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

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.

This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experimental group) and the TRUS-guided transperineal saturation biopsy group (control group). The research aims to evaluate the application of PSMA PET/MRI in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in csPCa detection rates between PSMA PET/MRI-TRUS guided prostate targeted biopsy and TRUS-guided saturation biopsy.

Inclusion Criteria:

• 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 Criteria

• 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