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PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Sponsor: First Affiliated Hospital of Fujian Medical University
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.
Official title: 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
Key Details
Gender
MALE
Age Range
30 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2025-05-07
Completion Date
2026-12-01
Last Updated
2025-09-15
Healthy Volunteers
No
Conditions
Interventions
PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy
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.
TRUS guided transperineal saturation biopsy
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)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China