be utilized for CT-guided prostate biopsy.
Prostate biopsy guided by mpMRI/US
Diagnostic testThe patient will undergo transrectal ultrasound (TRUS) prostate scanning. After co-registration and precise image fusion of TRUS findings with multiparametric MRI (mpMRI) data, a transperineal percutaneous approach will be employed to perform TRUS-guided prostate biopsy.
Systematic prostate biopsy
Diagnostic testThe patient will undergo systematic prostate biopsy under TRUS guidance.
Biospy outcome
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.
Duration of puncture operation
Record the time required for each patient's puncture procedure
Patient's pain level
Based on VAS pain score
Blood loss
Bleeding volume during and after operation
Complication
Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc.
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This trial is not recruiting at the moment. You can still explore other options:
