MpMRI, Prostate Cancer, PSMA PET/CT
Conditions
Keywords
Prostate cancer, PSMA PET/CT, mpMRI, Prostate biopsy
Brief summary
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
Interventions
DIAGNOSTIC_TESTProstate biopsy guided by PSMA PET/CT
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.
DIAGNOSTIC_TESTProstate biopsy guided by mpMRI/US
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.
DIAGNOSTIC_TESTSystematic prostate biopsy
The patient will undergo systematic prostate biopsy under TRUS guidance.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥40 years, male; 2. Serum PSA level 4-20 ng/mL; 3. Serum PSA level 4-20 ng/mL; 4. No contraindications to PSMA-PET/CT or MRI; 5. Signed informed consent.
Exclusion criteria
1. Serum PSA \>20 ng/mL; 2. History of prostate surgery/radiotherapy; 3. Acute prostatitis; 4. Coagulation disorders or active infection; 5. Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions; 6. Allergy to local anesthetics; 7. Inability to tolerate the biopsy procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biospy outcome | 12 months | Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of puncture operation | 12 months | Record the time required for each patient's puncture procedure |
| Patient's pain level | 12 months | Based on VAS pain score |
| Blood loss | 12 months | Bleeding volume during and after operation |
| Complication | 12 months | Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc. |
Countries
China
Contacts
Primary ContactHongbin Sun Sun, MD, PHD
Outcome results
None listed