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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET+/mpMRI+ group | Experimental | 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. |
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| PET+/mpMRI- group | Experimental | 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. |
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| PET-/mpMRI+ group | Active Comparator | 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. |
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| PET-/mpMRI- group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate biopsy guided by PSMA PET/CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biospy outcome | Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of puncture operation | Record the time required for each patient's puncture procedure | 12 months |
| Patient's pain level | Based on VAS pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongbin Sun Sun, MD, PHD | Contact | +86-02552271061 | docshb@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
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| Prostate biopsy guided by mpMRI/US | Diagnostic Test | 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. |
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| Systematic prostate biopsy | Diagnostic Test | The patient will undergo systematic prostate biopsy under TRUS guidance. |
|
| 12 months |
| Blood loss | Bleeding volume during and after operation | 12 months |
| Complication | Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc. | 12 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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