Prostate cancer (PCa) diagnosis faces challenges due to the low specificity of PIRADS 3–5 scores. A more precise imaging modality could reduce unnecessary biopsies. This study evaluates 68Ga-PSMA-PET and MRI fusion based cognitive biopsy for detecting and localizing clinically significant PCa, aiming to improve biopsy guidance and diagnostic accuracy.

This prospective diagnostic accuracy study included patients with suspected PCa based on elevated prostate-specific antigen (PSA) levels and suspicious lesions (PIRADS ≥3) on multiparametric MRI (mpMRI). A total of 26 patients underwent PSMA-PET/MRI, followed by both PSMA-PET/MRI-based cognitive biopsy and TRUS fusion biopsy. The primary objective was to evaluate the accuracy of PSMA-PET/MRI in guiding biopsy decisions.

The study included 26 male patients with suspected prostate carcinoma and serum PSA levels between 4-15 ng/mL. The median age was 63 years (IQR: 55-69), and the median serum PSA was 8.05 ng/mL (IQR: 6.0-11.7). Imaging assessments using 68Ga PSMA-PET/MRI reveals notable diagnostic performance, particularly in sensitivity and negative predictive value (NPV). The modality exhibits a high sensitivity of 100%, specificity at 75% and a positive predictive value (PPV) of 25.0% and an overall accuracy of 76.9%. The negative predictive value (NPV) was 100%, indicating that 68Ga PSMA-PET/MRI has a high sensitivity for detecting clinically significant prostate cancer. These results suggest that 68Ga PSMA-PET/MRI could be an effective tool for guiding targeted biopsies in patients with elevated PSA levels and suspected prostate cancer.

68Ga PSMA-PET/MRI showed high sensitivity (100%) and NPV (100%) in detecting clinically significant prostate cancer, making it a reliable tool for ruling out disease. Its moderate specificity (75%) and low PPV (25%) suggest that positive findings should be interpreted cautiously.

Our study highlights the potential of PSMA-PET/MRI fusion imaging as an effective diagnostic tool for refining patient selection for biopsy in suspected prostate cancer (PCa) cases. Its ability to differentiate between clinically significant and insignificant cancers offers a promising approach to mitigate unnecessary biopsies, thereby reducing patient morbidity and healthcare burden. The high negative predictive value (NPV) of 68Ga PSMA-PET/MRI supports its role as a valuable preliminary screening tool, minimizing redundant biopsy procedures while maintaining diagnostic accuracy.