PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy

NARecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

May 7, 2025

Primary Completion Date

May 1, 2026

Study Completion Date

December 1, 2026

Conditions
Prostate Cancer ScreeningPSMA-PET
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Trial Locations (1)

350005

RECRUITING

The First Affiliated Hospital of Fujian Medical University, Fuzhou

All Listed Sponsors
lead

First Affiliated Hospital of Fujian Medical University

OTHER