PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Application of PSMA PET/MRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial
First Affiliated Hospital of Fujian Medical University
230 participants
May 7, 2025
INTERVENTIONAL
Conditions
Summary
The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.
Eligibility
Inclusion Criteria5
- Serum PSA \> 4 ng/mL
- At least one prior negative prostate biopsy
- At least two consecutive increases in PSA and/or PHI
- Negative digital rectal examination
- Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3
Exclusion Criteria7
- Age ≤ 30 years or \> 85 years
- Concurrent presence of other malignant tumors
- Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
- Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.)
- Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)
- Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)
- Incomplete clinical or pathological data
Interventions
The experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed. Clinical and pathological data of the patients will be collected for statistical analysis.
The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.
Locations(1)
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NCT06923657