Study of PSMA PETMRI-Guided Prostate Targeted Biopsy Compared to Standard Biopsy in Men With PI-RADS 3 or Less and Previous Negative Biopsies

What this Trial Is About

Researchers are evaluating the use of PSMA PETMRI-guided prostate targeted biopsy compared to TRUS-guided transperineal saturation biopsy in men suspected of having prostate cancer who have had prior negative biopsies and a PI-RADS score of 3 or less. This study aims to improve early detection rates of clinically significant prostate cancer csPCa and reduce missed diagnoses by optimizing diagnostic tools and workflows. Participants will be randomly assigned to one of two groups. The experimental group will undergo PSMA PETMRI imaging if positive results are found, they will receive a targeted biopsy guided by both PSMA PETMRI and transrectal ultrasound TRUS. If PSMA PETMRI results are negative, only TRUS-guided transperineal saturation biopsy will be performed. The control group will receive standard TRUS-guided transperineal saturation biopsy without PSMA PETMRI. Clinical and pathological data will be collected for analysis. During the study, participants will undergo diagnostic evaluations including PSMA PETMRI scans and biopsies as assigned. Various outcome measures will be assessed perioperatively, including diagnostic sensitivity, specificity, predictive values, likelihood ratios, and diagnostic accuracy. Questionnaires and anxiety scales will be administered before and after biopsy at multiple time points up to 12 months to assess quality of life and decision-making. The study is open-label and randomized, with follow-up assessments scheduled over the course of a year.

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