Prostate cancer ranks as the second most common malignancy in men, with early detection playing a crucial role in reducing mortality. Traditional diagnostic methods, such as MRI-TRUS fusion biopsy, have shown limitations in accurately detecting clinically significant prostate cancer. This study aims to evaluate the effectiveness of 68Ga PSMA-PET/MRI fusion-based cognitive-targeted biopsy compared to MRI-TRUS fusion biopsy. By assessing detection rates for clinically significant prostate cancer and comparing biopsy core performance, the study seeks to enhance diagnostic precision and improve prostate cancer detection outcomes.

This prospective observational pilot study was conducted over two years in the Department of Urology and Nuclear Medicine, AIIMS, New Delhi. Patients with elevated PSA levels (4-15 ng/ml) and clinical suspicion of prostate cancer from the Urology OPD were screened. Eligible patients underwent pre-biopsy mpMRI and 68Ga PSMA PET/CT, followed by MRI-TRUS fusion targeted biopsy (PIRADS ≥3) and additional biopsies based on significant Ga68 PSMA PET/MRI fusion findings. Data were analyzed using SPSS, with results expressed as frequency, percentage, mean ± SD, and median (IQR). Statistical significance was set at p<0.05.

The study included 34 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 71.4% and a positive predictive value (PPV) of 38.5% and an overall accuracy of 75.8%. 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. Based on these findings, it is hypothesized that the high NPV of 68Ga PSMA-PET/MRI could help avoid unnecessary biopsies, making it a valuable preliminary screening tool to reduce redundant biopsy procedures.

Our study has demonstrated 68Ga PSMA-PET/MRI as a potential diagnostic imaging system which can help in selecting patients for biopsy as well as in guided targeted biopsies. Using 68Ga PSMA-PET/MRI as imaging to decide initial biopsy, we can avoid approximately 75% unnecessary biopsies who has PIRADS score 3 or more without missing any clinically significant prostate cancer.