An interventional study of Prostate biopsy guided by PSMA PET/CT and Prostate biopsy guided by mpMRI/US in PSMA PET/CT, Prostate Cancer and MpMRI, sponsored by Nanjing First Hospital, Nanjing Medical University. Not yet recruiting at 1 site in China. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Diagnostic
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 120 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
Diagnostic Test: Prostate biopsy guided by PSMA PET/CT
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
Diagnostic Test: Prostate biopsy guided by PSMA PET/CT
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on PSMA PET and positive on mpMRI. These patients will undergo prostate biopsy guided by mpMRI and US.
Diagnostic Test: Prostate biopsy guided by mpMRI/US
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on both PSMA PET and mpMRI. These patients will undergo systematic prostate biopsy.
Diagnostic Test: Systematic prostate biopsy
The 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.
The 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.
The 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.
Time frame: 12 months
Duration of puncture operation
Record the time required for each patient's puncture procedure
Time frame: 12 months
Patient's pain level
Based on VAS pain score
Time frame: 12 months
Blood loss
Bleeding volume during and after operation
Time frame: 12 months
Complication
Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc.
Time frame: 12 months
Plan to share: No
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Nanjing First Hospital, Nanjing Medical University